Clinical trial NCT06761950: Photobiomodulation Therapy on Pain and Range of Motion Following Flexor Tendon Repair
Official title: Early Photobiomodulation Therapy on Pain and Range of Motion Following Flexor Tendon Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photobiomodulation Therapy
Low Level Laser Therapy
Flexor Tendon Rupture
Flexor Tendon Repair
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Assessment of change of pain intensity
timeFrame: At baseline and after 4 weeks
Secondary outcomes:
measure: assessment of change of active range of motion of metacarpophalangeal joint
timeFrame: At baseline and after 4 weeks
measure: assessment of change of active range of motion of proximal interphalangeal joint
timeFrame: At baseline and after 4 weeks
measure: assessment of change of active range of motion of distal interphalangeal joint
timeFrame: At baseline and after 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals
Study officials:
References: