- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06500585
Effects of Mill's Manipulation Along With Muscle Energy Technique in Lateral Epicondylitis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan
- Ghosia Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient that have been diagnosed with lateral epicondylitis (pain and point tenderness over lateral epicondyle and / or 1-2cm distal to epicondyle).
- Both male and female patients between the age group of 18 to 45 years old.
- Any of the following tests positive: Cozen Test, Mills, Maudsley.
Exclusion Criteria:
- History of rheumatic arthritis
- History of elbow instability
- History of former fracture of the elbow
- History of cervical radiculopathy.
- History of radial tunnel syndrome (Patient with RTS will report pain over lateral forearm approximately 3 to 5 cm distal to the elbow worsens with rotational movements of the forearm).
- History of any neoplasia
- Any congenital or acquired deformity of upper limb.
- History of trauma.
- History of Corticosteroid injection within 6 months.
- Individual having symptoms of vertigo
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mill's Manipulation and Muscle Energy Technique
Group A will receive (Mills Manipulation + Muscle Energy Technique + Conventional therapy).
|
Mill's Manipulation:The therapist should apply a high-velocity low-amplitude thrust accompanied by a single application . Patients will be treated 3 times a week for 2 consecutive weeks. Muscle Energy Technique: Extensor carpi radialis stretch for 30 sec repeated 5 times during a single treatment session. Patients will be treated 3 times a week for 2 consecutive weeks. Conventional Therapy: Ultrasound therapy: Frequency: 1Mhz Pulse ultrasound: 1:4 Intensity: 1.5 W/cm2 Duration: 5min. Stretching of Wrist Extensors, 15 sec hold, 10 stretches/session/day. Wrist Extensors Isometric, resistance 5 to 10 seconds, 15 contractions/ session/day. Patients will be treated 3 times a week for 2 consecutive weeks. |
|
Other: Mill's Manipulation
Group B will receive (Mills Manipulation + Conventional therapy).
|
Mill's Manipulation: The therapist should apply a high-velocity low-amplitude thrust accompanied by a single application . Patients will be treated 3 times a week for 2 consecutive weeks. Conventional Therapy: Ultrasound therapy: Frequency: 1Mhz Pulse ultrasound: 1:4 Intensity: 1.5 W/cm2 Duration: 5 min. Stretching of Wrist Extensors: 15 sec hold, 10 stretches/session/day. Wrist extensors Isometric: resistance 5 to 10 seconds, 15 contractions/ session/day. Patients will be treated 3 times a week for 2 consecutive weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS
Time Frame: 2 weeks
|
The numeric pain rating scale (NPRS) measure the subjective intensity of pain.
NPRS is an eleven point scale from 0 to 10 is the most commonly used version which has good test-retest reliability ( r= .79-.96).
The NPRS is a reliable and valid pain assessment scale in LE.
|
2 weeks
|
|
Goniometer
Time Frame: 2 weeks
|
Universal goniometer is use to measure wrist ROM in flexion , extension, radial deviation, ulnar deviation, forearm pronation and forearm supination.The intraclass correlation coefficients (ICC) ranged from 0.945 to 0.973 which are classified for the goniometer measurements.
|
2 weeks
|
|
PRFEQ
Time Frame: 2 weeks
|
The PRTEE, formerly known as the Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow").
The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) PAIN subscale: (0 = no pain, 10 = worst imaginable) Pain - 5 items 2) FUNCTION subscale: (0 = no difficulty, 10 = unable to do) Specific activities - 6 items , Usual activities - 4 items .
Test-retest reliability of Korea version PRTEE was good total ICC= .962
(CI=.922-,982).
Therefore, it is a useful measure to evaluate the conditions of patients with lateral epicondylitis.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shamaila Yaqub, masters, Riphah International University
Publications and helpful links
General Publications
- Cheatham SW, Stull KR, Kolber MJ. Roller massage: is the numeric pain rating scale a reliable measurement and can it direct individuals with no experience to a specific roller density? J Can Chiropr Assoc. 2018 Dec;62(3):161-169.
- Sahoo S, Mohanty RK, Mohapatra J, Equebal A, Das SP. Efficacy of extension wrist hand orthosis on pain, grip strength and electromyographic activities in lateral epicondylitis: A randomized single-blind clinical trial. J Hand Ther. 2023 Oct-Dec;36(4):796-804. doi: 10.1016/j.jht.2023.06.006. Epub 2023 Jul 18.
- Kinandana GP, Dewi AANTN, Winaya IMN, Antari NKAJ, Wibawa A, Adhitya IPGS. The Efficacy of Blood Flow Restriction Training for Grip Strength and Disability in Lateral Epicondylitis. Bali Medical Journal. 2023;12(1):410-5.
- Kucuksen S, Yilmaz H, Salli A, Ugurlu H. Muscle energy technique versus corticosteroid injection for management of chronic lateral epicondylitis: randomized controlled trial with 1-year follow-up. Arch Phys Med Rehabil. 2013 Nov;94(11):2068-74. doi: 10.1016/j.apmr.2013.05.022. Epub 2013 Jun 22.
- Bagcaci S, Unuvar BS, Gercek H, Ugurlu I, Sert OA, Yilmaz K. A randomized controlled trial on pain, grip strength, and functionality in lateral elbow pain: Mulligan vs muscle energy techniques. J Back Musculoskelet Rehabil. 2023;36(2):419-427. doi: 10.3233/BMR-220061.
