A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy

Chronic Lower Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049644
• Other study ID #: 977015
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2022
• Source: Canandaigua VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 30, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Lower Back Pain
• Low Back Pain

Intervention

Procedure:
• Mechanical Diagnosis and Therapy
Identification of directional preference.
• Manual Therapy
Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.

Locations

Country	Name	City	State
United States	Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Canandaigua VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)