Clinical trial NCT02343809: Diacutaneous Fibrolysis on Lateral Epicondylitis
Official title: Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Tennis Elbow
Keywords: Physiotherapy
Lateral epicondylitis
Manual therapy
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain intensity
timeFrame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
measure: Pain free grip strength
timeFrame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
measure: Functional status
timeFrame: pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
measure: Global Rating of Change scale
timeFrame: post-intervention, after three months
Other outcomes:
Locations:
city: Cornellà de Llobregat
country: Spain
facility: Catalan Institut of Health - Sant Ildefons Rehabilitation Center
state: Barcelona
Study officials:
References: