Trial Outcomes & Findings for Chiropractic Manipulation and Medical Care for Low Back Pain (NCT NCT01211613)
NCT ID: NCT01211613
Last Updated: 2017-01-30
Results Overview
The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
4 weeks (post treatment)
Results posted on
2017-01-30
Participant Flow
We recruited 112 patients with a new episode of low back pain from the general population of the Greater Pittsburgh Metropolitan region. Recruitment took place during the period of time between November 2010 and April 2013.
197 patients were screened for potential eligibility. We excluded 85 patients for not meeting the inclusion criteria. Of the 40 patients randomized to Standard Medical Care, 3 never showed up for their first visit and 2 were withdrawn by the PI before receiving any treatments; leaving only 35 in that arm.
Participant milestones
| Measure |
Manual Manipulation
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
|
Mechanical Manipulation
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
|
Standard Medical Care
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
35
|
35
|
|
Overall Study
COMPLETED
|
34
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Manual Manipulation
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
|
Mechanical Manipulation
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
|
Standard Medical Care
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Chiropractic Manipulation and Medical Care for Low Back Pain
Baseline characteristics by cohort
| Measure |
Manual Manipulation
n=37 Participants
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
|
Mechanical Manipulation
n=35 Participants
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
|
Standard Medical Care
n=35 Participants
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 28.8 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 27.4 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 28.8 • n=4 Participants
|
|
Gender
Female
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (post treatment)The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).
Outcome measures
| Measure |
Manual Manipulation
n=37 Participants
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
|
Mechanical Manipulation
n=35 Participants
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
|
Standard Medical Care
n=35 Participants
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
|
|---|---|---|---|
|
Oswestry Low Back Pain Disability Index
|
-16.0 units on a scale
Standard Deviation 14.1
|
-8.9 units on a scale
Standard Deviation 11.9
|
-9.5 units on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 4 weeks (post treatment)Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating "no pain" and 10 indicating "unbearable pain". Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment).
Outcome measures
| Measure |
Manual Manipulation
n=37 Participants
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
|
Mechanical Manipulation
n=35 Participants
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
|
Standard Medical Care
n=35 Participants
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
|
|---|---|---|---|
|
Numeric Pain Rating Score.
|
-3.7 units on a scale
Standard Deviation 1.5
|
-2.6 units on a scale
Standard Deviation 1.6
|
-1.9 units on a scale
Standard Deviation 2.2
|
Adverse Events
Manual Manipulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mechanical Manipulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Medical Care
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
Michael J Schneider, DC, PhD
University of Pittsburgh, Department of Physical Therapy'
Phone: 412-383-6640
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place