Diacutaneous Fibrolysis on Lateral Epicondylitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Tennis Elbow

Intervention / Treatment
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* Other: Actual Diacutaneous Fibrolysis
* Other: Sham Diacutaneous Fibrolysis
* Other: Protocolized Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiotherapy, Lateral epicondylitis, Manual therapy