Treatment Efficacy of OMT for Carpal Tunnel Syndrome
1 other identifier
interventional
138
0 countries
N/A
Brief Summary
This study investigated whether an eight-week regimen of osteopathic manipulative treatment would have immediate and lasting positive effects on the symptoms, functional limitation and physiologic impairment associated with Carpal Tunnel Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 27, 2006
CompletedFirst Posted
Study publicly available on registry
October 31, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedMarch 16, 2017
March 1, 2017
3 years
October 27, 2006
March 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in the Median motor and sensory distal latencies.
Improvement in the patients'self-reported symptoms and functionality scores.
Secondary Outcomes (4)
Strength measured with one grip and three pinch strength tests.
Changes in sensation as measured by Current Perceptual Threshold.
Changes in the transverse and anterior/posterior interior diameters and cross-sectional areas of the carpal tunnel.
Carpal tunnel edema.
Study Arms (3)
Osteopathic Manipulative Treatment
EXPERIMENTALA protocol of specific osteopathic manipulative techniques was applied.
Placebo ultrasound
PLACEBO COMPARATORSub-therapeutic ultrasound was applied.
Standard Medical care
NO INTERVENTIONSubjects did not receive either study treatment, but continued to receive standard medical care.
Interventions
A protocol of specific Osteopathic manipulative techniques was used.
Sub-therapeutic ultrasound was applied in a standardized method.
Eligibility Criteria
You may qualify if:
- Men and women with a self-reported medical diagnosis of unilateral or bilateral CTS, between the ages of 21 and 65 and all races and ethnic groups.
- Median motor nerve distal latency greater than 4.2 ms
- A difference between ipsilateral Median and Ulnar motor nerve distal latency greater than 1.5 ms.
- Median nerve sensory nerve distal latency greater than 2.2 ms
- A difference between Median and Ulnar sensory nerve peak distal latency greater than 0.2 ms
You may not qualify if:
- severe CTS that has progressed to muscle atrophy
- pregnancy
- previous wrist surgery on the wrist to be studied
- systemic disease or condition including but not limited to diabetes mellitus, thyroid disorders, rheumatoid disorders, Paget's bone disease, gout, myxedema, multiple myeloma, acromegaly, hepatic disease, dialysis patients, or other diseases or conditions in which peripheral neuropathies are common.
- secondary cause of CTS such as a ganglion cyst, mass, or an accessory muscle shown by an MRI exam of the wrist.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott T Stoll, D.O., Ph.D.
Osteopathic Research Center University of North Texas Health Science Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 27, 2006
First Posted
October 31, 2006
Study Start
October 1, 2006
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
March 16, 2017
Record last verified: 2017-03