Skip to main content
OpenTrials
Completed

NCT Number: NCT03049644

A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Lower Back Pain

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Rochester, New York, 14620, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical Diagnosis and Therapy

Procedure

Identification of directional preference.

Other names: McKenzie

Manual Therapy

Procedure

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

Other names: Spinal Manipulative therapy

Primary outcomes

  1. PROMIS Global Health Scale (GHS)

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

    Change in Quality of Life Measure

Secondary outcomes

  1. PEG (Pain/enjoyment of life/general activity)

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

    Change in Pain

  2. Fear Avoidance

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

    It's not really safe for a person with my back problem to be physically active (1-5 scale)

  3. Catastrophizing

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

    I feel that my back pain is terrible and it's never going to get any better (1-5 scale)

  4. Behavioral Disengagement

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

    Due to my chronic back pain, I no longer engage in activities that are enjoyable and pleasant (1-5 scale_

Sponsors and collaborators

Lead sponsor

Canandaigua VA Medical Center

Fed

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 10, 2017
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.