Trial Outcomes & Findings for Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial (NCT NCT01765751)
NCT ID: NCT01765751
Last Updated: 2018-01-04
Results Overview
We will evaluate the clinician's ability to deliver three randomly assigned manual interventions to the cervical spine within specified traction force ranges (\<20 Newtons \[N\], 20-50N, \>50N). The primary outcome of this study is to determine the accuracy and consistency of traction force delivery ranges both between clinicians and within individual clinicians. Traction force ranges (C5 contact level and Occiput contact level) will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks and averaged to calculate final outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Day 1, 4, 8, 11, 14 (Each Study Visit)
Results posted on
2018-01-04
Participant Flow
Participant milestones
| Measure |
Manual Cervical Distraction Low Force
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Manual Cervical Distraction Medium Force
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Manual Cervical Distraction High Force
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Manual Cervical Distraction Low Force
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Manual Cervical Distraction Medium Force
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Manual Cervical Distraction High Force
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
Baseline Characteristics
Manual Cervical Distraction: Measuring Chiropractic Delivery for Neck Pain Clinical Trial
Baseline characteristics by cohort
| Measure |
Manual Cervical Distraction Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Manual Cervical Distraction Medium Force
n=16 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Manual Cervical Distraction High Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1, 4, 8, 11, 14 (Each Study Visit)Population: \*Cervical traction forces measured in Newtons (N) over four treatment visits for each participant. We recorded 23 missing values for traction forces due to 9 missing appointments (18 observations) and 5 instances of technical problems in data collection.
We will evaluate the clinician's ability to deliver three randomly assigned manual interventions to the cervical spine within specified traction force ranges (\<20 Newtons \[N\], 20-50N, \>50N). The primary outcome of this study is to determine the accuracy and consistency of traction force delivery ranges both between clinicians and within individual clinicians. Traction force ranges (C5 contact level and Occiput contact level) will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks and averaged to calculate final outcome.
Outcome measures
| Measure |
MCD Low Force
n=64 Number of Observations*
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=64 Number of Observations*
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=64 Number of Observations*
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Range of Traction Forces
C5 Contact Level
|
13.82 Newtons (N)
Standard Deviation 5.74
|
38.3 Newtons (N)
Standard Deviation 12.12
|
65.08 Newtons (N)
Standard Deviation 17.70
|
|
Range of Traction Forces
Occiput Contact Level
|
17.19 Newtons (N)
Standard Deviation 4.84
|
42.87 Newtons (N)
Standard Deviation 10.40
|
74.06 Newtons (N)
Standard Deviation 16.08
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5)The NDI is a 10-item questionnaire modified from the Oswestry Low Back Pain Disability Index. The NDI has been shown to be a reliable and valid measure of disability due to neck pain, and responsive for measuring change. Study Visit 1 and Study Visit 5 Measures occur 2 weeks apart. The NDI scale is measured on a scale of 0-50, with 0 indicating no disability and 50 indicating complete disability. This measure is an adjusted mean NDI change.
Outcome measures
| Measure |
MCD Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=16 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Neck Disability Index (NDI)
|
1.3 units on scale
Interval -1.0 to 3.5
|
4.2 units on scale
Interval 1.8 to 6.6
|
4.0 units on scale
Interval 1.8 to 6.2
|
SECONDARY outcome
Timeframe: Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5)The VAS has excellent metric properties, is easy to administer and score (0-100mm), and is commonly used in pain research. Our anchors will be no pain (score of 0) to worst pain imaginable (score of 100). We will ask participants to rate their current neck pain at baseline and pre-/post-treatment for all 5 study visits. This measure is adjusted mean neck pain VAS change. A single value was calculated by averaging.
