A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

Canandaigua VA Medical Center

Status: Completed

Conditions: Chronic Lower Back Pain

Treatments: Procedure: Mechanical Diagnosis and Therapy; Procedure: Manual Therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03049644

977015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

Mechanical Diagnosis and Therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Mechanical Diagnosis and Therapy

Manual Therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Manual Therapy