Trial Outcomes & Findings for The Effect of TheraBand® Kinesiology Tape on Post-manipulation Pain and Range of Motion (NCT NCT02691143)
NCT ID: NCT02691143
Last Updated: 2017-03-17
Results Overview
Six cervical ranges of motion values will be recorded utilizing the Acumar DataCapture hand-held dual inclinometer. Range of motion will be measured at maximum (max) degrees and average degrees of 6 trials and will include: flexion (F), extension (E), left side-bending (LSB), right side-bending (RSB), left rotation (LR), and right rotation (RR).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours
Results posted on
2017-03-17
Participant Flow
A convenience sample of who presented with acute non-complicated neck pain were recruited from an outpatient chiropractic clinic
Participant milestones
| Measure |
Manipulation Plus Tape
The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a "Y" strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal "I" strip applied at 50% tension at the site of pain.
|
Manipulation Only
The control group received manipulation from a licensed chiropractor only
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
23
|
|
Overall Study
COMPLETED
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of TheraBand® Kinesiology Tape on Post-manipulation Pain and Range of Motion
Baseline characteristics by cohort
| Measure |
Manipulation Plus Tape
n=27 Participants
The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a "Y" strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal "I" strip applied at 50% tension at the site of pain.
|
Manipulation Only
n=23 Participants
The control group received manipulation from a licensed chiropractor only
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.9 years
n=5 Participants
|
36.5 years
n=7 Participants
|
36.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hoursSix cervical ranges of motion values will be recorded utilizing the Acumar DataCapture hand-held dual inclinometer. Range of motion will be measured at maximum (max) degrees and average degrees of 6 trials and will include: flexion (F), extension (E), left side-bending (LSB), right side-bending (RSB), left rotation (LR), and right rotation (RR).
Outcome measures
| Measure |
Manipulation Plus Tape
n=27 Participants
The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a "Y" strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal "I" strip applied at 50% tension at the site of pain.
|
Manipulation Only
n=23 Participants
The control group received manipulation from a licensed chiropractor only
|
|---|---|---|
|
Change in Cervical Range of Motion
T1 Flexion Max
|
37.9 degrees
Interval 5.0 to 64.0
|
36.9 degrees
Interval 12.0 to 50.0
|
|
Change in Cervical Range of Motion
T2 Flexion Max
|
39.5 degrees
Interval 17.0 to 58.0
|
37.5 degrees
Interval 17.0 to 50.0
|
|
Change in Cervical Range of Motion
T3 Flexion Max
|
42.44 degrees
Interval 19.0 to 55.0
|
39 degrees
Interval 9.0 to 62.0
|
|
Change in Cervical Range of Motion
T1 Extension Max
|
34.3 degrees
Interval 17.0 to 45.0
|
32.4 degrees
Interval 11.0 to 46.0
|
|
Change in Cervical Range of Motion
T2 Extension Max
|
36.5 degrees
Interval 17.0 to 51.0
|
38.7 degrees
Interval 22.0 to 65.0
|
|
Change in Cervical Range of Motion
T3 Extension Max
|
41.7 degrees
Interval 15.0 to 60.0
|
36.9 degrees
Interval 16.0 to 52.0
|
|
Change in Cervical Range of Motion
T1 Left Side Bending Max
|
27.9 degrees
Interval 4.0 to 49.0
|
28 degrees
Interval 15.0 to 43.0
|
|
Change in Cervical Range of Motion
T2 Left Side Bending Max
|
30.5 degrees
Interval 1.0 to 45.0
|
33.7 degrees
Interval 8.0 to 61.0
|
|
Change in Cervical Range of Motion
T3 Left Side Bending Max
|
36.7 degrees
Interval 12.0 to 62.0
|
32.2 degrees
Interval 16.0 to 50.0
|
|
Change in Cervical Range of Motion
T1 Right Side Bending Max
|
31.6 degrees
Interval 10.0 to 49.0
|
32.7 degrees
Interval 19.0 to 53.0
|
|
Change in Cervical Range of Motion
T2 Right Side Bending Max
|
35.3 degrees
Interval 21.0 to 54.0
|
34.5 degrees
Interval 15.0 to 60.0
|
|
Change in Cervical Range of Motion
T3 Right Side Bending Max
|
39 degrees
Interval 21.0 to 62.0
|
35.1 degrees
Interval 14.0 to 58.0
|
|
Change in Cervical Range of Motion
T1 Left Rotation Max
|
54.5 degrees
Interval 22.0 to 99.0
|
51.7 degrees
Interval 24.0 to 87.0
|
|
Change in Cervical Range of Motion
T2 Left Rotation Max
|
53.2 degrees
Interval 18.0 to 86.0
|
53.2 degrees
Interval 17.0 to 83.0
|
|
Change in Cervical Range of Motion
T3 Left Rotation Max
|
52.8 degrees
Interval 27.0 to 86.0
|
50 degrees
Interval 22.0 to 94.0
|
|
Change in Cervical Range of Motion
T1 Right Rotation Max
|
52.6 degrees
Interval 17.0 to 78.0
|
50.2 degrees
Interval 20.0 to 85.0
|
|
Change in Cervical Range of Motion
T2 Right Rotation Max
|
53.8 degrees
Interval 16.0 to 72.0
|
50.9 degrees
Interval 20.0 to 90.0
|
|
Change in Cervical Range of Motion
T3 Right Rotation Max
|
56.5 degrees
Interval 15.0 to 78.0
|
52.5 degrees
Interval 14.0 to 93.0
|
SECONDARY outcome
Timeframe: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hoursSubjects rate their pain on the Numeric Pain Rating Scale (NPRS), a scale from 0-10, 0 being none and 10 being the worst imaginable.
Outcome measures
| Measure |
Manipulation Plus Tape
n=27 Participants
The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a "Y" strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal "I" strip applied at 50% tension at the site of pain.
|
Manipulation Only
n=23 Participants
The control group received manipulation from a licensed chiropractor only
|
|---|---|---|
|
Change in Numeric Pain Rating Scale (NPRS)
T2 Pain
|
5.4 units on a scale
Interval 2.0 to 8.0
|
5 units on a scale
Interval 2.0 to 9.0
|
|
Change in Numeric Pain Rating Scale (NPRS)
T1 Pain
|
6.1 units on a scale
Interval 2.0 to 9.0
|
5.7 units on a scale
Interval 2.0 to 9.0
|
|
Change in Numeric Pain Rating Scale (NPRS)
T3 Pain
|
4.9 units on a scale
Interval 1.0 to 8.0
|
4.9 units on a scale
Interval 1.0 to 9.0
|
Adverse Events
Manipulation Plus Tape
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Manipulation Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jena Slaski
Sport and Spine Rehab Clinical Research Foundation
Phone: 240-766-0300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place