Clinical trial NCT03025412: A Comparison of Endoscopic Surgery and Exercise Therapy in Patients With Longstanding Achilles Tendinopathy
Official title: A Comparison of Endoscopic Surgery and Conservative Treatment in Patients With Longstanding Mid-portion Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tendinopathy
Keywords: Achilles Tendon
Endoscopy
Minimally Invasive Surgical Procedures
Exercise therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: pain using The Victorian Institute of Sports Assessment - Achilles
timeFrame: 3 months (immediately following 12 week exercising)
measure: pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
timeFrame: 6 months after 12 week exercising
Secondary outcomes:
measure: pain using a numeric rating scale (NRS)
timeFrame: 3 months (immediately following 12 week exercising
measure: pain using a numeric rating scale (NRS)
timeFrame: 6 months after 12 week exercising
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: 3 months (immediately following 12 week exercising)
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: 6 months after 12 week exercising
measure: Tampa Scale of Kinesiophobia [TSK]
timeFrame: 3 months (immediately following 12 week exercising)
measure: Tampa Scale of Kinesiophobia [TSK]
timeFrame: 6 months after 12 week exercising
measure: Patient-clinician therapeutic relationship
timeFrame: 3 months (immediately following 12 week exercising)
measure: Patient-clinician therapeutic relationship
timeFrame: 6 months after 12 week exercising
measure: Maximal strength (one repetition maximum, 1RM)
timeFrame: 3 months (immediately following 12 week exercising)
measure: Maximal strength (one repetition maximum, 1RM)
timeFrame: 6 months after 12 week exercising
measure: Time-to-exhaustion
timeFrame: 3 months (immediately following 12 week exercising)
measure: Time-to-exhaustion
timeFrame: 6 months after 12 week exercising
measure: Physical activity level
timeFrame: 6 months follow-up after rehabilitation
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jorunn Helbostad, prof
role: STUDY_DIRECTOR
References: