Effect of Low Level Laser Therapy Versus Pulsed Ultrasound

NCT05904561 | Completed DMC

• 1 other identifier: Mai Mahmoud Abdelmonem
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; POSTPARTUM CARPAL TUNNEL SYNDROME

Outcome Measures

Primary Outcomes (1)

• 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

  From base line to 4 weeks from starting the treatment

Study Arms (3)

Group (A) (Study group A)

ACTIVE COMPARATOR

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.

Radiation: low level laser therapy

Group (B) (study group B)

EXPERIMENTAL

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

Radiation: low level laser therapy

Group (C) (control):

ACTIVE COMPARATOR

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.

Radiation: low level laser therapy

Interventions

low level laser therapy RADIATION

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

Also known as: pulsed ultrasound waves

Group (A) (Study group A); Group (B) (study group B); Group (C) (control):

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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.
• Pacemaker and implementable medical devices.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Faculty of Physical Therapy - Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Afaf Mohammed, Assist.Prof.

  Department of physical Therapy for Women's Health, Faculty of Physical Therapy Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 15, 2023
• Study Start: April 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 20, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

EG (1)