A Novel Multi-factorial Criteria-based Rehabilitation Program for Chronic Mid-portion Achilles Tendinopathy

NCT04384874 | Completed

• 1 other identifier: SSC-Achilles-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Sixty physically active patients (aged 18-45) with chronic mid-portion Achilles tendinopathy will be recruited to take part in the study. The patients will be diagnosed by a sports medicine doctor and an MRI scan and will be experiencing palpable Achilles pain at the time of inclusion. The patients will be randomized into either a group performing the Silbernagel combined concentric-eccentric program, or a group performing a novel multi-phase program with specific outcome measures. The study will assess the patients calf strength, reactive strength and running biomechanics at baseline, week's 6 and 12 of a rehabilitation program and be available for a 6 month, 12 month and 2 year follow-up interview. The VISA-A questionnaire will be the primary outcome measure and will be completed at each testing and follow-up session.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Change in VISA-A Questionnaire score

  This is a measure of pain and lower limb function associated with Achilles tendinopathy and a primary outcome measure will be the change in VISA-A questionnaire at various time points during the 12 week intervention and in the long-term follow-ups. A change of 20 points is typically observed after a rehabilitation program, while a 10 point increase is accepted as being clinically meaningful.

  This will be assessed at week 6 and 12, as well as 6, 12 and 24 month follow-ups

Secondary Outcomes (3)

• Plantar flexor strength

  This will be carried out at week 0, 6 and 12

• Running biomechanics

  This will be carried out at week 0, 6 and 12

• Lower limb reactive strength

  This will be carried out at week 6 and 12

Study Arms (2)

Silbernagel combined concentric-eccentric program

ACTIVE COMPARATOR

A graduated rehabilitation program using exercises with concentric and eccentric contractions and progressing to plyometric training. The exercises are performed daily with progression guided by pain symptoms. There is no specificity in prescribed exercise loading.

Other: Exercise therapy

SSC6

EXPERIMENTAL

A multi-stage rehabilitation program with focus on strength and reactive strength targets, as well as running gait re-training. These exercises will be initially carried out 3 days per week for the first 6 weeks with specific load targets prescribed.

Other: Exercise therapy

Interventions

Exercise therapy OTHER

A 12 week multi-stage exercise rehabilitation program

SSC6; Silbernagel combined concentric-eccentric program

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with mid-portion Achilles Tendinopathy by a sports medicine physician
• Have experienced symptoms for more than 3 months and less than 3 years
• Aged between 18-45 years,
• Regularly perform running-based exercise more than twice per week

You may not qualify if:

• Have a co-existing lower limb injury.
• Have had another running-related injury in the previous 12 months.
• Have had an Achilles injection in the past 6 months

Sponsors & Collaborators

• Sports Surgery Clinic, Santry, Dublin: lead

Study Sites (1)

Sports Surgery Clinic

Dublin, Leinster, Ireland

Location

Related Publications (1)

• Griffin C, Daniels K, Hill C, Franklyn-Miller A, Morin JB. A criteria-based rehabilitation program for chronic mid-portion Achilles tendinopathy: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2021 Aug 14;22(1):695. doi: 10.1186/s12891-021-04553-6.

  PMID: 34391384 DERIVED

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of lab services and research

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 12, 2020
• Study Start: January 29, 2020
• Primary Completion: January 30, 2023
• Study Completion: May 31, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

IE (1)