Diacutaneous Fibrolysis on Lateral Epicondylitis

Tennis Elbow Clinical Trial

Official title:

Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02343809
• Other study ID #: P14/032
• Status: Recruiting
• Phase: Phase 3
• First received: January 16, 2015
• Last updated: January 21, 2015
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to the mechanical pain of the locomotor system. In our clinical practice a favorable effect is observed in patients with chronic lateral epicondylitis, but there are no published studies evaluating the results of this technique.

The objective of this trial is to evaluate if DF provides a further improvement in pain intensity, pain-pressure threshold, function and pain-free grip strength, in patients with chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care Center.

Sixty subjects will be randomized (computer application) into three groups: Intervention Group, Placebo Group and Control Group. All the three groups receive the same protocolized treatment of physiotherapy and additionally. Additionally, the Intervention Group receives six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group receives six sessions (two sessions in a week during three weeks) of sham DF. The Control Group receives the protocolized treatment of physiotherapy only.

Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH questionnaire) and pain-free grip strength (digital dynamometer) will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through the Global Rating of Change (GROC) scale.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old and over

• Diagnosis of chronic lateral epicondylalgia

• Sign the informed consent form

Exclusion Criteria:

• Concomitant conditions affecting the same upper extremity

• Contraindications for Diacutaneous Fibrolysis

• Corticosteroid injections or similar agents in the three months prior to study inclusion

• Pending litigation or legal claim

• Poor language and communication skills making difficult to understand the informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Other:
• Actual Diacutaneous Fibrolysis
Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. The hook is deeply applied following the intermuscular septum between the muscles with an anatomical of functional relationship with the painful structure in order to release adherences between musculoskeletal structures.
• Sham Diacutaneous Fibrolysis
Sham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels.
• Protocolized Physiotherapy
Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy

Locations

Country	Name	City	State
Spain	Catalan Institut of Health - Sant Ildefons Rehabilitation Center	Cornellà de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity (VAS)	pre-intervention, post-intervention (two sessions in a week during three weeks), after three months	Yes
Secondary	Pressure Pain Threshold	pressure algometry	pre-intervention, post-intervention (two sessions in a week during three weeks), after three months	Yes
Secondary	Pain free grip strength	digital dynamometer	pre-intervention, post-intervention (two sessions in a week during three weeks), after three months	Yes
Secondary	Functional status	DASH questionnaire	pre-intervention, post-intervention (two sessions in a week during three weeks), after three months	Yes
Secondary	Global Rating of Change scale		post-intervention, after three months	Yes