NCT04742296

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

January 27, 2021

Last Update Submit

June 15, 2022

Conditions

Tendon Injury - Hand

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Pre-intervention, immediately after the intervention, eighth week

Secondary Outcomes (3)

  • Change in quick disabilities of arm, shoulder and hand (QuickDASH) score

    Pre-intervention, immediately after the intervention, eighth week

  • Change in short form-36 (SF-36) scores

    Pre-intervention, immediately after the intervention, eighth week

  • Return to work

    Eighth week

Study Arms (2)

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

Interventions

low level laser therapyDEVICE

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.

Also known as: Sham laser therapy
Sham group of low level laser therapyTreatment group of low level laser therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30905495BACKGROUND

  • Poorpezeshk 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.

    PMID: 30300099BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 8, 2021

Study Start

April 30, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

TU(1)