Tennis ElbowNCT02304952
Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia
A study testing Radiofrequency microtenotomy, Eccentric exercise and Arthrocare Topaz MicroDebrider in people with Tennis Elbow, run by St Goran's Hospital at 1 site in Sweden.
Trial summary
The aim is to study the effects related to function and pain during eccentric exercise and surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only eccentric exercise, in patients with lateral epicondylalgia unilaterally. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Radiofrequency microtenotomy, Eccentric exercise and Arthrocare Topaz MicroDebrider
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Sep 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over the age of 18 and under the age of 70 year
- lateral epicondylalgia at least two year
- tried conservative treatment
Who cannot join
- complicated systemic diseases (such as diabetes)
- understand spoken and or/written instructions in Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Capio Sankt Göran Hospital
Stockholm, Stockholm County, S-112 81
Tobias Wirén, MD, Director, +46858701161, tobias.wiren@capiostgoran.se
About this study
Official title: Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial
The aim is to study the effects related to function and pain during eccentric exercise and surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only eccentric exercise, in patients with lateral epicondylalgia unilaterally.
Read the detailed description
Of those affected by lateral epicondylalgia will 90% be free of symptoms within 8 months to 2 years with conservative treatment. In this study surgical radiofrequency microtenotomy and eccentric exercise for chronic (more than two year) lateral epicondylalgia that is unilaterally will be used as treatment. Patients is randomized to a group with eccentric exercise or a group with surgical radiofrequency microtenotomy and postoperatively eccentric exercise. Home based eccentric exercise program is instructed by a physical therapist and is performed for three months. Women start with 0.5 kg and men 1.0 kg weight, they perform 3 sets with 5 reps once a day and register pain and exercise in a diary. Function, pain and quality of life will be followed and are carried out after 6 weeks and after 3, 6 and 12 months. The surgery and eccentric exercise is instructed and followed at the investigators clinic.
- Conditions
- Tennis Elbow
- Being tested
- Radiofrequency microtenotomy, Eccentric exercise, Arthrocare Topaz MicroDebrider
- Keywords
- Lateral epicondylalgia, Pain, Function, Physiotherapy, Quality of Life
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency microtenotomyProcedure or surgery
Also called Minimally invasive surgery
For the minimally invasive surgery will Arthrocare Topaz MicroDebrider device be used. A small incision will be made and the tip of the device is placed on surface of the tendon to structure and activated for 0.5 second, at 5 mm distance intervals on the tendon creating a grid-like pattern.
Eccentric exerciseOther
Eccentric exercise for 3 months. The exercise will be performed once a day with 3 set and 5 reps, women start with 0.5 and men 1.0 kilo with a 10 % increase every week.
Arthrocare Topaz MicroDebriderDevice
| Study group | Role | What they receive |
|---|---|---|
| Eccentric exercise | Active comparator | Conservative treatment with eccentric exercise as self-training Receives: Other: Eccentric exercise |
| Radiofrequency microtenotomy | Active comparator | A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment Receives: Procedure: Radiofrequency microtenotomy; Device: Arthrocare Topaz MicroDebrider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function.
Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.
Measured: 12 month
Pain.
Pain estimated with Visual Analogue Scale (VAS 0-100 mm).
Measured: 12 month
Secondary outcomes (1)
Quality of life.
The Short Form-12 (SF-12) is a questionnaire which measures Quality of Life (QoL), which are both physically and emotionally based.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Goran's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Annette Heijne, PT, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304952
- Sponsor's protocol ID
- Lateral epicondylalgia
- Status last verified
- Jul 2016
- First submitted
- 24 Nov 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02304952
- Acronym / sponsor ID
- Lateral epicondylalgia
- Conditions
- Tennis Elbow
- Keywords
- Lateral epicondylalgia, Pain, Function, Physiotherapy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St Goran's HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Sep 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Dec 2014 (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.
The aim is to study the effects related to function and pain during eccentric exercise and surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only eccentric exercise, in patients with lateral epicondylalgia unilaterally.
Detailed description
Of those affected by lateral epicondylalgia will 90% be free of symptoms within 8 months to 2 years with conservative treatment. In this study surgical radiofrequency microtenotomy and eccentric exercise for chronic (more than two year) lateral epicondylalgia that is unilaterally will be used as treatment. Patients is randomized to a group with eccentric exercise or a group with surgical radiofrequency microtenotomy and postoperatively eccentric exercise. Home based eccentric exercise program is instructed by a physical therapist and is performed for three months. Women start with 0.5 kg and men 1.0 kg weight, they perform 3 sets with 5 reps once a day and register pain and exercise in a diary. Function, pain and quality of life will be followed and are carried out after 6 weeks and after 3, 6 and 12 months. The surgery and eccentric exercise is instructed and followed at the investigators clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric exercise | Active comparator | Other: Eccentric exerciseConservative treatment with eccentric exercise as self-training |
| Radiofrequency microtenotomy | Active comparator | Procedure: Radiofrequency microtenotomy, Device: Arthrocare Topaz MicroDebriderA minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over the age of 18 and under the age of 70 year
- lateral epicondylalgia at least two year
- tried conservative treatment
Key exclusion criteria (2 listed)
- complicated systemic diseases (such as diabetes)
- understand spoken and or/written instructions in Swedish
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 |
|---|---|---|
| Radiofrequency microtenotomyAlso: Minimally invasive surgeryFor the minimally invasive surgery will Arthrocare Topaz MicroDebrider device be used. A small incision will be made and the tip of the device is placed on surface of the tendon to structure and activated for 0.5 second, at 5 mm distance intervals on the tendon creating a grid-like pattern. | Procedure or surgery | Radiofrequency microtenotomy |
| Eccentric exerciseEccentric exercise for 3 months. The exercise will be performed once a day with 3 set and 5 reps, women start with 0.5 and men 1.0 kilo with a 10 % increase every week. | Other | Eccentric exercise |
| Arthrocare Topaz MicroDebrider | Device | Radiofrequency microtenotomy |
Primary outcome
Function.
Time frame: 12 month
Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.
Pain.
Time frame: 12 month
Pain estimated with Visual Analogue Scale (VAS 0-100 mm).
1 secondary outcome
Quality of life.
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
Related trials for Tennis Elbow
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
Annette Heijne, PT, PhD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency microtenotomy, Eccentric exercise and Arthrocare Topaz MicroDebrider in people with Tennis Elbow, run by St Goran's Hospital at 1 site in Sweden.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jul 2016. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena B Boman, PT, MSc (+46858701637, lena.boman@capiostgoran.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function. (time frame: 12 month). 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 27 Jul 2016.