Carpal Tunnel SyndromeNCT07660913
Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome
A study testing Matrix Rhythm Therapy and Conservative Physiotherapy in people with Carpal Tunnel Syndrome, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of matrix rhythm therapy, applied in addition to conventional treatment, on symptom severity, function, grip and pinch strength, and quality of life in patients with carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Matrix Rhythm Therapy and Conservative Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having a diagnosis of unilateral carpal tunnel syndrome confirmed by an orthopedist based on clinical examination and electromyography (EMG) testing.
- Being classified with mild-to-moderate carpal tunnel syndrome severity.
- Having symptoms persisting for at least 12 weeks.
- Having a Mini-Mental State Examination (MMSE) score greater than 24.
- Being literate (able to read and write).
Who cannot join
- History of prior carpal tunnel release surgery.
- History of corticosteroid injection into the affected hand/wrist.
- Having received physiotherapy for carpal tunnel syndrome within the last 6 months.
- Presence of any neurological signs or symptoms in the upper extremity other than carpal tunnel syndrome.
- History of prior surgery in the hand or wrist region due to other conditions.
- Diagnosis of any systemic neurological disease.
- Diagnosis of rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
- Having ongoing pain in the arm or hand due to any other underlying cause.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Bakircay University
Izmir, 35665
Bülent Toğram, +90 232 493 00 00, sbf@bakircay.edu.tr
About this study
Official title: Effectiveness of Matrix Rhythm Therapy on Symptom Severity and Function in Carpal Tunnel Syndrome: A Randomized, Placebo-Controlled, Assessor-Blinded Trial
The purpose of this study is to investigate the effects of matrix rhythm therapy, applied in addition to conventional treatment, on symptom severity, function, grip and pinch strength, and quality of life in patients with carpal tunnel syndrome.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Matrix Rhythm Therapy, Sham Matrix Rhythm Therapy, Conservative Physiotherapy
- 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.
Matrix Rhythm TherapyDevice
Active matrix rhythm therapy applied for 40 minutes per session (10 min paraspinal muscles, 10 min over the flexor retinaculum, 10 min to extensor muscles, and 10 min to flexor muscles), 2 sessions per week for 6 weeks.
Sham Matrix Rhythm TherapyDevice
Placebo application using the Hypervolt 2 Pro device for 40 minutes per session (10 min paraspinal, 10 min flexor retinaculum, 10 min extensors, 10 min flexors), 2 sessions per week for 6 weeks. It mimics the physical vibration and head shape of the matrix rhythm therapy device to maintain blinding.
Conservative PhysiotherapyOther
Participants use a night splint holding the wrist in neutral position. On clinic days, conservative physiotherapy sessions are administered immediately following the active or sham matrix rhythm therapy sessions, 2 days per week for 6 weeks. These supervised sessions include median nerve sliding exercises (3 sets, 5 reps) and passive stretching for wrist flexors/extensors (15-sec hold, 3 sets, 5 reps). In addition to clinical sessions, the same exercise protocol is performed at home twice daily and continued independently up to the 12th-week follow-up. Compliance with both splint wear and home exercises is strictly monitored using participant usage logs and exercise diaries.
| Study group | Role | What they receive |
|---|---|---|
| Matrix Rhythm Therapy Group | Experimental | This group will receive a conventional physiotherapy treatment combined with active matrix rhythm therapy. Receives: Device: Matrix Rhythm Therapy; Other: Conservative Physiotherapy |
| Sham Matrix Rhythm Therapy Group | Sham comparator | This group will receive a conventional physiotherapy treatment combined with a placebo application using the Hypervolt 2 Pro device. Receives: Device: Sham Matrix Rhythm Therapy; Other: Conservative Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks
This scale evaluates the severity of symptoms including pain, numbness, and paresthesia over the past two weeks. It consists of 11 items, each scored on a Likert scale from 1 (no symptoms) to 5 (most severe symptoms). The total score is calculated by dividing the sum of individual item scores by 11. Final scores range from 1 to 5, where higher scores indicate greater symptom severity.
Measured: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Functional Status Scale at 6 and 12 Weeks
This scale assesses hand-related functional limitations during daily activities. It consists of 8 items, each scored on a Likert scale from 1 (no difficulty) to 5 (cannot perform activity at all). The total score is calculated by dividing the sum of individual item scores by 8. Final scores range from 1 to 5, where higher scores indicate greater functional impairment.
Measured: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Secondary outcomes (3)
Change from Baseline in Hand Grip Strength at 6 and 12 Weeks
Measured using a hand dynamometer. The participant is seated with the shoulder adducted at 0 degrees, elbow flexed at 90 degrees, and forearm/wrist in neutral position. The measurement will be repeated three times for the affected hand with 5-second intervals, and the arithmetic mean will be recorded. Higher values indicate greater grip strength measured in kilograms (kg).
Measured: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Change from Baseline in Pinch Strength at 6 and 12 Weeks
Assessed using a pinch gauge to measure tip pinch strength. The participant is seated with the shoulder adducted at 0 degrees, elbow flexed at 90 degrees, and forearm/wrist in neutral position, and asked to squeeze the device with maximum effort using the tips of the thumb and index finger. The measurement will be repeated three times for the affected hand with 5-second intervals, and the arithmetic mean will be recorded. Higher values indicate greater pinch strength measured in kilograms (kg).
