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KinesiophobiaNCT06741215

Kinesophobia's Impact on Hand Tendon Rehabilitation

An observational study of Kinesiophobia and Tendon Injuries, run by Ankara Training and Research Hospital 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

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Kinesiophobia, Tendon Injuries
What is being tested?
Hand Rehabilitation
How many people
31 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Jun 2023to 12 Aug 2024
Phase
Observational
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent primary repair of flexor and/or extensor tendon injuries

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

    Ankara, Altindag, 06230

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Kinesiophobia on Rehabilitation Outcomes in Patients Undergoing Hand Tendon Surgery

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.

Read the 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.].

Being tested
Hand Rehabilitation
Keywords
Tendon Injuries, Kinesiophobia, Hand surgery, Rehabilitation
Medical subject headings
Kinesiophobia, Tendon Injuries

What participants receive

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

  • Hand RehabilitationOther

    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 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).

    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 was started in in the sixth week.

Study groups in NCT06741215
Study groupRoleWhat they receive
Group 1: High kinesiophobia groupTampa kinesiophobia score greater than 37
Receives: Other: Hand Rehabilitation
Group 2: Low kinesiophobia groupTampa kinesiophobia score less than 37
Receives: Other: Hand Rehabilitation

What is being measured

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

  1. Tampa Scale of Kinesiophobia (TSK) scores

    The original Tampa Scale of Kinesiophobia (TKS) was developed by Miller, Kopri and Todd in 1991 but was not published [Miller R., Kori S., Todd D. The Tampa Scale: a measure of kinesiophobia. Clin J Pain. 1991;7(1):51-52.]. TKS is a 17-item scale developed to measure fear of movement/reinjury. The scale includes parameters of injury/reinjury and fear-avoidance in work-related activities. We used the Turkish version in our study. [Acar S., Savci S., Keskinoğlu P., Akdeniz B., Özpelit E., Özcan Kahraman B., Karadibak D., Sevinc C. Tampa Scale of Kinesiophobia for Heart Turkish Version Study: cross-cultural adaptation, exploratory factor analysis, and reliability. J Pain Res. 2016 Jun 23;9:445-51.]

    Measured: six week

Secondary outcomes (3)
  1. Visual analog scale (VAS) scores

    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.]

    Measured: six week

  2. Total Active Motion (TAM)

    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.]

    Measured: six week

  3. Hand Functional Index (HFI) scores

    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.].

    Measured: six week

Timeline

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

  1. First posted18 Dec 2024
  2. Study start22 Jun 2023
  3. Primary completion21 Jun 2024
  4. Study completion12 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06741215
Sponsor's protocol ID
AnkaraTRH-FTR-NK-01
Status last verified
Dec 2024
First submitted
13 Dec 2024
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 Jan-Mar;33(1):13-24. doi: 10.1016/j.jht.2018.10.003. Epub 2019 Mar 21.

    PubMed 30905495
  • Cai L, Liu Y, Xu H, Xu Q, Wang Y, Lyu P. Incidence and Risk Factors of Kinesiophobia After Total Knee Arthroplasty in Zhengzhou, China: A Cross-Sectional Study. J Arthroplasty. 2018 Sep;33(9):2858-2862. doi: 10.1016/j.arth.2018.04.028. Epub 2018 Apr 23.

    PubMed 29776855
  • 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. doi: 10.1097/00000542-200112000-00013.

    PubMed 11748392
  • Bordeleau M, Vincenot M, Lefevre S, Duport A, Seggio L, Breton T, Lelard T, Serra E, Roussel N, Neves JFD, Leonard G. Treatments for kinesiophobia in people with chronic pain: A scoping review. Front Behav Neurosci. 2022 Sep 20;16:933483. doi: 10.3389/fnbeh.2022.933483. eCollection 2022.

    PubMed 36204486
  • Bilgin S, Cetin H, Karakaya J, Kose N. Multivariate Analysis of Risk Factors Predisposing to Kinesiophobia in Persons With Chronic Low Back and Neck Pain. J Manipulative Physiol Ther. 2019 Oct;42(8):565-571. doi: 10.1016/j.jmpt.2019.02.009. Epub 2019 Nov 23.

