Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia

NCT02304952 | Unknown

• 1 other identifier: Lateral epicondylalgia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tennis Elbow

Keywords

Lateral epicondylalgia; Pain; Function; Physiotherapy; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Function.

  Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.

  12 month

• Pain.

  Pain estimated with Visual Analogue Scale (VAS 0-100 mm).

  12 month

Secondary Outcomes (1)

• Quality of life.

  12 month

Study Arms (2)

Eccentric exercise

ACTIVE COMPARATOR

Conservative treatment with eccentric exercise as self-training

Other: Eccentric exercise

Radiofrequency microtenotomy

ACTIVE COMPARATOR

A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment

Procedure: Radiofrequency microtenotomy; Device: Arthrocare Topaz MicroDebrider

Interventions

Radiofrequency microtenotomy PROCEDURE

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.

Also known as: Minimally invasive surgery

Radiofrequency microtenotomy

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.

Eccentric exercise

Arthrocare Topaz MicroDebrider DEVICE

Radiofrequency microtenotomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Capio Sankt Görans Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Capio Sankt Göran Hospital

Stockholm, Stockholm County, S-112 81, Sweden

RECRUITING

MeSH Terms

Conditions

Tennis Elbow; Pain

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Annette Heijne, PT, PhD

  Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Lena B Boman, PT, MSc

CONTACT

+46858701637; lena.boman@capiostgoran.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 2, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

SE (1)