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Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis. (PNF)

Primary Purpose

Lateral Epicondylitis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Scapular PNF
Shoulder strengthening exercises
Sponsored by
Mahmoud Essam Abu Elfetouh Ghallab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring scapular PNF, scapular proprioceptive neuromuscular facilitation exercise, shoulder strengthening exercises

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (Scapular PNF)

Group B (Shoulder exercises)

Arm Description

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: Pulsed ultrasound over the lateral epicondyle for 5 min. Five minutes of deep friction massage. It will be consisted of deep circular motions using the fingertips over the area of maximal tenderness at the lateral epicondyle. Stretching exercise for extensor carpi radialis longus and brevis for 3 repetitions, each repetition will be 45 seconds with 30 seconds' rest. Strengthening exercise for wrist extensors, eccentric exercise for wrist extensors will be as follow: 3 sets, 10 repetitions, 1 min rest interval between each set.

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)

Outcomes

Primary Outcome Measures

Pain intensity by The Numeric Pain Rating Scale (NPRS)
(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.
Pain and functional disability by patient-rated tennis elbow evaluation (PRTEE)
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: PAIN subscale (0 = no pain, 10 = worst imaginable) • Pain - 5 items FUNCTION subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items
Grip strength by Jammar handheld dynamometer.
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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2023
Last Updated
July 9, 2023
Sponsor
Mahmoud Essam Abu Elfetouh Ghallab
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05947968
Brief Title
Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.
Acronym
PNF
Official Title
Scapular Proprioception Neuromuscular Facilitation Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahmoud Essam Abu Elfetouh Ghallab
Collaborators
Cairo University

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
The purpose of this study is to compare between the effect of scapular proprioceptive neuromuscular facilitation versus shoulder and scapular strengthening exercise on pain, functional outcome and grip strength in patients with lateral epicondylitis.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
scapular PNF, scapular proprioceptive neuromuscular facilitation exercise, shoulder strengthening exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Scapular PNF)
Arm Type
Experimental
Arm Description
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: Pulsed ultrasound over the lateral epicondyle for 5 min. Five minutes of deep friction massage. It will be consisted of deep circular motions using the fingertips over the area of maximal tenderness at the lateral epicondyle. Stretching exercise for extensor carpi radialis longus and brevis for 3 repetitions, each repetition will be 45 seconds with 30 seconds' rest. Strengthening exercise for wrist extensors, eccentric exercise for wrist extensors will be as follow: 3 sets, 10 repetitions, 1 min rest interval between each set.
Arm Title
Group B (Shoulder exercises)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Scapular PNF
Intervention Description
Scapular proprioceptive neuromuscular facilitation exercise: will be applied in two diagonals: anterior elevation and posterior depression posterior elevation and anterior depression for 3 sets of 10 repetitions, The rest interval between sets will be 20 seconds. 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.
Intervention Type
Other
Intervention Name(s)
Shoulder strengthening exercises
Intervention Description
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. Standing shoulder external rotation with elastic resistance. Bilateral external rotation with scapular retraction exercise. Resisted scapular retraction with shoulder external rotation (Middle trapezius muscle). Weighted scapular retraction and downward rotation Y-shape (lower trapezius muscle).
Primary Outcome Measure Information:
Title
Pain intensity by The Numeric Pain Rating Scale (NPRS)
Description
(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.
Time Frame
one month
Title
Pain and functional disability by patient-rated tennis elbow evaluation (PRTEE)
Description
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: PAIN subscale (0 = no pain, 10 = worst imaginable) • Pain - 5 items FUNCTION subscale (0 = no difficulty, 10 = unable to do) Specific activities - 6 items Usual activities - 4 items
Time Frame
one month
Title
Grip strength by Jammar handheld dynamometer.
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Ghallab, Master
Phone
00201001899452
Email
mahmoudasam93@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ahmed, Lecturer
Phone
00201223631604
Facility Information:
Facility Name
Cairo University
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Ghallab, Master
Phone
00201001899452
Email
mahmoudasam93@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Ahmed, Lecturer
Phone
00201223631604

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.

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