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Mobilization With Movement and Progressive Strengthening Exercises in Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mobilization with movement lateral Glides and Conventional Physiotherapy
Progressive Resistance Exercises and Conventional Physiotherapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Mobilization with movement, PRE, PRTEE, VAS, HD.

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • During Palpation found local tenderness over lateral side of epicondyle.
  • Diagnosed clinically minimum 3 month duration from orthopedic doctors/ department.
  • Positive Mills test or Cozen test.

Exclusion Criteria:

  • Traumatic injury
  • Any Positive history of ligament or tendon tear grade 3
  • Any kind of surgery around elbow past two months
  • Any History of systemic diseases
  • Any kind of neurological conditions like stroke, MS, CVA.

Sites / Locations

  • Bone and joints centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GROUP A

GROUP B

Arm Description

GROUP A

GROUP B

Outcomes

Primary Outcome Measures

Visual Analogue Scale
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.The VAS is pain numeric scale to find out pain intensity and pain level perceived by patients. The VAS is a subjective type pain scale measured the acute and chronic level pain. Score are marked between no pain and worst pain ( zero to 10)
Patients Related Tennis Elbow Evaluation
Measurements the patient functional status its 15 questionnaires In PRTEE First subscale is The Pain Subscale detail is 5 items Maximum or best score is 0 and worst score is 50 The Second Subscale or PRTEE is The Specific Activities detail is 6 items with finest score is 0 and least score is 60 The third one subscale of PRTEE the Usual Activities sub part 4 items with superior score is 0 and least score is 40. Third Fourth Part of PRTEE is The Function Subscale detail is performance bases specific activities and usual or regular activities Add up to specific or regular activities divided by 2 Maximum best score or prime score is 0 and least score is 50 Total detail Score of PRTEE is = Pain Subscale + Function Subscale Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score)
Hand Dynamometer Maximum Grip Strength
A dynamometer with high accuracy and sensitivity has recently been developed to assess grip strength. It provides maximal isometric grip strength measured.Many sports activities hand dynamometer is used to find out athlete performance around hand and forearm muscle strength. Sports, like baseball and tennis, where the hand is utilized for tossing or lifting make use of dynamometers to test hand strength

