NCT05413967

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

June 7, 2022

Last Update Submit

June 7, 2022

Conditions

Keywords

lateral epicondylitis ,Mills Manipulation,NIRSCHL exercises

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Mills manipulation in addition to myofasical release therapy

EXPERIMENTAL

mills manipulation

Other: Mills manipulation in addition to myofasical release therapy

Nirschl exercises in addition to myofascial release therapy

EXPERIMENTAL

Nirschel exercises

Other: Nirschl exercises in addition to myofascial release therapy

Interventions

Group A will receive Mills manipulation in addition to myofasical release therapy as baselin

Mills manipulation in addition to myofasical release therapy

Group B will receive Nirschl exercises in addition to myofascial release therapy as baseline

Nirschl exercises in addition to myofascial release therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSRD hospital Ferozpur Road LAHORE

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (4)

  • Pitsillides A, Stasinopoulos D. Cyriax Friction Massage-Suggestions for Improvements. Medicina (Kaunas). 2019 May 21;55(5):185. doi: 10.3390/medicina55050185.

    PMID: 31117314BACKGROUND
  • 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.

    PMID: 32454922BACKGROUND
  • 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.

    PMID: 34397403BACKGROUND
  • 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.

    PMID: 31387611BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Saba Rafique, ppdpt

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 10, 2022

Study Start

March 1, 2022

Primary Completion

February 28, 2023

Study Completion

March 31, 2023

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations