Clinical and Ultrasonographic Results of Intratissue Percutaneous Electrolysis in Lateral Epicondylitis

NCT02085928 | Completed DMC

• 1 other identifier: CEU-005
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis (LE) is the most common cause of lateral elbow pain. Intratissue percutaneous electrolysis (EPI technique) is a novel minimally invasive approach which consists in the application of a galvanic current through a puncture needle which produces a local inflammatory process in the soft tissue and the reparation of the affected tissue. The purpose of this study is to evaluate the clinical and ultrasonographic effectiveness of a multimodal program using the intratissue percutaneous electrolysis technique and exercises in the short term for patients with chronic lateral epicondylitis, and to determine whether the clinical outcomes achieved decline over time. This study is an observational one-way repeated measures design. 36 patients in a clinical setting presenting with lateral epicondylitis (mean age = 38, mean time since injury = 12.6 months) received one session of EPI per week over 4-6 weeks, associated with a home program of eccentric exercise and stretching. The main outcome measures were severity of pain (VAS, digital algometer, Cozen and Thompson tests), disability (DASH questionnaire), structural tendon changes (ultrasound), hypervascularity (power doppler) and patient's perceptions of overall outcome (4-point scale). Measurements at 6, 26 and 52 weeks follow-up included recurrence rates (increase of severity of pain or disability compared to discharge), the perception of overall outcome and success rates. Paired Student t-tests and Chi squared tests were applied to data. Enrollment into this study ended in September 2012. All outcome measures registered significant improvements between pre-intervention and discharge. Most patients (30, i.e. 83.3%) rated overall outcome as 'successful' at 6 weeks. The ultrasonographic finding revealed that the hypoechoic regions and hypervascularity of the extensor carpi radialis brevis change significantly. At 26 and 52 weeks, all participants (32) perceived a 'successful' outcome. Recurrence rates were null after discharge, and at the 6, 26 and 52 week follow-ups.

Conditions

Lateral Epicondylitis

Keywords

Tennis elbow; Lateral epicondylitis; Intratissue percutaneous electrolysis; Eccentric exercise; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pain at treatment discharge and at 6 weeks.

  * Intensity of elbow pain during activity was recorded using a visual analogue scale (VAS) score (0=no pain; 100=maximum intensity). * Pain-free pressure was measured with a digital algometer (Wenzhou Sundoo Instruments Co., Ltd, China). * Cozen and Thompson tests were performed in order to provoke localized pain over the lateral epicondyle.

  Baseline, at treatment discharge and at 6 weeks.

Secondary Outcomes (6)

• Change from baseline in disability at treatment discharge and at 6 weeks.

  Baseline, at treatment discharge and at 6 weeks.

• Change from baseline in ultrasound imaging at treatment discharge and at 6 weeks.

  Baseline, at treatment discharge and at 6 weeks.

• Change from at treatment discharge in recurrence at 6 weeks.

  At treatment discharge, 6 weeks.

• Change from 6 weeks in recurrence at 26 and 52 weeks.

  6 weeks, 26 weeks and 52 weeks.

• Change from at treatment discharge in patient's perceptions of overall outcome, at 6 weeks.

  At treatment discharge, 6 weeks.

Study Arms (1)

Lateral epicondylitis

Patients with lateral epicondylitis with persistent pain for at least 3 months

Other: Intratissue percutaneous electrolysis, associated with eccentric exercise and stretching

Interventions

Intratissue percutaneous electrolysis, associated with eccentric exercise and stretching OTHER

* The EPI technique was performed under ultrasound-guidance on the clinically relevant area (or areas of maximum tenderness to palpation and with ultrasonographic degenerative tendon changes) using an intensity of 4-6 mA during 3 seconds, approximately 3 times. We used the EPI machine (Cesmar Electromedicina S.L., Barcelona, Spain) and a GE Logiq E Portable Ultrasound Machine with GE Linear probe 12L-RS (5-13 mhz) (GE Healthcare, Wisconsin, EEUU). * The eccentric exercise program consisted of three series of up to 10 repetitions of eccentric work, repeated twice daily (morning and afternoon), under maximum load (initially with one kilogram) in an optimal and functional pain-free range. * The stretching program consisted of a stretching exercise for the epicondylar muscles consisting in three series of 7 repetitions twice a day (morning and afternoon.

Lateral epicondylitis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

36 participants with lateral epicondylitis

You may qualify if:

• Adult between 18-45 years of age
• Pain over the lateral humeral epicondyle provoked by at least two of the following: gripping, palpation, stretching of forearm extensor muscles and resisted wrist or middle finger extension
• Persistent pain for at least 3 months despite conservative treatments including medication (oral nonsteroidal antiinflammatory drugs (NSAIDs) and analgesics), brace application, or physiotherapy
• Patients with structural tendon changes at the origin of the extensors, demonstrated during musculoskeletal ultrasound
• Individuals who meet any of the following criteria are disqualified from enrollment of the study:

You may not qualify if:

• Patients with a history of advanced cervical arthrosis in the C4-C6 segments.
• Bilateral LE with central sensitization
• Symptoms compatible with posterior interosseous nerve entrapment.
• Previous surgery, fractures, trauma or previous history of rheumatic disorders in the area of the lateral epicondyle
• History of corticosteroid injection at the lateral epicondyle within the last 3 months
• Two experienced professionals performed recruitment and examination of subjects in order to assess for eligibility criteria. All eligible patients provided written informed consent.

Sponsors & Collaborators

• CEU San Pablo University: lead

Study Sites (1)

CEU San Pablo University

Boadilla del Monte, Madrid, 28660, Spain

Location

Related Publications (1)

• Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.

  PMID: 25122629 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Fermin Valera-Garrido, PT, PhD

  CEU San Pablo University; MVClinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 13, 2014
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

ES (1)