- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05947968
Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis. (PNF)
Scapular Proprioception Neuromuscular Facilitation Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is no standard treatment for lateral epicondylitis, it is always a combination of physical therapy modalities aimed to reduce pain and increase the ability to return functional activities participation. Accordingly, many researchers have added shoulder strengthening exercise to the rehabilitation plan for treating lateral epicondylitis.
Consequently, development of new concept of scapula motor control exercise using proprioceptive neuromuscular facilitation to add proximal stability to patients with lateral epicondylitis may be beneficial. We believe that this study can serve as a step toward documenting the evidence of scapular proprioceptive neuromuscular facilitation exercise in the treatment of patients with lateral epicondylitis which was not available before.
Patients with lateral epicondylitis will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo University. All participants will sign a written informed consent form. After group assignment, patients' demographics will be collected, and then assessment of pain, function and grip strength will be performed. The same assessment procedure will be conducted by the end of the treatment (by the end of the 12th visit).
The study will be two comparative groups, pre-post experimental design, the subjects will be randomly assigned into one of two groups:
- Group (I) : will receive scapular proprioceptive neuromuscular facilitation exercises.
- Group (II) : will receive shoulder strengthening exercises.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahmoud Ghallab, Master
- Phone Number: 00201001899452
- Email: mahmoudasam93@hotmail.com
Study Contact Backup
- Name: Mohamed Ahmed, Lecturer
- Phone Number: 00201223631604
Study Locations
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-
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Giza, Egypt
- Recruiting
- Cairo University
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Contact:
- Mahmoud Ghallab, Master
- Phone Number: 00201001899452
- Email: mahmoudasam93@hotmail.com
-
Contact:
- Mohamed Ahmed, Lecturer
- Phone Number: 00201223631604
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients will be included if they have the following criteria:
- Fifty-two male and female subjects.
- Patients complaining of chronic lateral epicondylitis (more than three months).
- Age between 20-50.
Exclusion Criteria:
Patients will be excluded if they had any of the following conditions:
- Received physiotherapy in last 3 months.
- Received corticosteroids injection in lateral epicondyle in last 3 months.
- Receiving anti-inflammatories medications on regular basis.
- Had neurologic problems in shoulder, neck and thoracic regions.
- Had history of rheumatic disease.
- Had cooperation difficulties due to cognitive disorders. All Patients will be instructed to keep away from activities that aggravate the symptoms such as grasping, lifting, knitting and using a screwdriver during the treatment period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Scapular PNF)
will receive scapular proprioceptive neuromuscular facilitation exercise plus conventional treatment of lateral epicondylitis for 12 sessions (3 sessions per week for four weeks). The conventional treatment of lateral epicondylitis will be:
|
Scapular proprioceptive neuromuscular facilitation exercise: will be applied in two diagonals:
Patients will lay on the unaffected side while the therapist stands in the line of desired motion. Firstly, the therapist will give preparatory instructions. In the beginning of the pattern, the therapist pulls the scapula to the elongated position and then gives instructions for the desired movement. |
|
Experimental: Group B (Shoulder exercises)
will receive shoulder strengthening exercise plus conventional treatment of lateral epicondylitis for 12 sessions (3 sessions per week for four weeks). Same conventional treatment in group (A) |
Shoulder strengthening exercises: The following four exercises will focus on shoulder and scapular strengthening. Before starting the program, the patients will be thoroughly instructed in the four exercises, and illustrations with specific exercise instructions will be provided. All subjects will perform the exercises with the affected side for three sets of 10 repetitions for each exercise, with a 1-minute rest between sets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity by The Numeric Pain Rating Scale (NPRS)
Time Frame: one month
|
(NPRS) is a unidimensional measure of pain intensity in adults.
Consists of 11-item NPRS.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable.
|
one month
|
|
Pain and functional disability by patient-rated tennis elbow evaluation (PRTEE)
Time Frame: one month
|
The PRTEE is a valid and reliable tool that may be used in both research and clinical settings to assess the subjective outcome in patient with lateral epicondylitis. Subjects will be asked to rate the level of discomfort and difficulty they had encountered in the previous week. High total scores imply more pain and impairment; the scale spans from 0 to 100. The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with LE. The PRTEE allows patients to rate their levels of pain and disability from 0 to 10, and consists of 2 subscales:
|
one month
|
|
Grip strength by Jammar handheld dynamometer.
Time Frame: one month
|
The Jammar hand grip dynamometer is valid and reliable, will be used to assess the subject's pain-free grip strength while they are lying on their side with their elbow extended and pronated.
Subjects will be instructed to squeeze the dynamometer handles until they experienced pain.
It will be performed three times with 20 s rest period between repetitions.
Average of three trials will be recorded in kilograms.
|
one month
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lateral epicondylitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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