Effectiveness Of A Physiotherapy Treatment Plan In Lateral Epicondylalgia

October 26, 2023 updated by: JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
Purpose: Test the effectiveness of a physiotherapy treatment in 90 patients with Lateral epicondylalgia (LE).

Study Overview

Status

Active, not recruiting

Detailed Description

Methods: LE is a musculoskeletal pain around the lateral epicondyle that may also present with decreased grip strength and/or neuromuscular disorders. An evidence-based treatment plan of dry needling, stretching and eccentric exercise in the patient with lateral epicondylalgia is established. It is carried out in two sessions, one session every 10 days and lasts about 45 minutes. There are three intervention arms: dry needling, atopic gel and NSAIDs, 30 patients in each group (n=90).

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ávila, Spain, 05005
        • Universidad Católica de Ávila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosed with lateral epicondylalgia

Exclusion Criteria:

  • diagnosed with compressive nerve syndromes with irradiation to the upper limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry needling+eccentric exercises
It is established a plan of treatment base on the evidence for dry needling, eccentric exercise in the patient with lateral epicondylalgia. This is done in two sessions, one session every 10 days and with a duration of about 45 minutes.
dry needling, stretching and eccentric exercise
Active Comparator: topical gel
application of topical gel to the area of pain
aplication of topical gel to the epicondyle
Active Comparator: NSAIDs
oral intake of NSAIDs
oral intake of NSAIDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionaire Hand 10
Time Frame: 1 month
score in discomfort hand 0-10. 0 is the lowest score and 10 is the highest score.
1 month
VAS Scale
Time Frame: 1 month
pain scale, where 0 is the minimum pain and 10 is the maximum pain.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain concentration measured with algometry
Time Frame: 10 days
pain when performing static pressures measured with an algometer
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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