Laser AcupunctureLASERNCT07014774
Efficacy of Laser Acupuncture on Carpal Tunnel Syndrome Following Hand Flexor Tendon Repair
A study testing Laser acupuncture and Traditional Therapy in people with Laser Acupuncture and Flexor Tendon Repair, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Laser Acupuncture, Flexor Tendon Repair, Hand Surgery
- What is being tested?
- Laser acupuncture and Traditional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
- Surgery occurred within a specific timeframe, often within 6-12 weeks prior to inclusion (Peters SE, Jha B, Ross M., 2021).
- Patient have clinical and electro diagnostic evidence of CTS.
- All patients enrolled to the study will have their informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Learning Hospitals Al Kaser Al Ayni Hospitals
Cairo
Mahmoud Adel Abdel-Hakim Amin, Physical Therapist, +201002737990, Dr.Mahmoud.A.Hakim@gmail.com
About this study
The purpose of this study is to determine the efficacy of laser acupuncture in alleviating CTS symptoms following flexor tendon repair in the hand.
Read the detailed description
This study holds significant importance for clinical practice, patient care, and research.
- Clinical Practice: It provides a potential framework for physical therapists to design targeted and effective interventions for laser acupuncture on CTS following flexor tendon repair in the hand.
- Patient Care: Improved rehabilitation outcomes can enhance patients' physical functionality, independence, and overall quality of life, addressing a critical gap in post-operative complications.
- Research Advancement: By contributing to the limited body of literature on laser acupuncture in this context, the study can stimulate further research and innovation in carpal tunnel syndrome following hand flexor tendon repair.
- Being tested
- Laser acupuncture, Traditional Therapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureDevice
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)
Traditional TherapyOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Relief:
Measured by the Visual Analog Scale (VAS) for pain, numbness, and tingling.
Measured: At baseline and after 8 weeks
Secondary outcomes (2)
- Grip Strength:
Measured with a hand dynamometer to assess the strength of hand muscles.
Measured: Measured at baseline and at the end of the intervention (8 weeks).
- Nerve Conduction Velocity (NCV):
Measured to assess median nerve conduction before and after the intervention
Measured: baseline and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser AcupunctureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Adel Abdel-Hakim Amin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014774
- Sponsor's protocol ID
- Mahmoud-005745
- Other IDs
- Internal2025-Tendon
- Acronym
- LASER
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser Acupuncture on Carpal Tunnel Syndrome Following Hand Flexor Tendon Repair
- ClinicalTrials.gov ID
- NCT07014774
- Acronym / sponsor ID
- LASER / Mahmoud-005745
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of laser acupuncture in alleviating CTS symptoms following flexor tendon repair in the hand.
Detailed description
This study holds significant importance for clinical practice, patient care, and research.
- Clinical Practice: It provides a potential framework for physical therapists to design targeted and effective interventions for laser acupuncture on CTS following flexor tendon repair in the hand.
- Patient Care: Improved rehabilitation outcomes can enhance patients' physical functionality, independence, and overall quality of life, addressing a critical gap in post-operative complications.
- Research Advancement: By contributing to the limited body of literature on laser acupuncture in this context, the study can stimulate further research and innovation in carpal tunnel syndrome following hand flexor tendon repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture | Experimental | Device: Laser acupuncture, Other: Traditional TherapyThis 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. |
| Traditional therapy | Active comparator | Other: Traditional TherapyThis 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
- Surgery occurred within a specific timeframe, often within 6-12 weeks prior to inclusion (Peters SE, Jha B, Ross M., 2021).
- Patient have clinical and electro diagnostic evidence of CTS.
- All patients enrolled to the study will have their informed consent.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupunctureLaser 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) | Device | Laser acupuncture |
| Traditional Therapy* 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 | Other | Laser acupuncture, Traditional therapy |
Primary outcome
Symptom Relief:
Time frame: At baseline and after 8 weeks
Measured by the Visual Analog Scale (VAS) for pain, numbness, and tingling.
2 secondary outcomes
- Grip Strength:
Time frame: Measured at baseline and at the end of the intervention (8 weeks).
- Nerve Conduction Velocity (NCV):
Time frame: baseline and 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture and Traditional Therapy in people with Laser Acupuncture and Flexor Tendon Repair, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Adel Abde-Hakim Amin, Physical Therapist (+201002737990, Dr.Mahmoud.A.Hakim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Relief: (time frame: At baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.