Clinical trial NCT03049644: A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy
Official title: Management of Chronic Lower Back Pain: A Randomized Controlled Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy Utilizing a Point of Care Methodology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lower Back Pain
Keywords: chronic lower back pain
Manual Therapy
Mechanical Diagnosis and Treatment
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
First posted: 2017-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PROMIS Global Health Scale (GHS)
timeFrame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Secondary outcomes:
measure: PEG (Pain/enjoyment of life/general activity)
timeFrame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
measure: Fear Avoidance
timeFrame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
measure: Catastrophizing
timeFrame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
measure: Behavioral Disengagement
timeFrame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
state: New York
Study officials:
affiliation: Canandaigua VA Medical Center
name: Paul E Dougherty, DC
role: PRINCIPAL_INVESTIGATOR
References: