Carpal Tunnel SyndromeNCT00803257
Effect of Lumbrical Stretching on Carpal Tunnel Syndrome
A study testing Lumbrical splint and Lumbrical exercises in people with Carpal Tunnel Syndrome, run by University of Pittsburgh at 1 site in United States.
Trial summary
Symptoms of CTS occur when any condition decreases the size of the carpal canal or increases the volume of the structures within the carpal canal, compressing the median nerve. One cause of the symptoms of CTS is the incursion of the lumbrical muscles of the hand into the carpal canal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Lumbrical splint and Lumbrical exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 yo
- Clinical symptoms of Carpal tunnel syndrome (CTS)
- Positive Tinel's, Phalen's, or Durkin's test
- Absence of thenar atrophy
- 2 pt discrimination of 5mm or less
Who cannot join
- Persons needing immediate CTS surgery
- Pregnancy
- Compressive neuropathy in the ipsilateral arm
- Diabetes
- prior CTS release
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Symptoms of CTS occur when any condition decreases the size of the carpal canal or increases the volume of the structures within the carpal canal, compressing the median nerve. One cause of the symptoms of CTS is the incursion of the lumbrical muscles of the hand into the carpal canal. Individuals with CTS tend to have tight lumbrical muscles which increase this incursion, thereby increasing CTS symptoms. An intervention designed to reduce the incursion of the lumbrical muscles should have an effect on the symptoms of CTS.
The purpose of this study is to systematically examine the effect of an intensive lumbrical muscle intervention, splinting to prevent lumbrical muscle incursion and lumbrical muscle exercises, on the symptoms of CTS. This project will be a randomized clinical trial to evaluate the effectiveness of a home program targeting the lumbrical muscles. One hundred and twenty subjects will be assigned to one of 4 groups: Group 1 will receive a home program of lumbrical muscle stretches combined with a lumbrical positioning splint; Group 2 will receive a home program of lumbrical muscle stretches combined with a night wrist cock-up splint; Group 3 will receive a home program of general stretches combined with a lumbrical positioning splint; and Group 4 will receive a home program of general stretches combined with a night wrist cock-up splint. After 1 month, 3 months, and 6 months the groups will be compared to determine if there is a significant reduction in symptoms between the groups.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Lumbrical splint and Lumbrical exercises
- Keywords
- Carpal Tunnel Syndrome, Splint, Hand exercises
- 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.
Lumbrical splint and Lumbrical exercisesOther
Subjects receive one of four possible interventions - Dose and Frequency are the same for each
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lumbrical splint and lumbrical stretches Receives: Other: Lumbrical splint and Lumbrical exercises |
| 2 | Active comparator | Lumbrical Splint and regular exercises Receives: Other: Lumbrical splint and Lumbrical exercises |
| 3 | Active comparator | Regular splint and lumbrical exercises Receives: Other: Lumbrical splint and Lumbrical exercises |
| 4 | Active comparator | Regular splint and regular exercises Receives: Other: Lumbrical splint and Lumbrical exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Principal investigator, Nancy Baker, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803257
- Sponsor's protocol ID
- 07030166
- Status last verified
- Jun 2012
- First submitted
- 4 Dec 2008
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baker NA, Moehling KK, Desai AR, Gustafson NP. Effect of carpal tunnel syndrome on grip and pinch strength compared with sex- and age-matched normative data. Arthritis Care Res (Hoboken). 2013 Dec;65(12):2041-5. doi: 10.1002/acr.22089.
PubMed 23925936Baker NA, Moehling KK, Rubinstein EN, Wollstein R, Gustafson NP, Baratz M. The comparative effectiveness of combined lumbrical muscle splints and stretches on symptoms and function in carpal tunnel syndrome. Arch Phys Med Rehabil. 2012 Jan;93(1):1-10. doi: 10.1016/j.apmr.2011.08.013.
PubMed 22200381
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lumbrical Stretching on Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT00803257
- Acronym / sponsor ID
- 07030166
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Splint, Hand exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Mar 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 Dec 2008 (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.
Symptoms of CTS occur when any condition decreases the size of the carpal canal or increases the volume of the structures within the carpal canal, compressing the median nerve. One cause of the symptoms of CTS is the incursion of the lumbrical muscles of the hand into the carpal canal. Individuals with CTS tend to have tight lumbrical muscles which increase this incursion, thereby increasing CTS symptoms. An intervention designed to reduce the incursion of the lumbrical muscles should have an effect on the symptoms of CTS.
The purpose of this study is to systematically examine the effect of an intensive lumbrical muscle intervention, splinting to prevent lumbrical muscle incursion and lumbrical muscle exercises, on the symptoms of CTS. This project will be a randomized clinical trial to evaluate the effectiveness of a home program targeting the lumbrical muscles. One hundred and twenty subjects will be assigned to one of 4 groups: Group 1 will receive a home program of lumbrical muscle stretches combined with a lumbrical positioning splint; Group 2 will receive a home program of lumbrical muscle stretches combined with a night wrist cock-up splint; Group 3 will receive a home program of general stretches combined with a lumbrical positioning splint; and Group 4 will receive a home program of general stretches combined with a night wrist cock-up splint. After 1 month, 3 months, and 6 months the groups will be compared to determine if there is a significant reduction in symptoms between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Lumbrical splint and Lumbrical exercisesLumbrical splint and lumbrical stretches |
| 2 | Active comparator | Other: Lumbrical splint and Lumbrical exercisesLumbrical Splint and regular exercises |
| 3 | Active comparator | Other: Lumbrical splint and Lumbrical exercisesRegular splint and lumbrical exercises |
| 4 | Active comparator | Other: Lumbrical splint and Lumbrical exercisesRegular splint and regular exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 yo
- Clinical symptoms of Carpal tunnel syndrome (CTS)
- Positive Tinel's, Phalen's, or Durkin's test
- Absence of thenar atrophy
- 2 pt discrimination of 5mm or less
Key exclusion criteria (6 listed)
- Persons needing immediate CTS surgery
- Pregnancy
- Compressive neuropathy in the ipsilateral arm
- Diabetes
- prior CTS release
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 |
|---|---|---|
| Lumbrical splint and Lumbrical exercisesSubjects receive one of four possible interventions - Dose and Frequency are the same for each | Other | 1, 2, 3, 4 |
Primary outcome
Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS)
Time frame: 1 month
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 13 Jun 2012.
- Derived from this study: PubMed 23925936Baker NA, Moehling KK, Desai AR, Gustafson NP. Effect of carpal tunnel syndrome on grip and pinch strength compared with sex- and age-matched normative data. Arthritis Care Res (Hoboken). 2013 Dec;65(12):2041-5. doi: 10.1002/acr.22089.
- Derived from this study: PubMed 22200381Baker NA, Moehling KK, Rubinstein EN, Wollstein R, Gustafson NP, Baratz M. The comparative effectiveness of combined lumbrical muscle splints and stretches on symptoms and function in carpal tunnel syndrome. Arch Phys Med Rehabil. 2012 Jan;93(1):1-10. doi: 10.1016/j.apmr.2011.08.013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbrical splint and Lumbrical exercises in people with Carpal Tunnel Syndrome, run by University of Pittsburgh 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 5 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 13 Jun 2012. 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?
Carpal Tunnel Syndrome Symptom Severity and Functional Status Scale (CTS-SSFS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803257, which also lists 2 linked publications.
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 13 Jun 2012.