A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

Sponsor

Canandaigua VA Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT03049644

Collaborator

(none)

Enrollment

Location

Arms

22.9

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lower Back Pain	Procedure: Mechanical Diagnosis and Therapy Procedure: Manual Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Dec 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

PROMIS Global Health Scale (GHS) [baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)]
Change in Quality of Life Measure

Secondary Outcome Measures

PEG (Pain/enjoyment of life/general activity) [baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)]
Change in Pain
Fear Avoidance [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)
Catastrophizing [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)
Behavioral Disengagement [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_

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center	Rochester	New York	United States	14620

Sponsors and Collaborators

Canandaigua VA Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul Dougherty, DC, Chief of Chiropractic/Residency Director, Canandaigua VA Medical Center

ClinicalTrials.gov Identifier:

NCT03049644

Other Study ID Numbers:

977015

First Posted:

Feb 10, 2017

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Paul Dougherty, DC, Chief of Chiropractic/Residency Director, Canandaigua VA Medical Center

chronic lower back pain

Manual Therapy

Mechanical Diagnosis and Treatment

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Apr 7, 2022