An interventional study of endoscopic surgery and physiotherapy and exercise in Tendinopathy, sponsored by Norwegian University of Science and Technology. Terminated at 1 site in Norway. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
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.
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
Procedure: endoscopic surgery · Behavioral: physiotherapy and exercise
Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases.
Behavioral: physiotherapy and exercise
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.
pain using The Victorian Institute of Sports Assessment - Achilles
Time frame: 3 months (immediately following 12 week exercising)
pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
Time frame: 6 months after 12 week exercising
pain using a numeric rating scale (NRS)
Time frame: 3 months (immediately following 12 week exercising
pain using a numeric rating scale (NRS)
Time frame: 6 months after 12 week exercising
Hospital Anxiety and Depression Scale (HAD)
Time frame: 3 months (immediately following 12 week exercising)
Hospital Anxiety and Depression Scale (HAD)
Time frame: 6 months after 12 week exercising
Tampa Scale of Kinesiophobia [TSK]
Time frame: 3 months (immediately following 12 week exercising)
Tampa Scale of Kinesiophobia [TSK]
Time frame: 6 months after 12 week exercising
Patient-clinician therapeutic relationship
assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
Time frame: 3 months (immediately following 12 week exercising)
Patient-clinician therapeutic relationship
assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after 12 week exercising
Physical activity level
measured by accelerometer
Time frame: 6 months follow-up after rehabilitation
Plan to share: Undecided
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Norwegian University of Science and Technology