- Nambi G, Alghadier M, Verma A, Aldhafian OR, Alshahrani NN, Saleh AK, Omar MA, Hassan TGT, Ibrahim MNA, El Behairy HF. Clinical and radiological effects of Corticosteroid injection combined with deep transverse friction massage and Mill's manipulation in lateral epicondylalgia-A prospective, randomized, single-blinded, sham controlled trial. PLoS One. 2023 Feb 13;18(2):e0281206. doi: 10.1371/journal.pone.0281206. eCollection 2023.
- Shukla N, Sharma D, Kumar C, Dixit N. A Comparative Analysis of Effectiveness of Mulligan's Mobilisation Versus Cyriax Approach in the Case of Tennis Elbow. Rivista Italiana di Filosofia Analitica Junior. 2023;14(1):333-41.
- Khuman PR, Trivedi P, Devi S, Sathyavani D, Nambi G, Shah K. Myofascial release technique in chronic lateral epicondylitis: a randomized controlled study. Int J Health Sci Res. 2013;3(7):45-52.
- Surangsrirat D, Bualuangngam T, Sri-iesaranusorn P, Chaiyaroj A, Buekban C, Thanawattano C, et al. Comparison of the Wrist Range of Motion Measurement between Inertial Measurement Unit Glove, Smartphone Device and Standard Goniometer. Applied Sciences. 2022;12(7):3418.
- Armstrong AD, MacDermid JC, Chinchalkar S, Stevens RS, King GJ. Reliability of range-of-motion measurement in the elbow and forearm. J Shoulder Elbow Surg. 1998 Nov-Dec;7(6):573-80. doi: 10.1016/s1058-2746(98)90003-9.
- Chapleau J, Canet F, Petit Y, Laflamme GY, Rouleau DM. Validity of goniometric elbow measurements: comparative study with a radiographic method. Clin Orthop Relat Res. 2011 Nov;469(11):3134-40. doi: 10.1007/s11999-011-1986-8. Epub 2011 Jul 21.
- Lee D-R, Kim J-S. Reliability and validity of the Korean version of patient-rated tennis elbow evaluation. Journal of Korean Society of Physical Medicine. 2014;9(1):25-33.
- Kalaskar G, Gurjalwar I, Phansopkar P, Chitale N, Wadhokar OC, Arora SP. Effect of Cyriax physiotherapy and conventional ultrasound on lateral epicondylitis.
- Saraswati PAS, Thanaya SAP, Nugraha MHS. The Effectiveness Of Dry Needling Versus Muscle Energy Technique Combined With Ultrasound Therapy In Reducing Disability Due To Tennis Elbow. Jurnal Keterapian Fisik. 2022:80-7.
- Parmar BA, Shukla YU. Effect of eccentric versus concentric exercise on pain, grip strength and function in lateral epicondylitis-a comparative study. Int J Sci Healthcare Res. 2020;5(2):98-109.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/01788
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lateral Epicondylitis
-
Hospital for Special Surgery, New YorkCompletedLateral Epicondylitis | Lateral Epicondylitis, Unspecified Elbow | Lateral Epicondylitis, Left Elbow | Lateral Epicondylitis, Right Elbow | Lateral Epicondylitis (Tennis Elbow) Bilateral | Medial Epicondylitis | Medial Epicondylitis, Right Elbow | Medial Epicondylitis, Left ElbowUnited States
-
Centre Mutualiste de Rééducation et de Réadaptation...RecruitingLateral Epicondylitis of the ElbowFrance
-
Haseki Training and Research HospitalCompletedLateral Epicondylitis (Tennis Elbow)Turkey
-
Gaziler Physical Medicine and Rehabilitation Education...CompletedLateral Epicondylitis | Lateral Epicondylitis (Tennis Elbow)Turkey (Türkiye)
-
Cairo UniversityRecruitingLateral Epicondylitis | Tennis Elbow | Lateral Epicondylitis, Unspecified ElbowLebanon
-
Singapore General HospitalNot yet recruitingLateral Epicondylitis, Unspecified Elbow
-
McMaster UniversityArthrex, Inc.; The Physicians' Services Incorporated Foundation; Radiological...TerminatedLateral Epicondylitis (Tennis Elbow)Canada, United States
-
Konya Beyhekim Training and Research HospitalRecruitingLateral Epicondylitis (Tennis Elbow)Turkey
-
Siddharth Padia, MDRecruiting
-
University of CadizNot yet recruitingElbow Tendinopathy | Epicondylitis | Epicondylitis, Lateral | Epicondylitis of the Elbow
Clinical Trials on Mill's Manipulation and Muscle Energy Technique
-
University of LahoreCompletedSacroiliac Joint DysfunctionPakistan
-
Universidad Católica San Antonio de MurciaUnknownSacroiliac DisorderSpain
-
Riphah International UniversityCompletedMills Manipulation and Mulligan PRP Affect Pain, Grip Strength and Function on Lateral EpicondylitisLateral EpicondylitisPakistan
-
Federal University of Health Science of Porto AlegreUnknown
-
Riphah International UniversityRecruitingUpper Cross SyndromePakistan
-
Riphah International UniversityCompleted
-
Foundation University IslamabadRecruiting
-
Lahore University of Biological and Applied SciencesLahore UBASNot yet recruitingAxillary Web Syndrome | Post-mastectomy
-
Riphah International UniversityNot yet recruitingLateral EpicondylitisPakistan
-
Maharishi Markendeswar University (Deemed to be...Completed