A Comparison of Endoscopic Surgery and Exercise Therapy in Patients With Longstanding Achilles Tendinopathy
Primary Purpose
Tendinopathy
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
endoscopic surgery
physiotherapy and exercise
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy focused on measuring Achilles Tendon, Endoscopy, Minimally Invasive Surgical Procedures, Exercise therapy
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
Sites / Locations
- Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endoscopic surgery
Conservative treatment
Arm Description
Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases.
Outcomes
Primary Outcome Measures
pain using The Victorian Institute of Sports Assessment - Achilles
pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
Secondary Outcome Measures
pain using a numeric rating scale (NRS)
pain using a numeric rating scale (NRS)
Hospital Anxiety and Depression Scale (HAD)
Hospital Anxiety and Depression Scale (HAD)
Tampa Scale of Kinesiophobia [TSK]
Tampa Scale of Kinesiophobia [TSK]
Patient-clinician therapeutic relationship
assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
Patient-clinician therapeutic relationship
assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
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.
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.
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.
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.
Physical activity level
measured by accelerometer
Full Information
NCT ID
NCT03025412
First Posted
January 17, 2017
Last Updated
April 11, 2019
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03025412
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties due to recently introduced new surgical procedure
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Achilles Tendon, Endoscopy, Minimally Invasive Surgical Procedures, Exercise therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic surgery
Arm Type
Experimental
Arm Description
Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases.
Intervention Type
Procedure
Intervention Name(s)
endoscopic surgery
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
physiotherapy and exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain using The Victorian Institute of Sports Assessment - Achilles
Time Frame
3 months (immediately following 12 week exercising)
Title
pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
Time Frame
6 months after 12 week exercising
Secondary Outcome Measure Information:
Title
pain using a numeric rating scale (NRS)
Time Frame
3 months (immediately following 12 week exercising
Title
pain using a numeric rating scale (NRS)
Time Frame
6 months after 12 week exercising
Title
Hospital Anxiety and Depression Scale (HAD)
Time Frame
3 months (immediately following 12 week exercising)
Title
Hospital Anxiety and Depression Scale (HAD)
Time Frame
6 months after 12 week exercising
Title
Tampa Scale of Kinesiophobia [TSK]
Time Frame
3 months (immediately following 12 week exercising)
Title
Tampa Scale of Kinesiophobia [TSK]
Time Frame
6 months after 12 week exercising
Title
Patient-clinician therapeutic relationship
Description
assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
Time Frame
3 months (immediately following 12 week exercising)
Title
Patient-clinician therapeutic relationship
Description
assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
Time Frame
6 months after 12 week exercising
Title
Maximal strength (one repetition maximum, 1RM)
Description
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.
Time Frame
3 months (immediately following 12 week exercising)
Title
Maximal strength (one repetition maximum, 1RM)
Description
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.
Time Frame
6 months after 12 week exercising
Title
Time-to-exhaustion
Description
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.
Time Frame
3 months (immediately following 12 week exercising)
Title
Time-to-exhaustion
Description
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.
Time Frame
6 months after 12 week exercising
Title
Physical activity level
Description
measured by accelerometer
Time Frame
6 months follow-up after rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorunn Helbostad, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Comparison of Endoscopic Surgery and Exercise Therapy in Patients With Longstanding Achilles Tendinopathy
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