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

NCT05846958 | Unknown

• 1 other identifier: Postpartum CTS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Neurophysiologic Abnormality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hand grip strength in Kg

  4 weeks

• Symptoms severity and functional capacity (Score)

  4 weeks

Study Arms (2)

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.

Device: laser acupuncture; Device: night splint

control group

ACTIVE COMPARATOR

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

Device: night splint

Interventions

laser acupuncture DEVICE

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 .

laser acupuncture

night splint DEVICE

wearing night splint for 4 weeks

control group; laser acupuncture

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Postpartum women with mild to moderate carpal tunnel syndrome will participate in this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Out clinic, Faculty of physical therapy

Dokki, Giza Governorate, 12613, Egypt

RECRUITING

Study Officials

• Afaf M Botla, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Afaf M Botla, professor

CONTACT

002701283126608; drafafmohamed@yahoo.com

Manal A ElShafei, Lecturer

CONTACT

002701220664518; manal.ahmed@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 6, 2023
• Study Start: April 1, 2023
• Primary Completion: July 20, 2023
• Study Completion: July 28, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

EG (1)