Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women

Neurophysiologic Abnormality Clinical Trial

— CTSLA  

Official title:

Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846958
• Other study ID #: Postpartum CTS
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: July 28, 2023

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: Afaf M Botla, professor
• Phone: 002701283126608
• Email: drafafmohamed[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 28, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Neurophysiologic Abnormality

Intervention

Device:
• laser acupuncture
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 splint
wearing night splint for 4 weeks

Locations

Country	Name	City	State
Egypt	Out clinic, Faculty of physical therapy	Dokki	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Secondary	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	4 weeks
Secondary	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)	4 weeks