Outcome measures
| Measure |
MCD Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=16 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Neck Pain Visual Analogue Scale (VAS)
|
9.1 mm
Interval -1.6 to 19.8
|
18.9 mm
Interval 7.7 to 30.1
|
24.7 mm
Interval 13.9 to 35.5
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 14 (Study Visit 5)The PROMIS-43 questionnaire will be used to measure general functional health status. PROMIS-43 questions measure physical function, anxiety, depression, fatigue, sleep disturbance, social role satisfaction, and pain interference and intensity. The table below displays the mean score at baseline. On the T-score metric \& interpretation: * A score of 40 is one SD lower than the mean of the reference population (REF POP). * A score of 60 is one SD higher than the mean of the REF POP. * For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average REF POP. This could be a desirable or undesirable outcome, depending upon the concept being measured. For Physical Function and Satisfaction with Social Role, higher scores reflect a better outcome, while for the remaining concepts, higher scores reflect a worse outcome. PROMIS - Pain Interference adjusted for baseline neck pain VAS.
Outcome measures
| Measure |
MCD Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=16 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Pain Interference (baseline)
|
53.2 T-score
Standard Deviation 6.7
|
54.9 T-score
Standard Deviation 5.2
|
51.2 T-score
Standard Deviation 5.6
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Pain Interference (Day 14)
|
50.0 T-score
Standard Deviation 8.4
|
49.6 T-score
Standard Deviation 7.5
|
51.6 T-score
Standard Deviation 4.9
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Physical Function (baseline)
|
27.7 T-score
Standard Deviation 5.2
|
25.3 T-score
Standard Deviation 5.0
|
26.4 T-score
Standard Deviation 4.5
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Physical Function (Day 14)
|
27.2 T-score
Standard Deviation 6.3
|
25.7 T-score
Standard Deviation 4.8
|
25.8 T-score
Standard Deviation 3.7
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Fatigue (baseline)
|
50.4 T-score
Standard Deviation 10.9
|
46.4 T-score
Standard Deviation 9.3
|
47.1 T-score
Standard Deviation 7.2
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Fatigue (Day 14)
|
53.8 T-score
Standard Deviation 12.6
|
47.0 T-score
Standard Deviation 6.4
|
45.6 T-score
Standard Deviation 7.4
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Sleep Disturbance (baseline)
|
51.3 T-score
Standard Deviation 3.0
|
51.3 T-score
Standard Deviation 3.0
|
51.5 T-score
Standard Deviation 2.6
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Sleep Disturbance (Day 14)
|
51.2 T-score
Standard Deviation 2.6
|
52.6 T-score
Standard Deviation 4.1
|
49.8 T-score
Standard Deviation 2.4
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Anxiety (baseline)
|
46.8 T-score
Standard Deviation 10.9
|
47.5 T-score
Standard Deviation 8.0
|
45.3 T-score
Standard Deviation 8.4
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Anxiety (Day 14)
|
45.3 T-score
Standard Deviation 9.8
|
46.2 T-score
Standard Deviation 7.2
|
43.4 T-score
Standard Deviation 5.8
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Depression (baseline)
|
42.6 T-score
Standard Deviation 6.8
|
43.9 T-score
Standard Deviation 7.8
|
43.6 T-score
Standard Deviation 5.5
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Depression (Day 14)
|
42.8 T-score
Standard Deviation 6.3
|
42.1 T-score
Standard Deviation 5.6
|
40.4 T-score
Standard Deviation 4.6
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Satisfaction with Social Role (baseline)
|
51.7 T-score
Standard Deviation 8.5
|
53.6 T-score
Standard Deviation 7.6
|
54.3 T-score
Standard Deviation 6.5
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-43)
PROMIS - Satisfaction with Social Role (Day 14)
|
50.9 T-score
Standard Deviation 11.2
|
55.2 T-score
Standard Deviation 8.0
|
53.4 T-score
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5)Population: The number analyzed in row differs from overall due to: 1. Data collection issue due to equipment problems. 2. Participants did not show up for data collection. 3. 3 Participants were lost to follow up
Cervical ranges of motion are a measure of functional status and can be used to assess dysfunction in the cervical spine. Baseline/visit 1 ("BL") cROM is displayed for Flexion-Extension, Lateral Bending, and Rotation. The mean change in cROM from visit 1 to visit 5 ("V5 change") is also displayed.
