NCT07360873

Brief Summary

Achilles tendinopathy is a common overuse injury in football players and is associated with pain, stiffness, and reduced functional performance. Conservative treatment options such as eccentric calf muscle exercises and heel insole lifts are frequently used in rehabilitation; however, evidence comparing their effectiveness remains limited. This randomized controlled trial compared the effects of eccentric calf muscle exercises and heel insole lifts on pain, ankle range of motion, and functional outcomes in male football players with Achilles tendinopathy. Participants were randomly assigned to one of two intervention groups. One group performed a structured eccentric calf muscle exercise program, while the other group used heel insole lifts during daily activities. Outcomes related to pain intensity, functional ability, calf muscle performance, and ankle range of motion were assessed at baseline and after completion of a 12-week intervention period. The results of this study aim to support evidence-based rehabilitation strategies for the management of Achilles tendinopathy in football players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

April 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 13, 2026

Last Update Submit

January 13, 2026

Conditions

Keywords

Achilles TendinopathyEccentric ExerciseHeel LiftCalf MuscleFootball PlayersSports RehabilitationPhysiotherapyAnkle Function

Outcome Measures

Primary Outcomes (2)

  • Functional Ability (Victorian Institute of Sports Assessment-Achilles, VISA-A)

    Functional status was assessed using the Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire. Scores range from 0 to 100, with higher scores indicating better function (less severe symptoms).

    Baseline and at 12 weeks

  • Pain Intensity (Visual Analogue Scale, VAS)

    Pain intensity was assessed using the Visual Analogue Scale (VAS), a 100-mm scale ranging from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate worse pain. Outcome is reported in millimeters (mm).

    Baseline and at 12 weeks

Study Arms (2)

Eccentric Calf Muscle Exercise Group

EXPERIMENTAL

Participants assigned to this arm received a structured eccentric calf muscle exercise program based on Alfredson's protocol for the management of Achilles tendinopathy.

Other: Eccentric Calf Muscle Exercises

Heel Insole Lift Group

ACTIVE COMPARATOR

Participants assigned to this arm were provided with heel insole lifts and instructed to use them during daily activities throughout the intervention period.

Device: Heel Insole Lift

Interventions

Eccentric calf muscle exercises were performed according to Alfredson's protocol. Participants completed three sets of fifteen repetitions, twice daily, seven days per week for 12 weeks. Exercises were performed on a step with the knee extended and flexed to target the gastrocnemius and soleus muscles. Resistance was progressively increased as pain decreased.

Eccentric Calf Muscle Exercise Group

Participants were provided with prefabricated heel insole lifts (approximately 12 mm) based on shoe size and instructed to wear them continuously in their regular footwear during daily activities for a 12-week period.

Heel Insole Lift Group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male football players aged 18 to 30 years
  • Clinical diagnosis of Achilles tendinopathy
  • Achilles tendon pain for at least one month
  • Pain intensity of 3 or higher on the Visual Analogue Scale
  • Pain aggravated by weight-bearing activities
  • Able to understand English and complete questionnaires
  • Willing to avoid other treatments for Achilles tendinopathy during the 12-week study period

You may not qualify if:

  • Lower limb injury within the past 6 months
  • Previous Achilles tendon rupture or surgery
  • Chronic ankle instability
  • Recent use of eccentric exercises or heel insole lifts
  • Metabolic or endocrine disorders
  • Current use of medications other than paracetamol
  • Unwillingness to comply with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FAME Football Club, Model Town, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (30)

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    PMID: 24261927BACKGROUND
  • Stasinopoulos D, Manias P. Comparing two eccentric exercise programmes for the management of Achilles tendinopathy. A pilot trial. J Bodyw Mov Ther. 2013 Jul;17(3):309-15. doi: 10.1016/j.jbmt.2012.11.003. Epub 2012 Dec 12.

    PMID: 23768274BACKGROUND
  • Siu WL, Chan CH, Lam CH, Lee CM, Ying M. Sonographic evaluation of the effect of long-term exercise on Achilles tendon stiffness using shear wave elastography. J Sci Med Sport. 2016 Nov;19(11):883-887. doi: 10.1016/j.jsams.2016.02.013. Epub 2016 Mar 11.

    PMID: 26996945BACKGROUND
  • Silbernagel KG, Hanlon S, Sprague A. Current Clinical Concepts: Conservative Management of Achilles Tendinopathy. J Athl Train. 2020 May;55(5):438-447. doi: 10.4085/1062-6050-356-19. Epub 2020 Apr 8.

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    BACKGROUND
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    PMID: 36538166BACKGROUND
  • Rabusin CL, Menz HB, McClelland JA, Evans AM, Malliaras P, Docking SI, Landorf KB, Gerrard JM, Munteanu SE. Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (HEALTHY): a randomised trial. Br J Sports Med. 2021 May;55(9):486-492. doi: 10.1136/bjsports-2019-101776. Epub 2020 Sep 28.

    PMID: 32988930BACKGROUND
  • Rabusin CL, Menz HB, McClelland JA, Evans AM, Landorf KB, Malliaras P, Docking SI, Munteanu SE. Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (the HEALTHY trial): study protocol for a randomised trial. J Foot Ankle Res. 2019 Mar 21;12:20. doi: 10.1186/s13047-019-0325-2. eCollection 2019.

