A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

NCT03049644 | Completed

• 1 other identifier: 977015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Lower Back Pain

Keywords

chronic lower back pain; Manual Therapy; Mechanical Diagnosis and Treatment

Outcome Measures

Primary Outcomes (1)

• PROMIS Global Health Scale (GHS)

  Change in Quality of Life Measure

  baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)

Secondary Outcomes (4)

• PEG (Pain/enjoyment of life/general activity)

  baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)

• Fear Avoidance

  baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)

• Catastrophizing

  baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)

• Behavioral Disengagement

  baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)

Study Arms (2)

Mechanical Diagnosis and Therapy

ACTIVE COMPARATOR

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.

Procedure: Mechanical Diagnosis and Therapy

Manual Therapy

ACTIVE COMPARATOR

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.

Procedure: Manual Therapy

Interventions

Mechanical Diagnosis and Therapy PROCEDURE

Identification of directional preference.

Also known as: McKenzie

Mechanical Diagnosis and Therapy

Manual Therapy PROCEDURE

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

Also known as: Spinal Manipulative therapy

Manual Therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Lower back pain (CLBP) (\>12 weeks)
• Veteran
• At least 18 years of age
• Directional preference on physical examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Canandaigua VA Medical Center: lead

Study Sites (1)

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

Rochester, New York, 14620, United States

Location

MeSH Terms

Interventions

Therapeutics; Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Study Officials

• Paul E Dougherty, DC

  Canandaigua VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Chiropractic/Residency Director

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 10, 2017
• Study Start: February 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: December 30, 2018
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)