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Lateral EpicondylitisNCT02085928

Clinical and Ultrasonographic Results of Intratissue Percutaneous Electrolysis in Lateral Epicondylitis

An observational study of Lateral Epicondylitis, run by CEU San Pablo University at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Lateral Epicondylitis
What is being tested?
Intratissue percutaneous electrolysis, associated with eccentric exercise and stretching
How many people
36 participants
Where
1 siteSpain
Study dates
Mar 2012to Sep 2013
Phase
Observational
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 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: 36 participants with lateral epicondylitis

Who may be able to join

  • 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:

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • CEU San Pablo University

    Boadilla del Monte, Madrid, 28660

Other trials in Spain

About this study

Official title: Clinical and Ultrasonographic Results of Intratissue Percutaneous Electrolysis (EPI Technique) in Chronic Lateral Epicondylitis: a Case Series With Prospective 12 Months Follow up

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.

Read more

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.

Read the detailed description

Patients received one session of EPI technique per week over 4 weeks (or over 6 weeks when pain persisted) associated with a home program consisting of eccentric exercise (EccEx) and stretching, initiated 24 hours after each session. The EccEx and stretching program was taught by a physiotherapist in the first session and monitored in subsequent sessions. At discharge, patients were instructed to perform only EccEx once daily for the first 6 weeks of the follow-up period.

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 milliampere (mA) during 3 seconds, approximately 3 times. The investigators 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). During the EPI technique, the patient was placed in a supine position, with the affected elbow placed in a position of 90° flexion and maximum pronation. The elbow was sterilized and the sonographic transducer, enclosed in a sterile cover over sterile applied gel, was placed at the lateral epicondyle (first approach) and over the humeroradial joint between the head of the radius and the capitulum of the humerus (second approach), where it remained throughout the procedure. A common target area was the deep surface of the common extensor tendon (origin of the ECRB [extensor carpi radialis brevis] and the EDC [extensor digitorum communis]) (first approach) and the deep surface of the ECRB, over the capsule and the lateral ulnar collateral ligament (second approach). A 0.3 x 25mm. (1 inch) needle was inserted at a 30° to 45° angle to the skin in the direction of the lateral epicondyle (first approach) and at a 80° angle to the skin, with the needle tip directed towards the humeroradial joint (second approach). In the first approach the needle was advanced parallel to the longitudinal plane of the tendon (in-plane approach); whereas in the second approach the needle was advanced along the short plane of the humeroradial joint (out-of-plane approach). Real-time ultrasonographic imaging provided guidance for both procedures. Once the needle reached the target tissue, readjustments of the needle position were made in order to ensure a correct stimulation. The generation of the galvanic current creates a white image (hyperechoic) as a result of the liberation of hydrogen gas due to the electrolysis. Oral paracetamol was used when necessary for the purpose of pain relief only.

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. From maximum wrist extension and radial deviation, rapid wrist flexion movement were performed, followed by a 2-second hold of the final position. In between series patients were given a rest period of 2-3 minutes. This formula was used for the duration of the physiotherapy program. The concentric contraction phase for returning to the starting position was nullified with the help of the other hand.

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), performed in a sitting position with a flexed wrist and fingers, ulnar deviation and elbow extension reaching the stretch limit without bounces, and held for 45 seconds, with a 30-second rest between repetitions.

Being tested
Intratissue percutaneous electrolysis, associated with eccentric exercise and stretching
Keywords
Tennis elbow, Lateral epicondylitis, Intratissue percutaneous electrolysis, Eccentric exercise, Ultrasonography
Medical subject headings
Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intratissue percutaneous electrolysis, associated with eccentric exercise and stretchingOther

    • 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.
Study groups in NCT02085928
Study groupRoleWhat they receive
Lateral epicondylitisPatients with lateral epicondylitis with persistent pain for at least 3 months
Receives: Other: Intratissue percutaneous electrolysis, associated with eccentric exercise and stretching

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, at treatment discharge and at 6 weeks.

Secondary outcomes (6)
  1. Change from baseline in disability at treatment discharge and at 6 weeks.

    • Disability was measured with the DASH questionnaire (0-100, being 100 the higher disability).

    Measured: Baseline, at treatment discharge and at 6 weeks.

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

    • Structural tendon changes were examined in the lateral epicondylar area, including the origin of the extensor tendon, ECRB, and the adjacent soft tissues with a GE Logiq E Portable Ultrasound Machine (GE Healthcare, Wisconsin, EEUU) under the guidelines defined by the European Society of Musculoskeletal Radiology. Structural tendon changes (tendon thickening, hypoechogenicity and intrasubstance tears) were demonstrated by the grey-scale US, and hypervascularity (not present or several areas) by Power Doppler (PD) examination. The same experienced professional performed all US and PD examinations and was blinded as to the phase of treatment.

    Measured: Baseline, at treatment discharge and at 6 weeks.

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

    • Success rates were then calculated based on perception of overall outcome; we considered excellent or good to be 'successful' and fair or poor to 'unsuccessful'

    Measured: At treatment discharge, 6 weeks.

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

    • Success rates were then calculated based on perception of overall outcome; we considered excellent or good to be 'successful' and fair or poor to 'unsuccessful'

    Measured: 6 weeks, 26 weeks and 52 weeks.

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

    • We also measured patient's perceptions of overall outcome using a 4-point scale: 'excellent' in the case of full return to all activity with no pain, 'good' if full return to all activity occurred with occasional mild pain, 'fair' if no pain was present with normal activities but significant pain occurred with heavy activities; and 'poor' in the case of little or no relief of pre-operative symptoms)

    Measured: At treatment discharge, 6 weeks.

  6. Change from 6 weeks in patient's perceptions of overall outcome, at 26 and 52 weeks.

    • We also measured patient's perceptions of overall outcome using a 4-point scale: 'excellent' in the case of full return to all activity with no pain, 'good' if full return to all activity occurred with occasional mild pain, 'fair' if no pain was present with normal activities but significant pain occurred with heavy activities; and 'poor' in the case of little or no relief of pre-operative symptoms)

    Measured: 6 weeks, 26 weeks, and 52 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2014 (estimated)
  2. Study startMar 2012
  3. Primary completionSep 2012
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02085928
Sponsor's protocol ID
CEU-005
Status last verified
Mar 2014
First submitted
7 Mar 2014
Last updated
13 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25122629

Questions about this trial

What is this clinical trial studying?

An observational study of Lateral Epicondylitis, run by CEU San Pablo University at 1 site in Spain.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 13 Mar 2014. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in pain at treatment discharge and at 6 weeks. (time frame: Baseline, at treatment discharge and at 6 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02085928, which also lists 1 linked publication.

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 13 Mar 2014.

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