Outcome measures
| Measure |
MCD Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=16 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=14 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Cervical Range of Motion (cROM).
BL - Mean Flexion-Extension
|
70.2 Degrees - Range of Motion
Standard Deviation 25.9
|
75.4 Degrees - Range of Motion
Standard Deviation 32.4
|
78.6 Degrees - Range of Motion
Standard Deviation 28.5
|
|
Cervical Range of Motion (cROM).
BL - Mean Lateral Bending
|
51.6 Degrees - Range of Motion
Standard Deviation 21.1
|
54.7 Degrees - Range of Motion
Standard Deviation 12.1
|
49.8 Degrees - Range of Motion
Standard Deviation 13.6
|
|
Cervical Range of Motion (cROM).
BL - Mean Rotation
|
88.5 Degrees - Range of Motion
Standard Deviation 25.4
|
91.1 Degrees - Range of Motion
Standard Deviation 22.8
|
88.5 Degrees - Range of Motion
Standard Deviation 19.7
|
|
Cervical Range of Motion (cROM).
Mean Change from BL to V5 - Flexion-Extension
|
0.8 Degrees - Range of Motion
Standard Deviation 14.9
|
6.1 Degrees - Range of Motion
Standard Deviation 31.7
|
4.9 Degrees - Range of Motion
Standard Deviation 25.2
|
|
Cervical Range of Motion (cROM).
Mean Change from BL to V5 - Lateral Bending
|
-4.7 Degrees - Range of Motion
Standard Deviation 24.3
|
-2.9 Degrees - Range of Motion
Standard Deviation 8.7
|
-2.3 Degrees - Range of Motion
Standard Deviation 24.1
|
|
Cervical Range of Motion (cROM).
Mean Change from BL to V5 - Rotation
|
2.3 Degrees - Range of Motion
Standard Deviation 15.5
|
-8.9 Degrees - Range of Motion
Standard Deviation 28
|
-8.1 Degrees - Range of Motion
Standard Deviation 37.5
|
SECONDARY outcome
Timeframe: Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5)We will ask all participants whether they feel the study procedure would relieve their neck pain using the Procedure Believability Questionnaire. The response choices will be: "Strongly believe the procedure will relieve my neck pain; Somewhat believe the procedure will relieve my neck pain; Somewhat believe the procedure will NOT relieve my neck pain; Strongly believe the procedure will NOT relieve my neck pain; and Don't know if the procedure will relieve my neck pain". A baseline (BL) evaluation will be completed based upon treatment description, and compared to assessments following study visit 1 (T1) and study visit 5 (T5) over a 2-week time period.
Outcome measures
| Measure |
MCD Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=16 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Procedure Believability Questionnaire
BL - Strongly WILL
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Procedure Believability Questionnaire
BL - Somewhat WILL
|
5 Participants
|
5 Participants
|
8 Participants
|
|
Procedure Believability Questionnaire
BL - Somewhat will not
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Procedure Believability Questionnaire
BL - Strongly will NOT
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Procedure Believability Questionnaire
BL - Don't know
|
8 Participants
|
4 Participants
|
4 Participants
|
|
Procedure Believability Questionnaire
T1 - Strongly WILL
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Procedure Believability Questionnaire
T1 - Somewhat WILL
|
6 Participants
|
10 Participants
|
8 Participants
|
|
Procedure Believability Questionnaire
T1 - Somewhat will not
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Procedure Believability Questionnaire
T1 - Strongly will NOT
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Procedure Believability Questionnaire
T1 - Don't know
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Procedure Believability Questionnaire
T5 - Strongly WILL
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Procedure Believability Questionnaire
T5 - Somewhat WILL
|
4 Participants
|
8 Participants
|
6 Participants
|
|
Procedure Believability Questionnaire
T5 - Somewhat will not
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Procedure Believability Questionnaire
T5 - Strongly will NOT
|
6 Participants
|
0 Participants
|
2 Participants
|
|
Procedure Believability Questionnaire
T5 - Don't know
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Procedure Believability Questionnaire
T5 - Missing
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5)The CEQ is a quick and easy-to-administer questionnaire for measuring treatment expectancy and rationale credibility of interventions for use in clinical outcome studies. Participants' perceptions of the study treatments were compared across groups using the CEQ. The CEQ credibility factor relates to how logical or believable a treatment is for the patient, whereas the expectancy factor refers to the patient's beliefs about improvements that might be achieved from the treatment \[61\]. CEQ scores for both the credibility and expectancy factors range from 3 to 27, with higher scores indicating greater belief in treatment credibility or expectancy for clinical improvement.
