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

NCT06761950 | Completed

• 1 other identifier: Reham-005391
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Photobiomodulation Therapy; Low Level Laser Therapy; Flexor Tendon Rupture; Flexor Tendon Repair

Outcome Measures

Primary Outcomes (1)

• Assessment of change of pain intensity

  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.

  At baseline and after 4 weeks

Secondary Outcomes (3)

• assessment of change of active range of motion of metacarpophalangeal joint

  At baseline and after 4 weeks

• assessment of change of active range of motion of proximal interphalangeal joint

  At baseline and after 4 weeks

• assessment of change of active range of motion of distal interphalangeal joint

  At baseline and after 4 weeks

Study Arms (2)

Low Level Laser Therapy

EXPERIMENTAL

This group included 22 patients with zone II, and III flexor tendon injuries whom have pain and limited range of motion post flexor tendon repair surgery and received low-level laser therapy, 3 sessions per week, for a period of 4 weeks in addition to their physical therapy program and medical treatment

Device: Low Level laser therapy; Other: medical treatment; Other: physical therapy program

placebo low level laser therapy

ACTIVE COMPARATOR

This group included 22 patients with zone II, and III flexor tendon injuries whom have pain and limited range of motion after flexor tendon repair surgery and received placebo low-level laser therapy, 3 sessions per week for 4 weeks in addition to their physical therapy program and medical treatment.

Device: Placebo low level laser therapy; Other: medical treatment; Other: physical therapy program

Interventions

Low Level laser therapy DEVICE

The patient received low-level laser therapy three times per week for four weeks, with immobilization maintained. The Mustang 2000 Laser device was used with an infrared laser probe to accelerate tendon healing. The device's specifications include peak power output of 15W, power density of 15W/cm2, wave length of 890nm, pulse frequency of 100Hz, spherical size of 0.002cm2, pulse duration of 130 ns, exposure duration of 60 sec, and energy density of 5.85J/cm2.

Low Level Laser Therapy

Placebo low level laser therapy DEVICE

Same as in the study group except turning on the device with covering probe by aluminum foil and ask patient to wear sun glasses to obtain the placebo effect 3 sessions per week for 4 weeks.

placebo low level laser therapy

medical treatment OTHER

the patients received their drugs from their treating physicians

Low Level Laser Therapy; placebo low level laser therapy

physical therapy program OTHER

patients received the traditional program after flexor tendon repair involving isometric exercise, stretching and mobilizations

Low Level Laser Therapy; placebo low level laser therapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: August 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 25, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)