A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

NCT ID: NCT03049644

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-12-30

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.

Conditions

Chronic Lower Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Mechanical Diagnosis and Therapy

Intervention Type: PROCEDURE

Identification of directional preference.

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.

Group Type: ACTIVE_COMPARATOR

Manual Therapy

Intervention Type: PROCEDURE

Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.

Interventions

Mechanical Diagnosis and Therapy

Identification of directional preference.

Intervention Type: PROCEDURE

Manual Therapy

Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.

Intervention Type: PROCEDURE

Other Intervention Names

McKenzie; Spinal Manipulative therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canandaigua VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Paul Dougherty, DC

Chief of Chiropractic/Residency Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul E Dougherty, DC

Role: PRINCIPAL_INVESTIGATOR

Canandaigua VA Medical Center

Locations

Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

977015

Identifier Type: -

Identifier Source: org_study_id