An interventional study of Mechanical Diagnosis and Therapy and Manual Therapy in Chronic Lower Back Pain, sponsored by Canandaigua VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Canandaigua VA Medical Center · Not applicable, Interventional, and Treatment
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.
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Canandaigua VA Medical Center is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Identification of directional preference.
Also known as: McKenzie
Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.
Also known as: Spinal Manipulative therapy
PROMIS Global Health Scale (GHS)
Change in Quality of Life Measure
Time frame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
PEG (Pain/enjoyment of life/general activity)
Change in Pain
Time frame: 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)
Time frame: 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)
Time frame: 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_
Time frame: baseline, 4 week and 8 week (assessing change from baseline to 4 weeks and 8 weeks)
Plan to share: Yes — We will publish results of study in a journal as a pilot study.
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Jun 2017, 4 months.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 4 months is below that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Canandaigua VA Medical Center