- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02026076
Manual Unloading of the Lumbar Spine: Can it Predict Responders to Mechanical Traction?
Manual Unloading of the Lumbar Spine: Can it Predict Response to Mechanical Traction? A Study or Reliability and Criterion Referenced Predictive Validity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will consist of two distinct components. Part one will be a reliability study of manual unloading. Two therapists, both familiar with the technique of manual unloading as described by Kaltenborn17, will perform a manual unloading test, blinded to the previous results. Ten consecutive patients will be recruited from a sample of convenience at the University Of Connecticut Health Center Department Of Rehabilitation. This test will be repeated on the same subjects within 7 days of initial testing. Tests of agreement will then be applied to determine intra and inter-rater reliability.
Part two will consist of a trial of lumbar traction in a group of subjects with low back pain without radiculopathy, anticipated n=30. At the time of enrollment, all subjects will complete a standardized informed consent form, detailing all potential risks of the trail. Consent will include permission for demographic data to be obtained from the standard intake form, and kept in a de-identified form in a secure location. All subjects will complete a screening form, which will ensure that the potential subjects do not have any of the excluding factors present. Prior to enrollment, all subjects will complete a standardized medical history form (kept as part of the medical record for all patients), as part of standard departmental practice. Additionally, participants will complete a modified Oswestry questionnaire as well as two 100 mm visual analog scales (VAS), one indicating pain at rest, the other indicating pain in their most provocative test motion (flexion, extension, or side flexion of the lumbar spine). Subjects will then be tested with unloading in standing as described by Kaltenborn. This test involves the therapist applying a low grade lifting force to the patient in a standing position, testing for symptomatic alleviation via the elimination of compression on pain sensitive structures. Results of this test will be coded as (+) relief or (-) relief. Prior to traction application, subjects will undergo a standardized, comprehensive examination (standard of care), which will include screening for exclusion criteria (myotomal weakness, sensation changes, positive neural tension signs). All subjects will be weighed prior to traction application to determine treatment force to be generated. To aid in determining BMI, subjects will also have their height measured. The reference test will consist of a single application of mechanical traction, 15 minutes, 30 seconds on/ 10 seconds off, at 50% of body weight with the treatment table in the opened position, while positioned in a supine, hook lying neutral posture. Post traction, all subjects will repeat AROM measures, and complete a second pair of VAS to determine immediate effect of the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
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Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ages 18-75
- non-radicular low back pain (LBP)
Exclusion Criteria:
- tumor,
- fracture,
- infectious disorder,
- central nervous system involvement,
- presence of medical red flags,
- absence of LBP,
- radicular leg pain (below the knee),
- pregnancy,
- epidural steroid injection within 4 weeks prior to study involvement,
- previous back surgery,
- workers compensation involvement
- active litigation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: manual unloading
All subjects will first undergo a manual unloading test, followed by a single application of mechanical lumbar traction to determine predictive effect
|
15 minutes at up to 50% body weight lumbar traction in supine hooklying with split table open
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Visual Analog pain scale in the most provocative movement
Time Frame: immediate post intervention (within 5 minutes following intervention)
|
immediate post intervention (within 5 minutes following intervention)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Isaac Moss, MD, UConn Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Manual Unloading
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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