Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia

NCT02304952 — Not applicable, Unknown, 100 participants, St Goran's Hospital

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Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial

RegistryNCT02304952
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment100 (Estimated)
SponsorSt Goran's Hospital (Other); collaborators: Karolinska Institutet
ConditionsTennis Elbow
InterventionsRadiofrequency microtenotomy, Eccentric exercise, Arthrocare Topaz MicroDebrider (Procedure, other, device)
Datesstart 2014-09-01, primary completion 2018-09-01 (estimated), completion 2018-09-01 (estimated), first posted 2014-12-02, last updated 2016-07-27
Locations1 site in Sweden

Related Papers Related Patents Related Grants Related Experts
All trials for Tennis Elbow All trials of Radiofrequency microtenotomy All trials of Eccentric exercise

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Eccentric exerciseActive comparatorOther: Eccentric exerciseConservative treatment with eccentric exercise as self-training
Radiofrequency microtenotomyActive comparatorProcedure: Radiofrequency microtenotomy; Device: Arthrocare Topaz MicroDebriderA minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment
  • Radiofrequency microtenotomy (Procedure), also known as 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 exercise (Other): 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 MicroDebrider (Device)

+Outcome measures

Primary outcomes

  • Function. [12 month]: Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.
  • Pain. [12 month]: Pain estimated with Visual Analogue Scale (VAS 0-100 mm).

Secondary outcomes

  • Quality of life. [12 month]: The Short Form-12 (SF-12) is a questionnaire which measures Quality of Life (QoL), which are both physically and emotionally based.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* over the age of 18 and under the age of 70 year
* lateral epicondylalgia at least two year
* tried conservative treatment

Exclusion Criteria:

* complicated systemic diseases (such as diabetes)
* understand spoken and or/written instructions in Swedish

+Locations (1)

FacilityCityCountryStatus
Capio Sankt Göran HospitalStockholm, Stockholm CountySwedenRecruiting

+Investigators