Photobiomodulation for Median Nerve Neuroplasticity in Carpal Tunnel Syndrome: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Lahore

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Photobiomodulation (Low-Level Laser Therapy)
  • Sham Photobiomodulation
  • Routine Physiotherapy Programme

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators