Back to resultsSpinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
spinal manipulative therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Currently experiencing low back pain defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain;
- Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour;
- Appropriate for conservative treatment for low back pain.
Exclusion Criteria:
- Non-English speaking;
- Systemic medical conditions know to affect sensation (e.g. diabetes);
- History of lumbar surgery or fracture within the past 6 months;
- Received spinal manipulative therapy for treatment of low back pain within past 6 months;
- Current or history of chronic pain condition other than low back pain
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
augmented spinal manipulative therapy
neutral spinal manipulative therapy
Arm Description
Participants in this group will receive spinal manipulative therapy provided by a practitioner interacting in a warm and friendly way who is free to respond to participant conversation. Participants in this group will receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.
Participants in this group will receive spinal manipulative therapy provided by a practitioner engaging in minimal interaction. Participants in this group will not receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.
Outcomes
Primary Outcome Measures
numeric pain rating scale
0 to 100 with 0= no pain at all to 100= worst pain imaginable
Secondary Outcome Measures
Oswestry Disability Index
0 to 100 with 0= no perceived disability to 100= greatest perceived disability
Back Performance Scale
0 to 15 with lower scores indicating better performance
Quantitative Sensory Testing
standardized thermal and pressure stimuli will be applied and participant will rate the pain associated with each using a 0= no pain to 100= worst pain imaginable numeric pain rating scale or a mechanical visual analog scale anchored with no pain and worst pain imaginable
Patient Centered Outcome Questionnaire
Participants indicate their usual level, desired level, successful level, and expected level of pain, fatigue, emotional distress, and interference using a 0= none at all to 100= worst imaginable numeric rating scale
Working alliance subscale of the Pain Rehabilitation Expectation Scale
Scored from 16= lesser therapeutic alliance to 64= greater therapeutic alliance
North American Spine Society Lumbar Spine Outcome Assessment
Participants will answer 3 questions: 1) If you had to spend the rest of your life with the low back pain you have right now, how would you feel about it? Scored from 1= very dissatisfied to 5= very satisfied; 2) Would you have the same intervention you received in this study again for low back pain? Scored from 1=Definitely not to 5= definitely yes; 3) . How would you rate the overall results of the intervention you received in this study for low back pain? Scored from 1= Terrible to 6= Excellent
Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale
a brief semi- structured interview
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02476383
Brief Title
Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
Official Title
Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
June 14, 2019 (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
This study considers whether treatment effects in response to spinal manipulative therapy for individuals experiencing low back pain are dependent upon the context in which the intervention is provided. Half of the participants will receive spinal manipulative therapy with encouragement to interact with the provider and information to enhance expectations for the effectiveness of the intervention. The other half will receive spinal manipulative therapy with minimal interaction with the provider.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
augmented spinal manipulative therapy
Arm Type
Active Comparator
Arm Description
Participants in this group will receive spinal manipulative therapy provided by a practitioner interacting in a warm and friendly way who is free to respond to participant conversation. Participants in this group will receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.
Arm Title
neutral spinal manipulative therapy
Arm Type
Active Comparator
Arm Description
Participants in this group will receive spinal manipulative therapy provided by a practitioner engaging in minimal interaction. Participants in this group will not receive information about the effectiveness of spinal manipulative therapy for some individuals experiencing low back pain.
Intervention Type
Procedure
Intervention Name(s)
spinal manipulative therapy
Intervention Description
refer to arm descriptions
Primary Outcome Measure Information:
Title
numeric pain rating scale
Description
0 to 100 with 0= no pain at all to 100= worst pain imaginable
Time Frame
Change in baseline at 2 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
0 to 100 with 0= no perceived disability to 100= greatest perceived disability
Time Frame
Change in baseline at 2 weeks
Title
Back Performance Scale
Description
0 to 15 with lower scores indicating better performance
Time Frame
Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks
Title
Quantitative Sensory Testing
Description
standardized thermal and pressure stimuli will be applied and participant will rate the pain associated with each using a 0= no pain to 100= worst pain imaginable numeric pain rating scale or a mechanical visual analog scale anchored with no pain and worst pain imaginable
Time Frame
change in baseline immediately following spinal manipulative therapy during day 1
Title
Patient Centered Outcome Questionnaire
Description
Participants indicate their usual level, desired level, successful level, and expected level of pain, fatigue, emotional distress, and interference using a 0= none at all to 100= worst imaginable numeric rating scale
Time Frame
change in baseline immediately following spinal manipulative therapy during day 1
Title
Working alliance subscale of the Pain Rehabilitation Expectation Scale
Description
Scored from 16= lesser therapeutic alliance to 64= greater therapeutic alliance
Time Frame
change in baseline immediately following spinal manipulative therapy during day 1
Title
North American Spine Society Lumbar Spine Outcome Assessment
Description
Participants will answer 3 questions: 1) If you had to spend the rest of your life with the low back pain you have right now, how would you feel about it? Scored from 1= very dissatisfied to 5= very satisfied; 2) Would you have the same intervention you received in this study again for low back pain? Scored from 1=Definitely not to 5= definitely yes; 3) . How would you rate the overall results of the intervention you received in this study for low back pain? Scored from 1= Terrible to 6= Excellent
Time Frame
2 weeks
Title
Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale
Description
a brief semi- structured interview
Time Frame
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 defined as pain located below the 12th rib and above the inferior gluteal fold with or without corresponding leg pain;
Low back pain symptom intensity rated as 4/10 or higher during the last 24 hour;
Appropriate for conservative treatment for low back pain.
Exclusion Criteria:
Non-English speaking;
Systemic medical conditions know to affect sensation (e.g. diabetes);
History of lumbar surgery or fracture within the past 6 months;
Received spinal manipulative therapy for treatment of low back pain within past 6 months;
Current or history of chronic pain condition other than low back pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel E 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
Plan to Share IPD
No
Learn more about this trial
Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain
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