Back to resultsA Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy
Primary Purpose
Chronic Lower Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mechanical Diagnosis and Therapy
Manual Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lower Back Pain focused on measuring chronic lower back pain, Manual Therapy, Mechanical Diagnosis and Treatment
Eligibility Criteria
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
Sites / Locations
- Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mechanical Diagnosis and Therapy
Manual Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
PROMIS Global Health Scale (GHS)
Change in Quality of Life Measure
Secondary Outcome Measures
PEG (Pain/enjoyment of life/general activity)
Change in Pain
Fear Avoidance
It's not really safe for a person with my back problem to be physically active (1-5 scale)
Catastrophizing
I feel that my back pain is terrible and it's never going to get any better (1-5 scale)
Behavioral Disengagement
Due to my chronic back pain, I no longer engage in activities that are enjoyable and pleasant (1-5 scale_
Full Information
NCT ID
NCT03049644
First Posted
February 1, 2017
Last Updated
March 29, 2022
Sponsor
Canandaigua VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03049644
Brief Title
A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canandaigua VA Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lower Back Pain
Keywords
chronic lower back pain, Manual Therapy, Mechanical Diagnosis and Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mechanical Diagnosis and Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mechanical Diagnosis and Therapy
Other Intervention Name(s)
McKenzie
Intervention Description
Identification of directional preference.
Intervention Type
Procedure
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
Spinal Manipulative therapy
Intervention Description
Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.
Primary Outcome Measure Information:
Title
PROMIS Global Health Scale (GHS)
Description
Change in Quality of Life Measure
Time Frame
baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Secondary Outcome Measure Information:
Title
PEG (Pain/enjoyment of life/general activity)
Description
Change in Pain
Time Frame
baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Title
Fear Avoidance
Description
It's not really safe for a person with my back problem to be physically active (1-5 scale)
Time Frame
baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Title
Catastrophizing
Description
I feel that my back pain is terrible and it's never going to get any better (1-5 scale)
Time Frame
baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Title
Behavioral Disengagement
Description
Due to my chronic back pain, I no longer engage in activities that are enjoyable and pleasant (1-5 scale_
Time Frame
baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Dougherty, DC
Organizational Affiliation
Canandaigua VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will publish results of study in a journal as a pilot study.
Learn more about this trial
A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy
We'll reach out to this number within 24 hrs