TendinopathyNCT03025412
A Comparison of Endoscopic Surgery and Exercise Therapy in Patients With Longstanding Achilles Tendinopathy
A study testing endoscopic surgery and physiotherapy and exercise in people with Tendinopathy, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- endoscopic surgery and physiotherapy and exercise
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 19 Apr 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mid-portion achilles tendinopathy
- pain during at least 3 months
- decreased function (a score less than 80 on VISA-A)
Who cannot join
- Physiotherapy during previous three months
- history of major achilles trauma
- cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences
Trondheim
About this study
Official title: 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.
- Conditions
- Tendinopathy
- Being tested
- endoscopic surgery, physiotherapy and exercise
- Keywords
- Achilles Tendon, Endoscopy, Minimally Invasive Surgical Procedures, Exercise therapy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgeryProcedure or 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.
physiotherapy and exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic surgery | Experimental | Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group. Receives: Procedure: endoscopic surgery; Behavioral: physiotherapy and exercise |
| Conservative treatment | Active comparator | Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases. Receives: Behavioral: physiotherapy and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain using The Victorian Institute of Sports Assessment - Achilles
Measured: 3 months (immediately following 12 week exercising)
pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
Measured: 6 months after 12 week exercising
Secondary outcomes (13)
pain using a numeric rating scale (NRS)
Measured: 3 months (immediately following 12 week exercising
pain using a numeric rating scale (NRS)
Measured: 6 months after 12 week exercising
Hospital Anxiety and Depression Scale (HAD)
Measured: 3 months (immediately following 12 week exercising)
Hospital Anxiety and Depression Scale (HAD)
Measured: 6 months after 12 week exercising
Tampa Scale of Kinesiophobia [TSK]
Measured: 3 months (immediately following 12 week exercising)
Tampa Scale of Kinesiophobia [TSK]
Measured: 6 months after 12 week exercising
Patient-clinician therapeutic relationship
assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
Measured: 3 months (immediately following 12 week exercising)
Patient-clinician therapeutic relationship
assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after 12 week exercising
Physical activity level
measured by accelerometer
Measured: 6 months follow-up after rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start19 Apr 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Why it stopped: recruitment difficulties due to recently introduced new surgical procedure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorunn Helbostad, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025412
- Sponsor's protocol ID
- 2016/1931
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2017
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Endoscopic Surgery and Conservative Treatment in Patients With Longstanding Mid-portion Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT03025412
- Acronym / sponsor ID
- 2016/1931
- Conditions
- Tendinopathy
- Keywords
- Achilles Tendon, Endoscopy, Minimally Invasive Surgical Procedures, Exercise therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties due to recently introduced new surgical procedure
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic surgery | Experimental | Procedure: endoscopic surgery, Behavioral: physiotherapy and exerciseAmbulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group. |
| Conservative treatment | Active comparator | Behavioral: physiotherapy and exercisePhysiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of mid-portion achilles tendinopathy
- pain during at least 3 months
- decreased function (a score less than 80 on VISA-A)
Key exclusion criteria (3 listed)
- Physiotherapy during previous three months
- history of major achilles trauma
- cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic surgeryAmbulatory 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. | Procedure or surgery | Endoscopic surgery |
| physiotherapy and exerciseExercise 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. | Behavioural | Conservative treatment, Endoscopic surgery |
Primary outcome
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
13 secondary outcomes
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
Time frame: 3 months (immediately following 12 week exercising)
Patient-clinician therapeutic relationship
Time frame: 6 months after 12 week exercising
Maximal strength (one repetition maximum, 1RM)
Time frame: 3 months (immediately following 12 week exercising)
Maximal strength (one repetition maximum, 1RM)
Time frame: 6 months after 12 week exercising
Time-to-exhaustion
Time frame: 3 months (immediately following 12 week exercising)
Time-to-exhaustion
Time frame: 6 months after 12 week exercising
Physical activity level
Time frame: 6 months follow-up after rehabilitation
Results and safety
The study was stopped early (reason given: recruitment difficulties due to recently introduced new surgical procedure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorunn Helbostad, prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic surgery and physiotherapy and exercise in people with Tendinopathy, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties due to recently introduced new surgical procedure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain using The Victorian Institute of Sports Assessment - Achilles (time frame: 3 months (immediately following 12 week exercising)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.