Photobiomodulation Therapy on Pain and Range of Motion Following Flexor Tendon Repair

Not Applicable

Completed

• Conditions: Photobiomodulation Therapy; Low Level Laser Therapy; Flexor Tendon Rupture; Flexor Tendon Repair

• Registration Number: NCT06761950
• Lead Sponsor: Cairo University

Brief Summary

The purpose of the study was to evaluate the therapeutic effect of low-level laser in improving pain and ROM following flexor tendon repair surgery.

Detailed Description

Flexor tendon injury is a common issue requiring early postoperative mobilization. Prolonged immobilization can lead to complications such as muscle atrophy, joint stiffness, osteoarthritis, infection, pain, joint cartilage ulceration, joint contracture, and tendon rupture. Low level laser therapy has been shown to accelerate inflammation, promote fibroblast proliferation, regulate procollagen messenger ribonucleic acid synthesis, accelerate bone repair and remodeling, encourage wound revascularization, and accelerate tissue repair. This study aims to evaluate the effectiveness of Low level laser therapy in pain management and improving range of motion after flexor tendon repair.

Study Timeline

• Study Start: 2024-08-01
• Primary Completion: 2024-11-01
• Status Verified: 2024-12
• Study Completion: 2024-12-25
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Last Update Submitted: 2024-12-31
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Forty-four patients of both genders with age ranged between 20 to 50 years will participate in this study.
• All patients with zone II and III flexor tendon injuries, will be suffered from pain following flexor tendon repair surgery.
• All patients with zone II and III flexor tendon injuries, will be suffered from limitation of range of motion deficiency following flexor tendon repair surgery
• All patients enrolled to the study will have their informed consent.

Exclusion Criteria

• A wound in the affected area
• Rheumatoid arthritis.
• Epilepsy or any psychological disorders
• Myelopathy or radiculopathy
• exposed hand tendons.
• Concomitant finger fractures, joint injuries, replantation or revascularizations, extensor tendon injury or crush injuries.
• Impairment of cognitive, perceptual or psychological function that would impede ability to follow verbal instruction.
• Multiple injuries to one flexor tendon, simultaneous injuries to bone and extensor tendons, skin loss, noncompliant patients or patients under 10 years, and gross contaminations of wounds.
• patients with tendon repair associated with a skin graft, nerve injury, arterial injury, systemic disease (e.g. diabetes mellitus), wound infection,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of change of pain intensity	At baseline and after 4 weeks	The Visual Analogue Scale is a 100mm line used for pain measurement, validated for various conditions like sleep, anxiety, breathlessness, and pruritus intensity. It accurately reflects pain changes, is reusable, and sensitive to acute pain changes.

Secondary Outcome Measures

Name	Time	Method
assessment of change of active range of motion of metacarpophalangeal joint	At baseline and after 4 weeks	Goniometers, typically made of plastic or metal, measure the degree of motion in a single plane by aligning a stationary arm, a movable arm, and a fulcrum with the joint axis. it was used to measure the active range of motion of metacarpophalangeal joint when the patient is in a sitting position.
assessment of change of active range of motion of proximal interphalangeal joint	At baseline and after 4 weeks	Goniometers, typically made of plastic or metal, measure the degree of motion in a single plane by aligning a stationary arm, a movable arm, and a fulcrum with the joint axis. it was used to measure the active range of motion of proximal interphalangeal joint when the patient is in a sitting position.
assessment of change of active range of motion of distal interphalangeal joint	At baseline and after 4 weeks	Goniometers, typically made of plastic or metal, measure the degree of motion in a single plane by aligning a stationary arm, a movable arm, and a fulcrum with the joint axis. it was used to measure the active range of motion of distal interphalangeal joint when the patient is in a sitting position.

Trial Locations

Locations (1)

Cairo university hospitals; 🇪🇬 Cairo, Egypt