Outcome measures
| Measure |
MCD Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=16 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Credibility and Expectancy Questionnaire (CEQ)
Credibility Factor - Basline 1 Visit
|
19.8 units on a scale (range 3-27)
Standard Deviation 2.2
|
23.1 units on a scale (range 3-27)
Standard Deviation 3.4
|
21.0 units on a scale (range 3-27)
Standard Deviation 3.9
|
|
Credibility and Expectancy Questionnaire (CEQ)
Credibility Factor - Study Visit 1
|
15.5 units on a scale (range 3-27)
Standard Deviation 7.0
|
19.9 units on a scale (range 3-27)
Standard Deviation 5.2
|
22.1 units on a scale (range 3-27)
Standard Deviation 4.8
|
|
Credibility and Expectancy Questionnaire (CEQ)
Credibility Factor - Study Visit 5
|
13.8 units on a scale (range 3-27)
Standard Deviation 8.0
|
19.9 units on a scale (range 3-27)
Standard Deviation 7.5
|
22.7 units on a scale (range 3-27)
Standard Deviation 4.0
|
|
Credibility and Expectancy Questionnaire (CEQ)
Expectancy Factor - Baseline Visit 1
|
15.8 units on a scale (range 3-27)
Standard Deviation 4.0
|
19.7 units on a scale (range 3-27)
Standard Deviation 4.7
|
16.0 units on a scale (range 3-27)
Standard Deviation 6.9
|
|
Credibility and Expectancy Questionnaire (CEQ)
Expectancy Factor - Study Visit 1
|
13.4 units on a scale (range 3-27)
Standard Deviation 6.2
|
17.8 units on a scale (range 3-27)
Standard Deviation 5.8
|
19.3 units on a scale (range 3-27)
Standard Deviation 6.7
|
|
Credibility and Expectancy Questionnaire (CEQ)
Expectancy Factor - Study Visit 5
|
11.4 units on a scale (range 3-27)
Standard Deviation 7.8
|
15.1 units on a scale (range 3-27)
Standard Deviation 8.3
|
17.8 units on a scale (range 3-27)
Standard Deviation 6.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 8 (Study Visit 3), Day 11 (Study Visit 4)Population: The numbers analyzed in the row differ from the overall due to: (1) Data not collected due to technical problems, (2) Patient did not show up for the visit, (3) 3 participants lost to follow up.
