Trial Outcomes & Findings for Patient Response to Spinal Manipulation (NCT NCT01670292)

Last Updated: 2017-12-05

Results Overview

VAS - Visual Analog Scale - Scale: 0-100 mm (anchors: 0 mm = No Pain, 100 mm = Worst Imaginable Pain). VAS Interpretation: A higher score indicates greater pain intensity. In this study, improvement of 30% from the baseline value was considered clinically significant. RMDQ - Roland Morris disability questionnaire - Scale: 0 (no disability) to 24 (maximum disability). RMDQ Interpretation: Greater levels of disability are reflected by higher scores. In this study, improvement of 30% from the baseline value was considered clinically significant.

Recruitment status

COMPLETED

Study phase

Target enrollment

82 participants

Primary outcome timeframe

Baseline to 6 weeks

Results posted on

2017-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: HVLA-SM Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation Participants receive treatments of HVLA-SM to the lumbar spine in the side-lying position. Treatment frequency is twice per week for 6 weeks.
Overall Study STARTED	82
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: HVLA-SM Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation Participants receive treatments of HVLA-SM to the lumbar spine in the side-lying position. Treatment frequency is twice per week for 6 weeks.
Overall Study Lost to Follow-up	14

Baseline Characteristics

Patient Response to Spinal Manipulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: HVLA-SM n=82 Participants Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation
Age, Continuous	44.9 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Baseline Patient-Centered Outcome Measures VAS	46.1 units on a scale STANDARD_DEVIATION 18.1 • n=5 Participants
Baseline Patient-Centered Outcome Measures RMDQ	9.5 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks

Population: 82 and 68 participants completed at baseline and after 6 weeks, respectively. Data from all participants (n=82) were used in statistical analysis. The reported data represents the mean change from baseline to week 6.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=82 Participants Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined All participants are in this group, this simply defines the mean Combined force/moment (C).
Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ) Mean Reduction in VAS score (mm)	20.1 units on a scale (see description above) Interval 14.1 to 26.1	—	—	—
Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ) Mean Reduction in RMDQ score	4.8 units on a scale (see description above) Interval 3.7 to 5.8	—	—	—

PRIMARY outcome

Timeframe: Baseline, 2 weeks, 6 weeks

Population: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. The number of observations at each of the 3 time points for individual measures is equal to or lower than these numbers due to missing data.

LSS\* contains 5 variables: global stiffness (GS, unit: Newton/mm) at L3 from 1) hand palpation 2) a hand-held device \& 3) an automated indenter device; global stiffness variation (GSV, unit: Newton/mm) between GS from L1 to L5 from 4) hand palpation \& 5) a hand-held device. \*LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=82 Participants Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=71 Participants There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=68 Participants There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined All participants are in this group, this simply defines the mean Combined force/moment (C).
Lumbar-spine Stiffness (LSS) LSS - Palpatory - GS (N/mm) at L3	4.8 N/mm Standard Deviation 1.8	4.3 N/mm Standard Deviation 1.8	4.2 N/mm Standard Deviation 1.3	—
Lumbar-spine Stiffness (LSS) LSS - Hand-held - GS (N/mm) at L3	7.7 N/mm Standard Deviation 2.1	7.5 N/mm Standard Deviation 1.8	7.6 N/mm Standard Deviation 2.2	—
Lumbar-spine Stiffness (LSS) LSS - Automated - GS (N/mm) at Ant	5.2 N/mm Standard Deviation 1.5	5.3 N/mm Standard Deviation 1.4	5.3 N/mm Standard Deviation 1.5	—
Lumbar-spine Stiffness (LSS) LSS - Palpatory - GSV (N/mm)	2.3 N/mm Standard Deviation 1.5	2.0 N/mm Standard Deviation 1.1	1.9 N/mm Standard Deviation 1.1	—
Lumbar-spine Stiffness (LSS) LSS - Hand-held - GSV (N/mm)	2.3 N/mm Standard Deviation 1.3	2.1 N/mm Standard Deviation 1.1	2.1 N/mm Standard Deviation 1.3	—

