Carpal Tunnel SyndromeNCT01102868
IMS-treatment and Canalis Carpi Syndrome
A study testing Needle in acupuncture point Li11 and IMS of the musculus pronator teres in people with Carpal Tunnel Syndrome, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial summary
Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist, leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition often involves surgery. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Needle in acupuncture point Li11 and IMS of the musculus pronator teres
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2009to Jan 2012
- 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 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Canalis Carpi Syndrome verified by ultrasound and clinically
- Both genders
- Age from 18 to 67
Who cannot join
- Negative neurophysiology result.
- Epilepsy,
- Heart disease,
- Rheumatism
- Unstable angina pectoris,
- Metal -allergy,
Show all 10Show fewer
- Needle- phobia,
- Infection
- Hemophilia
- Cognitive problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Randomized Controlled Trial of IMS-treatment Versus Scam for Canalis Carpi Syndrome
Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist, leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition often involves surgery.
In this study we wish to se if there is an effect of using intramuscular stimulation (IMS) to release the tension of nervus medianus in the lower arm. The study will be performed by randomization to IMS of musculus pronator teres or a control ("Scam IMS treatment" to the acupuncture point Li11). The two insertion points are approximately 1cm apart in the lower arm.
Read the detailed description
The most important outcome measure is ultra sound measured diameters for nervus medianus in the carpal tunnel
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Needle in acupuncture point Li11, IMS of the musculus pronator teres
- 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.
Needle in acupuncture point Li11Device
Also called Needles
Acupuncture needle in acupuncture point Li11
IMS of the musculus pronator teresDevice
Also called Needles
Acupuncture needle in musculus pronator teres
| Study group | Role | What they receive |
|---|---|---|
| Needle in acupuncture point Li11 | Sham comparator | Acupuncture needle in the acupuncture point Li11 Receives: Device: Needle in acupuncture point Li11 |
| IMS of musculus pronator teres | Experimental | Acupuncture needle in musculus pronator teres Receives: Device: IMS of the musculus pronator teres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of the Nervae medianus in the Carpal Tunnel
Measured: End 2011
Secondary outcomes (2)
Health complaints
Measured: End 2011
Power of the hand grip
Measured: End 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stein Atle Lie, Professor, Principal investigator, Uni Health, University Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102868
- Sponsor's protocol ID
- IMS1234
- Status last verified
- Jan 2012
- First submitted
- 29 Mar 2010
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kvist KB, Hilland R, Enehaug R, Schjelderup J, Lie SA, Halse AK. The treatment effect of intramuscular stimulation on carpal tunnel syndrome: A blinded randomized trial on 75 patients. J Bodyw Mov Ther. 2021 Jul;27:522-528. doi: 10.1016/j.jbmt.2021.03.020. Epub 2021 Apr 20.
PubMed 34391281
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomized Controlled Trial of IMS-treatment Versus Scam for Canalis Carpi Syndrome
- ClinicalTrials.gov ID
- NCT01102868
- Acronym / sponsor ID
- IMS1234
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Apr 2010 (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.
Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist, leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition often involves surgery.
In this study we wish to se if there is an effect of using intramuscular stimulation (IMS) to release the tension of nervus medianus in the lower arm. The study will be performed by randomization to IMS of musculus pronator teres or a control ("Scam IMS treatment" to the acupuncture point Li11). The two insertion points are approximately 1cm apart in the lower arm.
Detailed description
The most important outcome measure is ultra sound measured diameters for nervus medianus in the carpal tunnel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle in acupuncture point Li11 | Sham comparator | Device: Needle in acupuncture point Li11Acupuncture needle in the acupuncture point Li11 |
| IMS of musculus pronator teres | Experimental | Device: IMS of the musculus pronator teresAcupuncture needle in musculus pronator teres |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Canalis Carpi Syndrome verified by ultrasound and clinically
- Both genders
- Age from 18 to 67
Key exclusion criteria (10 listed)
- Negative neurophysiology result.
- Epilepsy,
- Heart disease,
- Rheumatism
- Unstable angina pectoris,
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 |
|---|---|---|
| Needle in acupuncture point Li11Also: NeedlesAcupuncture needle in acupuncture point Li11 | Device | Needle in acupuncture point Li11 |
| IMS of the musculus pronator teresAlso: NeedlesAcupuncture needle in musculus pronator teres | Device | IMS of musculus pronator teres |
Primary outcome
Diameter of the Nervae medianus in the Carpal Tunnel
Time frame: End 2011
2 secondary outcomes
Health complaints
Time frame: End 2011
Power of the hand grip
Time frame: End 2011
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 23 Jan 2012.
- Derived from this study: PubMed 34391281Kvist KB, Hilland R, Enehaug R, Schjelderup J, Lie SA, Halse AK. The treatment effect of intramuscular stimulation on carpal tunnel syndrome: A blinded randomized trial on 75 patients. J Bodyw Mov Ther. 2021 Jul;27:522-528. doi: 10.1016/j.jbmt.2021.03.020. Epub 2021 Apr 20.
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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.
Stein Atle Lie, Professor principal investigator
Uni Health, University Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle in acupuncture point Li11 and IMS of the musculus pronator teres in people with Carpal Tunnel Syndrome, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
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 10 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 23 Jan 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 Norway. 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. Some participants in this study may receive a placebo. 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?
Diameter of the Nervae medianus in the Carpal Tunnel (time frame: End 2011). 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 NCT01102868, which also lists 1 linked publication.
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 23 Jan 2012.