Clinical trial NCT06741215: Kinesophobia's Impact on Hand Tendon Rehabilitation
Official title: The Effect of Kinesiophobia on Rehabilitation Outcomes in Patients Undergoing Hand Tendon Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kinesiophobia
Tendon Injuries
Keywords: Tendon Injuries
Kinesiophobia
Hand surgery
Rehabilitation
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent primary repair of flexor and/or extensor tendon injuries

Brief summary: Surgically repaired hand tendon injuries may be adversely affected by kinesiophobia during rehabilitation. In this pioneering study, we aimed to investigate the impact of kinesiophobia on functional recovery and rehabilitation outcomes during postoperative rehabilitation of hand tendon injuries.

Detailed description: Patients who underwent primary repair of flexor and/or extensor tendons were included in the study. Data from patients treated with a staged rehabilitation program beginning with passive mobilization in the first week and incorporating electrotherapy and in-person physiotherapy starting from the sixth week were retrospectively analyzed. Patients were grouped as high kinesiophobia (TKS ≥37) or low kinesiophobia (TKS \<37) based on their 6th-week assessment. Total Active Motion (TAM) score, Visual Analog Scale (VAS), grip strength, Hand Functional Index (HFI), and Tampa Kinesiophobia Scale (TKS) scores were recorded and statistically compared at the 6th and 12th weeks.

The data of patients who underwent primary tendon repair and received the necessary hand rehabilitation at our hospital were retrospectively analyzed. Passive mobilization exercises were initiated for these patients in the first postoperative week. Flexor tendon repair patients were immobilized for 3-4 weeks postoperatively. During this period, passive mobilization exercises were performed for the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints with controlled movement. After removing the splint in the third or fourth week, tendon-gliding exercises were initiated, followed by isolated tendon-gliding exercises in the fifth week. Electrotherapy was started in the sixth week (5 days a week, for 15 sessions), including hydromassage, pulsed ultrasound, transcutaneous electrical nerve stimulation (TENS), and hot pack therapy. Gentle stretching exercises were performed on joints with ROM limitations. Light resistance exercises were introduced during the 7th-8th week, and strengthening exercises with daily-use weights were started in the 10th-12th week.

For extensor tendon repair patients, immobilization lasting 3-6 weeks was applied based on the injury level. During immobilization, passive range of motion (ROM) exercises were performed for adjacent joints while the hand remained in the splint. After splint removal, active and passive ROM exercises, and tendon-gliding exercises with gradually increasing intensity were started according to the injury level. Electrotherapy and in-person physiotherapy began in the sixth week, and gentle stretching for joints with ROM limitations and strengthening exercises were introduced starting in the 8th-10th week.

The data included the patient's age, sex, occupation, type of injury, injury level, time elapsed since the injury, dominant hand, duration of splint use, and the treatment methods applied. Additionally, at the 6th and 12th weeks, pre- and post-physiotherapy measurements of range of motion (ROM), Visual Analog Scale (VAS) scores, Hand Functional Index (HFI) scores, Tampa Kinesiophobia Scale (TKS) scores, and hand grip (HG) strength scores were recorded.

Finger ROM measurements were performed using a finger goniometer. ROM values for the affected finger's MCP, PIP, and DIP joints were recorded. The measured ROM values were evaluated according to the Total Active Motion (TAM) scoring system of the American Society for Surgery of the Hand. TAM is calculated by subtracting the total extension lag from the sum of active flexion angles of the affected finger's MCP, PIP, and DIP joints. Each patient's pre- and post-treatment TAM values were calculated and recorded \[Collocott SJF, Kelly E, Foster M, Myhr H, Wang A, Ellis RF. A randomized clinical trial comparing early active motion programs: Earlier hand function, TAM, and orthotic satisfaction with a relative motion extension program for zones V and VI extensor tendon repairs. J Hand Ther. 2020;33(1):13-24.\].

Pain severity was assessed pre- and post-treatment using the VAS. In this scale, where 0 indicates no pain, and 10 indicates the most severe pain, patients were asked to rate their pain on a line from 0 to 10. VAS is a simple, valid, and reliable method commonly used to assess pain in studies. Pain severity was categorized as follows: VAS 1-4 (mild pain), VAS 5-6 (moderate pain), and VAS 7-10 (severe pain) \[Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61.\].

The HFI consists of 9 questions evaluating wrist and finger movements. The first question is scored from 0-3 (0=performs the movement completely with normal speed, 1=delayed performance, 2=partial performance, 3=unable to perform), while questions 2, 3, 4, 5, 8, and 9 are scored from 0-2 (0=performs the movement completely, 1=performs with difficulty and delay, 2=unable to perform). Questions 6 and 7 are scored from 1-3 (1=performs the movement completely, 2=performs with difficulty and delay, 3=partial performance). The total score ranges from 2 to 21, with higher scores indicating worse hand function \[Lefevre-Colau MM, Poiraudeau S, Fermanian J, Etchepare F, Alnot JY, Le Viet D, Leclercq C, Oberlin C, Bargy F, Revel M. Responsiveness of the Cochin rheumatoid hand disability scale after surgery. Rheumatology (Oxford). 2001;40(8):843-50.\].

Kinesiophobia was assessed using the Turkish version of the TSK. This scale consists of 17 items measuring fear of movement and/or reinjury. It evaluates fear-avoidance parameters in daily activities with statements such as, "I am afraid of injuring myself if I exercise," "I cannot do what normal people do because I injure myself too easily," and "My body will always be at risk because of what happened to me." Patients respond to these statements by selecting one of the options: strongly disagree, disagree, agree, or strongly agree, scored as 1-4, respectively. Items 4, 8, 12, and 16 are reverse scored, and the total score ranges from 17 to 68, with higher scores indicating higher levels of kinesiophobia. A threshold score of 37 was used to classify patients: those with Tampa scores ≥37 were categorized as the high-kinesiophobia group. In contrast, those with scores \<37 were categorized as the low-kinesiophobia group \[Tuna Z, Oskay D. Fear of movement and its effects on hand function after tendon repair. Hand Surg Rehabil. 2018:S2468-1229(18)30092-6.\].

Eligibility criteria: Inclusion Criteria:

• Clinical diagnosis of underwent primary repair for flexor and/or extensor tendon injuries

Exclusion Criteria:

* Patients with associated fractures
* Peripheral nerve and vascular injuries
* Rheumatoid arthritis
* Diabetes mellitus
* Peripheral artery disease
* Other rheumatic diseases affecting the hand

Primary outcomes:
measure: Tampa Scale of Kinesiophobia (TSK) scores
timeFrame: six week
Secondary outcomes:
measure: Visual analog scale (VAS) scores
timeFrame: six week
measure: Total Active Motion (TAM)
timeFrame: six week
measure: Hand Functional Index (HFI) scores
timeFrame: six week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital
state: Altindag
Study officials:
affiliation: Department of Physical Therapy and Rehabilitation, University of Health Sciences
name: Nadide Koca, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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