Secondary Outcome Measures

Full Information

First Posted
April 28, 2022
Last Updated
April 28, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05358054
Brief Title
Mobilization With Movement and Progressive Strengthening Exercises in Lateral Epicondylitis
Official Title
Comparison of Mulligan Mobilization With Movement and Progressive Strengthening Exercises in Patients With Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
February 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to compare the mobilization with movement and progressive strengthening exercises in individuals with lateral epicondylitis on VAS, PRTEE and Hand Grip strength . A randomized clinical trial was conducted at Bone and Joint center and Khyaban medical center, Rawalpindi. The sample size was 40 calculated through open-epi tool . The participants were divided into two groups each having 20 participants. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using enveloped sealed. Only 20 to 60 years participants with chronic lateral epicondylitis included in that study . Tools used in this study are SELF STRUCTURE QUESTIONNAIRE, VAS visual analogue scale range is 0 TO 10 O is no pain 10 is unbearable pain , PRTEE patient ratted tennis elbow evaluation 15 questionnaire form 3 sub-scale total 100 scores 0 is best 100 is worst, hand held Dynamo-meter , Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 21.
Detailed Description
Epicondylitis is common in persons who frequently overuse the upper arm, particularly with activities that involve rotation of the arm with flexion and extension. Anyone who performs repetitive movements involving extension of the wrist or hand for at least two hours a day, which can include anyone sitting at a computer and using a mouse. Professional who are commonly effected are Tennis Players, Squash Players, Badminton Players ,Painters, Plumbers, Computer user and Musician. Lateral Epicondylitis affect the extensor muscle around elbow also common for extensor type pathology. Evidence suggests that Prevalence of Tennis elbow generally affects about 1 to 3 % general population from 35 to 50 years . Lateral epicondylitis of young age around 20 years is usually due to overused sustained pressure during laptop working and it mainly effect the dominant hand usually right hand. The condition tends to affect men and women equally. The annual incidence is one to three percent in the United States. Despite the condition being commonly referred to as tennis elbow, tennis players make up only 10% of the patient population. Half of the tennis players develop pain around the elbow, of which 75% represent true tennis elbow. Diagnosis of Lateral Epicondylitis is based on the palpation around lateral elbow region , found local tenderness around lateral epicondyle region and Cozen test , Mill,s test. Literature review: A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines and the key words used were Lateral Epicondylitis , Tennis Elbow, PRE, Strengthening exercises ,VAS, exercises programme for tennis elbow, .The purpose of the literature review is to find out the pre-existing literature regarding the mobilization with movement and PRE interventions for Lateral Epicondylitis . In 2020, The Effects of Mulligan's Mobilization with movement technique in patients with lateral epicondylitis. MWM is secure and shows efficacy in terms of outcomes at elbow pain (VAS) , Functional Capacity( FC) PRTEE, and Pain less maximized grip strength, these all parameters showed significant improvement. An experimental study was conducted in 2017 Effects of progressive strengthening exercises in chronic lateral epicondylitis. The group receiving PRE showed significant improvement in study variables (VAS, PRTEE, Grip Strength). The group which performed PRE and conventional physiotherapy showed greater improvement than alone conventional treatment for lateral epicondylitis . RCT was conducted in 2016 MWM compared to supervised exercises in patients with lateral epicondylitis. This study showed that the group with mulligan technique's showed effectiveness in term of reduction of pain and improved Grip Hand Strength (GHS) as compared with supervised exercise program group. An Intervention Comparative study was conducted in 2013 Effectiveness of MWM compared with manipulation of wrist in lateral epicondylitis . The variables were pain , Functional disability recorded by VAS, PRTEE, and Hand Dynamo-meter .This study showed that mulligan mobilization plus conventional treatment was much more effective in treatment of tennis elbow . RCT was conducted in 2012 MWM as adjunct to conventional physiotherapy in treatment of chronic lateral epicondylitis stated that Mobilization with movement group showed significant improvement in pain reduction at VAS and improved Pain Free Grip Strength .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Mobilization with movement, PRE, PRTEE, VAS, HD.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
Experimental
Arm Description
GROUP A
Arm Title
GROUP B
Arm Type
Experimental
Arm Description
GROUP B
Intervention Type
Other
Intervention Name(s)
Mobilization with movement lateral Glides and Conventional Physiotherapy
Intervention Description
(The Mobilization with movement technique is(lateral glide) applied to the patient by a physiotherapist to patients at supine level position. First we identify pain free region each patients. The lateral humerus above the condyle of elbow joint are fixed by therapist. Then therapist ask to patients perform the active movement ten times. The same procedure repeats number of 3 sets, 10 number of repetition. The rest of interval fifteen to twenty seconds with in the sets Grip strength (pain Free Strength ) was evaluated in kilogram using a dynamometer. The measurements using dynamometer patients posture is erect sit position , the elbow at 90 degree flexion , shoulder would be abducted , rest of joint forearm and wrist in neutral during measurements. conventional therapy list of conventional physiotherapy are therapeutic ultrasound , deep transverse friction massage and stretching
Intervention Type
Other
Intervention Name(s)
Progressive Resistance Exercises and Conventional Physiotherapy
Intervention Description
4 STEPS Progressive resistive EXERCISES have a 4 step to application Step 1 Clenching fist strongly, resisted wrist Flexion, Extension, wrist rotation with a stick) Step 2 The therapeutic band exercised performed at wrist Flexion(WF), Wrist Extension(WE), Wrist Ulnar Deviation(WED) , and Wrist Radial Deviation(WRD).Step 3 Patient asked to perform combined wrist rotatory movements using e.g. table top as a support. Step 4 Soft ball compressing exercises, Transferring buttons from cup into another, Twisting a towel into the roll, Hand Rotating both directions at table AND CONVENTIONAL PHYSIOTHERAPY and list of conventional physiotherapy are therapeutic ultrasound , deep transverse friction massage and stretching
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.The VAS is pain numeric scale to find out pain intensity and pain level perceived by patients. The VAS is a subjective type pain scale measured the acute and chronic level pain. Score are marked between no pain and worst pain ( zero to 10)
Time Frame
1st Day
Title
Patients Related Tennis Elbow Evaluation
Description
Measurements the patient functional status its 15 questionnaires In PRTEE First subscale is The Pain Subscale detail is 5 items Maximum or best score is 0 and worst score is 50 The Second Subscale or PRTEE is The Specific Activities detail is 6 items with finest score is 0 and least score is 60 The third one subscale of PRTEE the Usual Activities sub part 4 items with superior score is 0 and least score is 40. Third Fourth Part of PRTEE is The Function Subscale detail is performance bases specific activities and usual or regular activities Add up to specific or regular activities divided by 2 Maximum best score or prime score is 0 and least score is 50 Total detail Score of PRTEE is = Pain Subscale + Function Subscale Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score)
Time Frame
1st Day
Title
Hand Dynamometer Maximum Grip Strength
Description
A dynamometer with high accuracy and sensitivity has recently been developed to assess grip strength. It provides maximal isometric grip strength measured.Many sports activities hand dynamometer is used to find out athlete performance around hand and forearm muscle strength. Sports, like baseball and tennis, where the hand is utilized for tossing or lifting make use of dynamometers to test hand strength
Time Frame
1st day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: During Palpation found local tenderness over lateral side of epicondyle. Diagnosed clinically minimum 3 month duration from orthopedic doctors/ department. Positive Mills test or Cozen test. Exclusion Criteria: Traumatic injury Any Positive history of ligament or tendon tear grade 3 Any kind of surgery around elbow past two months Any History of systemic diseases Any kind of neurological conditions like stroke, MS, CVA.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lal Gul Khan, MScPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bone and joints centre
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Mobilization With Movement and Progressive Strengthening Exercises in Lateral Epicondylitis

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