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

NCT ID: NCT05846958

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-07-28

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

Conditions

Neurophysiologic Abnormality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

laser acupuncture

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.

Group Type: EXPERIMENTAL

laser acupuncture

Intervention Type: 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 .

night splint

Intervention Type: DEVICE

wearing night splint for 4 weeks

control group

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

Group Type: ACTIVE_COMPARATOR

night splint

Intervention Type: DEVICE

wearing night splint for 4 weeks

Interventions

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 .

Intervention Type: DEVICE

night splint

wearing night splint for 4 weeks

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Afaf Mohamed Botla

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Afaf M Botla, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Out clinic, Faculty of physical therapy

Dokki, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Afaf M Botla, professor

Role: CONTACT

drafafmohamed@yahoo.com

002701283126608

Manal A ElShafei, Lecturer

Role: CONTACT

manal.ahmed@cu.edu.eg

002701220664518

Facility Contacts

Afaf M Botla, professor

Role: primary

drafafmohamed@yahoo.com

002701283126608

Manal ElShafei, Lecutrer

Role: backup

manal.ahmed@cu.edu.eg

002701220664518

Other Identifiers

Postpartum CTS

Identifier Type: -

Identifier Source: org_study_id