NCT06741215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 13, 2024

Last Update Submit

December 17, 2024

Conditions

Keywords

Tendon InjuriesKinesiophobiaHand surgeryRehabilitation

Outcome Measures

Primary Outcomes (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. \[Acar S., Savci S., Keskinoğlu P., Akdeniz B., Özpelit E., Özcan Kahraman B., Karadibak D., Sevinc C. Tampa Scale of Kinesiophobia for Heart Turkish Version Study: cross-cultural adaptation, exploratory factor analysis, and reliability. J Pain Res. 2016 Jun 23;9:445-51.\]

    six week

Secondary Outcomes (3)

  • Visual analog scale (VAS) scores

    six week

  • Total Active Motion (TAM)

    six week

  • Hand Functional Index (HFI) scores

    six week

Study Arms (2)

Group 1: High kinesiophobia group

Tampa kinesiophobia score greater than 37

Other: Hand Rehabilitation

Group 2: Low kinesiophobia group

Tampa kinesiophobia score less than 37

Other: Hand Rehabilitation

Interventions

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.

Group 1: High kinesiophobia groupGroup 2: Low kinesiophobia group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (19)

  • 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.

    PMID: 30905495BACKGROUND
  • 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.

    PMID: 29776855BACKGROUND
  • 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.

    PMID: 11748392BACKGROUND
  • 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.

    PMID: 36204486BACKGROUND
  • 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.

    PMID: 31771838BACKGROUND
  • 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.

    PMID: 37124389BACKGROUND
  • 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.

    PMID: 33662934BACKGROUND
  • 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.

    PMID: 38414551BACKGROUND
  • 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.

    PMID: 35052284BACKGROUND
  • 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.

    PMID: 38610859BACKGROUND
  • 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.

    PMID: 39195133BACKGROUND
  • 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.

    PMID: 35968616BACKGROUND
  • 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.

    PMID: 11511751BACKGROUND
  • 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.

    PMID: 14562186BACKGROUND
  • 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.

    PMID: 23826721BACKGROUND
  • Guney-Deniz H, Irem Kinikli G, Caglar O, Atilla B, Yuksel I. Does kinesiophobia affect the early functional outcomes following total knee arthroplasty? Physiother Theory Pract. 2017 Jun;33(6):448-453. doi: 10.1080/09593985.2017.1318988. Epub 2017 May 8.

    PMID: 28481125BACKGROUND
  • Filardo G, Merli G, Roffi A, Marcacci T, Berti Ceroni F, Raboni D, Bortolotti B, Kon E, Marcacci M. Kinesiophobia and depression affect total knee arthroplasty outcome in a multivariate analysis of psychological and physical factors on 200 patients. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3417-3423. doi: 10.1007/s00167-016-4201-3. Epub 2016 Jun 21.

    PMID: 27329175BACKGROUND
  • Tuna Z, Oskay D, Gokkurt A, Mete O, Baglan Yentur S, Ambarcioglu P. Does earlier splint removal truly affect functional recovery and kinesiophobia after tendon repair? Hand Surg Rehabil. 2020 Sep;39(4):310-315. doi: 10.1016/j.hansur.2020.01.006. Epub 2020 Feb 20.

    PMID: 32088423BACKGROUND
  • Das De S, Vranceanu AM, Ring DC. Contribution of kinesophobia and catastrophic thinking to upper-extremity-specific disability. J Bone Joint Surg Am. 2013 Jan 2;95(1):76-81. doi: 10.2106/JBJS.L.00064.

    PMID: 23283376BACKGROUND

MeSH Terms

Conditions

KinesiophobiaTendon Injuries

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersWounds and Injuries

Study Officials

  • Nadide Koca, M.D.

    Department of Physical Therapy and Rehabilitation, University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physical Therapy and Rehabilitation

Study Record Dates

First Submitted

December 13, 2024

First Posted

December 18, 2024

Study Start

June 22, 2023

Primary Completion

June 21, 2024

Study Completion

August 12, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations