Mind Body Intervention for Chronic Lower Back Pain

Study Overview
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Brief Summary
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This pilot study will evaluate the feasibility of having a non-behavioral health provider deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the combined intervention of CBT-p and MT and those undergoing MT alone.

Detailed Description
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Given that this is a pilot study we will use simple descriptive statistics for patient characteristics, including age, sex, BMI and baseline scores on outcome measures. In addition we will assess the inter-rater reliability of the scoring of the delivery of the CBT-p by the two trained practitioners utilizing kappa statistics. We will perform data analyses using SPSS.

Official Title
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Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study

Conditions
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Chronic Lower Back Pain

Intervention / Treatment
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* Procedure: Manual Therapy
* Procedure: Mind Body Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 69 years of age with CLBP who are high risk for poor prognosis based on SBST currently undergoing chiropractic care. Exclusion Criteria: Contraindications to either MT or CBT-p. Patients who are currently undergoing CBT-p who have been treated for substance abuse in the past year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 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: Manual Therapy<br>Spinal Manipulative therapy (SMT) for the purpose of this study we will allow the use of other types of MT, including non-thrust spinal mobilization and flexion-distraction technique. | Procedure: Manual Therapy<br>* Manual Therapy Arm<br>* Other names: Flexion Distraction Therapy;|
| Experimental: Mind Body Intervention (MBI)<br>Mind Body Intervention will consist of a combination of the previously described manual therapy and Cognitive Behavioral Therapy for pain (CBT-p). Cognitive Behavioral Therapy for pain management has three basic components. The treatment rationale, coping skills training and application and maintenance of learned coping skills. | Procedure: Manual Therapy<br>* Manual Therapy Arm<br>* Other names: Flexion Distraction Therapy;Procedure: Mind Body Intervention<br>* Combination of manual therapy and cognitive behavioral therapy for pain.<br>* Other names: Cognitive Behavioral Therapy for Pain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | The VAS is a patient completed analogue measure that evaluates pain intensity on a 100 mm long horizontal line, which is anchored at each end with a statement representing the extremes of the dimension being measured. In this case the left hand side reads, no pain and the right hand side reads worst pain possible. The VAS scale utilized will assess pain at the current time. The VAS has been established as a reliable, valid and generalizable measure that can be administered in a wide range of clinical and experimental settings. | Baseline and 6 weeks post baseline (immediately post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Global Health Scale (GHS) | Health outcomes assessment has advanced to a point where generic health-related quality of life (HRQL) measures are often used to examine the health status of populations and the effects of medical interventions. Generic HRQL profile measures, such as the SF-36 Health Survey, provide multiple health domains scores (e.g., physical function, mental health, pain, vitality, etc.), but not an overall index score. Patient reported outcome measurement information system has developed a quality of life tool that provides an overall index score for quality of life. The main advantage of the PROMIS measures over other static health status measures is that the PROMIS domain item banks and scores allow flexibility in administration using either targeted short forms or computerized adaptive testing. This form has recently been validated in comparison to the EuroQual. | Baseline and 6 weeks post baseline (immediately post intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lower Back Pain, Manual Therapy, Cognitive Behavioral Therapy