Photobiomodulation TherapyNCT06761950
Photobiomodulation Therapy on Pain and Range of Motion Following Flexor Tendon Repair
A study testing Low Level laser therapy, medical treatment and physical therapy program in people with Photobiomodulation Therapy and Low Level Laser Therapy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Photobiomodulation Therapy, Low Level Laser Therapy, Flexor Tendon Rupture
- What is being tested?
- Low Level laser therapy, medical treatment and physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early 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.
Read the 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.
- Conditions
- Photobiomodulation Therapy, Low Level Laser Therapy, Flexor Tendon Rupture, Flexor Tendon Repair
- Being tested
- Low Level laser therapy, Placebo low level laser therapy, medical treatment, physical therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level laser therapyDevice
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 therapyDevice
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 treatmentOther
the patients received their drugs from their treating physicians
physical therapy programOther
patients received the traditional program after flexor tendon repair involving isometric exercise, stretching and mobilizations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Placebo low level laser therapy; Other: medical treatment; Other: physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 4 weeks
Secondary outcomes (3)
assessment of change of active range of motion of metacarpophalangeal joint
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.
Measured: At baseline and after 4 weeks
assessment of change of active range of motion of proximal interphalangeal joint
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.
Measured: At baseline and after 4 weeks
assessment of change of active range of motion of distal interphalangeal joint
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.
Measured: At baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Aug 2024
- Primary completion1 Nov 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photobiomodulation TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Hesham Mohamed El-Sheikh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761950
- Sponsor's protocol ID
- Reham-005391
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Photobiomodulation Therapy on Pain and Range of Motion Following Flexor Tendon Repair
- ClinicalTrials.gov ID
- NCT06761950
- Acronym / sponsor ID
- Reham-005391
- Conditions
- Photobiomodulation Therapy, Low Level Laser Therapy, Flexor Tendon Rupture, Flexor Tendon Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser Therapy | Experimental | Device: Low Level laser therapy, Other: medical treatment, Other: physical therapy programThis 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 |
| placebo low level laser therapy | Active comparator | Device: Placebo low level laser therapy, Other: medical treatment, Other: physical therapy programThis 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- A wound in the affected area
- Rheumatoid arthritis.
- Epilepsy or any psychological disorders
- Myelopathy or radiculopathy
- exposed hand tendons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level laser therapyThe 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. | Device | Low Level Laser Therapy |
| Placebo low level laser therapySame 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. | Device | placebo low level laser therapy |
| medical treatmentthe patients received their drugs from their treating physicians | Other | Low Level Laser Therapy, placebo low level laser therapy |
| physical therapy programpatients received the traditional program after flexor tendon repair involving isometric exercise, stretching and mobilizations | Other | Low Level Laser Therapy, placebo low level laser therapy |
Primary outcome
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.
3 secondary outcomes
assessment of change of active range of motion of metacarpophalangeal joint
Time frame: At baseline and after 4 weeks
assessment of change of active range of motion of proximal interphalangeal joint
Time frame: At baseline and after 4 weeks
assessment of change of active range of motion of distal interphalangeal joint
Time frame: At baseline and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level laser therapy, medical treatment and physical therapy program in people with Photobiomodulation Therapy and Low Level Laser Therapy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of pain intensity (time frame: At baseline and after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.