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

A Comparison of Endoscopic Surgery and Conservative Treatment in Patients With Longstanding Mid-portion Achilles Tendinopathy

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03025412
Enrollment
10
Registered
2017-01-19
Start date
2017-04-19
Completion date
2018-12-01
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendinopathy

Keywords

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

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.

Interventions

PROCEDUREendoscopic surgery

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.

BEHAVIORALphysiotherapy and exercise

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.

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
pain using The Victorian Institute of Sports Assessment - Achilles3 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

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HAD)3 months (immediately following 12 week exercising)
Patient-clinician therapeutic relationship3 months (immediately following 12 week exercising)assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
Tampa Scale of Kinesiophobia [TSK]3 months (immediately following 12 week exercising)
Time-to-exhaustion3 months (immediately following 12 week exercising)A time-to-exhaustion test will be performed by the participants, with the same movement as described for the 1RM-test. If there is bilateral pain, the most painful side will be tested. The plantar flexion movement will be performed with a frequency of 0.5 Hz, starting with a load of 5 kg. Each minute additional 5 kg will be added until exhaustion is achieved or pain exceeds 5 on a VAS-scale. This is a common test in studies where one wish to assess aerobic endurance capacity.
Physical activity level6 months follow-up after rehabilitationmeasured by accelerometer
Maximal strength (one repetition maximum, 1RM)3 months (immediately following 12 week exercising)Measures of maximal strength will be conducted in the following manner; participants do a warm up routine where they perform 8-15 repetitions with a comfortable load. This is performed in a leg-press machine. The load is gradually increased, and the participant performs the exercise once per attempt. 3 minutes break are given in between each attempt. The heaviest load the participants manages to lift is their 1RM, and is planned to be achieved within 3-6 attempts.
pain using a numeric rating scale (NRS)3 months (immediately following 12 week exercising

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026