An interventional study of Photobiomodulation (Low-Level Laser Therapy) and Sham Photobiomodulation in Carpal Tunnel Syndrome (CTS), sponsored by University of Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by University of Lahore · Not applicable, Interventional, and Treatment
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Among 25 studies in Carpal Tunnel Syndrome with a site in Pakistan — 4 open to participants now, 6 under way, none of them phase 3. Carpal Tunnel Syndrome · Pakistan.
Among the 25 studies in Carpal Tunnel Syndrome with a site in Pakistan, this one is the 2nd largest by planned enrollment of the 21 interventional ones that give a count, is one of 3 that started in 2026, is one of 20 with no phase, and was the 24th registered.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
Browse Carpal Tunnel Syndrome studies →4 of the 25 studies in Carpal Tunnel Syndrome with a site in Pakistan are open now. Recruiting first, the newest first:
Ibadat International University, Islamabad · Sites in Pakistan
Ages 18–45
Riphah International University · Sites in Pakistan
Ages 20–45
Combined Military Hospital Kohat Pakistan · Sites in Pakistan
Ages 18+
A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →
Of the 73 Carpal Tunnel Syndrome studies recruiting now, 27 (37%) set no upper age limit and 37 (51%) stop at 75 or younger; 1 takes children under 18; 10 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
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25 studies; the count open now beside each. This study's row is marked.
First in 2021; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 70 is above the median of 60 across 444 interventional studies indexed under Carpal Tunnel Syndrome.
Median enrollment 48 across the 21 interventional studies, 123 across the 4 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.
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None of the 25 has an industry lead sponsor. The 10 most frequent:
University of Lahore is the lead sponsor of 234 studies on the registry; 43 are open to participants now.
University of Lahore has 2 studies filed under Carpal Tunnel Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Carpal Tunnel Syndrome with a site in Pakistan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07714720University of LahorePhotobiomodulation for Median Nerve Neuroplasticity in Carpal Tunnel Syndrome: A Randomized Controlled Trial | 2027-05-15 |
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Among the 25 studies in Carpal Tunnel Syndrome with a site in Pakistan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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).
Carpal tunnel syndrome is a compressive neuropathy of the median nerve associated with focal demyelination, impaired axonal transport, intraneural oedema, pain, sensory disturbance and functional limitation. Although conservative treatments can reduce symptoms, the physiological and structural processes accompanying median nerve recovery remain insufficiently characterized.
Photobiomodulation delivers non-thermal red or near-infrared light to biological tissue. Its proposed effects include modulation of mitochondrial activity, cellular energy production, oxidative signalling and inflammatory responses. Experimental evidence also suggests potential effects on Schwann-cell activity, axonal repair and neurotrophic signalling. However, clinical studies of photobiomodulation for carpal tunnel syndrome have generally been limited by small samples, heterogeneous treatment parameters and reliance on symptomatic outcomes without integrated assessment of nerve physiology, morphology and molecular responses.
This study will investigate whether adjunctive 830-nm photobiomodulation produces greater median nerve recovery than sham photobiomodulation when both groups receive the same routine physiotherapy. The primary hypothesis is that active photobiomodulation will produce greater improvement in median nerve sensory conduction velocity at the end of the four-week intervention. Follow-up assessment will examine whether any observed effect is maintained after treatment completion.
Electrophysiological testing will characterize changes in median nerve function, while high-resolution ultrasonography will assess structural changes in the nerve. Serum brain-derived neurotrophic factor will be evaluated as an exploratory circulating biomarker and will not be interpreted as a specific standalone measure of median nerve neuroplasticity. Patient-reported symptoms, functional status, pain and hand strength will be assessed to determine the clinical relevance of any physiological or structural changes.
By integrating electrophysiological, ultrasonographic, clinical and exploratory molecular measurements, the study aims to clarify whether the symptomatic effects of photobiomodulation are accompanied by objective evidence of median nerve recovery. The findings may help refine outcome selection and treatment parameters for future confirmatory trials.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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
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.
Time frame: Baseline, Week 4 and week 8
Change From Baseline in Median Nerve Distal Motor Latency
Median nerve distal motor latency will be measured in milliseconds (ms) using a standardized nerve conduction study, with stimulation at the wrist and recording from the abductor pollicis brevis muscle. The same stimulation distance, electrode placement, equipment settings and skin-temperature controls will be used at each assessment. Change will be calculated as the follow-up value minus the baseline value. A negative change indicates reduced latency and improved motor conduction.
