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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05413967
Recruitment Status : Recruiting
First Posted : June 10, 2022
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief Summary:
To find effects of mills manipulation versus NIRSCHL EXERCISES on pain ,strength and function in patients with lateral epicondylitis.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Other: Mills manipulation in addition to myofasical release therapy Other: Nirschl exercises in addition to myofascial release therapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Mills Manipulation Versus NIRSCHL Exercises on Pain, Strength and Function in Patients With Lateral Epicondylitis
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mills manipulation in addition to myofasical release therapy
mills manipulation
Other: Mills manipulation in addition to myofasical release therapy
Group A will receive Mills manipulation in addition to myofasical release therapy as baselin

Experimental: Nirschl exercises in addition to myofascial release therapy
Nirschel exercises
Other: Nirschl exercises in addition to myofascial release therapy
Group B will receive Nirschl exercises in addition to myofascial release therapy as baseline




Primary Outcome Measures :
  1. Numeric Pain Rating scale (NPRS) [ Time Frame: 10 months ]
    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.

  2. Hand dynamometer [ Time Frame: 10 MONTHS ]
    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.

  3. Patient Rated Tennis Elbow Evaluation(PRTEE) [ Time Frame: 10 Months ]
    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.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05413967


Contacts
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Contact: Imran Amjad, Phd 03324390125 imran.amjad@riphah.edu.pk

Locations
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Pakistan
PSRD hospital Ferozpur Road LAHORE Recruiting
Lahore, Punjab, Pakistan
Contact: SABA RAFIQUE, ppdpt    03034045433    saba.rafique@riphah.edu.pk   
Sub-Investigator: Sadia Moazzam, MSPT-OM         
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Saba Rafique, ppdpt Riphah International University
Publications:
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT05413967    
Other Study ID Numbers: REC/RCR&AHS/22/0129
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
lateral epicondylitis ,Mills Manipulation,NIRSCHL exercises
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries