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Effect of Combined Focused Extracorporeal Shockwave Therapy and High-Intensity Laser Therapy versus Monotherapy in Carpal Tunnel Syndrome

Effect of Combined Focused Extracorporeal Shockwave Therapy and High-Intensity Laser Therapy versus Monotherapy in Carpal Tunnel Syndrome: A Randomized Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260127002
Enrollment
36
Registered
2026-01-27
Start date
2026-05-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carpal tunnel syndrome of all severity levels, classified by electrophysiological findings Carpal Tunnel Syndrome Median Nerve Peripheral Nervous System Diseases Extracorporeal Shockwave Therapy Laser Therapy, High-Intensity Rehabilitation Pain Management Electrodiagnosis

Interventions

Participants receive both focused extracorporeal shockwave therapy (ESWT) and high-intensity laser therapy (HILT) in the same treatment session once weekly for five consecutive weeks. All procedures a
Experimental Device,Active Comparator Device,Active Comparator Device
Combined Focused Extracorporeal Shockwave Therapy and High-Intensity Laser Therapy,Focused Extracorporeal Shockwave Therapy with Sham Laser,High-Intensity Laser Therapy with Sham ESWT

Sponsors

Phayao Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older. 2. Presenting with clinical symptoms such as numbness, pain, or weakness of the hand or fingers. 3. At least one positive physical examination test including Phalens test, Carpal compression test also known as Durkans test, or Tinels sign. 4. Diagnosis confirmed by electrodiagnostic testing according to the American Association of Neuromuscular and Electrodiagnostic Medicine criteria covering all severity levels mild, moderate, and severe. 5. Symptom duration not exceeding 36 months.

Exclusion criteria

Exclusion criteria: 1. History of carpal tunnel release surgery or corticosteroid injection within the past 6 months. 2. Presence of other conditions that may mimic carpal tunnel syndrome, such as cervical radiculopathy or polyneuropathy. 3. Pregnancy. 4. Systemic diseases affecting peripheral nerves, such as diabetes mellitus, rheumatoid arthritis, systemic lupus erythematosus (SLE), or vasculitis. 5. Bleeding disorders or current use of anticoagulant therapy. 6. Presence of a cardiac pacemaker.

Design outcomes

Primary

MeasureTime frame
Symptom severity score at baseline, at week 5, and at weeks 8, 12, and 24 during follow-up Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire (BCTQ)

Secondary

MeasureTime frame
Functional status score at baseline, at week 5, and at weeks 8, 12, and 24 during follow-up Functional Status Scale of the Boston Carpal Tunnel Questionnaire (BCTQ),Pain intensity at baseline, at week 5, and at weeks 8, 12, and 24 during follow-up Visual Analog Scale (VAS) for wrist and hand pain,Numbness intensity at baseline, at week 5, and at weeks 8, 12, and 24 during follow-up Visual Analog Scale (VAS) for hand numbness,Responder rate at week 8 after completion of treatment Proportion of participants achieving at least 5.5-point (MCID) and 8.9-point reduction in BCTQ-SSS,Durability of treatment effect at weeks 8, 12, and 24 during follow-up Maintenance of BCTQ-SSS improvement at MCID threshold from post-treatment through week 24,Subgroup analysis in severe CTS at baseline, at week 5, and at weeks 8, 12 and 24 during follow-up Change in BCTQ-SSS among participants with severe CTS according to AANEM electrodiagnostic criteria

Countries

Thailand

Contacts

Public ContactThiti Thoowadaratrakool

Medical Education Center, Phayao Hospital

thiti387@gmail.com054409300

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026