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Hand Flexor TendonNCT07233369

Effect of Myofascial Release on Pain, Grip Strength, Manual Dexterity, and Quality of Life in Late-Term Rehabilitation of Hand Flexor Tendon Repairs

A study testing Fascial mobilization therapy and conventional physiotherapy in people with Hand Flexor Tendon and Facial Mobilization, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hand Flexor Tendon, Facial Mobilization, Exercise
What is being tested?
Fascial mobilization therapy and conventional physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Nov 2025to 1 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tuğba Çevik, PT contact

05345251455

cvktubaa@gmail.com

Turkey (Türkiye)1 site
  • Hasan Kalyoncu University

    Gaziantep, Şahinbey, 27100

Other trials in Turkey (Türkiye)

About this study

Official title: Myofascial Release

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.

Read the detailed description

The hand is the organ we use most in our daily activities, sports activities, expressing ourselves, and performing our jobs. Flexor tendon injuries are among the most common injuries to the hand. The incidence of flexor tendon injuries is estimated at 7-14 per 100,000 people. The flexor tendon can be injured by a blunt or sharp instrument, crushed, or torn by avulsion. It is difficult for tendons to heal without surgery after an injury. Because tendons are composed of living cells and connective tissue, healing begins with cells from both inside and outside the tendon when the tendon ends are brought together. However, scar tissue that forms after surgery adheres the repaired tendons to the surrounding area, limiting movement. Therefore, rehabilitation protocols implemented to ensure proper gliding again and postoperative splinting are essential for tendon healing in tendon injuries are crucial. Tendon Rehabilitation Extension block splints should place the wrist in 30 degrees of flexion to reduce tension in flexor tendon repairs and minimize the risk of postoperative tendon rupture, with the metacarpophalangeal joints at 45-70 degrees of flexion and the interphalangeal joints held in near full extension or slight flexion (15 degrees). Sutures are removed two weeks postoperatively. Thanks to advances in biomechanics and clinical research, there is a general understanding that early therapy-guided tendon release is more beneficial than strict immobilization in efforts to achieve maximum functional recovery. Mobilization promotes intrinsic tendon healing, increases tensile strength, and improves tendon glide while reducing adhesion formation. All of this translates to optimized joint motion, fewer flexion contractures, and overall improved functional outcomes. Tendon repair rehabilitation programs are ideally structured to improve overall hand function while facilitating diverse soft tissue injuries. Flexor tendon rehabilitation protocols are broadly divided into three groups: immobilization, early passive mobilization, and early active mobilization. The selection of a rehabilitation protocol should be determined by considering factors such as the patient's age, ability to comply with treatment, and suture strength.

Current techniques in flexor tendon repair have led to advancements in rehabilitation practice, encouraging a shift from passive methods to early, controlled, and more active approaches. Optimal flexor tendon surgery and treatment outcomes depend on a patient-centered protocol rather than a strictly structured protocol.

Individuals aged 18-65 who have suffered a flexor tendon injury and have undergone related surgery, and who have no neurological symptoms in the repaired extremity will be included in the study.

Individuals who have previously undergone hand surgery for any reason other than this injury, who have a comorbid mental, physical, or neurological chronic illness, who have cognitive problems that impede communication, or who have any other problems that impede cooperation will not be included in the study. When we divided the included individuals into two groups, the control group will receive only conventional physiotherapy, while the study group will additionally receive myofascial release exercises. Pre- and post-treatment evaluations will be conducted. The aim of our randomized controlled trial was to investigate the effects of myofascial release on pain, dexterity, function, and quality of life in the late-stage rehabilitation of hand flexor tendon repairs.

Being tested
Fascial mobilization therapy, conventional physiotherapy
Keywords
hand flexor tendon, facial mobilization, Exercise, pain, grip strenght, hand skills, quality of life
Medical subject headings
Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fascial mobilization therapyOther

    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.

  • conventional physiotherapyOther

    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.

Study groups in NCT07233369
Study groupRoleWhat they receive
Fascial mobilization groupExperimentalThis group will get a specific programme that combinated with conventional physiotherapy and myofascial release therapy
Receives: Other: Fascial mobilization therapy
Control groupActive comparatorThis group will get conventional physiotherapy that is include range of motion exercises, electrotherapy and resistance exercise training.
Receives: Other: conventional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through of the study, average 8 weeks

  2. 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.

    Measured: through of the study, average 8 weeks

  3. 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."

    Measured: through of the study, average 8 weeks

  4. 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.

    Measured: through of the study, average 8 weeks

Secondary outcomes (4)
  1. Upper extremity functionality

    The Questionnaire for Arm, Shoulder, and Hand Disabilities (Q-DASH) will be used to assess individuals' upper extremity functions. This questionnaire is a self-administered measurement tool with validated validity and reliability in Turkish. The validity and reliability of the Turkish version of the DASH questionnaire (DASH-T) was conducted in Turkey by Düger et al. in 2006. The questionnaire, consisting of 30 questions, assesses the individual's ability to perform functional activities (21 items), pain (5 items), and psychosocial aspects of the disease (4 items). The total score ranges from 0 to 100, with a higher score indicating better outcomes.

    Measured: through of the study, average 8 weeks

  2. Range of Motion

    A Universal Goniometer will be used to assess normal range of motion. Measurements will be made regarding shoulder flexion, extension, abduction, adduction, internal and external rotation ranges of motion in three planes of the upper extremity shoulder joint, and the results will be recorded in degrees.

    Measured: through of the study, average 8 weeks

  3. Kinesiophobia

    This is the measure we will use to assess patients' fear of movement in our study. This scale, frequently used in the literature, is based on fear avoidance, fear of work-related activities, and fear of movement or re-injury.

    Measured: through of the study, average 8 weeks

  4. Daily living activities

    It is a 15-question questionnaire that measures the severity of wrist pain and the level of disability in daily life activities.

    Measured: through of the study, average 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start30 Nov 2025 (estimated)
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

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
Model description
Participants were divided in two groups. One group will get intervention. One group will be the control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07233369
Sponsor's protocol ID
2025/092
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35719196
  • 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.

    PubMed 17106618
  • 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.

    PubMed 26958129
  • 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.

    PubMed 27022514
  • 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.

    PubMed 26659831
  • 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.

    PubMed 27975005
  • Stevens KA, Caruso JC, Fallahi AKM, Patino JM. Flexor Tendon Lacerations. 2023 Jun 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK493223/

    PubMed 29630275
  • 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.

    PubMed 36819329
  • 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.

    PubMed 28149205

Questions about this trial

What is this clinical trial studying?

A study testing Fascial mobilization therapy and conventional physiotherapy in people with Hand Flexor Tendon and Facial Mobilization, run by Hasan Kalyoncu University 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Nov 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 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tuğba Çevik, PT (05345251455, cvktubaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The pain (time frame: through of the study, average 8 weeks). 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 NCT07233369, which also lists 9 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 18 Nov 2025.

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