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

Study Overview
=================
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.

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

Conditions
-----------------
Tendinopathy

Intervention / Treatment
-----------------
* Procedure: endoscopic surgery
* Behavioral: physiotherapy and exercise


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic surgery<br>Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group. | Procedure: endoscopic surgery<br>* 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.<br>Behavioral: physiotherapy and exercise<br>* 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.<br>|
| Active Comparator: Conservative treatment<br>Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases. | Behavioral: physiotherapy and exercise<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Tampa Scale of Kinesiophobia [TSK] |  | 6 months after 12 week exercising | 
| Patient-clinician therapeutic relationship | assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR) | 3 months (immediately following 12 week exercising) | 
| Patient-clinician therapeutic relationship | assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR) | 6 months after 12 week exercising | 
| Maximal strength (one repetition maximum, 1RM) | 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. | 3 months (immediately following 12 week exercising) | 
| Maximal strength (one repetition maximum, 1RM) | 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. | 6 months after 12 week exercising | 
| Time-to-exhaustion | 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. | 3 months (immediately following 12 week exercising) | 
| Time-to-exhaustion | 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. | 6 months after 12 week exercising | 
| Physical activity level | measured by accelerometer | 6 months follow-up after rehabilitation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achilles Tendon, Endoscopy, Minimally Invasive Surgical Procedures, Exercise therapy