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Median Nerve Sensory Nerve Action Potential Amplitude
Median nerve sensory nerve action potential amplitude will be measured in microvolts (µV) using a standardized nerve conduction study performed by a blinded neurophysiologist. The same recording technique and equipment settings will be used at each assessment. Change will be calculated as the follow-up value minus the baseline value. A positive change indicates an increase in sensory response amplitude.
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Median Nerve Cross-Sectional Area
The cross-sectional area of the median nerve will be measured in square millimetres (mm²) using high-resolution ultrasonography at the carpal tunnel inlet at the level of the pisiform. The nerve will be traced within the hyperechoic epineurial border. Three measurements will be obtained and averaged at each assessment. The same anatomical level, participant position, ultrasound settings and blinded assessor will be used throughout the study. Change will be calculated as the follow-up value minus the baseline value. A negative change indicates a reduction in median nerve enlargement.
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score
Symptom severity will be assessed using the 11-item Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire. Each item is scored from 1 to 5, and the subscale score is calculated as the mean of the completed items. Total subscale scores range from 1 to 5, with higher scores indicating more severe symptoms. Change will be calculated as the follow-up score minus the baseline score. A negative change indicates improvement
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Boston Carpal Tunnel Questionnaire Functional Status Scale Score
Functional status will be assessed using the 8-item Functional Status Scale of the Boston Carpal Tunnel Questionnaire. Each item is scored from 1 to 5, and the subscale score is calculated as the mean of the completed items. Total subscale scores range from 1 to 5, with higher scores indicating greater functional limitation. Change will be calculated as the follow-up score minus the baseline score. A negative change indicates improvement.
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Pain Intensity Measured Using the Visual Analogue Scale
Pain intensity will be measured using a 100-mm horizontal Visual Analogue Scale, ranging from 0 mm, representing no pain, to 100 mm, representing the worst imaginable pain. Change will be calculated as the follow-up score minus the baseline score. A negative change indicates reduced pain intensity.
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Handgrip Strength
Handgrip strength of the affected hand will be measured in kilograms (kg) using a Jamar hydraulic hand dynamometer and standardized positioning. Three trials will be performed with a standardized rest period between trials, and the mean of the three measurements will be used for analysis. Change will be calculated as the follow-up value minus the baseline value. A positive change indicates improved grip strength.
Time frame: Baseline, Week 4 and Week 8
Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be recorded from the first intervention session through the final follow-up assessment. Events will include, but will not be limited to, increased wrist or hand pain, skin irritation, erythema, burning sensation, altered sensation, headache or any other unfavorable medical occurrence. The number and percentage of participants experiencing one or more adverse events will be reported for each intervention group.
Time frame: From the first intervention session through Week 8
Change From Baseline in Serum Brain-Derived Neurotrophic Factor Concentration
Serum brain-derived neurotrophic factor concentration will be measured in picograms per millilitre (pg/mL) using a standardized enzyme-linked immunosorbent assay. Blood collection time, clotting duration, centrifugation, storage temperature, freeze-thaw exposure and assay procedures will be standardized across assessments. Samples from both intervention groups will be analysed in the same assay batches where feasible. Change will be calculated as the follow-up concentration minus the baseline concentration. This outcome will be interpreted as an exploratory circulating biomarker and not as a specific standalone measure of median nerve neuroplasticity.
Time frame: Baseline, Week 4 and Week 8
Plan to share: Yes — De-identified individual participant data underlying the published results will be shared. These data will include coded participant identifiers, treatment allocation, baseline demographic and clinical characteristics, treatment attendance and adherence, nerve conduction measurements, median nerve cross-sectional area, serum BDNF concentration, BCTQ symptom and functional scores, pain intensity, grip strength, adverse events and missing-data indicators at baseline, Week 4 and Week 8. Derived analysis variables and a data dictionary will also be provided. Names, contact information, exact dates, signed consent forms, biological samples and other potentially identifying information will not be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for May 2027, 9 months later.
Of 251 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 9 months is below that.
Counting every sponsor, half of 261 studies reached it within 12 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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