A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

Management of Chronic Lower Back Pain: A Randomized Controlled Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy Utilizing a Point of Care Methodology

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lower Back Pain
• Intervention / Treatment: Procedure: Mechanical Diagnosis and Therapy; Procedure: Manual Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Mechanical Diagnosis and Therapy; Identification of directional preference.; Other Names: McKenzie
Active Comparator: 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.	Procedure: Manual Therapy; Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.; Other Names: Spinal Manipulative therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEG (Pain/enjoyment of life/general activity)	Change in Pain	baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Fear Avoidance	It's not really safe for a person with my back problem to be physically active (1-5 scale)	baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Catastrophizing	I feel that my back pain is terrible and it's never going to get any better (1-5 scale)	baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Behavioral Disengagement	Due to my chronic back pain, I no longer engage in activities that are enjoyable and pleasant (1-5 scale_	baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)

Collaborators and Investigators

• Sponsor: Canandaigua VA Medical Center
• Investigators: Principal Investigator: Paul E Dougherty, DC, Canandaigua VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Manual Therapy; chronic lower back pain; Mechanical Diagnosis and Treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 977015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will publish results of study in a journal as a pilot study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No