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Diacutaneous Fibrolysis on Lateral Epicondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02343809
Recruitment Status : Unknown
Verified January 2015 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Recruiting
First Posted : January 22, 2015
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief 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.


Condition or disease Intervention/treatment Phase
Tennis Elbow Other: Actual Diacutaneous Fibrolysis Other: Sham Diacutaneous Fibrolysis Other: Protocolized Physiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial.
Study Start Date : October 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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: 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: Protocolized Physiotherapy
Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy

Control Group
Protocolized Physiotherapy
Other: Protocolized Physiotherapy
Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months ]
    Pain intensity (VAS)


Secondary Outcome Measures :
  1. Pressure Pain Threshold [ Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months ]
    pressure algometry

  2. Pain free grip strength [ Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months ]
    digital dynamometer

  3. Functional status [ Time Frame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months ]
    DASH questionnaire

  4. Global Rating of Change scale [ Time Frame: post-intervention, after three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343809


Locations
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Spain
Catalan Institut of Health - Sant Ildefons Rehabilitation Center Recruiting
Cornellà de Llobregat, Barcelona, Spain, 08940
Contact: Carlos López, M.Sc    934711912    carlesldc@gmail.com   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation

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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02343809    
Other Study ID Numbers: P14/032
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015
Keywords provided by Jordi Gol i Gurina Foundation:
Physiotherapy
Lateral epicondylitis
Manual therapy
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries