Carpal Tunnel SyndromePhase 2NCT01093209
Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
A Phase 2 study testing Interferential Laser Therapy in people with Carpal Tunnel Syndrome and Neuropathic Pain, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The purpose of this study is to determine the efficacy of the interferential laser therapy in the wrist and hand pain and disability reduction and force improvement in the carpal tunnel syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed laser therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Neuropathic Pain
- What is being tested?
- Interferential Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Apr 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed of Carpal Tunnel Syndrome by means of an Electromyography Study.
- Patients with or not previous surgery.
- Patients with an age of 18 years or older.
- Patients having a signed informed consent.
Who cannot join
- Patients with severe hand traumatisms.
- Patients with cervical radiculopathy.
- Patients with Outlet Thoracic Syndrome.
- Patients bearing osteo syntheses material.
- Patients suffering tumoral pathology.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the efficacy of the interferential laser therapy in the wrist and hand pain and disability reduction and force improvement in the carpal tunnel syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed laser therapy. Settings: Ramon y Cajal Hospital. Department of Rehabilitation. Physical therapy unit. Electrotherapy section. Occupational Therapy. Department of Neurology.
Read the detailed description
The spatiotemporal superposition of two independent and opposite beams of laser generates a constructive interference pattern that increases the therapeutic effects in the irradiated tissue. Patient suffering pain from diagnosed carpal tunnel syndrome will receive conventional or interferential laser therapy. This is a comparative randomized and double blind clinical study. Two identical lasers in near infrared range will be used. Frequency of sessions: daily. Irradiated technique: manual, contact and punctual. Pain will be evaluated by visual analog scale at rest and during analytical wrist movement. Disability will be evaluated by the DASH and BOSTON questionnaire. Evaluation will take place at pre and post-treatment times.
- Conditions
- Carpal Tunnel Syndrome, Neuropathic Pain
- Being tested
- Interferential Laser Therapy
- Keywords
- Carpal Tunnel Syndrome, Interferential laser therapy, Low-level laser therapy, Neuropathic pain, Median nerve compression
- Medical subject headings
- Carpal Tunnel Syndrome, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential Laser TherapyDevice
PROCEDURE: Interventional group: Two independents and identical probes. Energy dose per point and per probe: 5 J. Continuous emission. Treatment time:8 minutes. Sessions: 10. Frequency of the sessions: daily. Irradiation technique: handily, in contact and at 7 points over distal pathway of median nerve.Control group: Sham laser:650 nm.Scanning mode.Outpout power:1 mW.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Laser Therapy | Sham comparator | Not described Receives: Device: Interferential Laser Therapy |
| Interferential Laser Therapy | Active comparator | Not described Receives: Device: Interferential Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Visual Analogue Scale during wrist analitical movements.
Measured: 5 minutes
Secondary outcomes (3)
Disability Arm Shoulder and Hand questionnaire (DASH)
Measured: 15 minutes
Boston Carpal Tunnel Questionnaire
Measured: 5 minutes
Dinamometry
Power grip and pinch grip.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2010
- Study completionApr 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Investigators
- Ramon Montes-Molina, PT, MsC, Principal investigator, Unit of PhysiotherapyFidel Martinez-Ruiz, Physicist, Study director, Unit Biomechanics and Biomaterials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093209
- Sponsor's protocol ID
- Ramón y Cajal Hospital
- Status last verified
- Mar 2010
- First submitted
- 24 Mar 2010
- 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
- Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT01093209
- Acronym / sponsor ID
- Ramón y Cajal Hospital
- Conditions
- Carpal Tunnel Syndrome, Neuropathic Pain
- Keywords
- Carpal Tunnel Syndrome, Interferential laser therapy, Low-level laser therapy, Neuropathic pain, Median nerve compression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Mar 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.
The purpose of this study is to determine the efficacy of the interferential laser therapy in the wrist and hand pain and disability reduction and force improvement in the carpal tunnel syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed laser therapy. Settings: Ramon y Cajal Hospital. Department of Rehabilitation. Physical therapy unit. Electrotherapy section. Occupational Therapy. Department of Neurology.
Detailed description
The spatiotemporal superposition of two independent and opposite beams of laser generates a constructive interference pattern that increases the therapeutic effects in the irradiated tissue. Patient suffering pain from diagnosed carpal tunnel syndrome will receive conventional or interferential laser therapy. This is a comparative randomized and double blind clinical study. Two identical lasers in near infrared range will be used. Frequency of sessions: daily. Irradiated technique: manual, contact and punctual. Pain will be evaluated by visual analog scale at rest and during analytical wrist movement. Disability will be evaluated by the DASH and BOSTON questionnaire. Evaluation will take place at pre and post-treatment times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Laser Therapy | Sham comparator | Device: Interferential Laser Therapy |
| Interferential Laser Therapy | Active comparator | Device: Interferential Laser Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed of Carpal Tunnel Syndrome by means of an Electromyography Study.
- Patients with or not previous surgery.
- Patients with an age of 18 years or older.
- Patients having a signed informed consent.
Key exclusion criteria (5 listed)
- Patients with severe hand traumatisms.
- Patients with cervical radiculopathy.
- Patients with Outlet Thoracic Syndrome.
- Patients bearing osteo syntheses material.
- Patients suffering tumoral pathology.
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 |
|---|---|---|
| Interferential Laser TherapyPROCEDURE: Interventional group: Two independents and identical probes. Energy dose per point and per probe: 5 J. Continuous emission. Treatment time:8 minutes. Sessions: 10. Frequency of the sessions: daily. Irradiation technique: handily, in contact and at 7 points over distal pathway of median nerve.Control group: Sham laser:650 nm.Scanning mode.Outpout power:1 mW. | Device | Conventional Laser Therapy, Interferential Laser Therapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 5 minutes
Visual Analogue Scale during wrist analitical movements.
3 secondary outcomes
Disability Arm Shoulder and Hand questionnaire (DASH)
Time frame: 15 minutes
Boston Carpal Tunnel Questionnaire
Time frame: 5 minutes
Dinamometry
Time frame: 5 minutes
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.
Ramon Montes-Molina, PT, MsC principal investigator
Unit of Physiotherapy
Fidel Martinez-Ruiz, Physicist study director
Unit Biomechanics and Biomaterials
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 Interferential Laser Therapy in people with Carpal Tunnel Syndrome and Neuropathic Pain, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 4 inclusion and 5 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 Spain. 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.
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?
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?
Visual Analogue Scale (VAS) (time frame: 5 minutes). 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.