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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02343809
Other study ID # P14/032
Secondary ID
Status Recruiting
Phase Phase 3
First received January 16, 2015
Last updated January 21, 2015
Start date October 2014
Est. completion date January 2016

Study information

Verified date January 2015
Source Jordi Gol i Gurina Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Catalan Institut of Health - Sant Ildefons Rehabilitation Center Cornellà de Llobregat Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity Pain intensity (VAS) pre-intervention, post-intervention (two sessions in a week during three weeks), after three months Yes
Secondary Pressure Pain Threshold pressure algometry pre-intervention, post-intervention (two sessions in a week during three weeks), after three months Yes
Secondary Pain free grip strength digital dynamometer pre-intervention, post-intervention (two sessions in a week during three weeks), after three months Yes
Secondary Functional status DASH questionnaire pre-intervention, post-intervention (two sessions in a week during three weeks), after three months Yes
Secondary Global Rating of Change scale post-intervention, after three months Yes
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