We will describe electromyographic (EMG) activity of superficial neck muscles during delivery of the three manual interventions during visits 3 and 4. EMG measurements are an exploratory outcome variable in this study. RMS EMG TREATMENT DESCRIPTIONS: * (A) Ratio of Root Mean square (RMS) EMG during Treatment at C5/RMS EMG during maximum voluntary contraction (MVC) * (B) RMS EMG during Treatment at C5/RMS EMG during Prone Resting * (C) RMS EMG during Treatment at Occiput (OCC)/RMS EMG during MVC * (D) RMS EMG during Treatment at OCC/ RMS EMG during Prone Resting MUSCLES: * LES-Left erector Spinae Muscle * RES-Right Erector Spinae Muscle * LTRPS- Left Trapezius muscle * RTRPS- Right Trapezius Muscle * LSCM- Left Sternocleido Mastoid muscle * RSCM- Right Sternocleido Mastoid Muscle ACRONYM KEY: * RMS-Root Mean Square Value * MVC-Maximum Voluntary Contraction * C5-Cervical vertebrae contact * OCC-Occipital contact * EMG-Electromyographic activity
Outcome measures
| Measure |
MCD Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=13 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=15 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (B) - LSCM
|
1.36 ratio
Standard Deviation 0.50
|
1.68 ratio
Standard Deviation 1.27
|
1.78 ratio
Standard Deviation 1.40
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (A) - LES
|
0.30 ratio
Standard Deviation 0.15
|
0.25 ratio
Standard Deviation 0.15
|
0.27 ratio
Standard Deviation 0.19
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (B) - RES
|
2.17 ratio
Standard Deviation 2.20
|
2.06 ratio
Standard Deviation 0.92
|
1.81 ratio
Standard Deviation 1.53
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (A) - LES
|
0.25 ratio
Standard Deviation 0.20
|
0.26 ratio
Standard Deviation 0.22
|
0.31 ratio
Standard Deviation 0.25
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (A) - RES
|
0.28 ratio
Standard Deviation 0.28
|
0.34 ratio
Standard Deviation 0.14
|
0.16 ratio
Standard Deviation 0.13
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (A) - LTRPS
|
0.27 ratio
Standard Deviation 0.25
|
0.23 ratio
Standard Deviation 0.12
|
0.22 ratio
Standard Deviation 0.20
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (A) - RTRPS
|
0.42 ratio
Standard Deviation 0.30
|
0.37 ratio
Standard Deviation 0.26
|
0.29 ratio
Standard Deviation 0.25
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (A) - LSCM
|
0.24 ratio
Standard Deviation 0.26
|
0.22 ratio
Standard Deviation 0.18
|
0.14 ratio
Standard Deviation 0.10
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (A) - RSCM
|
0.15 ratio
Standard Deviation 0.07
|
0.19 ratio
Standard Deviation 0.17
|
0.13 ratio
Standard Deviation 0.12
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (B) - LES
|
1.32 ratio
Standard Deviation 1.04
|
2.03 ratio
Standard Deviation 1.46
|
1.40 ratio
Standard Deviation 0.76
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (B) - RES
|
1.67 ratio
Standard Deviation 0.92
|
2.53 ratio
Standard Deviation 2.12
|
2.13 ratio
Standard Deviation 1.78
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (B) - LTRPS
|
1.41 ratio
Standard Deviation 0.44
|
1.80 ratio
Standard Deviation 0.85
|
1.27 ratio
Standard Deviation 0.37
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (B) - RTRPS
|
1.29 ratio
Standard Deviation 0.18
|
1.31 ratio
Standard Deviation 0.22
|
1.20 ratio
Standard Deviation 0.22
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (B) - RSCM
|
1.47 ratio
Standard Deviation 0.66
|
1.83 ratio
Standard Deviation 1.13
|
1.41 ratio
Standard Deviation 0.66
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (C) - LES
|
0.21 ratio
Standard Deviation 0.17
|
0.22 ratio
Standard Deviation 0.19
|
0.25 ratio
Standard Deviation 0.19
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (C) - RES
|
0.25 ratio
Standard Deviation 0.22
|
0.24 ratio
Standard Deviation 0.15
|
0.16 ratio
Standard Deviation 0.16
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (C) - LTRPS
|
0.23 ratio
Standard Deviation 0.20
|
0.19 ratio
Standard Deviation 0.12
|
0.24 ratio
Standard Deviation 0.22
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (C) - RTRPS
|
0.36 ratio
Standard Deviation 0.29
|
0.36 ratio
Standard Deviation 0.26
|
0.31 ratio
Standard Deviation 0.29
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (C) - LSCM
|
0.24 ratio
Standard Deviation 0.24
|
0.15 ratio
Standard Deviation 0.15
|
0.12 ratio
Standard Deviation 0.09
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (C) - RSCM
|
