Diacutaneous Fibrolysis on Lateral Epicondylitis

January 21, 2015 updated by: Jordi Gol i Gurina Foundation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Cornellà de Llobregat, Barcelona, Spain, 08940
        • Recruiting
        • Catalan Institut of Health - Sant Ildefons Rehabilitation Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy
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.
Other: Protocolized Physiotherapy
Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy
Sham Comparator: Placebo Group
Sham Diacutaneous Fibrolysis and Protocolized Physiotherapy
Other: Protocolized Physiotherapy
Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy
Other: 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.
Other: Control Group
Protocolized Physiotherapy
Other: Protocolized Physiotherapy
Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Pain intensity (VAS)
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold
Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
pressure algometry
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Pain free grip strength
Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
digital dynamometer
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Functional status
Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
DASH questionnaire
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Global Rating of Change scale
Time Frame: post-intervention, after three months
post-intervention, after three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordi Gol i Gurina Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Estimate)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P14/032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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