NCT05539586

Brief Summary

Achilles tendinopathy is characterized by pain, decreased performance and swelling in and around the tendon. Up to 29% of patients with Achilles tendinopathy may require surgical intervention. It can be complicated by partial tears or complete rupture, placing a long-term burden on the healthcare system and making treatment more difficult. The most common location of Achilles tendinopathy is in the insertional area of the calcaneus, 1.5 to 2 cm cranial to the bone. The most common location of pathologic inflammation was at the fascial intersection of the medial gastrocnemius and soleus when fused with the proximal Achilles tendon (66% of patients and the distal part of the Achilles tendon near the calcaneus. The four cornerstones of tendon histopathology are: cellular activation and increased cell number, increased ground substance, collagen disorganization and neovascularization. In addition, blood supply is one of the most influential factors in tendon tissue repair. A recent clinical trial compared the outcome after low frequency microwave hyperthermia with traditional ultrasound. The hyperthermia group recorded significantly better results after treatment and one month later. The use of deep heating modalities, due to their beneficial effects of increased circulation and cellular metabolism resulting in increased waste and nutrient exchange in a specific area, has long been accepted as part of the treatment of overuse tendinopathies . The application of heat has been reported to improve blood flow and oxygen saturation in the Achilles tendon.Physical therapies based on electrical or electromagnetic stimulation have been used in rehabilitation, in some cases combining electrical therapy with radiofrequency. Specifically, resistive capacitive electrical transfer therapy (CRet) has been used in physical rehabilitation and sports medicine to treat muscle, bone, ligament and tendon injuries. CRet is a non-invasive electrothermal therapy classified as deep thermotherapy, which is based on the application of electrical currents within the radiofrequency range of 300 kHz - 1.2 MHz. he effects attributed to this technique include increased deep and superficial blood circulation, vasodilatation, increased temperature, elimination of excess fluid and increased cell proliferation. Some of these reactions, such as increased blood perfusion, are known to be related to the increase in temperature, but others, such as increased cell proliferation, appear to be primarily related to the passage of current. There are currently numerous treatment proposals for this pathology, however, the only one that has shown significant improvements are eccentric exercise protocols. The only drawback of this type of exercise is that the results are obtained in the long term. There is currently no study that has compared the effectiveness of adding a tecartherapy protocol to the eccentric exercise protocol in chronic Achilles tendinopathy in athletes in the short and medium term in both functional and structural variables.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

September 8, 2022

Last Update Submit

September 13, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in numerical pain rating scale (0-10)

    EVA pain scale will be used, where the patient will tell us the pain in numerical form.

    Baseline; 3 weeks follow-up; 7 weeks follow-up

  • Change in visual analogue scale (0-100 mm)

    EVA pain scale will be used, where the patient will point on a fingertip on a straight line without numbers which has been his perception of pain.

    Baseline; 3 weeks follow-up; 7 weeks follow-up

Secondary Outcomes (7)

  • Strength (kilograms)

    Baseline; 3 weeks follow-up; 7 weeks follow-up

  • Ankle range of motion in loading (degrees)

    Baseline; 3 weeks follow-up; 7 weeks follow-up

  • VISA-A questionnaire

    Baseline; 3 weeks follow-up; 7 weeks follow-up

  • GROC scale

    Baseline; 3 weeks follow-up; 7 weeks follow-up

  • Cross-sectional area (mm2)

    Baseline; 3 weeks follow-up; 7 weeks follow-up

  • +2 more secondary outcomes

Study Arms (2)

Tecar group

EXPERIMENTAL
Other: Tecartherapy

Sham Group

SHAM COMPARATOR
Other: Sham

Interventions

Patients will receive therapeutic exercise sessions for 7 weeks and 7 tecartherapy sessions.

Tecar group
ShamOTHER

Patients will receive therapeutic exercise sessions for 7 weeks and 7 sessions of simulated tecartherapy.

Sham Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study participants must have signed the informed consent form in order to evaluate their participation in the study.
  • Actively practice some sporting activity.
  • Have a medical diagnosis of chronic Achilles tendinopathy of more than 3 months of evolution.
  • Not having previously received any tecartherapy treatment.
  • Be over 18 years of age.

You may not qualify if:

  • Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity.
  • Subjects with bilateral tendinopathies.
  • Subjects who report allergies to the conductive cream.
  • Not understanding the information provided by the therapist.
  • Participating in other research studies.
  • Subjects undergoing pharmacological medical treatment that may interfere with the measurements, such as treatment with anticonvulsants, antidepressants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

Jacobo Rodríguez-Sanz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 14, 2022

Study Start

December 1, 2022

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

September 14, 2022

Record last verified: 2022-09