- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03025412
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Trondheim, Norway
- Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endoscopic surgery
Ambulatory surgery.
Postoperative rehabilitation.
From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
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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.
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.
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Active Comparator: Conservative treatment
Physiotherapy and exercise.
First physiotherapy consultation: Information, advice, instructions.
Exercise regime during 12 weeks in three phases.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain using The Victorian Institute of Sports Assessment - Achilles
Time Frame: 3 months (immediately following 12 week exercising)
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3 months (immediately following 12 week exercising)
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pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
Time Frame: 6 months after 12 week exercising
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6 months after 12 week exercising
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain using a numeric rating scale (NRS)
Time Frame: 3 months (immediately following 12 week exercising
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3 months (immediately following 12 week exercising
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pain using a numeric rating scale (NRS)
Time Frame: 6 months after 12 week exercising
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6 months after 12 week exercising
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Hospital Anxiety and Depression Scale (HAD)
Time Frame: 3 months (immediately following 12 week exercising)
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3 months (immediately following 12 week exercising)
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Hospital Anxiety and Depression Scale (HAD)
Time Frame: 6 months after 12 week exercising
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6 months after 12 week exercising
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Tampa Scale of Kinesiophobia [TSK]
Time Frame: 3 months (immediately following 12 week exercising)
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3 months (immediately following 12 week exercising)
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Tampa Scale of Kinesiophobia [TSK]
Time Frame: 6 months after 12 week exercising
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6 months after 12 week exercising
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Patient-clinician therapeutic relationship
Time Frame: 3 months (immediately following 12 week exercising)
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assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
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3 months (immediately following 12 week exercising)
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Patient-clinician therapeutic relationship
Time Frame: 6 months after 12 week exercising
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assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
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6 months after 12 week exercising
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Maximal strength (one repetition maximum, 1RM)
Time Frame: 3 months (immediately following 12 week exercising)
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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.
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3 months (immediately following 12 week exercising)
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Maximal strength (one repetition maximum, 1RM)
Time Frame: 6 months after 12 week exercising
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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.
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6 months after 12 week exercising
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Time-to-exhaustion
Time Frame: 3 months (immediately following 12 week exercising)
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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.
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3 months (immediately following 12 week exercising)
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Time-to-exhaustion
Time Frame: 6 months after 12 week exercising
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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.
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6 months after 12 week exercising
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Physical activity level
Time Frame: 6 months follow-up after rehabilitation
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measured by accelerometer
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6 months follow-up after rehabilitation
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Collaborators and Investigators
Investigators
- Study Director: Jorunn Helbostad, prof, Norwegian University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/1931
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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