Chronic Lower Back PainNCT03049644
A Trial Comparing Mechanical Diagnosis and Treatment to Manual Therapy
A study testing Mechanical Diagnosis and Therapy and Manual Therapy in people with Chronic Lower Back Pain, run by Canandaigua VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Lower Back Pain
- What is being tested?
- Mechanical Diagnosis and Therapy and Manual Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Lower back pain (CLBP) (>12 weeks)
- Veteran
- At least 18 years of age
- Directional preference on physical examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
Rochester, New York, 14620
About this study
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
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.
Read the 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.
- Conditions
- Chronic Lower Back Pain
- Being tested
- Mechanical Diagnosis and Therapy, Manual Therapy
- Keywords
- chronic lower back pain, Manual Therapy, Mechanical Diagnosis and Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Diagnosis and TherapyProcedure or surgery
Also called McKenzie
Identification of directional preference.
Manual TherapyProcedure or surgery
Also called Spinal Manipulative therapy
Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Diagnosis and Therapy | Active comparator | 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. Receives: Procedure: Mechanical Diagnosis and Therapy |
| Manual Therapy | Active comparator | 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. Receives: Procedure: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Global Health Scale (GHS)
Change in Quality of Life Measure
Measured: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Secondary outcomes (4)
PEG (Pain/enjoyment of life/general activity)
Change in Pain
Measured: 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)
Measured: 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)
Measured: 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_
Measured: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canandaigua VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Dougherty, DC, Canandaigua VA Medical Center
- Investigators
- Paul E Dougherty, DC, Principal investigator, Canandaigua VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049644
- Sponsor's protocol ID
- 977015
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 2017
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will publish results of study in a journal as a pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03049644
- Acronym / sponsor ID
- 977015
- Conditions
- Chronic Lower Back Pain
- Keywords
- chronic lower back pain, Manual Therapy, Mechanical Diagnosis and Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Canandaigua VA Medical CenterUS federal agency
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Diagnosis and Therapy | Active comparator | Procedure: Mechanical Diagnosis and TherapyMechanical 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 | Active comparator | Procedure: Manual TherapyManual 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic Lower back pain (CLBP) (>12 weeks)
- Veteran
- At least 18 years of age
- Directional preference on physical examination
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Diagnosis and TherapyAlso: McKenzieIdentification of directional preference. | Procedure or surgery | Mechanical Diagnosis and Therapy |
| Manual TherapyAlso: Spinal Manipulative therapyMechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation. | Procedure or surgery | Manual Therapy |
Primary outcome
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
4 secondary outcomes
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)
Fear Avoidance
Time frame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Catastrophizing
Time frame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Behavioral Disengagement
Time frame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Yes. We will publish results of study in a journal as a pilot study.
Related trials for Chronic Lower Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul E Dougherty, DC principal investigator
Canandaigua VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Diagnosis and Therapy and Manual Therapy in people with Chronic Lower Back Pain, run by Canandaigua VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Global Health Scale (GHS) (time frame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.