PRIMARY outcome

Timeframe: Baseline, 2 weeks, 6 weeks

LSS contains 2 variables: Palpatory and Handheld device - normalized global stiffness variation (nGSV, unitless). LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, lower than normal.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=82 Participants Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=71 Participants There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=68 Participants There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined All participants are in this group, this simply defines the mean Combined force/moment (C).
Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation LSS - Palpatory - nGSV	0.5 unitless Standard Deviation 0.2	0.5 unitless Standard Deviation 0.2	0.5 unitless Standard Deviation 0.2	—
Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation LSS - Hand-held - nGSV	0.3 unitless Standard Deviation 0.1	0.3 unitless Standard Deviation 0.1	0.3 unitless Standard Deviation 0.1	—

PRIMARY outcome

Timeframe: Baseline, 2 weeks, 6 weeks

FRR contains 4 variables, which are the average right and left back muscle FRR obtained using 1) maximum EMG during flexion, and 2) maximum EMG during extension to normalize EMG during full flexion; and asymmetry between the right and left back muscle FRRs using 3) maximum EMG during flexion, and 4) maximum EMG during extension to normalize EMG during full flexion FRR Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=82 Participants Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=71 Participants There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=68 Participants There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined All participants are in this group, this simply defines the mean Combined force/moment (C).
Flexion-Relaxation Ratio (FRR) Flexion FRR	4.7 ratio Standard Deviation 3.7	5.8 ratio Standard Deviation 5.4	5.5 ratio Standard Deviation 5.6	—
Flexion-Relaxation Ratio (FRR) Extension FRR	9.2 ratio Standard Deviation 9.5	10.4 ratio Standard Deviation 11.6	9.4 ratio Standard Deviation 10.5	—
Flexion-Relaxation Ratio (FRR) Asymmetry in flexion FRR	1.5 ratio Standard Deviation 0.5	1.4 ratio Standard Deviation 0.5	1.4 ratio Standard Deviation 0.4	—
Flexion-Relaxation Ratio (FRR) Asymmetry in extension FRR	1.4 ratio Standard Deviation 0.7	1.4 ratio Standard Deviation 0.4	1.4 ratio Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: 6 weeks

Population: Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.

SSL\* contains variables: maximum amplitude (Newton) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C). \*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal. Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=575 Spinal Manipulations Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=575 Spinal Manipulations There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=575 Spinal Manipulations There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined n=575 Spinal Manipulations All participants are in this group, this simply defines the mean Combined force/moment (C).
Kinetic Measure - Spinal Segment Load (SSL) Force Preload force (N)	-56.5 Newton (N) Standard Deviation 87.2	-67.0 Newton (N) Standard Deviation 55.0	-117.2 Newton (N) Standard Deviation 59.4	170.3 Newton (N) Standard Deviation 64.9
Kinetic Measure - Spinal Segment Load (SSL) Force Peak thrust force (N)	-128.3 Newton (N) Standard Deviation 163.4	-172.3 Newton (N) Standard Deviation 141.9	-276.4 Newton (N) Standard Deviation 137.1	385.1 Newton (N) Standard Deviation 169.5

SECONDARY outcome

Timeframe: 6 weeks

SSL\* contains variables: maximum amplitude (Newton\*Meter for moment) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C). \*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal. Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=575 Spinal Manipulations Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=575 Spinal Manipulations There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=575 Spinal Manipulations There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined n=575 Spinal Manipulations All participants are in this group, this simply defines the mean Combined force/moment (C).
Kinetic Measure - Spinal Segment Load (SSL) Moment Preload moment (N*M)	19.8 Newton*Meter Standard Deviation 23.4	-1.0 Newton*Meter Standard Deviation 19.4	-45.4 Newton*Meter Standard Deviation 29.4	58.5 Newton*Meter Standard Deviation 27.8
Kinetic Measure - Spinal Segment Load (SSL) Moment Peak thrust moment (N*M)	31.0 Newton*Meter Standard Deviation 46.0	-3.4 Newton*Meter Standard Deviation 39.9	-76.0 Newton*Meter Standard Deviation 42.2	99.5 Newton*Meter Standard Deviation 41.9

