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

NCT06112145 | Completed

• 1 other identifier: AŞH-MK-ÇS
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexor Tendon Rupture; Hand Injuries; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline and 4th week

• 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.

  baseline and 4th week

Secondary Outcomes (2)

• Duruoz Hand Index

  baseline and 4th week

• Short Form-36

  baseline and 4th week

Study Arms (2)

group I

EXPERIMENTAL

Flexor tendon zon II rupture patients

Other: rehabilitation program

group II

EXPERIMENTAL

Flexor tendon other zon rupture patients

Other: rehabilitation program

Interventions

rehabilitation program 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 I; group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 19345768 BACKGROUND

• 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.

  PMID: 25700105 BACKGROUND

• 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.

  PMID: 17298858 BACKGROUND

• 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.

  PMID: 11562553 BACKGROUND

MeSH Terms

Conditions

Hand Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nazife K KAPAN, MD

  Kırşehir Ahi Evran University, Kırşehir/TURKEY

  PRINCIPAL INVESTIGATOR

• Merve K KAPAN, PT

  Ankara City Hospital, Ankara/TURKEY

  PRINCIPAL INVESTIGATOR

• Berat Meryem A ALKAN, Prof. Dr.

  Ankara City Hospital, Ankara/TURKEY

  STUDY DIRECTOR

• Bedriye B BAŞKAN, Prof. Dr.

  Ankara City Hospital, Ankara/TURKEY

  STUDY DIRECTOR

• Tezel YŞ YILDIRIM ŞAHAN, Assoc. Prof.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigatör

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 1, 2023
• Study Start: November 1, 2023
• Primary Completion: December 21, 2023
• Study Completion: January 18, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

TU (1)