"Effects of Rigid Tape in Patients With Chronic Achilles Tendinopathy"
ConditionAchilles Tendinopathy (AT)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Gran Rosario
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Any ankle or foot surgery
History of Achilles rupture
Heel pain in the last 3 months
Systemic disorders/diseases
Trial design
Design model
Parallel
Treatments tested in this trial
Rigid Tape
Other interventionInelastic rigid tape (Strappal) applied to discharge the Achilles tendon
Placebo Control
Other interventionA pre-tape and a short piece of rigid tape applied without tension.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Rigid Tape groupExperimental treatment 1 intervention
Group B: Placebo Tape groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change on pain intensity
The Visual Analog Scale (VAS) will be used to assess pain intensity during running and jumping. This scale consists of a sequence of numbers from 0 (no pain) to 100 mm (most severe pain).
Time frame
At baseline, immediately and 72 hours after the interventionSecondary outcomes
1
Change on single leg vertical jump
This test will assess the height in cm and power of a vertical jump using the My Jump app, validated by Gallardo-Fuentes in 2016. The instructions will be jumping as high as possible with hands on the subject's waist. Participants will perform 3 repetitions in a non-consecutive manner.
Time frame
At baseline, immediately and 72 hours after the intervention2
Change on feeling of comfort of the tape
The satisfaction of the tape will be assessed by the Likert Scale. This rating scale measures the positive or negative response to the intervention. The format of this scale will be divided into five levels: "very uncomfortable", "uncomfortable", "normal", "comfortable", and "very comfortable".
Time frame
Immediately and 72 hours after the intervention3
Change in perception of improvement of the treatment
The Global Rating of Change (GROC) scale is a patient-reported outcome measure used to assess the subjective perception of change in a patient's condition following an intervention. It helps determine whether a patient's condition has improved, worsened, or remained the same since the start of treatment. The magnitude of this difference is recorded on an 11-point visual analog scale, starting from "0" (no change) as the midpoint, and presenting at its extremes "-5" (much worse) and "+5" (completely better).
Time frame
72 hours after the interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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