SECONDARY outcome

Timeframe: 6 weeks

SSL\* contains variables: rate of loading for force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C). \*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal. Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=575 Spinal Manipulations Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=575 Spinal Manipulations There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=575 Spinal Manipulations There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined n=575 Spinal Manipulations All participants are in this group, this simply defines the mean Combined force/moment (C).
Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force	-599.2 Newton/second Standard Deviation 897.1	-598.1 Newton/second Standard Deviation 668.8	-1145.2 Newton/second Standard Deviation 713.6	1537.5 Newton/second Standard Deviation 955.4

SECONDARY outcome

Timeframe: 6 weeks

SSL\* contains variables: rate of loading for moment in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C). \*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal. Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=575 Spinal Manipulations Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=575 Spinal Manipulations There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=575 Spinal Manipulations There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined n=575 Spinal Manipulations All participants are in this group, this simply defines the mean Combined force/moment (C).
Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment	51.3 Newton*Meters/second Standard Deviation 201.8	-40.4 Newton*Meters/second Standard Deviation 183.7	-210.2 Newton*Meters/second Standard Deviation 159.0	275.2 Newton*Meters/second Standard Deviation 194.9

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 6 weeks

Population: Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. Number of observations made at the three time points were 82, 70, and 68, respectively.

1\) The questionnaire contains 7 PROMIS-29 specific items: Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction with Participation in Social Role (anchors: 1= 'Not at all', 5= 'Very much', higher score is worse). Each PROMIS-29 specific item is reported in raw score (4-20) and scored in T-score (T), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for a population. On the T-score metric \& interpretation: * A score of 40 is one SD lower than the mean of the reference population. * A score of 60 is one SD higher than the mean of the reference population. * 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 standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=82 Participants Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=70 Participants There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=68 Participants There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined All participants are in this group, this simply defines the mean Combined force/moment (C).
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale P29 - Anxiety	49.18 T-score Standard Deviation 8.87	47.93 T-score Standard Deviation 7.87	46.58 T-score Standard Deviation 7.78	—
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale P29 - Depression	47.02 T-score Standard Deviation 7.78	45.97 T-score Standard Deviation 7.07	44.38 T-score Standard Deviation 6.06	—
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale P29 - Fatigue	53.72 T-score Standard Deviation 8.19	51.93 T-score Standard Deviation 7.84	50.09 T-score Standard Deviation 7.87	—
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale P-29 - Pain Interference	60.26 T-score Standard Deviation 5.70	57.78 T-score Standard Deviation 6.37	55.12 T-score Standard Deviation 7.52	—
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale P29 - Physical Function	33.31 T-score Standard Deviation 3.93	32.29 T-score Standard Deviation 3.84	30.07 T-score Standard Deviation 3.97	—
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale P29- Sleep Disturbance	52.23 T-score Standard Deviation 3.13	51.11 T-score Standard Deviation 3.23	51.79 T-score Standard Deviation 3.10	—
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale P29 - Satisfaction w/ Participation in Social Role	45.45 T-score Standard Deviation 6.84	46.51 T-score Standard Deviation 6.75	49.75 T-score Standard Deviation 7.71	—

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 6 weeks

1\) The PROMIS questionnaire contains 1 PROMIS global item: Pain NRS, Scale: 0-10 (anchors: 0 = No Pain, 10 = Worst Imaginable Pain, higher score is worse). The PROMIS global item is not scored but reported in raw score.

