Trial Outcomes & Findings for The Mechanisms of Manual Therapy in the Treatment of Low Back Pain (NCT NCT01168999)
NCT ID: NCT01168999
Last Updated: 2015-10-28
Results Overview
Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
110 participants
Primary outcome timeframe
baseline
Results posted on
2015-10-28
Participant Flow
The study was undertaken in a lab on the University of Florida. Participants were recruited through written and electronic advertisement approved by the University of Florida Institutional Review Board. The first participant was enrolled in the study in November of 2009 and the final participant completed the study in January of 2013.
Participant milestones
| Measure |
Spinal Manipulative Therapy
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
27
|
28
|
|
Overall Study
COMPLETED
|
26
|
26
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Spinal Manipulative Therapy
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
Baseline Characteristics
The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Baseline characteristics by cohort
| Measure |
Spinal Manipulative Therapy
n=28 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=27 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
110 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
32.07 years
STANDARD_DEVIATION 10.98 • n=99 Participants
|
33.22 years
STANDARD_DEVIATION 13.29 • n=107 Participants
|
31.56 years
STANDARD_DEVIATION 11.85 • n=206 Participants
|
29.85 years
STANDARD_DEVIATION 12.09 • n=7 Participants
|
31.68 years
STANDARD_DEVIATION 11.85 • n=31 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
27 participants
n=107 Participants
|
27 participants
n=206 Participants
|
28 participants
n=7 Participants
|
110 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: baselineAssess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=28 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=27 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Believability of Placebo
|
67 percentage of participants
|
37 percentage of participants
|
78 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: baselinehow helpful participants expect the assigned intervention will be in decreasing their low back pain
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=28 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=27 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Expectation for Treatment Effectiveness
|
54 percent expecting less pain
|
26 percent expecting less pain
|
59 percent expecting less pain
|
11 percent expecting less pain
|
PRIMARY outcome
Timeframe: Change from Baseline at 2 weeksA 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=26 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=26 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
|
11.23 units on a scale
Standard Deviation 14.01
|
14.03 units on a scale
Standard Deviation 17.88
|
9.44 units on a scale
Standard Deviation 25.90
|
8.20 units on a scale
Standard Deviation 12.64
|
PRIMARY outcome
Timeframe: Change from Baseline at 2 weeksThe Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=26 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=26 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
|
4.46 units on a scale
Standard Deviation 8.28
|
2.08 units on a scale
Standard Deviation 7.36
|
2.69 units on a scale
Standard Deviation 8.33
|
2.54 units on a scale
Standard Deviation 8.47
|
PRIMARY outcome
Timeframe: baseline and immediately following their assigned intervention during the initial sessionParticipants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating "no pain at all" and 100 mm indicating "the worst pain imaginable".
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=28 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=27 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
|
8.14 units on a scale
Standard Deviation 20.48
|
-3.04 units on a scale
Standard Deviation 12.92
|
1.22 units on a scale
Standard Deviation 16.03
|
-2.93 units on a scale
Standard Deviation 17.84
|
SECONDARY outcome
Timeframe: Change from Baseline at 2 weeksLow back flexion range of motion was measured in degrees using a gravity inclinometer
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=26 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=26 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
|
1.58 degrees
Standard Deviation 8.65
|
2.67 degrees
Standard Deviation 13.91
|
-0.33 degrees
Standard Deviation 9.55
|
-0.54 degrees
Standard Deviation 9.25
|
SECONDARY outcome
Timeframe: Change from Baseline at 2 weeksLow back extension range of motion was measured in degrees using a gravity inclinometer
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=26 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=26 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
|
-1.50 degrees
Standard Deviation 9.58
|
-0.07 degrees
Standard Deviation 11.26
|
1.26 degrees
Standard Deviation 4.95
|
-0.21 degrees
Standard Deviation 7.82
|
SECONDARY outcome
Timeframe: Change from Baseline at 2 weeksLow back right sidebending range of motion was measured in degrees using a gravity inclinometer
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=26 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=26 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
|
0.92 degrees
Standard Deviation 8.68
|
-0.19 degrees
Standard Deviation 1.24
|
0.63 degrees
Standard Deviation 7.53
|
0.50 degrees
Standard Deviation 9.50
|
SECONDARY outcome
Timeframe: Change from Baseline at 2 weeksLow back left sidebending range of motion was measured in degrees using a gravity inclinometer
Outcome measures
| Measure |
Spinal Manipulative Therapy
n=26 Participants
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
|
Sham Spinal Manipulative Therapy
n=26 Participants
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
|
Enhanced Sham Spinal Manipulative Therapy
n=27 Participants
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
|
Natural History
n=28 Participants
These participants sat quietly for 5 minutes during the initial and final testing sessions.
|
|---|---|---|---|---|
|
Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
|
2.15 degrees
Standard Deviation 8.04
|
-0.15 degrees
Standard Deviation 6.37
|
1 degrees
Standard Deviation 6.66
|
-1.36 degrees
Standard Deviation 6.41
|
Adverse Events
Spinal Manipulative Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Spinal Manipulative Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Sham Spinal Manipulative Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Natural History
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place