A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

Study Overview
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Brief Summary
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Mechanical diagnosis and treatment (MDT) and Manual Therapy (MT) have both demonstrated efficacy in the management of CLBP. The use of a Point of Care (POC) design in this study will allow for comparison of these two treatment modalities in a clinical setting. The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients utilizing the POC methodology.

Detailed Description
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20 new patients entering the chiropractic clinic who meet inclusion criteria including demonstrating a directional preference upon physical examination during their initial evaluation will be recruited. Patients will be queried as to interest and those interested will be consented. Patients will then be randomized utilizing a computer generated randomization chart to receive either MDT or MT delivered in a pragmatic manner. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey (GHS)), psychosocial questions and Self Efficacy (2 Question). Outcomes will be collected at baseline, 4 weeks and 8 weeks post baseline.

Official Title
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Management of Chronic Lower Back Pain: A Randomized Controlled Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy Utilizing a Point of Care Methodology

Conditions
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Chronic Lower Back Pain

Intervention / Treatment
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* Procedure: Mechanical Diagnosis and Therapy
* Procedure: Manual Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic Lower back pain (CLBP) (>12 weeks) Veteran At least 18 years of age Directional preference on physical examination Exclusion Criteria: Non Veteran >89 years of age Non Mechanical Cause of LBP Unable to identify directional preference on physical examination Contraindications to manual therapy (cauda equina syndrome, spinal neoplasia or metastatic disease, destructive joint pathology such as rheumatoid arthritis, bowel/bladder dysfunction (associated with the back pain), peripheral neuropathy or progressive lumbosacral radiculopathy, progressive myelopathy or neurogenic claudication or any absolute contraindications to MT such as acute fracture of the lumbar spine) Open Worker's compensation case

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanical Diagnosis and Therapy<br>Mechanical diagnosis refers to the classification based on examination of posture and range of motion of the spine, associated with the assessment of subjective symptomatic responses. | Procedure: Mechanical Diagnosis and Therapy<br>* Identification of directional preference.<br>* Other names: McKenzie;|
| Active Comparator: Manual Therapy<br>Manual therapy (MT) is a broad term encompassing many techniques which attempt to affect possible pain contributors such as joints, tendons, ligaments, and muscles, typically using the therapist's hands but may also utilize a tool or instrument in the case of some soft tissue mobilization therapies as well as low force instrument assisted spinal manipulation therapy. | Procedure: Manual Therapy<br>* Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.<br>* Other names: Spinal Manipulative therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Global Health Scale (GHS) | Change in Quality of Life Measure | baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEG (Pain/enjoyment of life/general activity) | Change in Pain | baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) | 
| Fear Avoidance | It's not really safe for a person with my back problem to be physically active (1-5 scale) | baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) | 
| Catastrophizing | I feel that my back pain is terrible and it's never going to get any better (1-5 scale) | baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) | 
| Behavioral Disengagement | Due to my chronic back pain, I no longer engage in activities that are enjoyable and pleasant (1-5 scale_ | baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) | 

 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, Mechanical Diagnosis and Treatment