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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03025412
• Other study ID #: 2016/1931
• Status: Terminated
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2024
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Procedure:
• endoscopic 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.

Behavioral:
• physiotherapy 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.

Locations

Country	Name	City	State
Norway	Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain using The Victorian Institute of Sports Assessment - Achilles		3 months (immediately following 12 week exercising)
Primary	pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)		6 months after 12 week exercising
Secondary	pain using a numeric rating scale (NRS)		3 months (immediately following 12 week exercising
Secondary	pain using a numeric rating scale (NRS)		6 months after 12 week exercising
Secondary	Hospital Anxiety and Depression Scale (HAD)		3 months (immediately following 12 week exercising)
Secondary	Hospital Anxiety and Depression Scale (HAD)		6 months after 12 week exercising
Secondary	Tampa Scale of Kinesiophobia [TSK]		3 months (immediately following 12 week exercising)
Secondary	Tampa Scale of Kinesiophobia [TSK]		6 months after 12 week exercising
Secondary	Patient-clinician therapeutic relationship	assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)	3 months (immediately following 12 week exercising)
Secondary	Patient-clinician therapeutic relationship	assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)	6 months after 12 week exercising
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	Physical activity level	measured by accelerometer	6 months follow-up after rehabilitation