Efficacy of Laser Acupuncture on Carpal Tunnel Syndrome Following Hand Flexor Tendon Repair

NCT07014774 | Not Yet Recruiting

• 2 other identifiers: Mahmoud-005745Internal2025-Tendon
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of laser acupuncture in alleviating CTS symptoms following flexor tendon repair in the hand.

Conditions

Laser Acupuncture; Flexor Tendon Repair; Hand Surgery; Carpal Tunnel Syndrome (CTS)

Outcome Measures

Primary Outcomes (1)

• Symptom Relief:

  Measured by the Visual Analog Scale (VAS) for pain, numbness, and tingling.

  At baseline and after 8 weeks

Secondary Outcomes (2)

• - Grip Strength:

  Measured at baseline and at the end of the intervention (8 weeks).

• - Nerve Conduction Velocity (NCV):

  baseline and 8 weeks.

Study Arms (2)

Laser acupuncture

EXPERIMENTAL

This group includes 30 patients who have had flexor tendon repair surgery and will receive laser acupuncture inform of acupuncture points associated with the median nerve pathway in addition to traditional physical therapy. Patients will receive 3 sessions per week for 8 weeks; each laser acupuncture session lasts 12 minutes, laser applied directly to 12 acupuncture points each point 60 seconds.

Device: Laser acupuncture; Other: Traditional Therapy

Traditional therapy

ACTIVE COMPARATOR

This group includes 30 patients who have had flexor tendon repair surgery and will receive standard postoperative care including physical therapy and medical treatment as needed. Patients will receive 3 sessions per week for 8 weeks; the time of session is 30 minutes according to patient ability.

Other: Traditional Therapy

Interventions

Laser acupuncture DEVICE

Laser acupuncture is a modern, non-invasive approach to acupuncture that uses low-level laser therapy (LLLT) instead of traditional needles to stimulate acupuncture points. This technique combines the principles of traditional Chinese medicine with modern technology to provide pain relief and promote healing (Chon et al., 2019). * Device: UNIPHY PHYACTION 740, made in EEC device. * Laser type: Gallium aluminum arsenide laser. * Wavelength: 808 nm. * Power Output: 200 mW. * Dose/energy density: 4J/point. * Frequency of treatment: Three times weekly for 8 weeks. * Duration: 12 min. * Cumulative dose: 48J/point. * Target Acupuncture Points: Key points for CTS: PC4 (Ximen), PC6 (Neiguan), PC7 (Daling), PC8 (Laogong), LI4 (Hegu), LI10 (Shousanli), LI11 (Quchi), HT-2 (Qingling), HT7 (Shenmen), HT-8 (Shaofu), LU9 (Taiyuan) and LU10 (Yuji)

Laser acupuncture

Traditional Therapy OTHER

* Splinting/Bracing: Patients in the two groups will advised to wear a static wrist splint locked at 0\_ wrist flexion for at least 8 h at night throughout the entire length of the study as the primary management which reduce pressure on the median nerve. * Physical Therapy: Engaging in specific exercises, such as nerve glide exercises and wrist stretches, can improve mobility and reduce symptoms. These exercises aim to restore normal movement of the median nerve and alleviate compression

Laser acupuncture; Traditional therapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 20-40 years who have undergone flexor tendon repair surgery.
• Patients who have undergone primary or secondary repair of flexor tendons in the hand at zone 4 (zone of carpal tunnel as it often be complicated by postoperative adhesions due to close quarters and synovial sheath of the carpal tunnel) (Fulchignoni C et al., 2020).
• Patient have clinical and electro diagnostic evidence of CTS.
• All patients enrolled to the study will have their informed consent.

You may not qualify if:

• Pre-existing neurological disorders.
• Systemic illnesses affecting nerve function (e.g., diabetes).
• Contraindications to laser therapy.
• Pregnancy or breastfeeding.
• Active infections or open wounds in the hand or wrist.
• Previous history of carpal tunnel release surgery or received an injection of steroid for CTS.
• Previous history of brachial plexus injury or median nerve injury.
• Other severe neurological or musculoskeletal conditions.
• Epilepsy or any psychological disorders.
• Cancer.
• Spots over the treated points.
• Pacemaker or implanted devices.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Learning Hospitals Al Kaser Al Ayni Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Central Study Contacts

Mahmoud Adel Abde-Hakim Amin, Physical Therapist

CONTACT

+201002737990; Dr.Mahmoud.A.Hakim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 15, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)