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

NCT ID: NCT06112145

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-01-18

Brief 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. 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.

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.

Conditions

Flexor Tendon Rupture; Hand Injuries; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group I

Flexor tendon zon II rupture patients

Group Type: EXPERIMENTAL

rehabilitation program

Intervention Type: OTHER

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.

group II

Flexor tendon other zon rupture patients

Group Type: EXPERIMENTAL

rehabilitation program

Intervention Type: OTHER

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.

Interventions

rehabilitation program

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Nazife Kapan

Principal investigatör

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nazife K KAPAN, MD

Role: PRINCIPAL_INVESTIGATOR

Kırşehir Ahi Evran University, Kırşehir/TURKEY

Merve K KAPAN, PT

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital, Ankara/TURKEY

Berat Meryem A ALKAN, Prof. Dr.

Role: STUDY_DIRECTOR

Ankara City Hospital, Ankara/TURKEY

Bedriye B BAŞKAN, Prof. Dr.

Role: STUDY_DIRECTOR

Ankara City Hospital, Ankara/TURKEY

Tezel YŞ YILDIRIM ŞAHAN, Assoc. Prof.

Role: STUDY_DIRECTOR

Health Sciences Univercity, Gülhane faculty of physiotherapy and rehabilitation, Ankara/TURKEY

Locations

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 19345768 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25700105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17298858 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11562553 (View on PubMed)

Other Identifiers

AŞH-MK-ÇS

Identifier Type: -

Identifier Source: org_study_id