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Effects of Mills Manipulation and Nirschel Exercises in Patients With Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mills manipulation in addition to myofasical release therapy
Nirschl exercises in addition to myofascial release therapy
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 lateral epicondylitis ,Mills Manipulation,NIRSCHL exercises

Eligibility Criteria

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

Inclusion Criteria:

  • Pain on lateral epicondyle of humerus when palpated, in the age group of 40-60 years
  • Both male and female are included
  • Unilateral symptomatic lateral epicondylitis
  • Tenderness over palpation of extensor carpi radialis brevis muscle muscle (ECRB)
  • Patients with positive cozens test (resisted wrist extension and radial deviation is painful) ,mills test (passive elbow extension & wrist flexion is painful) and maudsley test(resisted middle finger extension is painful)
  • Patients having symptoms of lateral epicondylitis for > 3 months

Exclusion Criteria:

  • Radial nerve entrapment
  • Cervical radiculopathy
  • Corticosteroid injection within 4 weeks
  • Had received any conservative treatment for lateral epicondylitis in last 4 weeks before entering the study
  • Post-surgery patients of lateral epicondylitis
  • Radiological findings of extensor tendon calcification

Sites / Locations

  • PSRD hospital Ferozpur Road LAHORERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mills manipulation in addition to myofasical release therapy

Nirschl exercises in addition to myofascial release therapy

Arm Description

mills manipulation

Nirschel exercises

Outcomes

Primary Outcome Measures

Numeric Pain Rating scale (NPRS)
The NPRS is used to access the patient intensity of pain. Its score ranges from 0-10 with 0 is being the least painful while 10 is worst. Patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the last 24 hours. The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours. The NPRS is found to be valid and reliable method for measuring patients perceived pain.
Hand dynamometer
Hand dynamometer is used to measure the grip strength of the patients. It is considered as a primary clinical measure according to internationally accepted normal hand grip strength ratings in Kgs in patients with various musculoskeletal conditions associated with decreased hand grip strength.
Patient Rated Tennis Elbow Evaluation(PRTEE)
Patient related tennis elbow evaluation is used to access pain and functional disability of LE patients. The index has two subscales,5 questions are related to pain are scored 0-10, for each question related to pain 0 refereed to no pain while 10 referred as worst pain imaginable. The functional disability scale 0 referred to no difficulty while 10 being referred to unable to do.PRTEE is a valid and reliable instrument for LE patients.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2022
Last Updated
June 7, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05413967
Brief Title
Effects of Mills Manipulation and Nirschel Exercises in Patients With Lateral Epicondylitis
Official Title
Effects of Mills Manipulation Versus NIRSCHL Exercises on Pain, Strength and Function in Patients With Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

