A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy
- Conditions
- Chronic Lower Back Pain
- Interventions
- Procedure: Manual TherapyProcedure: Mechanical Diagnosis and Therapy
- Registration Number
- NCT03049644
- Lead Sponsor
- Canandaigua VA Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Chronic Lower back pain (CLBP) (>12 weeks)
- Veteran
- At least 18 years of age
- Directional preference on physical examination
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manual Therapy Manual Therapy 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. Mechanical Diagnosis and Therapy Mechanical Diagnosis and Therapy 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.
- Primary Outcome Measures
Name Time Method PROMIS Global Health Scale (GHS) baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) Change in Quality of Life Measure
- Secondary Outcome Measures
Name Time Method PEG (Pain/enjoyment of life/general activity) baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) Change in Pain
Behavioral Disengagement baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) Due to my chronic back pain, I no longer engage in activities that are enjoyable and pleasant (1-5 scale_
Fear Avoidance baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) It's not really safe for a person with my back problem to be physically active (1-5 scale)
Catastrophizing baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks) I feel that my back pain is terrible and it's never going to get any better (1-5 scale)
Trial Locations
- Locations (1)
Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
🇺🇸Rochester, New York, United States