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=82 Participants Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=70 Participants There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=68 Participants There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined All participants are in this group, this simply defines the mean Combined force/moment (C).
PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS	5.57 units on a scale Standard Deviation 1.63	4.46 units on a scale Standard Deviation 1.95	3.59 units on a scale Standard Deviation 2.18	—

SECONDARY outcome

Timeframe: Baseline, 2 weeks, 6 weeks

Question asked of participants: "During the past week, how bothersome have each of the following symptoms been?" The bothersomeness questionnaire contains two items: a) low back pain \& b) leg pain (sciatica). Scale: 0-10 (anchors: 0 = Not at all bothersome, 10 = Extremely bothersome)

Outcome measures

Outcome measures
Measure	Experimental: HVLA-SM n=82 Participants Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation	HVLA-SM After 2 Weeks n=70 Participants There is only one group/arm, this is the data for the same group of participants after two weeks.	HVLA-SM After 6 Weeks n=68 Participants There is only one group/arm, this is the data for the same group of participants after six weeks.	Combined All participants are in this group, this simply defines the mean Combined force/moment (C).
Bothersomeness Low Back Pain	6.18 units on a scale Standard Deviation 1.93	4.80 units on a scale Standard Deviation 2.14	3.63 units on a scale Standard Deviation 2.30	—
Bothersomeness Leg Pain (Sciatica)	3.29 units on a scale Standard Deviation 3.18	2.61 units on a scale Standard Deviation 2.91	1.94 units on a scale Standard Deviation 2.68	—

Adverse Events

Experimental: HVLA-SM*

Serious events: 0 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental: HVLA-SM* n=82 participants at risk Experimental High Velocity Low Amplitude Spinal Manipulation HVLA-SM: High Velocity Low Amplitude Spinal Manipulation
Musculoskeletal and connective tissue disorders Neck pain/stiffness	2.4% 2/82 • 6 weeks 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/stiffness	35.4% 29/82 • 6 weeks 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	2.4% 2/82 • 6 weeks 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	2.4% 2/82 • 6 weeks 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	24.4% 20/82 • 6 weeks 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 and low back pain/stiffness	6.1% 5/82 • 6 weeks 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	4.9% 4/82 • 6 weeks 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 and extremity pain/stiffness	2.4% 2/82 • 6 weeks 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 extremity pain/stiffness	1.2% 1/82 • 6 weeks 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 Pain/stiffness in the extremities	1.2% 1/82 • 6 weeks 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 Lower/extremity pain/stiffness	2.4% 2/82 • 6 weeks 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 and extremity pain and headache	1.2% 1/82 • 6 weeks 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/stiffness and numbness/tingling	1.2% 1/82 • 6 weeks 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 and numbness/tingling	1.2% 1/82 • 6 weeks 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.
General disorders Upper respiratory infection	6.1% 5/82 • 6 weeks 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.
General disorders Sinus congestion/upper respiratory symptoms/allergy	6.1% 5/82 • 6 weeks 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.
General disorders Insect bite	1.2% 1/82 • 6 weeks 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.
General disorders Hypertension	1.2% 1/82 • 6 weeks 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.
General disorders Gastrointestinal symptoms	1.2% 1/82 • 6 weeks 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.
General disorders Hemorrhoids	1.2% 1/82 • 6 weeks 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.
General disorders Nausea and tooth/facial pain and sinus congestion	1.2% 1/82 • 6 weeks 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.
General disorders Nausea and back pain/stiffness	1.2% 1/82 • 6 weeks 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.
General disorders Dental caries	1.2% 1/82 • 6 weeks 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.
General disorders Asthma and lower respiratory infection	1.2% 1/82 • 6 weeks 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.
General disorders Upper respiratory infection and allergy	1.2% 1/82 • 6 weeks 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.
General disorders Hemorrhoids and nasal congestion	1.2% 1/82 • 6 weeks 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.
Skin and subcutaneous tissue disorders Laceration	2.4% 2/82 • 6 weeks 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.
Skin and subcutaneous tissue disorders Blister	2.4% 2/82 • 6 weeks 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

Dr. Ting Xia

Palmer Center for Chiropractic Research

Phone: 563-884-5161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place