NCT07233369

Brief Summary

The aim of this study was to investigate the effectiveness of myofascial release exercises performed in the late period compared to classical physiotherapy training in individuals with hand flexor tendon repair.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

hand flexor tendonfacial mobilizationExercisepaingrip strenghthand skillsquality of life

Outcome Measures

Primary Outcomes (4)

  • The pain

    Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

    through of the study, average 8 weeks

  • Grip strength

    A hand dynamometer will be used to measure patients' grip strength. Grip strength is measured with the Jamar hand dynamometer, recommended by the American Association of Hand Therapists (AETD) and whose validity and reliability have been confirmed in numerous studies. This device is considered the gold standard for measuring hand grip strength. Measurements will be taken before and after treatment, and three times, 10 seconds apart. Each measurement will be taken at the same difficulty level. Generally, the average of the three measurements will be taken.

    through of the study, average 8 weeks

  • Hand skills

    The Nine-Hole Peg test, used to assess manual dexterity, involves patients quickly removing nine wooden pegs from a storage box, placing them in random holes, then collecting them from the holes and returning them to the storage compartment. The time is measured in seconds using a stopwatch, and anything over 20 seconds is considered a "loss of skill."

    through of the study, average 8 weeks

  • Short form SF-36 Quality of life

    Individuals' quality of life will be assessed using short form 36 (SF-36). SF-36 is a 36-question scale consisting of physical function, physical role, emotional role, pain, vitality, general health, and mental health subscales.

    through of the study, average 8 weeks

Secondary Outcomes (4)

  • Upper extremity functionality

    through of the study, average 8 weeks

  • Range of Motion

    through of the study, average 8 weeks

  • Kinesiophobia

    through of the study, average 8 weeks

  • Daily living activities

    through of the study, average 8 weeks

Study Arms (2)

Fascial mobilization group

EXPERIMENTAL

This group will get a specific programme that combinated with conventional physiotherapy and myofascial release therapy

Other: Fascial mobilization therapy

Control group

ACTIVE COMPARATOR

This group will get conventional physiotherapy that is include range of motion exercises, electrotherapy and resistance exercise training.

Other: conventional physiotherapy

Interventions

Patients in this group will receive training in myofascial release exercises in addition to the exercises in the control group. Similar to the control group, patients in this group will be asked to continue home exercises five times a week for eight weeks after their two-week treatment.The patients in the study group will receive the same treatment, twice a week for 12 weeks, with each session lasting 45 minutes.

Fascial mobilization group

Conservative treatment methods such as TENS, Hotpack and normal joint range of motion exercises and tendon gliding exercises and streching exercise will be applied twice a week for 12 weeks, with each session lasting 45 minutes.

Control group

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 and 65,
  • Having a hand flexor tendon injury and subsequent surgery,
  • Not having a symptom of deterioration in the extremity being cared for,
  • Having adequate communication skills,
  • Voluntarily participating in the study.

You may not qualify if:

  • Having had previous hand surgery for any reason other than this injury,
  • Having a comorbid mental, physical, or neurological chronic illness,
  • Having cognitive problems that prevent communication,
  • Having any problem that prevents cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27100, Turkey (Türkiye)

Location

Related Publications (9)

  • Sheereen FJ, Sarkar B, Sahay P, Shaphe MA, Alghadir AH, Iqbal A, Ali T, Ahmad F. Comparison of Two Manual Therapy Programs, including Tendon Gliding Exercises as a Common Adjunct, While Managing the Participants with Chronic Carpal Tunnel Syndrome. Pain Res Manag. 2022 Jun 8;2022:1975803. doi: 10.1155/2022/1975803. eCollection 2022.

  • Yakut Y, Yakut E, Bayar K, Uygur F. Reliability and validity of the Turkish version short-form McGill pain questionnaire in patients with rheumatoid arthritis. Clin Rheumatol. 2007 Jul;26(7):1083-7. doi: 10.1007/s10067-006-0452-6. Epub 2006 Nov 15.

  • Ennaciri B, Mahfoud M, El Bardouni A, Berrada MS. Exceptional laceration of flexor digitorum tendons proximal to a severe palmar hand wound: a case report with literature review. Pan Afr Med J. 2015 Nov 20;22:266. doi: 10.11604/pamj.2015.22.266.7495. eCollection 2015.

  • Mattar TG, Junior RM, Cho AB, Paula EJ, Rezende MR. COMPARATIVE STUDY BETWEEN TRADITIONAL TENOLYSES AND WITH INTRAOPERATIVE AWAKENING PERFORMED ON THE FLEXOR OSTEOFIBROUS TUNNEL REGION OF THE HANDS (ZONE 2). Rev Bras Ortop. 2015 Dec 8;44(4):324-9. doi: 10.1016/S2255-4971(15)30161-0. eCollection 2009 Jan.

  • Quadlbauer S, Pezzei Ch, Jurkowitsch J, Reb P, Beer T, Leixnering M. Early Passive Movement in flexor tendon injuries of the hand. Arch Orthop Trauma Surg. 2016 Feb;136(2):285-93. doi: 10.1007/s00402-015-2362-z. Epub 2015 Dec 11.

  • Watanabe K, Ota H, Sasaki H. Eight-strand Cross-locked Cruciate Flexor Tendon Repair Using Double-stranded Suture: A Description of the Surgical Technique. Plast Reconstr Surg Glob Open. 2016 Nov 7;4(11):e1048. doi: 10.1097/GOX.0000000000001048. eCollection 2016 Nov.

  • Stevens KA, Caruso JC, Fallahi AKM, Patino JM. Flexor Tendon Lacerations. 2023 Jun 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493223/

  • Ranjan V, Mehta M, Mehta M, Mishra P, Joshi T, Kumar T. The Outcomes of Flexor Tendon Injury Repair of the Hand: A Clinico-Epidemiological Study. Cureus. 2023 Jan 18;15(1):e33912. doi: 10.7759/cureus.33912. eCollection 2023 Jan.

  • Moradi A, Menendez ME, Kachooei AR, Isakov A, Ring D. Update of the Quick DASH Questionnaire to Account for Modern Technology. Hand (N Y). 2016 Dec;11(4):403-409. doi: 10.1177/1558944715628006. Epub 2016 Feb 2.

MeSH Terms

Conditions

Motor ActivityPain

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tuğba Çevik

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba Çevik, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were divided in two groups. One group will get intervention. One group will be the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapy

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

November 30, 2025

Primary Completion

January 30, 2026

Study Completion

April 1, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations