Clinical trial NCT05846958: Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women
Official title: Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurophysiologic Abnormality
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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

1. 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.
2. Control Group:

Each patient in this group will wear night splint every night for 4 weeks

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: sensory nerve conduction velocity (SNCV) measured in m/s
timeFrame: 4 weeks
Secondary outcomes:
measure: Hand grip strength in Kg
timeFrame: 4 weeks
measure: Symptoms severity and functional capacity (Score)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Out clinic, Faculty of physical therapy
state: Giza
Study officials:
affiliation: Cairo University
name: Afaf M Botla, Professor
role: PRINCIPAL_INVESTIGATOR
References: