Carpal Tunnel SyndromePhase 1/2NCT00634699
The Treatment of Carpal Tunnel Syndrome Using Thumb Pressure Along the Median Nerve
A Phase 1/2 study testing Active Comparator, ischemic compressions in people with Carpal Tunnel Syndrome, run by Guy Hains Chiropractor at 1 site in Canada.
Trial summary
The purpose of this study is to find the efficacy of treating the muscles in the inside (biceps,pronator teres) of the arm in order to eliminate the carpal tunnel syndrome .The authors hypothesise that eliminating the trigger points located in these muscles would diminish the symptoms associated with the carpal tunnel… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Active Comparator, ischemic compressions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Sep 2010
- Phase
- Phase 1/2
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 20 and 60 years old from the city and the surrounding Trois-Rivières with chronic carpal tunnel syndrome,
- Daily pain in the hand that lasted at least 3 months
Who cannot join
- History of upper limb or neck surgery,
- Pregnancy and systemic pathologies possibly related to carpal tunnel syndrome, such as hypothyroidism, diabetes and rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuropathy Along the Median Nerve: Etiology of Symptoms Associated With the Carpal Tunnel Syndrome: a Preliminary Study.
The purpose of this study is to find the efficacy of treating the muscles in the inside (biceps,pronator teres) of the arm in order to eliminate the carpal tunnel syndrome .The authors hypothesise that eliminating the trigger points located in these muscles would diminish the symptoms associated with the carpal tunnel syndrome.
Read the detailed description
The carpal tunnel syndrome is a common condition which should treated by surgery only when conservative approaches has been tried.In the present trial the authors intend to find the effectiveness of treating the triggers points located in the biceps muscle, the pronator teres muscle and the biceps aponeurosis on the symptoms normally associated with the carpal tunnel syndrome.
The technique used in this trial will be ischemic compression(thumb tip pressure)on the trigger points located on the previous sites.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Active Comparator, ischemic compressions
- 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.
Active Comparator, ischemic compressionsProcedure or surgery
Also called Pressure Point Therapy
Ischemic Compressions,3 times a week,5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| One | Experimental | Ischemic Compression on Triggers Points on Muscles along the Median Nerve. Active Comparator Receives: Procedure: Active Comparator, ischemic compressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain,functional disabilities
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startSep 2006
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy Hains Chiropractor
- Sponsor type
- University, hospital or other
- Investigators
- Guy Hains, DC, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634699
- Sponsor's protocol ID
- Éthic Committee, UQTR
- Status last verified
- Jun 2011
- First submitted
- 6 Mar 2008
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathy Along the Median Nerve: Etiology of Symptoms Associated With the Carpal Tunnel Syndrome: a Preliminary Study.
- ClinicalTrials.gov ID
- NCT00634699
- Acronym / sponsor ID
- Éthic Committee, UQTR
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guy Hains ChiropractorUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Mar 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.
The purpose of this study is to find the efficacy of treating the muscles in the inside (biceps,pronator teres) of the arm in order to eliminate the carpal tunnel syndrome .The authors hypothesise that eliminating the trigger points located in these muscles would diminish the symptoms associated with the carpal tunnel syndrome.
Detailed description
The carpal tunnel syndrome is a common condition which should treated by surgery only when conservative approaches has been tried.In the present trial the authors intend to find the effectiveness of treating the triggers points located in the biceps muscle, the pronator teres muscle and the biceps aponeurosis on the symptoms normally associated with the carpal tunnel syndrome.
The technique used in this trial will be ischemic compression(thumb tip pressure)on the trigger points located on the previous sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One | Experimental | Procedure: Active Comparator, ischemic compressionsIschemic Compression on Triggers Points on Muscles along the Median Nerve. Active Comparator |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults between 20 and 60 years old from the city and the surrounding Trois-Rivières with chronic carpal tunnel syndrome,
- Daily pain in the hand that lasted at least 3 months
Key exclusion criteria (2 listed)
- History of upper limb or neck surgery,
- Pregnancy and systemic pathologies possibly related to carpal tunnel syndrome, such as hypothyroidism, diabetes and rheumatoid arthritis.
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 |
|---|---|---|
| Active Comparator, ischemic compressionsAlso: Pressure Point TherapyIschemic Compressions,3 times a week,5 weeks. | Procedure or surgery | One |
Primary outcome
Pain,functional disabilities
Time frame: One year
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 28 Jun 2011.
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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.
Guy Hains, DC principal investigator
Université du Québec à Trois-Rivières
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Active Comparator, ischemic compressions in people with Carpal Tunnel Syndrome, run by Guy Hains Chiropractor at 1 site in Canada.
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 2 inclusion and 2 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 28 Jun 2011. 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Pain,functional disabilities (time frame: One year). 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 28 Jun 2011.