Efficacy of a Stretching Protocol for Lateral Epicondylitis
Primary Purpose
Epicondylitis, Lateral, Elbow Tendinopathy, Epicondylitis of the Elbow
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Passive and active analytical stretching exercises
Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
Sponsored by
About this trial
This is an interventional treatment trial for Epicondylitis, Lateral focused on measuring epicondylitis, Elbow Tendinopathy, stretch, physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Adult subjects over 18 years of age.
- Clinical diagnosis of lateral epicondylitis made by the Rehabilitation Physicians collaborating in this study.
- Patient's prior informed consent for inclusion in the study.
Exclusion Criteria:
- Patients with significant psychological, neurological and physical impairments that would prevent the recruitment of the information necessary for the research.
- Patients with significant psychological, neurological and physical alterations that would prevent the application of the treatments necessary for the research.
- Patients in a situation of legal litigation that could be affected by their participation in this study.
- Refusal to participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control group
Experimental
Arm Description
Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
Passive and active analytical stretching exercises described by Neiger and Simons , applying them to the muscle chain involved in lateral epicondylitis described by Busquet
Outcomes
Primary Outcome Measures
Elbow Pain
Measurement of pain perception: by means of a visual analogue scale (VAS), consisting of drawing a 100 mm long line in a centred position on a DINA A4 paper, cut with a segment perpendicular to it at each end. After informing the subject that the left and right segments represent the absence of pain and the maximum pain imaginable respectively, the subject is asked to point with a pencil on the line to the point where their pain is located.
Grip strength
A dynamometer shall be used for the test. Special care was taken to ensure that all subjects had the same position in order to be able to compare results. After informing the patient how to perform this test, the evaluation process consists of performing a maximum grip force for three seconds, executing it three times and with a minimum time interval of 60 seconds between them to avoid muscle fatigue. After completion of the test, the arithmetic mean of the results will be considered as the result.
Secondary Outcome Measures
Full Information
NCT ID
NCT05238090
First Posted
February 3, 2022
Last Updated
February 18, 2022
Sponsor
University of Cadiz
1. Study Identification
Unique Protocol Identification Number
NCT05238090
Brief Title
Efficacy of a Stretching Protocol for Lateral Epicondylitis
Official Title
Efficacy of a Whole Upper Limb Stretching Protocol for Lateral Epicondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 30, 2022 (Anticipated)
Primary Completion Date
May 3, 2022 (Anticipated)
Study Completion Date
May 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cadiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the applying a stretching protocol to lateral epicondylitis.
Detailed Description
Epicondylitis is one of the most common soft tissue disorders of the locomotor system of the upper limb. Despite the existence of a large number of therapeutic alternatives for this type of injury, no agreed treatment protocol has been found. Some authors even suggest treating the patient from a more global biomechanical perspective.
OBJECTIVES. To evaluate the efficacy of applying a stretching protocol to the entire muscle chain involved in this injury and circumscribed to the entire affected upper limb.
METHODOLOGY. The study will be made up of 40 patients of both genders, randomly distributed in two groups: a control group made up of twenty patients to whom the usual Physiotherapy treatment will be applied, and an experimental group made up of the rest of the subjects, in which a stretching protocol will be applied to the whole upper limb affected and defined for this study. The evaluation process will consist of measuring pain perception using a visual analogue scale (VAS) and grip strength with a dynamometer. These measurements will be performed on all study subjects before starting treatment, at week 4 and week 6.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis, Lateral, Elbow Tendinopathy, Epicondylitis of the Elbow, Epicondylitis
Keywords
epicondylitis, Elbow Tendinopathy, stretch, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomised, single-blind, multicentre, randomised study.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Passive and active analytical stretching exercises described by Neiger and Simons , applying them to the muscle chain involved in lateral epicondylitis described by Busquet
Intervention Type
Other
Intervention Name(s)
Passive and active analytical stretching exercises
Intervention Description
For each stretching technique described, 3 repetitions of 15 seconds duration will be performed of 15 seconds duration each, within the patient's tolerance threshold. In any case, the impossibility of performing any technique due to exacerbation of pain shall be recorded in a patient record created for this study, noting the technique in question and the reason for its technique in question and the reason for its non-application. Passive stretches shall be applied in the same order for all subjects.
The physiotherapists in charge of applying the treatments will be trained in advance in the different techniques to be applied and will not in the different techniques to be applied and shall not intervene at any time in the two previous phases.
Both the control group and the study group will receive their respective treatments two days a week for four weeks. In no case will any other type of treatment be associated treatment during the whole process.
Intervention Type
Other
Intervention Name(s)
Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
Intervention Description
Static stretching of the extensor carpi radialis brevis and eccentric strengthening of the wrist extensor musculature
Primary Outcome Measure Information:
Title
Elbow Pain
Description
Measurement of pain perception: by means of a visual analogue scale (VAS), consisting of drawing a 100 mm long line in a centred position on a DINA A4 paper, cut with a segment perpendicular to it at each end. After informing the subject that the left and right segments represent the absence of pain and the maximum pain imaginable respectively, the subject is asked to point with a pencil on the line to the point where their pain is located.
Time Frame
1,5 months
Title
Grip strength
Description
A dynamometer shall be used for the test. Special care was taken to ensure that all subjects had the same position in order to be able to compare results. After informing the patient how to perform this test, the evaluation process consists of performing a maximum grip force for three seconds, executing it three times and with a minimum time interval of 60 seconds between them to avoid muscle fatigue. After completion of the test, the arithmetic mean of the results will be considered as the result.
Time Frame
1,5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects over 18 years of age.
Clinical diagnosis of lateral epicondylitis made by the Rehabilitation Physicians collaborating in this study.
Patient's prior informed consent for inclusion in the study.
Exclusion Criteria:
Patients with significant psychological, neurological and physical impairments that would prevent the recruitment of the information necessary for the research.
Patients with significant psychological, neurological and physical alterations that would prevent the application of the treatments necessary for the research.
Patients in a situation of legal litigation that could be affected by their participation in this study.
Refusal to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Jesus Vinolo
Phone
697953671
Email
mariajesus.vinolo@uca.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Martin
Organizational Affiliation
Cadiz University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication in journals indexed in the Journal Citation Report (JCR),in the field of Rehabilitation and Physical Medicine and Physiotherapy.
2. Dissemination of results in national and international Congresses of Rehabilitation and Physical Medicine and Physiotherapy.
3. Dissemination to the public, press releases and explanatory brochures of the project.
IPD Sharing Time Frame
In two years. In December 2023.
IPD Sharing Access Criteria
open file
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Efficacy of a Stretching Protocol for Lateral Epicondylitis
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