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
No

5. Study Description

Brief Summary
To find effects of mills manipulation versus NIRSCHL EXERCISES on pain ,strength and function in patients with lateral epicondylitis.
Detailed Description
Lateral epicondylitis is also known as tennis elbow, an overuse injury that is characterized by pain and tenderness over the lateral epicondyle. The exact etiology has not been well identified, however its commonly associated with repetitive micro trauma from excessive gripping, wrist extension radial deviation or forearm supination. Extensor carpi radialis brevis is the most affected muscle. The aim of this study is to access the effects of mills manipulation versus Nirschl exercises on pain, strength, and function in patients with lateral epicondylitis. This study will be a Randomized Clinical trial and will be conducted at Pakistan society for rehabilitation of disabled and Mayo Hospital in Lahore. Patients of aged 20-40 years having insidious onset of lateral elbow pain with positive cozens test, Mills test and Maudsley test will be taken. Patients with radial nerve entrapment, cervical radiculopathy and those receiving injections of corticosteroids in last 4 weeks are excluded. The study will include 32 patients randomly divided into two groups A and group B. The study will be completed within the time duration of 10 months after approval of synopsis. Group A will receive mills manipulation while Group B will receive Nirschl exercises. myofascial release therapy will be given to both groups as baseline. both groups will receive 3 sessions per week for 4 weeks (12 sessions), data will be taken by using numeric pain rating scale for pain, hand dynamometer for grip strength and Patient rated tennis elbow evaluation for evaluation of function, at the start of treatment and the end of treatment session. Data will be analysed on SPSS-25. Key words: lateral epicondylitis, mills manipulation, Nirschl exercises, Patient rated tennis elbow evaluation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
lateral epicondylitis ,Mills Manipulation,NIRSCHL exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mills manipulation in addition to myofasical release therapy
Arm Type
Experimental
Arm Description
mills manipulation
Arm Title
Nirschl exercises in addition to myofascial release therapy
Arm Type
Experimental
Arm Description
Nirschel exercises
Intervention Type
Other
Intervention Name(s)
Mills manipulation in addition to myofasical release therapy
Intervention Description
Group A will receive Mills manipulation in addition to myofasical release therapy as baselin
Intervention Type
Other
Intervention Name(s)
Nirschl exercises in addition to myofascial release therapy
Intervention Description
Group B will receive Nirschl exercises in addition to myofascial release therapy as baseline
Primary Outcome Measure Information:
Title
Numeric Pain Rating scale (NPRS)
Description
The NPRS is used to access the patient intensity of pain. Its score ranges from 0-10 with 0 is being the least painful while 10 is worst. Patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the last 24 hours. The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours. The NPRS is found to be valid and reliable method for measuring patients perceived pain.
Time Frame
10 months
Title
Hand dynamometer
Description
Hand dynamometer is used to measure the grip strength of the patients. It is considered as a primary clinical measure according to internationally accepted normal hand grip strength ratings in Kgs in patients with various musculoskeletal conditions associated with decreased hand grip strength.
Time Frame
10 MONTHS
Title
Patient Rated Tennis Elbow Evaluation(PRTEE)
Description
Patient related tennis elbow evaluation is used to access pain and functional disability of LE patients. The index has two subscales,5 questions are related to pain are scored 0-10, for each question related to pain 0 refereed to no pain while 10 referred as worst pain imaginable. The functional disability scale 0 referred to no difficulty while 10 being referred to unable to do.PRTEE is a valid and reliable instrument for LE patients.
Time Frame
10 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pain on lateral epicondyle of humerus when palpated, in the age group of 40-60 years Both male and female are included Unilateral symptomatic lateral epicondylitis Tenderness over palpation of extensor carpi radialis brevis muscle muscle (ECRB) Patients with positive cozens test (resisted wrist extension and radial deviation is painful) ,mills test (passive elbow extension & wrist flexion is painful) and maudsley test(resisted middle finger extension is painful) Patients having symptoms of lateral epicondylitis for > 3 months Exclusion Criteria: Radial nerve entrapment Cervical radiculopathy Corticosteroid injection within 4 weeks Had received any conservative treatment for lateral epicondylitis in last 4 weeks before entering the study Post-surgery patients of lateral epicondylitis Radiological findings of extensor tendon calcification
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saba Rafique, ppdpt
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PSRD hospital Ferozpur Road LAHORE
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SABA RAFIQUE, ppdpt
Phone
03034045433
Email
saba.rafique@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sadia Moazzam, MSPT-OM

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31117314
Citation
Pitsillides A, Stasinopoulos D. Cyriax Friction Massage-Suggestions for Improvements. Medicina (Kaunas). 2019 May 21;55(5):185. doi: 10.3390/medicina55050185.
Results Reference
background
PubMed Identifier
32454922
Citation
Ma KL, Wang HQ. Management of Lateral Epicondylitis: A Narrative Literature Review. Pain Res Manag. 2020 May 5;2020:6965381. doi: 10.1155/2020/6965381. eCollection 2020.
Results Reference
background
PubMed Identifier
34397403
Citation
Landesa-Pineiro L, Leiros-Rodriguez R. Physiotherapy treatment of lateral epicondylitis: A systematic review. J Back Musculoskelet Rehabil. 2022;35(3):463-477. doi: 10.3233/BMR-210053.
Results Reference
background
PubMed Identifier
31387611
Citation
Yan C, Xiong Y, Chen L, Endo Y, Hu L, Liu M, Liu J, Xue H, Abududilibaier A, Mi B, Liu G. A comparative study of the efficacy of ultrasonics and extracorporeal shock wave in the treatment of tennis elbow: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2019 Aug 6;14(1):248. doi: 10.1186/s13018-019-1290-y.
Results Reference
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Effects of Mills Manipulation and Nirschel Exercises in Patients With Lateral Epicondylitis

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