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Flexor Tendon RuptureNCT06112145

Are Rehabilitation Results in Flexor Tendon Zone II Injuries as Bad as Feared?

A study testing rehabilitation program in people with Flexor Tendon Rupture and Hand Injuries, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The hand is the basic functional organ of the human body and is responsible for complex tasks such as grasping and catching. It also plays an important role in a person's daily life, self-care activities and business life. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2023to 18 Jan 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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Had a traumatic flexor tendon injury
  • In the acute period after repair (1-4 weeks)

Who cannot join

  • Accompanying fracture, dislocation, burn
  • infection, malignancy
  • Patients using steroid-nonsteroidal drugs and having cognitive dysfunction

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara City Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

The hand is the basic functional organ of the human body and is responsible for complex tasks such as grasping and catching. It also plays an important role in a person's daily life, self-care activities and business life. When the flexor tendon system, which is necessary for the effective use of the hand, is damaged, it can cause physical, socioeconomic deterioration, mood disorders and permanent disabilities in the individual. Treatment of flexor tendon injuries after appropriate surgical repair ıt includes an intensive rehabilitation program. In this study, it was aimed to investigate the early rehabilitation results of patients who underwent a rehabilitation program after Zone II flexor tendon injury by comparing the improvements in joint range of motion, pain, functionality and quality of life with other zone injuries.

Read the detailed description

Tendon cuts constitute a significant portion of hand injuries. Today, most flexor tendon ruptures are repaired the same day as the injury or a few days later. Rehabilitation after flexor tendon repair is at least as important as surgical repair. Hand rehabilitation protocol after tendon repair; It consists of four periods: 1-4 weeks early period, 4-6 weeks early intermediate period, 6-8 weeks intermediate period, 8-12 weeks late period. Modified Duran Protocol is one of the earliest passive mobilization methods. According to this protocol, it has been reported that 3-5 mm of passive movement of the tendon anastomosis is effective in preventing tendon adhesions. In the literature, the number of studies examining rehabilitation results in patients with flexor tendon zone II injuries is quite limited. Post-operative rehabilitation results are worse in patients with zone II tendon injuries compared to other flexor zone injuries. This study aimed to investigate the early rehabilitation results of patients who underwent a rehabilitation program after Zone II flexor tendon injury by comparing the improvements in joint range of motion, pain, functionality and quality of life with other zone injuries. 70 patients who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital Traumatic Hand Clinic due to flexor tendon injury and met the inclusion criteria for the study will be included. Demographic characteristics of the patients (age, gender), occupation, cause of injury, injured hand, dominant hand, smoking, and injury zones will be recorded. Patients with zone II injuries Group I, Patients with other zone injuries will be divided into Group II. In this study, Modified Duran early passive mobilization protocol was used to protect the repaired tendon and reduce the risk of adhesion will be followed. The physiotherapist will advised each patient on the things to consider after the operation, orthosis use and care, and the rehabilitation process. Early passive mobilization exercises in the form of passive flexion and extension and edema massage will be taught to all fingers of the injured hand in a dorsal blocking orthosis and will be recommended to be applied every two hours during the day. Patient follow-up will last four weeks and afterwards, measurements will be repeated.

Being tested
rehabilitation program
Medical subject headings
Hand Injuries

What participants receive

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

  • rehabilitation programOther

    All fingers of the injured hand are fitted with a dorsal blocking orthosis. Early passive mobilization exercises in the form of passive flexion and extension and edema massage will be taught and it will be recommended to be applied every two hours during the day.

Study groups in NCT06112145
Study groupRoleWhat they receive
group IExperimentalFlexor tendon zon II rupture patients
Receives: Other: rehabilitation program
group IIExperimentalFlexor tendon other zon rupture patients
Receives: Other: rehabilitation program

What is being measured

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

  1. Visual Analog Scale

    Pain intensity of patients at rest and during activity will be evaluated with a visual analog scale (VAS). For VAS evaluation, the meanings of the numbers from 0 to 10 placed on a 10 cm line were explained to the patients. It will be announced that no pain is 0 points, moderate pain is 5 points, and the most severe pain is 10 points. According to these explanations, the patient will be asked to mark the pain on a 10 cm line. Pain intensity will be determined by measuring the distance between the marked place and the starting point with a ruler.

    Measured: baseline and 4th week

  2. Range of motion

    Range of motion is one of the most commonly used outcome variables after hand tendon injuries and will be preferred because it provides objective information about the effectiveness of the treatment. Since this study covers the acute period after repair, the normal joint movement of the patients will be evaluated passively. The measurement will be made with a goniometer.

    Measured: baseline and 4th week

Secondary outcomes (2)

  1. Duruoz Hand Index

    Duruoz Hand Index is a self-reported measure of the patient's self-reported hand movements in the kitchen, while dressing, performing personal hygiene, at work, and other general movements. It consists of 18 items on skills. Scores range from 0 to 40 for kitchen work, from 0 to 10 for dressing, hygiene and office work, and from 0 to 20 for the "other" category. Patients rated their abilities as 0 (no difficulty) and 5 (impossible) to reach a total score between 0-90. A higher score represents greater activity restriction and more difficulty.

    Measured: baseline and 4th week

  2. Short Form-36

    It is a 36-question scale consisting of physical function, physical role difficulty, emotional role difficulty, pain, vitality, general health and mental health subscales. Each subscale; It is scored so that "0" indicates the lowest and "100" indicates the best level of quality of life.

    Measured: baseline and 4th week

Timeline

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

  1. First posted1 Nov 2023
  2. Study start1 Nov 2023
  3. Primary completion21 Dec 2023
  4. Study completion18 Jan 2024

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112145
Sponsor's protocol ID
AŞH-MK-ÇS
Status last verified
May 2024
First submitted
27 Oct 2023
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.

    PubMed 19345768

  • Kannas S, Jeardeau TA, Bishop AT. Rehabilitation following zone II flexor tendon repairs. Tech Hand Up Extrem Surg. 2015 Mar;19(1):2-10. doi: 10.1097/BTH.0000000000000076.

    PubMed 25700105

  • Tang JB. Indications, methods, postoperative motion and outcome evaluation of primary flexor tendon repairs in Zone 2. J Hand Surg Eur Vol. 2007 Apr;32(2):118-29. doi: 10.1016/J.JHSB.2006.12.009. Epub 2007 Feb 12.

    PubMed 17298858

  • Cetin A, Dincer F, Kecik A, Cetin M. Rehabilitation of flexor tendon injuries by use of a combined regimen of modified Kleinert and modified Duran techniques. Am J Phys Med Rehabil. 2001 Oct;80(10):721-8. doi: 10.1097/00002060-200110000-00003.

    PubMed 11562553

Questions about this trial

What is this clinical trial studying?

A study testing rehabilitation program in people with Flexor Tendon Rupture and Hand Injuries, run by Kirsehir Ahi Evran Universitesi 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 2 inclusion and 3 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 8 May 2024. 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?

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?

Visual Analog Scale (time frame: baseline and 4th week). The study lists 2 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 NCT06112145, which also lists 4 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 8 May 2024.

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