0.13 ratio
Standard Deviation 0.07
|
0.17 ratio
Standard Deviation 0.16
|
0.12 ratio
Standard Deviation 0.08
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (D) - LES
|
1.41 ratio
Standard Deviation 0.95
|
1.54 ratio
Standard Deviation 1.06
|
1.49 ratio
Standard Deviation 0.88
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (D) - RES
|
1.77 ratio
Standard Deviation 1.43
|
1.41 ratio
Standard Deviation 0.25
|
1.58 ratio
Standard Deviation 1.38
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (D) - LTRPS
|
1.38 ratio
Standard Deviation 0.57
|
1.47 ratio
Standard Deviation 0.60
|
1.24 ratio
Standard Deviation 0.19
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (D) - RTRPS
|
1.68 ratio
Standard Deviation 1.72
|
1.38 ratio
Standard Deviation 0.28
|
1.21 ratio
Standard Deviation 0.16
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (D) - LSCM
|
1.30 ratio
Standard Deviation 0.26
|
1.48 ratio
Standard Deviation 0.54
|
1.69 ratio
Standard Deviation 0.98
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 3 - (D) - RSCM
|
1.32 ratio
Standard Deviation 0.34
|
1.48 ratio
Standard Deviation 0.43
|
1.49 ratio
Standard Deviation 0.75
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (A) - RES
|
0.20 ratio
Standard Deviation 0.18
|
0.28 ratio
Standard Deviation 0.17
|
0.20 ratio
Standard Deviation 0.22
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (A) - LTRPS
|
0.24 ratio
Standard Deviation 0.23
|
0.22 ratio
Standard Deviation 0.20
|
0.25 ratio
Standard Deviation 0.24
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (A) - RTRPS
|
0.43 ratio
Standard Deviation 0.27
|
0.28 ratio
Standard Deviation 0.22
|
0.30 ratio
Standard Deviation 0.25
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (A) - LSCM
|
0.11 ratio
Standard Deviation 0.09
|
0.27 ratio
Standard Deviation 0.22
|
0.13 ratio
Standard Deviation 0.09
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (A) - RSCM
|
0.22 ratio
Standard Deviation 0.19
|
0.18 ratio
Standard Deviation 0.22
|
0.15 ratio
Standard Deviation 0.12
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (B) - LES
|
1.34 ratio
Standard Deviation 0.83
|
1.71 ratio
Standard Deviation 1.54
|
1.75 ratio
Standard Deviation 1.50
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (B) - LTRPS
|
1.36 ratio
Standard Deviation 0.41
|
1.31 ratio
Standard Deviation 0.19
|
1.84 ratio
Standard Deviation 1.69
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (B) - RTRPS
|
1.61 ratio
Standard Deviation 1.21
|
1.14 ratio
Standard Deviation 0.38
|
1.27 ratio
Standard Deviation 0.13
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (B) - LSCM
|
1.29 ratio
Standard Deviation 0.38
|
1.82 ratio
Standard Deviation 0.97
|
2.20 ratio
Standard Deviation 1.29
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (B) - RSCM
|
1.53 ratio
Standard Deviation 0.95
|
1.55 ratio
Standard Deviation 1.15
|
1.67 ratio
Standard Deviation 0.92
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (C) - LES
|
0.27 ratio
Standard Deviation 0.15
|
0.27 ratio
Standard Deviation 0.20
|
0.22 ratio
Standard Deviation 0.17
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (C) - RES
|
0.13 ratio
Standard Deviation 0.10
|
0.30 ratio
Standard Deviation 0.22
|
0.15 ratio
Standard Deviation 0.17
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (C) - LTRPS
|
0.23 ratio
Standard Deviation 0.21
|
0.21 ratio
Standard Deviation 0.20
|
0.21 ratio
Standard Deviation 0.24
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (C) - RTRPS
|
0.38 ratio
Standard Deviation 0.27
|
0.32 ratio
Standard Deviation 0.29
|
0.31 ratio
Standard Deviation 0.26
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (C) - LSCM
|
0.12 ratio
Standard Deviation 0.15
|
0.17 ratio
Standard Deviation 0.13
|
0.12 ratio
Standard Deviation 0.09
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (C) - RSCM
|
0.19 ratio
Standard Deviation 0.17
|
0.22 ratio
Standard Deviation 0.24
|
0.14 ratio
Standard Deviation 0.17
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (D) - LES
|
1.29 ratio
Standard Deviation 0.54
|
1.68 ratio
Standard Deviation 1.12
|
1.59 ratio
Standard Deviation 1.43
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (D) - RES
|
1.08 ratio
Standard Deviation 0.51
|
1.32 ratio
Standard Deviation 0.65
|
1.76 ratio
Standard Deviation 1.12
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (D) - LTRPS
|
1.48 ratio
Standard Deviation 0.74
|
1.40 ratio
Standard Deviation 0.70
|
1.49 ratio
Standard Deviation 0.56
