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

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ClinicalTrials.gov Identifier: NCT03025412
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.


Condition or disease Intervention/treatment Phase
Tendinopathy Procedure: endoscopic surgery Behavioral: physiotherapy and exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Endoscopic Surgery and Conservative Treatment in Patients With Longstanding Mid-portion Achilles Tendinopathy
Actual Study Start Date : April 19, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.
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.

Active Comparator: Conservative treatment
Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases.
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.




Primary Outcome Measures :
  1. pain using The Victorian Institute of Sports Assessment - Achilles [ Time Frame: 3 months (immediately following 12 week exercising) ]
  2. pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A) [ Time Frame: 6 months after 12 week exercising ]

Secondary Outcome Measures :
  1. pain using a numeric rating scale (NRS) [ Time Frame: 3 months (immediately following 12 week exercising ]
  2. pain using a numeric rating scale (NRS) [ Time Frame: 6 months after 12 week exercising ]
  3. Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 3 months (immediately following 12 week exercising) ]
  4. Hospital Anxiety and Depression Scale (HAD) [ Time Frame: 6 months after 12 week exercising ]
  5. Tampa Scale of Kinesiophobia [TSK] [ Time Frame: 3 months (immediately following 12 week exercising) ]
  6. Tampa Scale of Kinesiophobia [TSK] [ Time Frame: 6 months after 12 week exercising ]
  7. Patient-clinician therapeutic relationship [ Time Frame: 3 months (immediately following 12 week exercising) ]
    assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)

  8. Patient-clinician therapeutic relationship [ Time Frame: 6 months after 12 week exercising ]
    assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)

  9. Maximal strength (one repetition maximum, 1RM) [ Time Frame: 3 months (immediately following 12 week exercising) ]
    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.

  10. Maximal strength (one repetition maximum, 1RM) [ Time Frame: 6 months after 12 week exercising ]
    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.

  11. Time-to-exhaustion [ Time Frame: 3 months (immediately following 12 week exercising) ]
    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.

  12. Time-to-exhaustion [ Time Frame: 6 months after 12 week exercising ]
    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.

  13. Physical activity level [ Time Frame: 6 months follow-up after rehabilitation ]
    measured by accelerometer



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025412


Contacts
Contact: Håvard Østerås, phd 0047 73559305 havard.osteras@ntnu.no

Locations
Norway
Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences Recruiting
Trondheim, Norway
Contact: Håvard Østerås, PhD    0047 73559305    havard.osteras@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Jorunn Helbostad, prof Norwegian University of Science and Technology

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03025412     History of Changes
Other Study ID Numbers: 2016/1931
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Achilles Tendon
Endoscopy
Minimally Invasive Surgical Procedures
Exercise therapy

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries