Management of Chronic Lower Back Pain: A Randomized Controlled Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy Utilizing a Point of Care Methodology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Lower Back Pain
- Sponsor
- Canandaigua VA Medical Center
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- PROMIS Global Health Scale (GHS)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Paul Dougherty, DC
Chief of Chiropractic/Residency Director
Canandaigua VA Medical Center
Eligibility Criteria
Inclusion Criteria
- •Chronic Lower back pain (CLBP) (\>12 weeks)
- •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
Outcomes
Primary Outcomes
PROMIS Global Health Scale (GHS)
Time Frame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Change in Quality of Life Measure
Secondary Outcomes
- PEG (Pain/enjoyment of life/general activity)(baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks))
- Behavioral Disengagement(baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks))
- Fear Avoidance(baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks))
- Catastrophizing(baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks))