Back to resultsThe Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
spinal manipulation
sham spinal manipulation
Enhanced sham spinal manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, spinal manipulation, manual therapy, placebo
Eligibility Criteria
Inclusion Criteria:
- currently experiencing low back pain which does not extend below the knees
- rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
- appropriate for conservative management of low back pain
- english speaking
Exclusion Criteria:
- surgery to the low back over the past 6 months
- systemic disease known to effect sensation
- other chronic pain condition unrelated to low back pain
- fracture as a cause of low back pain
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Placebo Comparator
Arm Label
spinal manipulation
sham spinal manipulation
natural history
Enhanced sham spinal manipulation
Arm Description
a spinal manipulation known to be effective in the treatment of low back pain for some individuals
a sham spinal manipulation intended to mimic the studied spinal manipulation
No intervention is provided to participants in this arm of the study
a sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
Outcomes
Primary Outcome Measures
Believability of Placebo
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
Expectation for Treatment Effectiveness
how helpful participants expect the assigned intervention will be in decreasing their low back pain
Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
The 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.
Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
Participants 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".
Secondary Outcome Measures
Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
Low back flexion range of motion was measured in degrees using a gravity inclinometer
Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
Low back extension range of motion was measured in degrees using a gravity inclinometer
Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
Low back right sidebending range of motion was measured in degrees using a gravity inclinometer
Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01168999
Brief Title
The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Official Title
The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether a novel placebo for comparison to spinal manipulation is believable and creates similar expectation for treatment effectiveness as the studied spinal manipulation technique. Additionally, we wish to compare outcomes related to low back pain, function, and pain sensitivity between people receiving the placebo, spinal manipulation, and no therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, spinal manipulation, manual therapy, placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spinal manipulation
Arm Type
Active Comparator
Arm Description
a spinal manipulation known to be effective in the treatment of low back pain for some individuals
Arm Title
sham spinal manipulation
Arm Type
Placebo Comparator
Arm Description
a sham spinal manipulation intended to mimic the studied spinal manipulation
Arm Title
natural history
Arm Type
No Intervention
Arm Description
No intervention is provided to participants in this arm of the study
Arm Title
Enhanced sham spinal manipulation
Arm Type
Placebo Comparator
Arm Description
a sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
Intervention Type
Other
Intervention Name(s)
spinal manipulation
Intervention Description
Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain
Intervention Type
Other
Intervention Name(s)
sham spinal manipulation
Intervention Description
Sham spinal manipulation intended to mimic the studied spinal manipulation
Intervention Type
Other
Intervention Name(s)
Enhanced sham spinal manipulation
Intervention Description
Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
Primary Outcome Measure Information:
Title
Believability of Placebo
Description
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
Time Frame
baseline
Title
Expectation for Treatment Effectiveness
Description
how helpful participants expect the assigned intervention will be in decreasing their low back pain
Time Frame
baseline
Title
Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
Description
A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Time Frame
Change from Baseline at 2 weeks
Title
Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
Description
The 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.
Time Frame
Change from Baseline at 2 weeks
Title
Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
Description
Participants 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".
Time Frame
baseline and immediately following their assigned intervention during the initial session
Secondary Outcome Measure Information:
Title
Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
Description
Low back flexion range of motion was measured in degrees using a gravity inclinometer
Time Frame
Change from Baseline at 2 weeks
Title
Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
Description
Low back extension range of motion was measured in degrees using a gravity inclinometer
Time Frame
Change from Baseline at 2 weeks
Title
Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
Description
Low back right sidebending range of motion was measured in degrees using a gravity inclinometer
Time Frame
Change from Baseline at 2 weeks
Title
Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
Description
Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
Time Frame
Change from Baseline at 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
currently experiencing low back pain which does not extend below the knees
rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
appropriate for conservative management of low back pain
english speaking
Exclusion Criteria:
surgery to the low back over the past 6 months
systemic disease known to effect sensation
other chronic pain condition unrelated to low back pain
fracture as a cause of low back pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Bialosky, PT, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24361109
Citation
Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.
Results Reference
derived
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The Mechanisms of Manual Therapy in the Treatment of Low Back Pain
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