    PMID: 30949243BACKGROUND
  • Prudencio DA, Maffulli N, Migliorini F, Serafim TT, Nunes LF, Sanada LS, Okubo R. Eccentric exercise is more effective than other exercises in the treatment of mid-portion Achilles tendinopathy: systematic review and meta-analysis. BMC Sports Sci Med Rehabil. 2023 Jan 26;15(1):9. doi: 10.1186/s13102-023-00618-2.

    PMID: 36698184BACKGROUND
  • O'Neill S, Watson PJ, Barry S. WHY ARE ECCENTRIC EXERCISES EFFECTIVE FOR ACHILLES TENDINOPATHY? Int J Sports Phys Ther. 2015 Aug;10(4):552-62.

    PMID: 26347394BACKGROUND
  • Martin RL, Chimenti R, Cuddeford T, Houck J, Matheson JW, McDonough CM, Paulseth S, Wukich DK, Carcia CR. Achilles Pain, Stiffness, and Muscle Power Deficits: Midportion Achilles Tendinopathy Revision 2018. J Orthop Sports Phys Ther. 2018 May;48(5):A1-A38. doi: 10.2519/jospt.2018.0302.

    PMID: 29712543BACKGROUND
  • Maffulli N, Longo UG, Kadakia A, Spiezia F. Achilles tendinopathy. Foot Ankle Surg. 2020 Apr;26(3):240-249. doi: 10.1016/j.fas.2019.03.009. Epub 2019 Apr 18.

    PMID: 31031150BACKGROUND
  • Leung WKC, Chu KL, Lai C. Sonographic evaluation of the immediate effects of eccentric heel drop exercise on Achilles tendon and gastrocnemius muscle stiffness using shear wave elastography. PeerJ. 2017 Jul 19;5:e3592. doi: 10.7717/peerj.3592. eCollection 2017.

    PMID: 28740756BACKGROUND
  • Lee KKW, Ling SKK, Yung PSH. Controlled trial to compare the Achilles tendon load during running in flatfeet participants using a customized arch support orthoses vs an orthotic heel lift. BMC Musculoskelet Disord. 2019 Nov 13;20(1):535. doi: 10.1186/s12891-019-2898-0.

    PMID: 31722697BACKGROUND
  • Karamat MS, Jamil A. Comparative effects of myofascial release with and without eccentric resistance on pain, range of motion, and functional disability in patients with Achilles tendinopathy. J Bodyw Mov Ther. 2024 Oct;40:1066-1071. doi: 10.1016/j.jbmt.2024.07.029. Epub 2024 Jul 9.

    PMID: 39593413BACKGROUND
  • Habets B, van Cingel RE. Eccentric exercise training in chronic mid-portion Achilles tendinopathy: a systematic review on different protocols. Scand J Med Sci Sports. 2015 Feb;25(1):3-15. doi: 10.1111/sms.12208. Epub 2014 Mar 20.

    PMID: 24650048BACKGROUND
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    BACKGROUND
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    PMID: 26327530BACKGROUND
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    BACKGROUND
  • de Jonge S, van den Berg C, de Vos RJ, van der Heide HJ, Weir A, Verhaar JA, Bierma-Zeinstra SM, Tol JL. Incidence of midportion Achilles tendinopathy in the general population. Br J Sports Med. 2011 Oct;45(13):1026-8. doi: 10.1136/bjsports-2011-090342.

    PMID: 21926076BACKGROUND
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    PMID: 35279020BACKGROUND
  • Couppe C, Svensson RB, Silbernagel KG, Langberg H, Magnusson SP. Eccentric or Concentric Exercises for the Treatment of Tendinopathies? J Orthop Sports Phys Ther. 2015 Nov;45(11):853-63. doi: 10.2519/jospt.2015.5910. Epub 2015 Oct 15.

    PMID: 26471850BACKGROUND
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    BACKGROUND
  • Bourke J, Munteanu S, Garofolini A, Taylor S, Malliaras P. Efficacy of heel lifts for mid-portion Achilles tendinopathy (the LIFT trial): study protocol for a randomised controlled trial. Trials. 2024 May 24;25(1):345. doi: 10.1186/s13063-024-08185-8.

    PMID: 38790025BACKGROUND
  • Beyer R, Kongsgaard M, Hougs Kjaer B, Ohlenschlaeger T, Kjaer M, Magnusson SP. Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1704-11. doi: 10.1177/0363546515584760. Epub 2015 May 27.

    PMID: 26018970BACKGROUND
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    PMID: 29731662BACKGROUND
  • Aiyegbusi, A., Owoeye, I., Balogun, O., Fapojuwo, O., & Akinloye, O. (2021). Prevalence of Achilles Tendinopathy and Associated Selected Intrinsic Risk Factors among Nigerian Footballers. Muscles, Ligaments & Tendons Journal (MLTJ), 11(1).

    BACKGROUND

Study Officials

  • Adnan Hashim, DPT

    Department of Physical Therapy, The University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation to minimize assessment bias. Participants and care providers were not blinded due to the nature of the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two parallel groups to receive either an eccentric calf muscle exercise program or heel insole lifts for a 12-week intervention period.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor of Physical Therapy Student

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

April 5, 2025

Primary Completion

July 8, 2025

Study Completion

August 12, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because this study was conducted as an academic research project. The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.

Locations