Diacutaneous Fibrolysis on Lateral Epicondylitis
- Conditions
- Tennis Elbow
- Interventions
- Other: Protocolized PhysiotherapyOther: Actual Diacutaneous FibrolysisOther: Sham Diacutaneous Fibrolysis
- Registration Number
- NCT02343809
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 18 years old and over
- Diagnosis of chronic lateral epicondylalgia
- Sign the informed consent form
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Protocolized Physiotherapy Protocolized Physiotherapy Placebo Group Protocolized Physiotherapy Sham Diacutaneous Fibrolysis and Protocolized Physiotherapy Intervention Group Protocolized Physiotherapy Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy Intervention Group Actual Diacutaneous Fibrolysis Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy Placebo Group Sham Diacutaneous Fibrolysis Sham Diacutaneous Fibrolysis and Protocolized Physiotherapy
- Primary Outcome Measures
Name Time Method Pain intensity pre-intervention, post-intervention (two sessions in a week during three weeks), after three months Pain intensity (VAS)
- Secondary Outcome Measures
Name Time Method Pain free grip strength pre-intervention, post-intervention (two sessions in a week during three weeks), after three months digital dynamometer
Functional status pre-intervention, post-intervention (two sessions in a week during three weeks), after three months DASH questionnaire
Pressure Pain Threshold pre-intervention, post-intervention (two sessions in a week during three weeks), after three months pressure algometry
Global Rating of Change scale post-intervention, after three months
Trial Locations
- Locations (1)
Catalan Institut of Health - Sant Ildefons Rehabilitation Center
🇪🇸Cornellà de Llobregat, Barcelona, Spain