Photobiomodulation for Median Nerve Neuroplasticity in Carpal Tunnel Syndrome: A Randomized Contr… (NCT07714720) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Photobiomodulation for Median Nerve Neuroplasticity in Carpal Tunnel Syndrome: A Randomized Controlled Trial
Pakistan70 participantsStarted 2026-08-15
Plain-language summary
Carpal Tunnel Syndrome (CTS) is the most common peripheral entrapment neuropathy, causing pain, paresthesia, and hand dysfunction due to median nerve compression at the wrist. While physiotherapy provides symptom relief, it does not effectively address the underlying neuroplastic deficits of the median nerve. Photobiomodulation (PBM), delivered at 830 nm near-infrared wavelength, has shown potential to enhance peripheral nerve regeneration via cytochrome c oxidase activation, ATP synthesis, and upregulation of neurotrophic factors including brain-derived neurotrophic factor (BDNF). This randomized controlled trial will evaluate whether 830 nm PBM (200 mW, 4 J/cm², 12 sessions over 4 weeks) combined with routine physiotherapy produces significantly greater neuroplastic recovery of the median nerve - assessed by high-resolution ultrasound (HRUS) measurement of median nerve cross-sectional area (CSA), nerve conduction study parameters and serum BDNF - compared to sham PBM combined with identical physiotherapy in adults with mild-to-moderate CTS. Neuroplasticity was operationalised as a multimodal construct comprising: (1) functional recovery, indexed by nerve conduction study parameters; (2) structural remodelling, indexed by median nerve cross-sectional area on high-resolution ultrasound; and (3) molecular neuroplastic signalling, indexed by serum BDNF. This multimodal approach was adopted because no single measure captures the full construct of peripheral nerve neuroplasticity (Padua et al., 2020).
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Age 18-60 years
* Clinical diagnosis of unilateral mild-to-moderate carpal tunnel syndrome based on positive Phalen test and/or Tinel sign
* Electrophysiological confirmation of CTS via nerve conduction study (NCS) meeting AANEM 2012 diagnostic criteria for mild-to-moderate CTS
* No prior photobiomodulation or laser therapy to the affected wrist within the preceding 3 months
* Ability to attend 3 treatment sessions per week for 4 consecutive weeks
* Able and willing to provide written informed consent (in Urdu or English)
Exclusion Criteria
* Bilateral carpal tunnel syndrome
* Previous surgical release of the carpal tunnel on the affected side
* Systemic peripheral neuropathy (e.g., diabetes mellitus, hypothyroidism, Charcot-Marie-Tooth disease)
* Pregnancy or breastfeeding
* Implanted cardiac pacemaker, defibrillator, or other active electronic implant
* Active malignancy at or near the treatment site
* Current use of photosensitising medications (e.g., tetracyclines, amiodarone, psoralens)
* Corticosteroid injection into the carpal tunnel within the preceding 3 months
* Rheumatoid arthritis or other inflammatory joint disease affecting the wrist
* Open wounds, acute skin infection, or tattooed skin at the treatment site
* Inability to attend 3 sessions per week for 4 weeks
* Severe CTS confirmed by NCS (complete sensory or motor axon loss)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Median Nerve Sensory Conduction Velocity at Week 4 and week 8