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Diacutaneous Fibrolysis on Lateral Epicondylitis

Primary Purpose

Tennis Elbow

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Actual Diacutaneous Fibrolysis
Sham Diacutaneous Fibrolysis
Protocolized Physiotherapy
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Physiotherapy, Lateral epicondylitis, Manual therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catalan Institut of Health - Sant Ildefons Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Intervention Group

Placebo Group

Control Group

Arm Description

Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy

Sham Diacutaneous Fibrolysis and Protocolized Physiotherapy

Protocolized Physiotherapy

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity (VAS)

Secondary Outcome Measures

Pressure Pain Threshold
pressure algometry
Pain free grip strength
digital dynamometer
Functional status
DASH questionnaire
Global Rating of Change scale

Full Information

First Posted
January 16, 2015
Last Updated
January 21, 2015
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT02343809
Brief Title
Diacutaneous Fibrolysis on Lateral Epicondylitis
Official Title
Effectiveness of Diacutaneous Fibrolysis on Chronic Lateral Epicondylitis. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Physiotherapy, Lateral epicondylitis, Manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy
Arm Title
Placebo Group
Arm Type
Sham Comparator
Arm Description
Sham Diacutaneous Fibrolysis and Protocolized Physiotherapy
Arm Title
Control Group
Arm Type
Other
Arm Description
Protocolized Physiotherapy
Intervention Type
Other
Intervention Name(s)
Actual Diacutaneous Fibrolysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Diacutaneous Fibrolysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Protocolized Physiotherapy
Intervention Description
Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity (VAS)
Time Frame
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
pressure algometry
Time Frame
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Title
Pain free grip strength
Description
digital dynamometer
Time Frame
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Title
Functional status
Description
DASH questionnaire
Time Frame
pre-intervention, post-intervention (two sessions in a week during three weeks), after three months
Title
Global Rating of Change scale
Time Frame
post-intervention, after three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Catalan Institut of Health - Sant Ildefons Rehabilitation Center
City
Cornellà de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08940
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos López, M.Sc
Phone
934711912
Email
carlesldc@gmail.com

12. IPD Sharing Statement

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Diacutaneous Fibrolysis on Lateral Epicondylitis

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