Chronic Lower Back Pain
Conditions
Keywords
chronic lower back pain, Manual Therapy, Mechanical Diagnosis and Treatment
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.
Interventions
PROCEDUREMechanical Diagnosis and Therapy
Identification of directional preference.
PROCEDUREManual Therapy
Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.
Sponsors
Canandaigua VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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\_ |
Countries
United States
Outcome results
None listed