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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06761950
Enrollment
44
Registered
2025-01-07
Start date
2024-08-01
Completion date
2024-12-25
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICELow Level laser therapy

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.

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.

OTHERmedical treatment

the patients received their drugs from their treating physicians

OTHERphysical therapy program

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Assessment of change of pain intensityAt baseline and after 4 weeksThe 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

MeasureTime frameDescription
assessment of change of active range of motion of metacarpophalangeal jointAt baseline and after 4 weeksGoniometers, 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 jointAt baseline and after 4 weeksGoniometers, 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 jointAt baseline and after 4 weeksGoniometers, 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026