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

NCT ID: NCT06761950

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2024-12-25

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low Level Laser Therapy

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

Group Type EXPERIMENTAL

Low Level laser therapy

Intervention Type 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.

medical treatment

Intervention Type OTHER

the patients received their drugs from their treating physicians

physical therapy program

Intervention Type OTHER

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

placebo low level laser therapy

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.

Group Type ACTIVE_COMPARATOR

Placebo low level laser therapy

Intervention Type 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

Intervention Type OTHER

the patients received their drugs from their treating physicians

physical therapy program

Intervention Type OTHER

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

Interventions

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Low 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.

Intervention Type DEVICE

Placebo low level laser therapy

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.

Intervention Type DEVICE

medical treatment

the patients received their drugs from their treating physicians

Intervention Type OTHER

physical therapy program

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

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rehab Hesham Mohamed El-Sheikh

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo university hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Reham-005391

Identifier Type: -

Identifier Source: org_study_id

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