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

NCT07714720 | Not Yet Recruiting DMC

• 1 other identifier: REC/019/25/6332
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Photobiomodulation; Median Nerve; Randomized Controlled Trial; Low-Level Light Therapy; Brain-Derived Neurotrophic Factor; Ultrasonography; Physical Therapy Modalities; Neuronal Plasticity; Carpal Tunnel Syndrome; Nerve Conduction Studies

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Median Nerve Sensory Conduction Velocity at Week 4 and week 8

  Median nerve sensory conduction velocity will be measured in metres per second (m/s) using a standardized nerve conduction study performed by a blinded neurophysiologist. Electrode placement, stimulation distance, equipment settings and skin temperature will be standardized across assessments. Change will be calculated as the Week 4 and 8 value minus the baseline value. A positive change indicates improvement in sensory conduction velocity.

  Baseline, Week 4 and week 8

Secondary Outcomes (8)

• Change From Baseline in Median Nerve Distal Motor Latency

  Baseline, Week 4 and Week 8

• Change From Baseline in Median Nerve Sensory Nerve Action Potential Amplitude

  Baseline, Week 4 and Week 8

• Change From Baseline in Median Nerve Cross-Sectional Area

  Baseline, Week 4 and Week 8

• Change From Baseline in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score

  Baseline, Week 4 and Week 8

• Change From Baseline in Boston Carpal Tunnel Questionnaire Functional Status Scale Score

  Baseline, Week 4 and Week 8

Other Outcomes (1)

• Change From Baseline in Serum Brain-Derived Neurotrophic Factor Concentration

  Baseline, Week 4 and Week 8

Study Arms (2)

Group A - Active PBM + Routine PT

EXPERIMENTAL

830 nm photobiomodulation (200 mW, 46-diode cluster probe, 4 J/cm², continuous wave) applied over the carpal tunnel region (volar wrist), 3 sessions/week for 4 weeks (12 sessions total). Combined with wrist splinting in neutral position (nocturnal) and median nerve gliding exercises (3 × 10 reps twice daily).

Device: Photobiomodulation (Low-Level Laser Therapy); Other: Routine Physiotherapy Programme

Group B - Sham PBM + Routine PT

SHAM COMPARATOR

Identical procedure using a deactivated PBM device (confirmed output \<1 mW by calibrated power meter). Same probe, contact time, and positioning as Group A. Combined with identical routine physiotherapy (wrist splinting + nerve gliding exercises).

Device: Sham Photobiomodulation; Other: Routine Physiotherapy Programme

Interventions

Photobiomodulation (Low-Level Laser Therapy) DEVICE

Photobiomodulation (PBM) delivered using a 46-diode cluster probe at 830 nm wavelength, 200 mW optical output power, continuous wave mode, 4 J/cm² energy density, applied in static contact technique over the carpal tunnel (volar wrist surface, 3-5 cm proximal to distal wrist crease). Application time per session: approximately 200 seconds (\~3.3 minutes). Treatment schedule: 3 sessions per week for 4 consecutive weeks (12 sessions total). Sham device output confirmed \<1 mW by calibrated photodiode power meter.

Also known as: Low-Level Laser Therapy, LLLT, Low-Level Light Therapy, PBMT

Group A - Active PBM + Routine PT

Sham Photobiomodulation DEVICE

Deactivated PBM device identical in external appearance to the active device. Applied using the same 46-diode cluster probe, contact technique, and duration (approximately 200 seconds) as the active arm. Output power confirmed \<1 mW by calibrated photodiode power meter (LaserCheck or equivalent) at baseline, session 6, and session 12 for the first five enrolled participants. No therapeutic light emission occurs.

Group B - Sham PBM + Routine PT

Routine Physiotherapy Programme OTHER

Participants will receive an 4-week routine physiotherapy programme comprising median nerve mobilization, night splinting, and tendon-gliding exercises. Median nerve mobilization will use six sequential positions progressing from wrist-neutral finger/thumb flexion to finger, wrist, and thumb extension, forearm supination, and assisted thumb stretching. Each position will be held for 5 seconds; the sequence will be repeated 10 times, three times daily. A neutral volar wrist splint allowing free finger and thumb movement will be worn nightly for 6-8 hours. Tendon-gliding exercises will include straight hand, hook fist, full fist, tabletop, and straight fist positions. Each position will be held for 5 seconds, with 10 repetitions performed three times daily. A physiotherapist will teach and monitor the programme. Participants will receive illustrated instructions and maintain an adherence diary. Exercises will be modified or stopped if symptoms worsen.

Also known as: Multimodal Physiotherapy Programme, Conventional Physiotherapy, Standard Conservative Physiotherapy

Group A - Active PBM + Routine PT; Group B - Sham PBM + Routine PT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Dr Sajid Mehmood, MS (OMPT)

  University of Lahore

  PRINCIPAL INVESTIGATOR

• Dr Ashfaq Ahmad, PhD

  University of Lahore

  STUDY DIRECTOR

• Dr Umair Ahmed, PhD

  University of Lahore

  STUDY CHAIR

• Dr Ishaq Ahmed, PhD

  University of Lahore

  STUDY CHAIR

Central Study Contacts

Sajid Mehmood, MS (OMPT)

CONTACT

923218486974; drmsajidphy@gmail.com

Dr Ashfaq Ahmad, PhD

CONTACT

923009449192; ashfaq.ahmad@uipt.uol.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to active versus sham allocation. The sham device is identical in appearance to the active device; an opaque probe cover prevents light emission detection. The device emits an identical audible operating tone in both conditions. Sham device thermal output is confirmed \<0.1°C above ambient temperature. Treating physiotherapists are aware of allocation but do not conduct outcome assessments. The outcome assessor and neurophysiologist conducting NCS are blinded throughout.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The de-identified IPD and supporting information will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
• Access Criteria: De-identified IPD and supporting materials will be available to qualified researchers submitting a methodologically sound proposal with a clearly defined scientific purpose. Requests will be reviewed by the Principal Investigator and institutional sponsor. Research ethics approval may be required depending on the proposed analysis. Approved researchers must sign a data-use agreement prohibiting participant re-identification, unauthorized redistribution and use beyond the approved purpose. Data will be provided through a secure repository or encrypted transfer. Requests should be directed to the Principal Investigator using the contact information in this ClinicalTrials.gov record.

Locations

PA (1)