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Effect of Low Level Laser Therapy Versus Pulsed Ultrasound

Primary Purpose

Carpal Tunnel Syndrome, POSTPARTUM CARPAL TUNNEL SYNDROME

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low level laser therapy
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postpartum women with mild to moderate carpal tunnel syndrome will participate in this study. Their ages will range from 25 to 35 years old. Their BMI will be ranged from 25 to 30 Kg/m2. The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve conduction velocity slow on finger/wrist measurement, sensory nerve latency >3.5 ms, normal terminal motor latency; moderate: sensory potential preserved with motor slowing, distal motor latency to abductor pollicis brevis (APB) < 6.5 ms) (Bland, 2000 and Dumitru and Zwarts, 2002). Positive phalen's test. Positive tinel's test. Unilateral or bilateral carpal tunnel affection will be included. 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. Pacemaker and implementable medical devices.

Sites / Locations

  • Faculty of Physical Therapy - Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Group (A) (Study group A)

Group (B) (study group B)

Group (C) (control):

Arm Description

It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive low level laser therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices.

It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive pulsed ultrasound therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices

It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive wrist exercises (strengthening exercises for thenar muscles, wrist flexors. Extensors, grip strengthening, stretching, nerve glide, neurodynamic technique and tendon glide) for 15 minutes, three times per week for 4 weeks (total of 12 sessions) and home advices only.

Outcomes

Primary Outcome Measures

Pain Intensity
measure pain intensity for each woman in all groups (A, B and C). The VAS is usually presented as a 10-cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability and validity, as well as its ratio scale properties make the VAS the optimal tool for describing pain intensity

Secondary Outcome Measures

Full Information

First Posted
June 1, 2023
Last Updated
August 24, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05904561
Brief Title
Effect of Low Level Laser Therapy Versus Pulsed Ultrasound
Official Title
Effect of Low Level Laser Therapy Versus Pulsed Ultrasound on Postpartum Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

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

5. Study Description

Brief Summary
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 was clinically diagnosed in more than half of women (62%). Neurophysiological evaluation diagnosed that CTs in around half of women (43%) was positive in one hand at least, also, it was reported that about half of women with CTs during pregnancy still complained of CTs symptoms one year after delivery.
Detailed Description
Carpal tunnel syndrome pain and discomfort during postpartum period may interfere with the mother ability to successfully breastfeed due to increased physical load on the mother's hands and repetitive need for flexion during breastfeeding and carrying of the baby. Observation of peripheral oedema in about 80% of pregnant women, especially in the period of third trimester is common, it is due to hormonal changes that cause reduction of venous return, fluid retention which decrease the carpal tunnel diameter and increase compression of the median nerve. Also, increase production of relaxin hormone leads to relaxation of the transverse carpal ligament and flattening of it that increase compression of the median nerve. Symptoms of CTs differ from tingling, numbness and palmar side pain in radial 3.5 fingers. Typically, at night, patients are awakened by a numb hand. Complaints like decrease in hand strength, difficulty of holding things and dropping are common. Sensory distribution, median nerve hypoesthesia, positive provocative tests and atrophy or weakness of the thenar muscles may be shown in physical examination. Nerve conduction study (NCS) has been showed as the gold standard in the diagnosis of CTs since it provides information about the physiological health of median nerve over the carpal tunnel. NCS measures sensory and motor nerve action potential which determines the severity of nerve entrapment. Conservative treatment of CTs includes; local steroid injection, non-steroidal anti-inflammatory drugs, splinting, modification of activity, physical therapy modalities like ultrasound, low level laser therapy and stretching exercises. Low level Laser therapy (LLLT) has analgesic and anti- inflammatory effect. Also, LLL improves the metabolic processes and increases protein synthesis that improves blood flow, blood vessel health and cell regeneration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, POSTPARTUM CARPAL TUNNEL SYNDROME

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (A) (Study group A)
Arm Type
Active Comparator
Arm Description
It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive low level laser therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices.
Arm Title
Group (B) (study group B)
Arm Type
Experimental
Arm Description
It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive pulsed ultrasound therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices
Arm Title
Group (C) (control):
Arm Type
Active Comparator
Arm Description
It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive wrist exercises (strengthening exercises for thenar muscles, wrist flexors. Extensors, grip strengthening, stretching, nerve glide, neurodynamic technique and tendon glide) for 15 minutes, three times per week for 4 weeks (total of 12 sessions) and home advices only.
Intervention Type
Radiation
Intervention Name(s)
low level laser therapy
Other Intervention Name(s)
pulsed ultrasound waves
Intervention Description
comparing between the effect of low level laser therapy (LLLT) and pulsed ultrasound on post-partum carpal tunnel syndrome. All interventions that were pre-specified to be administered as part of the protocol, even if a particular intervention is not "of interest
Primary Outcome Measure Information:
Title
Pain Intensity
Description
measure pain intensity for each woman in all groups (A, B and C). The VAS is usually presented as a 10-cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability and validity, as well as its ratio scale properties make the VAS the optimal tool for describing pain intensity
Time Frame
From base line to 4 weeks from starting the treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postpartum women with mild to moderate carpal tunnel syndrome will participate in this study. Their ages will range from 25 to 35 years old. Their BMI will be ranged from 25 to 30 Kg/m2. The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve conduction velocity slow on finger/wrist measurement, sensory nerve latency >3.5 ms, normal terminal motor latency; moderate: sensory potential preserved with motor slowing, distal motor latency to abductor pollicis brevis (APB) < 6.5 ms) (Bland, 2000 and Dumitru and Zwarts, 2002). Positive phalen's test. Positive tinel's test. Unilateral or bilateral carpal tunnel affection will be included. 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. Pacemaker and implementable medical devices.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afaf Mohammed, Assist.Prof.
Organizational Affiliation
Department of physical Therapy for Women's Health, Faculty of Physical Therapy Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Physical Therapy - Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Low Level Laser Therapy Versus Pulsed Ultrasound

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