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Completed

NCT Number: NCT06761950

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

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.

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

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.

Medical treatment

Other

the patients received their drugs from their treating physicians

physical therapy program

Other

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

Primary outcomes

  1. Assessment of change of pain intensity

    Time frame: 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 outcomes

  1. assessment of change of active range of motion of metacarpophalangeal joint

    Time frame: 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.

  2. assessment of change of active range of motion of proximal interphalangeal joint

    Time frame: 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.

  3. assessment of change of active range of motion of distal interphalangeal joint

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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