Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Spinal Manipulative Therapy Treatment Effect Modifiers in Individuals With Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: spinal manipulative therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: augmented spinal manipulative therapy<br>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. | Procedure: spinal manipulative therapy<br>* refer to arm descriptions<br>|
| Active Comparator: neutral spinal manipulative therapy<br>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. | Procedure: spinal manipulative therapy<br>* refer to arm descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric pain rating scale | 0 to 100 with 0= no pain at all to 100= worst pain imaginable | Change in baseline at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | 0 to 100 with 0= no perceived disability to 100= greatest perceived disability | Change in baseline at 2 weeks | 
| Back Performance Scale | 0 to 15 with lower scores indicating better performance | Change in baseline immediately following spinal manipulative therapy during day 1 and at 2 weeks | 
| 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 | change in baseline immediately following spinal manipulative therapy during day 1 | 
| 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 | change in baseline immediately following spinal manipulative therapy during day 1 | 
| Working alliance subscale of the Pain Rehabilitation Expectation Scale | Scored from 16= lesser therapeutic alliance to 64= greater therapeutic alliance | change in baseline immediately following spinal manipulative therapy during day 1 | 
| 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 | 2 weeks | 
| Semi- structured qualitative interview seeking insight into answers on the working alliance subscale of the pain rehabilitation expectation scale | a brief semi- structured interview | 2 weeks |