Neurophysiologic AbnormalityCTSLANCT05846958
Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women
A study testing laser acupuncture and night splint in people with Neurophysiologic Abnormality, run by Cairo University at 1 site in Egypt.
Trial summary
BACKGROUND: Carpal tunnel syndrome (CTS), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel CTs is a very common complication found in pregnancy, which is reported as high as 62% in pregnant females. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neurophysiologic Abnormality
- What is being tested?
- laser acupuncture and night splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their BMI will be range from 25 to 30 Kg/m2.
- The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve latency >3.5 ms at third digit, moderate: sensory nerve latency >3.5 ms at third digit and median motor latency>4.2 ms)
- Positive phalen's test.
- Positive tinel's test.
- Carpal tunnel of dominant hand could be participated.
Who cannot join
- History of brachial plexopathy or malignancy.
- Radial, ulnar neuropathy, proximal median neuropathy or polyneuropathy.
- Previous wrist surgery or steroid injection for carpal tunnel syndrome.
- History of trauma, fracture, deformity or inflammation in the wrist, such as rheumatoid arthritis.
- Coagulation abnormalities, pregnancy, fever and infections.
- Skin disease and skin cancer.
- Spots, birthmarks or tattoos over the work points. 8- Pacemaker and implementable medical devices.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Out clinic, Faculty of physical therapy
Dokki, Giza Governorate, 12613
Afaf M Botla, professor, 002701283126608, drafafmohamed@yahoo.com
Manal ElShafei, Lecutrer, 002701220664518, manal.ahmed@cu.edu.eg
About this study
Official title: Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women: A Randomized Controlled Clinical Trial
BACKGROUND: Carpal tunnel syndrome (CTS), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel CTs is a very common complication found in pregnancy, which is reported as high as 62% in pregnant females. The functioning of median nerve is compromised in almost all pregnant females especially during the third trimester of pregnancy, the majority may still feel some symptoms up to 3 years after delivery. Many clinicians have used LLLT on acupuncture points, which is called laser acupuncture (LA), to treat many clinical problems, such as musculoskeletal pain, lateral epicondylitis, headaches, etc. In contrast with traditional acupuncture needles, LA is a non-invasive therapy that does not cause tingling/pain during procedures Objective: to determine efficacy of laser acupuncture on electrophysiological parameters of median nerve in postpartum women
Read the detailed description
Intervention description
- Experimental Group: Each patient in this group will receive laser acupuncture on PC4 (Ximen), PC6 (Neiguan), PC7 (Daling), PC8 (Laogong), LI4 (Hegu), LI10 (Shousanli), LI11 (Quchi), HT3 (Shaohai), HT7 (Shenmen), LU10 (Yuji) acupoints in addition to wearing night splint. LA will be applied to each acupuncture point for 10 s with at least 4J/points based on the recommended LLLT treatment doses for CTS of the World Association of Laser Therapy.
- Control Group:
Each patient in this group will wear night splint every night for 4 weeks
- Conditions
- Neurophysiologic Abnormality
- Being tested
- laser acupuncture, night splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureDevice
Each patient in experimental group will receive laser acupuncture for 10 s with at least 4J/point for each point.10 minutes, three times per week for 4 weeks (total of 12 sessions)
nieght splint for 4 weeks .
night splintDevice
wearing night splint for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| laser acupuncture | Experimental | Each patient in this group will receive laser acupuncture based on the recommended LLLT treatment doses for CTS of the World Association of Laser Therapy. Receives: Device: laser acupuncture; Device: night splint |
| control group | Active comparator | Each patient in this group will wear night splint every night for 4 weeks Receives: Device: night splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory nerve conduction velocity (SNCV) measured in m/s
will be measured at the beginning of the study and at the end of the treatment program througth EMG
Measured: 4 weeks
Secondary outcomes (2)
Hand grip strength in Kg
will be measured at the beginning of the study and at the end of the treatment program using pinch grip dynamometer
Measured: 4 weeks
Symptoms severity and functional capacity (Score)
will be measured at the beginning of the study and at the end of the treatment program using Boston symptoms severity scale (BSSS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Apr 2023
- Primary completion20 Jul 2023 (estimated)
- Study completion28 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurophysiologic AbnormalityStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afaf Mohamed Botla, Cairo University
- Investigators
- Afaf M Botla, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846958
- Sponsor's protocol ID
- Postpartum CTS
- Acronym
- CTSLA
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05846958
- Acronym / sponsor ID
- CTSLA / Postpartum CTS
- Conditions
- Neurophysiologic Abnormality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 28 Jul 2023 (estimated)
- First posted
- 6 May 2023 (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.
