Median Nerve CompressionPhase 2NCT01562860
Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy
A Phase 2 study testing Pronator Teres Release, dual compression release and median nerve release only in people with Median Nerve Compression, run by Christine M. Kleinert Institute for Hand and Microsurgery at 1 site in United States.
Trial summary
The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Median Nerve Compression
- What is being tested?
- Pronator Teres Release, dual compression release and median nerve release only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2019
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Peripheral neuropathy of the median nerve secondary to trauma
- Presence of thoracic outlet syndrome
- Presence of cervical disk disease
- Under the age of 18 and over the age of 65
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Christine M. Kleinert Institute for Hand and Microsurgery
Louisville, Kentucky, 40202
Christina L Kaufman, PhD, 502-562-0390, ckaufman@cmki.org
Millicent L Horn, BS, 502-562-0307, mhorn@cmki.org
About this study
Official title: The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study
The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.
- Conditions
- Median Nerve Compression
- Being tested
- Pronator Teres Release, dual compression release, median nerve release only
- Keywords
- median nerve, carpal tunnel syndrome, Pronator Teres Release
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pronator Teres ReleaseProcedure or surgery
Also called carpal tunnel release
Surgical release of median nerve compression
dual compression releaseProcedure or surgery
Both the carpal tunnel compression and the pronator teres compression will be released on the same day.
dual compression releaseProcedure or surgery
both procedures will be done on the same day
median nerve release onlyProcedure or surgery
only the carpal tunnel compression is released
| Study group | Role | What they receive |
|---|---|---|
| Carpal Tunnel and Pronator Teres Release | Active comparator | Patients enrolled in this arm of the study will have both surgical procedures performed at the same time Receives: Procedure: dual compression release |
| Carpal Tunnel Release only | Active comparator | Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery. Receives: Procedure: Pronator Teres Release; Procedure: dual compression release; Procedure: median nerve release only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)
The primary outcome measure will be the difference between the pre and post operative assessments of the questionnaire, which will represent the degree of improvement as result of the surgical intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJul 2010
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median Nerve CompressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuna Ozyurekoglu, MD, Principal investigator, Christine M. Kleinert Institute for Hand and Microsurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562860
- Sponsor's protocol ID
- 10.0039
- Status last verified
- Jan 2018
- First submitted
- 8 Aug 2011
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT01562860
- Acronym / sponsor ID
- 10.0039
- Conditions
- Median Nerve Compression
- Keywords
- median nerve, carpal tunnel syndrome, Pronator Teres Release
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christine M. Kleinert Institute for Hand and MicrosurgeryUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 26 Mar 2012 (estimated)
- 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.
The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel and Pronator Teres Release | Active comparator | Procedure: dual compression releasePatients enrolled in this arm of the study will have both surgical procedures performed at the same time |
| Carpal Tunnel Release only | Active comparator | Procedure: Pronator Teres Release, Procedure: dual compression release, Procedure: median nerve release onlyPatients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Peripheral neuropathy of the median nerve secondary to trauma
- Presence of thoracic outlet syndrome
- Presence of cervical disk disease
- Under the age of 18 and over the age of 65
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 |
|---|---|---|
| Pronator Teres ReleaseAlso: carpal tunnel releaseSurgical release of median nerve compression | Procedure or surgery | Carpal Tunnel Release only |
| dual compression releaseBoth the carpal tunnel compression and the pronator teres compression will be released on the same day. | Procedure or surgery | Carpal Tunnel Release only |
| dual compression releaseboth procedures will be done on the same day | Procedure or surgery | Carpal Tunnel and Pronator Teres Release |
| median nerve release onlyonly the carpal tunnel compression is released | Procedure or surgery | Carpal Tunnel Release only |
Primary outcome
Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)
Time frame: 12 months
The primary outcome measure will be the difference between the pre and post operative assessments of the questionnaire, which will represent the degree of improvement as result of the surgical intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Tuna Ozyurekoglu, MD principal investigator
Christine M. Kleinert Institute for Hand and Microsurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pronator Teres Release, dual compression release and median nerve release only in people with Median Nerve Compression, run by Christine M. Kleinert Institute for Hand and Microsurgery 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 0 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jan 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuna Ozyurekoglu, MD (502-561-4263, tozyurekoglu@cmki.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire) (time frame: 12 months). 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 25 Jan 2018.