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

Primary Purpose

Neurophysiologic Abnormality

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser acupuncture
night splint
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurophysiologic Abnormality

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Out clinic, Faculty of physical therapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

laser acupuncture

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)

Full Information

First Posted
April 6, 2023
Last Updated
April 26, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05846958
Brief Title
Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women
Acronym
CTSLA
Official Title
Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
July 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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. Control Group: Each patient in this group will wear night splint every night for 4 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurophysiologic Abnormality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Each patient in this group will wear night splint every night for 4 weeks
Intervention Type
Device
Intervention Name(s)
laser acupuncture
Intervention Description
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
Intervention Name(s)
night splint
Intervention Description
wearing night splint for 4 weeks
Primary Outcome Measure Information:
Title
sensory nerve conduction velocity (SNCV) measured in m/s
Description
will be measured at the beginning of the study and at the end of the treatment program througth EMG
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Hand grip strength in Kg
Description
will be measured at the beginning of the study and at the end of the treatment program using pinch grip dynamometer
Time Frame
4 weeks
Title
Symptoms severity and functional capacity (Score)
Description
will be measured at the beginning of the study and at the end of the treatment program using Boston symptoms severity scale (BSSS)
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postpartum women with mild to moderate carpal tunnel syndrome will participate in this study
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afaf M Botla, professor
Phone
002701283126608
Email
drafafmohamed@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manal A ElShafei, Lecturer
Phone
002701220664518
Email
manal.ahmed@cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afaf M Botla, Professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Out clinic, Faculty of physical therapy
City
Dokki
State/Province
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afaf M Botla, professor
Phone
002701283126608
Email
drafafmohamed@yahoo.com
First Name & Middle Initial & Last Name & Degree
Manal ElShafei, Lecutrer
Phone
002701220664518
Email
manal.ahmed@cu.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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