Tendon Injury - HandNCT04742296
The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8
A study testing low level laser therapy in people with Tendon Injury - Hand, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
Trial summary
This study examines the rehabilitation results when low-level laser therapy is applied in zone 5-8 extensor tendon injuries. Rehabilitation results will be evaluated with both objective measurements and patient reported outcome measures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendon Injury - Hand
- What is being tested?
- low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2020to 30 Dec 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Primary repair due to extensor tendon injury between Zones V-VIII
- Applying to the Hand Rehabilitation Policlinic at the end of the postoperative 1st week
Who cannot join
- Accompanying flexor tendon injury, fracture, vascular and / or nerve injury
- Active using of steroids or non-steroidal anti-inflammatory drugs
- Systemic infection or malignancy
- Pregnant or breastfeeding women
- Active wound infection
- Having a cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8: A Randomized Controlled Trial
This study examines the rehabilitation results when low-level laser therapy is applied in zone 5-8 extensor tendon injuries. Rehabilitation results will be evaluated with both objective measurements and patient reported outcome measures. The study was planned as a double-blind, placebo-controlled, randomized, two-arm study. Participants in both treatment groups will be given exercise therapy in accordance with the early active mobilization protocol and appropriate splint will be given to be used while exercising.
- Conditions
- Tendon Injury - Hand
- Being tested
- low level laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyDevice
Also called Sham laser therapy
We will use laser light that has continuous wave mode, power of 100 mW, energy density of 7,5 joule/cm2, treatment time as 300 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group of low level laser therapy | Active comparator | Not described Receives: Device: low level laser therapy |
| Sham group of low level laser therapy | Placebo comparator | Not described Receives: Device: low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total active motion degrees
The difference of active range of motion (ROM) measurements between injured and non-injured digit(s). ROM measurement will be made with the help of a standard hand goniometer and the measured degree will be recorded.
Measured: Pre-intervention, immediately after the intervention, eighth week
Grip strength
Grip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms.
Measured: Eighth week
Change in visual analog scale (VAS) score
VAS is a scale used to assess pain. Minimum value of the scale is 0 and maximum is 10. Higher scores mean a worse outcome.
Measured: Pre-intervention, immediately after the intervention, eighth week
Change in metacarpophalangeal joint circumference
It will be used to evaluate edema in the dorsum of the hand. Measurement will be made with the help of a tape measure. The measured value will be recorded in milimeters.
Measured: Pre-intervention, immediately after the intervention, eighth week
Secondary outcomes (3)
Change in quick disabilities of arm, shoulder and hand (QuickDASH) score
A scale used for measuring physical function and symptoms of upper extremities. Minimum value of the scale is 0 and maximum is 100. Higher scores mean a worse outcome.
Measured: Pre-intervention, immediately after the intervention, eighth week
Change in short form-36 (SF-36) scores
A scale used for determining quality of life. This form evaluates the quality of life under 9 different headings. Minimum value of all headings is %0 and maximum is %100. Higher scores mean a better outcome.
Measured: Pre-intervention, immediately after the intervention, eighth week
Return to work
The rehabilitation period required for patients to return to work
Measured: Eighth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start30 Apr 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tendon Injury - HandStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish League Against Rheumatism
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, faruk erdogan, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742296
- Sponsor's protocol ID
- TRASD-FE-TEZ
- Status last verified
- Jun 2022
- First submitted
- 27 Jan 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Collocott SJF, Kelly E, Foster M, Myhr H, Wang A, Ellis RF. A randomized clinical trial comparing early active motion programs: Earlier hand function, TAM, and orthotic satisfaction with a relative motion extension program for zones V and VI extensor tendon repairs. J Hand Ther. 2020 Jan-Mar;33(1):13-24. doi: 10.1016/j.jht.2018.10.003. Epub 2019 Mar 21.
PubMed 30905495Poorpezeshk N, Ghoreishi SK, Bayat M, Pouriran R, Yavari M. Early Low-Level Laser Therapy Improves the Passive Range of Motion and Decreases Pain in Patients with Flexor Tendon Injury. Photomed Laser Surg. 2018 Oct;36(10):530-535. doi: 10.1089/pho.2018.4458.
