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Not yet recruiting NCT07123246

"Effects of Rigid Tape in Patients With Chronic Achilles Tendinopathy"

No phase Interventional Achilles Tendinopathy (AT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rigid Tape, Placebo Control.
Who it may be relevant to
Registry conditions: Achilles Tendinopathy (AT). Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The aim of this study will be to determine the clinical effects of rigid tape in patients with chronic MAT. The secondary outcomes will be to evaluate the immediate and short term pain, the height and pain during the vertical jump, the satisfaction of the use of the tape and the global rating of change (GROC) of the intervention. This study will be a double-blinded randomized clinical trial comprising a total sample size of 36 participants with MAT of both genders and aged between 18 and 50 years. Subjects will undergo a screening process by a sports medicine doctor by different diagnostic tests to identify those presenting a diagnosis of painful MAT and then, they will be randomized into either a group performing experimental rigid tape (G1), or a group performing placebo tape (G2). The study will assess the subjects immediate and short-term tendon pain following the tape application during running and vertical jump. Also the tape satisfaction and GROC will be assessed. The rigid tape will be applied in the central portion of the Achilles tendon. Primary and secondary outcomes will be measured at baseline, immediate after the application of the tape and 72 hours after. The GROC will only be assessed at the end of the treatment. All the evaluations will be performed by a blinded physiotherapist. The patient will also be blinded.

Interventions

  • Other Rigid Tape
    Inelastic rigid tape (Strappal) applied to discharge the Achilles tendon
  • Other Placebo Control
    A pre-tape and a short piece of rigid tape applied without tension.

Primary outcome measures

  • Change on pain intensity [Time frame: At baseline, immediately and 72 hours after the intervention]
Secondary outcome measures (3)
  • Change on single leg vertical jump [Time frame: At baseline, immediately and 72 hours after the intervention]
  • Change on feeling of comfort of the tape [Time frame: Immediately and 72 hours after the intervention]
  • Change in perception of improvement of the treatment [Time frame: 72 hours after the intervention]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of unilateral or bilateral MAT
  • Achilles pain > 3 months
  • Age ranging between 18 to 50 years, both genders
  • Read and speak Spanish well enough to provide informed consent and follow study instructions.
  • Pain during running and jumping.

Exclusion criteria

  • Any ankle or foot surgery
  • History of Achilles rupture
  • Heel pain in the last 3 months
  • Systemic disorders/diseases
  • Body mass index > 30kg/m2
  • Self-report of pregnancy
  • Pain < 2/100 of average pain on VAS
  • VISA A score > 90 points

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 32267723
  • de Vries A, Zwerver J, Diercks R, Tak I, van Berkel S, van Cingel R, van der Worp H, van den Akker-Scheek I. Effect of patellar strap and sports tape on pain in patellar tendinopathy: A randomized controlled trial. Scand J Med Sci Sports. 2016 Oct;26(10):1217-24. doi: 10.1111/sms.12556. Epub 2015 Sep 17. PMID 26376953
  • Dar G, Mei-Dan E. Immediate effect of infrapatellar strap on pain and jump height in patellar tendinopathy among young athletes. Prosthet Orthot Int. 2019 Feb;43(1):21-27. doi: 10.1177/0309364618791619. Epub 2018 Aug 13. PMID 30101673

Identifiers

NCT: NCT07123246 · Rigid Tape and Achilles Tendon

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