    PubMed 31771838
  • Bennett DJ, Bango J, Rothkopf DM. Hand Therapy after Flexor and Extensor Tendon Repair: Assessing Predictors of Loss to Follow-up. Plast Reconstr Surg Glob Open. 2023 Apr 26;11(4):e4941. doi: 10.1097/GOX.0000000000004941. eCollection 2023 Apr.

    PubMed 37124389
  • Bartlett O, Farnsworth JL. The Influence of Kinesiophobia on Perceived Disability in Patients With an Upper-Extremity Injury: A Critically Appraised Topic. J Sport Rehabil. 2021 Mar 3;30(5):818-823. doi: 10.1123/jsr.2020-0179.

    PubMed 33662934
  • Alshahrani MS, Reddy RS. Kinesiophobia, limits of stability, and functional balance assessment in geriatric patients with chronic low back pain and osteoporosis: a comprehensive study. Front Neurol. 2024 Feb 13;15:1354444. doi: 10.3389/fneur.2024.1354444. eCollection 2024.

    PubMed 38414551
  • Alshahrani MS, Reddy RS, Tedla JS, Asiri F, Alshahrani A. Association between Kinesiophobia and Knee Pain Intensity, Joint Position Sense, and Functional Performance in Individuals with Bilateral Knee Osteoarthritis. Healthcare (Basel). 2022 Jan 7;10(1):120. doi: 10.3390/healthcare10010120.

    PubMed 35052284
  • Alito A, Cifalino ME, Fontana JM, Verme F, Pitera P, Capodaglio P. Tackling Kinesiophobia in Chronic Shoulder Pain: A Case Report on the Combined Effect of Pain Education and Whole-Body Cryostimulation. J Clin Med. 2024 Apr 3;13(7):2094. doi: 10.3390/jcm13072094.

    PubMed 38610859
  • Aleksic M, Selakovic I, Tomanovic Vujadinovic S, Kadija M, Milovanovic D, Meissner W, Zaslansky R, Sreckovic S, Dubljanin-Raspopovic E. Understanding Kinesiophobia: Predictors and Influence on Early Functional Outcomes in Patients with Total Knee Arthroplasty. Geriatrics (Basel). 2024 Aug 13;9(4):103. doi: 10.3390/geriatrics9040103.

    PubMed 39195133
  • Al-Amiry B, Rahim A, Knutsson B, Mattisson L, Sayed-Noor A. Kinesiophobia and its association with functional outcome and quality of life 6-8 years after total hip arthroplasty. Acta Orthop Traumatol Turc. 2022 Jul;56(4):252-255. doi: 10.5152/j.aott.2022.21318.

    PubMed 35968616
  • 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 Aug;40(8):843-50. doi: 10.1093/rheumatology/40.8.843.

    PubMed 11511751
  • Duruoz MT, Cerrahoglu L, Dincer-Turhan Y, Kursat S. Hand function assessment in patients receiving haemodialysis. Swiss Med Wkly. 2003 Aug 9;133(31-32):433-8. doi: 10.4414/smw.2003.10216.

    PubMed 14562186
  • Osteras N, Risberg MA, Kvien TK, Engebretsen L, Nordsletten L, Bruusgaard D, Schjervheim UB, Haugen IK, Hammer HB, Provan S, Oiestad BE, Semb AG, Rollefstad S, Hagen KB, Uhlig T, Slatkowsky-Christensen B, Kjeken I, Flugsrud G, Grotle M, Sesseng S, Edvardsen H, Natvig B. Hand, hip and knee osteoarthritis in a Norwegian population-based study--the MUST protocol. BMC Musculoskelet Disord. 2013 Jul 5;14:201. doi: 10.1186/1471-2474-14-201.

    PubMed 23826721

Questions about this trial

What is this clinical trial studying?

An observational study of Kinesiophobia and Tendon Injuries, run by Ankara Training and Research Hospital 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 1 inclusion and 6 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 18 Dec 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?

Tampa Scale of Kinesiophobia (TSK) scores (time frame: six week). 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 NCT06741215, which also lists 19 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 18 Dec 2024.

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