PubMed 30300099
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low-level Laser Therapy in Extensor Tendon Injuries Between Zones 5-8: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04742296
- Acronym / sponsor ID
- TRASD-FE-TEZ
- Conditions
- Tendon Injury - Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Turkish League Against RheumatismUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 8 Feb 2021 (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.
This study examines the rehabilitation results when low-level laser therapy is applied in zone 5-8 extensor tendon injuries. Rehabilitation results will be evaluated with both objective measurements and patient reported outcome measures. The study was planned as a double-blind, placebo-controlled, randomized, two-arm study. Participants in both treatment groups will be given exercise therapy in accordance with the early active mobilization protocol and appropriate splint will be given to be used while exercising.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group of low level laser therapy | Active comparator | Device: low level laser therapy |
| Sham group of low level laser therapy | Placebo comparator | Device: low level laser therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- Primary repair due to extensor tendon injury between Zones V-VIII
- Applying to the Hand Rehabilitation Policlinic at the end of the postoperative 1st week
Key exclusion criteria (6 listed)
- Accompanying flexor tendon injury, fracture, vascular and / or nerve injury
- Active using of steroids or non-steroidal anti-inflammatory drugs
- Systemic infection or malignancy
- Pregnant or breastfeeding women
- Active wound infection
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 therapyAlso: Sham laser therapyWe will use laser light that has continuous wave mode, power of 100 mW, energy density of 7,5 joule/cm2, treatment time as 300 seconds. | Device | Sham group of low level laser therapy, Treatment group of low level laser therapy |
Primary outcome
Change in total active motion degrees
Time frame: Pre-intervention, immediately after the intervention, eighth week
The difference of active range of motion (ROM) measurements between injured and non-injured digit(s). ROM measurement will be made with the help of a standard hand goniometer and the measured degree will be recorded.
Grip strength
Time frame: Eighth week
Grip strength measurement will be made with the Jamar dynamometer. The measured value will be recorded in kilograms.
Change in visual analog scale (VAS) score
Time frame: Pre-intervention, immediately after the intervention, eighth week
VAS is a scale used to assess pain. Minimum value of the scale is 0 and maximum is 10. Higher scores mean a worse outcome.
Change in metacarpophalangeal joint circumference
Time frame: Pre-intervention, immediately after the intervention, eighth week
It will be used to evaluate edema in the dorsum of the hand. Measurement will be made with the help of a tape measure. The measured value will be recorded in milimeters.
3 secondary outcomes
Change in quick disabilities of arm, shoulder and hand (QuickDASH) score
Time frame: Pre-intervention, immediately after the intervention, eighth week
Change in short form-36 (SF-36) scores
Time frame: Pre-intervention, immediately after the intervention, eighth week
Return to work
Time frame: Eighth week
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 21 Jun 2022.
- Background: PubMed 30905495Collocott SJF, Kelly E, Foster M, Myhr H, Wang A, Ellis RF. A randomized clinical trial comparing early active motion programs: Earlier hand function, TAM, and orthotic satisfaction with a relative motion extension program for zones V and VI extensor tendon repairs. J Hand Ther. 2020 Jan-Mar;33(1):13-24. doi: 10.1016/j.jht.2018.10.003. Epub 2019 Mar 21.
- Background: PubMed 30300099Poorpezeshk N, Ghoreishi SK, Bayat M, Pouriran R, Yavari M. Early Low-Level Laser Therapy Improves the Passive Range of Motion and Decreases Pain in Patients with Flexor Tendon Injury. Photomed Laser Surg. 2018 Oct;36(10):530-535. doi: 10.1089/pho.2018.4458.
- Individual participant dataSharing planned: Undecided
Related trials for Tendon Injury - Hand
Recruiting
Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
Tendon Adhesion, Zone II Flexor Tendon Injury
Recruiting
3D Hand Orthosis Trial
Hand Injuries and Disorders, Neurological Conditions
Recruiting
Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair
Flexor Tendon Injury, Tendon Injury - Hand
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Recruiting
Effects of Extracorporeal Shock Wave Therapy After Flexor Tendon Injury
Tendon Injury - Hand
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 in people with Tendon Injury - Hand, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 21 Jun 2022. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Change in total active motion degrees (time frame: Pre-intervention, immediately after the intervention, eighth week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04742296, which also lists 2 linked publications.
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 21 Jun 2022.