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

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

Study Overview

• Status: Recruiting
• Conditions: Neurophysiologic Abnormality
• Intervention / Treatment: Device: laser acupuncture; Device: night splint

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Afaf M Botla, professor; Phone Number: 002701283126608; Email: drafafmohamed@yahoo.com
• Study Contact Backup: Name: Manal A ElShafei, Lecturer; Phone Number: 002701220664518; Email: manal.ahmed@cu.edu.eg

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12613
      • Recruiting
      • Out clinic, Faculty of physical therapy
      • Contact: Afaf M Botla, professor; Phone Number: 002701283126608; Email: drafafmohamed@yahoo.com
      • Contact: Manal ElShafei, Lecutrer; Phone Number: 002701220664518; Email: manal.ahmed@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 .; Device: night splint; wearing night splint for 4 weeks
Active Comparator: control group; Each patient in this group will wear night splint every night for 4 weeks	Device: night splint; wearing night splint for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Afaf M Botla, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): July 20, 2023
• Study Completion (Anticipated): July 28, 2023

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 8, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Postpartum CTS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No