A Comparison of Endoscopic Surgery and Exercise Therapy in Patients With Longstanding Achilles Tendinopathy

NCT03025412 | Terminated

• 1 other identifier: 2016/1931
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise is a preferred treatment modality for mid-portion achilles tendinopathy. Despite this, as many as 44 % of achilles tendinopathy patients do not respond to exercise treatment. Surgery for midportion achilles tendinopathy has for many years been done as an open procedure. New knowledge resulted in a variety of minimally invasive procedures and the development of endoscopic surgery. In this study, the effect of non-open surgery and conservative treatment (physiotherapy and exercises) will be compared.

Conditions

Tendinopathy

Keywords

Achilles Tendon; Endoscopy; Minimally Invasive Surgical Procedures; Exercise therapy

Outcome Measures

Primary Outcomes (2)

• pain using The Victorian Institute of Sports Assessment - Achilles

  3 months (immediately following 12 week exercising)

• pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)

  6 months after 12 week exercising

Secondary Outcomes (13)

• pain using a numeric rating scale (NRS)

  3 months (immediately following 12 week exercising

• pain using a numeric rating scale (NRS)

  6 months after 12 week exercising

• Hospital Anxiety and Depression Scale (HAD)

  3 months (immediately following 12 week exercising)

• Hospital Anxiety and Depression Scale (HAD)

  6 months after 12 week exercising

• Tampa Scale of Kinesiophobia [TSK]

  3 months (immediately following 12 week exercising)

Study Arms (2)

Endoscopic surgery

EXPERIMENTAL

Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.

Procedure: endoscopic surgery; Behavioral: physiotherapy and exercise

Conservative treatment

ACTIVE COMPARATOR

Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases.

Behavioral: physiotherapy and exercise

Interventions

endoscopic surgery PROCEDURE

Ambulatory surgery. Same surgeon for all patients. General anesthesia. Full debridement of the paratenon and crural fascia. Also the plantaris longus tendon is debrided, but no additional tenotomy executed. Postoperative rehabilitation. Oral nonsteroidal anti-inflammatory drugs 7 days postoperatively. Active ankle dorsiflexion and plantar flexion from day 1 postoperative. Partly weight bearing (30 kg) from day 1 postoperative. Full weight bearing allowed from week 3 postoperative. Gradually increased load, both in activity of daily living, stationary bike and stretching, with individually and pragmatic progression due to pain response. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.

Endoscopic surgery

physiotherapy and exercise BEHAVIORAL

Exercise schedule: Weeks 1-6, Eccentric unilateral loading while standing on the step of a staircase performed in two exercises; with straight knee and with bent knee. Weeks 7-9, Eccentric - Concentric loading while standing on the step of a staircase performed with straight knee and bent knee. Dose: 15 repetitions x 3 performed with straight knee, and 15 repetitions x 3 performed with bent knee. 3 - 4 times a week. Weeks 10-12, Eccentric - Concentric loading while standing on the step of a staircase performed with straight knee and bent knee. Dose: 15 repetitions maximum (15RM) x 3 performed with straight knee, and 15 RM x 3 performed with bent knee. 3 - 4 times a week. One leg performance or hand hold weight for extra load is used to obtain the exact number of RM.

Conservative treatment; Endoscopic surgery

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of mid-portion achilles tendinopathy
• pain during at least 3 months
• decreased function (a score less than 80 on VISA-A)

You may not qualify if:

• Physiotherapy during previous three months
• history of major achilles trauma
• cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences

Trondheim, Norway

Location

MeSH Terms

Conditions

Tendinopathy

Interventions

Endoscopy; Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jorunn Helbostad, prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: April 19, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

NO (1)