Measured: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Change from Baseline in the EQ-5D-5L Index Score at 6 and 12 Weeks
Evaluated using the EuroQol (EQ-5D-5L) scale, which covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels. These responses are converted into a single health-state index score using the country-specific value set. Index scores typically range from less than 0 to 1, where higher scores indicate a better health-related quality of life.
Measured: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomly assigned to either the intervention group or the control group in a 1:1 allocation ratio. To eliminate potential confounding effects on the outcome measures, stratified randomization will be implemented based on the affected hand (dominant vs. non-dominant extremity), ensuring an equal distribution of dominant and non-dominant hand involvement between the two groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ertan Şahinoğlu, PhD, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660913
- Sponsor's protocol ID
- 2963
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Matrix Rhythm Therapy on Symptom Severity and Function in Carpal Tunnel Syndrome: A Randomized, Placebo-Controlled, Assessor-Blinded Trial
- ClinicalTrials.gov ID
- NCT07660913
- Acronym / sponsor ID
- 2963
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- 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 investigate the effects of matrix rhythm therapy, applied in addition to conventional treatment, on symptom severity, function, grip and pinch strength, and quality of life in patients with carpal tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly assigned to either the intervention group or the control group in a 1:1 allocation ratio. To eliminate potential confounding effects on the outcome measures, stratified randomization will be implemented based on the affected hand (dominant vs. non-dominant extremity), ensuring an equal distribution of dominant and non-dominant hand involvement between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Matrix Rhythm Therapy Group | Experimental | Device: Matrix Rhythm Therapy, Other: Conservative PhysiotherapyThis group will receive a conventional physiotherapy treatment combined with active matrix rhythm therapy. |
| Sham Matrix Rhythm Therapy Group | Sham comparator | Device: Sham Matrix Rhythm Therapy, Other: Conservative PhysiotherapyThis group will receive a conventional physiotherapy treatment combined with a placebo application using the Hypervolt 2 Pro device. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having a diagnosis of unilateral carpal tunnel syndrome confirmed by an orthopedist based on clinical examination and electromyography (EMG) testing.
- Being classified with mild-to-moderate carpal tunnel syndrome severity.
- Having symptoms persisting for at least 12 weeks.
- Having a Mini-Mental State Examination (MMSE) score greater than 24.
- Being literate (able to read and write).
Key exclusion criteria (8 listed)
- History of prior carpal tunnel release surgery.
- History of corticosteroid injection into the affected hand/wrist.
- Having received physiotherapy for carpal tunnel syndrome within the last 6 months.
- Presence of any neurological signs or symptoms in the upper extremity other than carpal tunnel syndrome.
- History of prior surgery in the hand or wrist region due to other conditions.
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 |
|---|---|---|
| Matrix Rhythm TherapyActive matrix rhythm therapy applied for 40 minutes per session (10 min paraspinal muscles, 10 min over the flexor retinaculum, 10 min to extensor muscles, and 10 min to flexor muscles), 2 sessions per week for 6 weeks. | Device | Matrix Rhythm Therapy Group |
| Sham Matrix Rhythm TherapyPlacebo application using the Hypervolt 2 Pro device for 40 minutes per session (10 min paraspinal, 10 min flexor retinaculum, 10 min extensors, 10 min flexors), 2 sessions per week for 6 weeks. It mimics the physical vibration and head shape of the matrix rhythm therapy device to maintain blinding. | Device | Sham Matrix Rhythm Therapy Group |
| Conservative PhysiotherapyParticipants use a night splint holding the wrist in neutral position. On clinic days, conservative physiotherapy sessions are administered immediately following the active or sham matrix rhythm therapy sessions, 2 days per week for 6 weeks. These supervised sessions include median nerve sliding exercises (3 sets, 5 reps) and passive stretching for wrist flexors/extensors (15-sec hold, 3 sets, 5 reps). In addition to clinical sessions, the same exercise protocol is performed at home twice daily and continued independently up to the 12th-week follow-up. Compliance with both splint wear and home exercises is strictly monitored using participant usage logs and exercise diaries. | Other | Matrix Rhythm Therapy Group, Sham Matrix Rhythm Therapy Group |
Primary outcome
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks
Time frame: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
This scale evaluates the severity of symptoms including pain, numbness, and paresthesia over the past two weeks. It consists of 11 items, each scored on a Likert scale from 1 (no symptoms) to 5 (most severe symptoms). The total score is calculated by dividing the sum of individual item scores by 11. Final scores range from 1 to 5, where higher scores indicate greater symptom severity.
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Functional Status Scale at 6 and 12 Weeks
Time frame: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
This scale assesses hand-related functional limitations during daily activities. It consists of 8 items, each scored on a Likert scale from 1 (no difficulty) to 5 (cannot perform activity at all). The total score is calculated by dividing the sum of individual item scores by 8. Final scores range from 1 to 5, where higher scores indicate greater functional impairment.
3 secondary outcomes
Change from Baseline in Hand Grip Strength at 6 and 12 Weeks
Time frame: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Change from Baseline in Pinch Strength at 6 and 12 Weeks
Time frame: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Change from Baseline in the EQ-5D-5L Index Score at 6 and 12 Weeks
Time frame: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matrix Rhythm Therapy and Conservative Physiotherapy in people with Carpal Tunnel Syndrome, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 8 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ertan Şahinoğlu, PhD (+90 232 493 00 00 ext. 14101, ertan.sahinoglu@bakircay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks (time frame: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)). The study lists 2 primary outcomes in all. 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 8 Jul 2026.