Diacutaneous Fibrolysis on Lateral Epicondylitis
Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 16, 2015
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 22, 2015
January 1, 2015
1.1 years
January 16, 2015
January 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity
Pain intensity (VAS)
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Secondary Outcomes (4)
Pressure Pain Threshold
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Pain free grip strength
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Functional status
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
Study Arms (3)
Intervention Group
EXPERIMENTALActual Diacutaneous Fibrolysis and Protocolized Physiotherapy
Placebo Group
SHAM COMPARATORSham Diacutaneous Fibrolysis and Protocolized Physiotherapy
Control Group
OTHERProtocolized Physiotherapy
Interventions
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 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 physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy
Eligibility Criteria
You may qualify if:
- years old and over
- Diagnosis of chronic lateral epicondylalgia
- Sign the informed consent form
You may not qualify if:
- Concomitant conditions affecting the same upper extremity
- Contraindications for Diacutaneous Fibrolysis
- Pending litigation or legal claim
- Poor language and communication skills making difficult to understand the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catalan Institut of Health - Sant Ildefons Rehabilitation Center
Cornellà de Llobregat, Barcelona, 08940, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2015
First Posted
January 22, 2015
Study Start
October 1, 2014
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
January 22, 2015
Record last verified: 2015-01