BACKGROUND: Carpal tunnel syndrome (CTS), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel CTs is a very common complication found in pregnancy, which is reported as high as 62% in pregnant females. The functioning of median nerve is compromised in almost all pregnant females especially during the third trimester of pregnancy, the majority may still feel some symptoms up to 3 years after delivery. Many clinicians have used LLLT on acupuncture points, which is called laser acupuncture (LA), to treat many clinical problems, such as musculoskeletal pain, lateral epicondylitis, headaches, etc. In contrast with traditional acupuncture needles, LA is a non-invasive therapy that does not cause tingling/pain during procedures Objective: to determine efficacy of laser acupuncture on electrophysiological parameters of median nerve in postpartum women
Detailed description
Intervention description
- Experimental Group: Each patient in this group will receive laser acupuncture on PC4 (Ximen), PC6 (Neiguan), PC7 (Daling), PC8 (Laogong), LI4 (Hegu), LI10 (Shousanli), LI11 (Quchi), HT3 (Shaohai), HT7 (Shenmen), LU10 (Yuji) acupoints in addition to wearing night splint. LA will be applied to each acupuncture point for 10 s with at least 4J/points based on the recommended LLLT treatment doses for CTS of the World Association of Laser Therapy.
- Control Group:
Each patient in this group will wear night splint every night for 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser acupuncture | Experimental | Device: laser acupuncture, Device: night splintEach patient in this group will receive laser acupuncture based on the recommended LLLT treatment doses for CTS of the World Association of Laser Therapy. |
| control group | Active comparator | Device: night splintEach patient in this group will wear night splint every night for 4 weeks |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Their BMI will be range from 25 to 30 Kg/m2.
- The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve latency >3.5 ms at third digit, moderate: sensory nerve latency >3.5 ms at third digit and median motor latency>4.2 ms)
- Positive phalen's test.
- Positive tinel's test.
- Carpal tunnel of dominant hand could be participated.
Key exclusion criteria (7 listed)
- History of brachial plexopathy or malignancy.
- Radial, ulnar neuropathy, proximal median neuropathy or polyneuropathy.
- Previous wrist surgery or steroid injection for carpal tunnel syndrome.
- History of trauma, fracture, deformity or inflammation in the wrist, such as rheumatoid arthritis.
- Coagulation abnormalities, pregnancy, fever and infections.
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 acupunctureEach patient in experimental group will receive laser acupuncture for 10 s with at least 4J/point for each point.10 minutes, three times per week for 4 weeks (total of 12 sessions) nieght splint for 4 weeks . | Device | laser acupuncture |
| night splintwearing night splint for 4 weeks | Device | control group, laser acupuncture |
Primary outcome
sensory nerve conduction velocity (SNCV) measured in m/s
Time frame: 4 weeks
will be measured at the beginning of the study and at the end of the treatment program througth EMG
2 secondary outcomes
Hand grip strength in Kg
Time frame: 4 weeks
Symptoms severity and functional capacity (Score)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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. This study is not recruiting at the moment.
Afaf M Botla, Professor principal investigator
Cairo University
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 night splint in people with Neurophysiologic Abnormality, 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 7 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afaf M Botla, professor (002701283126608, drafafmohamed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory nerve conduction velocity (SNCV) measured in m/s (time frame: 4 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 6 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.