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

Lateral Epicondylitis Clinical Trial

Official title:

Effects of Mills Manipulation Versus NIRSCHL Exercises on Pain, Strength and Function in Patients With Lateral Epicondylitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413967
• Other study ID #: REC/RCR&AHS/22/0129
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2022
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Other:
• Mills manipulation in addition to myofasical release therapy
Group A will receive Mills manipulation in addition to myofasical release therapy as baselin
• Nirschl exercises in addition to myofascial release therapy
Group B will receive Nirschl exercises in addition to myofascial release therapy as baseline

Locations

Country	Name	City	State
Pakistan	PSRD hospital Ferozpur Road LAHORE	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Landesa-Piñeiro L, Leirós-Rodríguez R. Physiotherapy treatment of lateral epicondylitis: A systematic review. J Back Musculoskelet Rehabil. 2022;35(3):463-477. doi: 10.3233/BMR-210053. Review. — View 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. Review. — View Citation

Pitsillides A, Stasinopoulos D. Cyriax Friction Massage-Suggestions for Improvements. Medicina (Kaunas). 2019 May 21;55(5). pii: E185. doi: 10.3390/medicina55050185. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 months
Primary	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.	10 MONTHS
Primary	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.	10 Months