Compression Neuropathy, Carpal TunnelPhase 1/2NCT00634738
The Treatment of the Median Nerve for the Elimination of the Symptoms Associated With the Carpal Tunnel Syndrome
A Phase 1/2 study testing Ischemic Compression (thumb Pressure) in people with Compression Neuropathy, Carpal Tunnel, run by Guy Hains Chiropractor at 1 site in Canada.
Trial summary
In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the aponeurosis of the biceps and in the pronator teres muscle. We hypothesise that by eliminating these trigger points,using ischemic compressions, may diminish the symptoms. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Compression Neuropathy, Carpal Tunnel
- What is being tested?
- Ischemic Compression (thumb Pressure)
- 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
- Jan 2007to 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
- No healthy volunteers
- Adult
Who may be able to join
- Between 20 and 60 years old,
- Numbness in the hand affecting the thumb, the index finger, the middle finger and half the ring finger,
- To have suffered from discomfort on a daily basis for at least three months and to agree to a course of 15 chiropractic treatments at no cost.
Who cannot join
- History of upper limb or neck surgery,
- Pregnancy and systemic pathologies possibly related to CTS, 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
In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the aponeurosis of the biceps and in the pronator teres muscle.
We hypothesise that by eliminating these trigger points,using ischemic compressions, may diminish the symptoms.
Read the detailed description
Using one thumb on the other,the pressure is applied 10 seconds on each TrPs.The treatment is done on each visit for a total of 15(without Charge).
- Conditions
- Compression Neuropathy, Carpal Tunnel
- Being tested
- Ischemic Compression (thumb Pressure)
- Keywords
- ischemic compression;carpal tunnel syndrome
- 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.
Ischemic Compression (thumb Pressure)Procedure or surgery
Also called Pressure point therapy
Pressure, one thumb on the other, applied on the trigger points
| Study group | Role | What they receive |
|---|---|---|
| one | Experimental | Not described Receives: Procedure: Ischemic Compression (thumb Pressure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levine DW Questionnaire (J.Bone Joint Surg Am 1993;75:1585-92)on carpal tunnel syndrome
Measured: after 15treatments,30 days after,6 months later
Secondary outcomes (1)
A numerical scale,filled by the patient,where they give their perceived improvement from 0% to 100%.
Measured: After 15 treatments, 30 days later and 6 months later.
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 startJan 2007
- 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 Compression Neuropathy, Carpal TunnelStudies 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
- Martin Descarreaux, DC PHD, Study chair, UQTR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634738
- Sponsor's protocol ID
- cer-06-115-06.03
- Other IDs
- no grants
- Status last verified
- Jun 2010
- First submitted
- 6 Mar 2008
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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
- NCT00634738
- Acronym / sponsor ID
- cer-06-115-06.03
- Conditions
- Compression Neuropathy, Carpal Tunnel
- Keywords
- ischemic compression;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
- Jan 2007
- 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.
In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the aponeurosis of the biceps and in the pronator teres muscle.
We hypothesise that by eliminating these trigger points,using ischemic compressions, may diminish the symptoms.
Detailed description
Using one thumb on the other,the pressure is applied 10 seconds on each TrPs.The treatment is done on each visit for a total of 15(without Charge).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one | Experimental | Procedure: Ischemic Compression (thumb Pressure) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 20 and 60 years old,
- Numbness in the hand affecting the thumb, the index finger, the middle finger and half the ring finger,
- To have suffered from discomfort on a daily basis for at least three months and to agree to a course of 15 chiropractic treatments at no cost.
Key exclusion criteria (2 listed)
- History of upper limb or neck surgery,
- Pregnancy and systemic pathologies possibly related to CTS, 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 |
|---|---|---|
| Ischemic Compression (thumb Pressure)Also: Pressure point therapyPressure, one thumb on the other, applied on the trigger points | Procedure or surgery | one |
Primary outcome
Levine DW Questionnaire (J.Bone Joint Surg Am 1993;75:1585-92)on carpal tunnel syndrome
Time frame: after 15treatments,30 days after,6 months later
1 secondary outcome
A numerical scale,filled by the patient,where they give their perceived improvement from 0% to 100%.
Time frame: After 15 treatments, 30 days later and 6 months later.
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.
Martin Descarreaux, DC PHD study chair
UQTR
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 Ischemic Compression (thumb Pressure) in people with Compression Neuropathy, Carpal Tunnel, 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 3 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?
Levine DW Questionnaire (J.Bone Joint Surg Am 1993;75:1585-92)on carpal tunnel syndrome (time frame: after 15treatments,30 days after,6 months later). 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.