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (D) - RTRPS
|
1.26 ratio
Standard Deviation 0.50
|
1.36 ratio
Standard Deviation 0.42
|
1.31 ratio
Standard Deviation 0.14
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (D) - LSCM
|
1.65 ratio
Standard Deviation 1.73
|
2.38 ratio
Standard Deviation 1.86
|
2.37 ratio
Standard Deviation 2.57
|
|
Cervical Muscle Electromyographic (EMG) Activity
Visit 4 - (D) - RSCM
|
1.31 ratio
Standard Deviation 0.44
|
1.54 ratio
Standard Deviation 0.63
|
1.32 ratio
Standard Deviation 0.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14 (Study Visit 5)Participants' satisfaction with study procedures and staff were assessed at Study Visit 5 using standard questions. Participants rated their satisfaction with various elements of the study (e.g., treatments received, clinicians) using a 5 category response from 1 (strongly satisfied) to 5 (strongly dissatisfied) with categories collapsed into satisfied (categories 1 and 2) or not satisfied (categories 3, 4 or 5) for interpretation.
Outcome measures
| Measure |
MCD Low Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD Medium Force
n=16 Participants
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
MCD High Force
n=16 Participants
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Patient Satisfaction Questionnaire
Satisfied with Treatment
|
7 Participants
|
9 Participants
|
15 Participants
|
|
Patient Satisfaction Questionnaire
Satisfied with Clinician
|
14 Participants
|
14 Participants
|
15 Participants
|
Adverse Events
Manual Cervical Distraction Low Force
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Manual Cervical Distraction Medium Force*
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Manual Cervical Distraction High Force*
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Manual Cervical Distraction Low Force
n=16 participants at risk
Manual Cervical Distraction (MCD) forces will be limited to less than 20N in the low force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Manual Cervical Distraction Medium Force*
n=16 participants at risk
Manual Cervical Distraction(MCD) forces will be limited to between 20N-50N in the medium force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
Manual Cervical Distraction High Force*
n=16 participants at risk
Manual Cervical Distraction (MCD) forces will be limited to greater than 50N in the high force group. Dosing for this clinical trial is limited to 3 sets of 5 repetitions with a hand contact on one cervical vertebra of highest clinical importance and 3 sets of 5 repetitions with a hand contact on the occiput.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
18.8%
3/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
12.5%
2/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
18.8%
3/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Thoracic Pain
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck and back pain/stiffness
|
12.5%
2/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Tenderness
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
General soreness
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Headache and neck/back pain
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain and extremity pain/stiffness
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck, back and extremity pain/stiffness
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain/stiffness and headache and dizziness/vertigo
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain/stiffness and chest soreness
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Ear and labyrinth disorders
Dizzinesss/imbalance/vertigo
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Ear and labyrinth disorders
Ear infection
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Endocrine disorders
Thyroid disregulation
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Eye disorders
Increased intraocular pressure
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory infection
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection and joint pain
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
6.2%
1/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
0.00%
0/16 • AE data were collected during five study visits over a two week period
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
|
Additional Information
Maruti R. Gudavalli, PhD
Palmer College of Chiropractic
Phone: 563-884-5260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place