ClinicalTrials.Veeva

Menu

Diacutaneous Fibrolysis on Lateral Epicondylitis

F

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status and phase

Unknown
Phase 3

Conditions

Tennis Elbow

Treatments

Other: Protocolized Physiotherapy
Other: Sham Diacutaneous Fibrolysis
Other: Actual Diacutaneous Fibrolysis

Study type

Interventional

Funder types

Other

Identifiers

NCT02343809
P14/032

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

Intervention Group
Experimental group
Description:
Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy
Treatment:
Other: Protocolized Physiotherapy
Other: Actual Diacutaneous Fibrolysis
Placebo Group
Sham Comparator group
Description:
Sham Diacutaneous Fibrolysis and Protocolized Physiotherapy
Treatment:
Other: Protocolized Physiotherapy
Other: Sham Diacutaneous Fibrolysis
Control Group
Other group
Description:
Protocolized Physiotherapy
Treatment:
Other: Protocolized Physiotherapy

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems