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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112145
• Other study ID #: ASH-MK-ÇS
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Kirsehir Ahi Evran Universitesi
• Contact: Nazife K KAPAN, MD
• Phone: 03125526000
• Email: nazifekapan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Flexor Tendon Rupture
• Hand Injuries
• Rehabilitation
• Rupture
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	baseline and 4th week
Secondary	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.	baseline and 4th week