Clinical trial NCT05358054: Mobilization With Movement and Progressive Strengthening Exercises in Lateral Epicondylitis
Official title: Comparison of Mulligan Mobilization With Movement and Progressive Strengthening Exercises in Patients With Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Mobilization with movement, PRE, PRTEE, VAS, HD.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the mobilization with movement and progressive strengthening exercises in individuals with lateral epicondylitis on VAS, PRTEE and Hand Grip strength . A randomized clinical trial was conducted at Bone and Joint center and Khyaban medical center, Rawalpindi. The sample size was 40 calculated through open-epi tool . The participants were divided into two groups each having 20 participants. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using enveloped sealed. Only 20 to 60 years participants with chronic lateral epicondylitis included in that study . Tools used in this study are SELF STRUCTURE QUESTIONNAIRE, VAS visual analogue scale range is 0 TO 10 O is no pain 10 is unbearable pain , PRTEE patient ratted tennis elbow evaluation 15 questionnaire form 3 sub-scale total 100 scores 0 is best 100 is worst, hand held Dynamo-meter , Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 21.

Detailed description: Epicondylitis is common in persons who frequently overuse the upper arm, particularly with activities that involve rotation of the arm with flexion and extension.

Anyone who performs repetitive movements involving extension of the wrist or hand for at least two hours a day, which can include anyone sitting at a computer and using a mouse. Professional who are commonly effected are Tennis Players, Squash Players, Badminton Players ,Painters, Plumbers, Computer user and Musician.

Lateral Epicondylitis affect the extensor muscle around elbow also common for extensor type pathology.

Evidence suggests that Prevalence of Tennis elbow generally affects about 1 to 3 % general population from 35 to 50 years .

Lateral epicondylitis of young age around 20 years is usually due to overused sustained pressure during laptop working and it mainly effect the dominant hand usually right hand.

The condition tends to affect men and women equally. The annual incidence is one to three percent in the United States. Despite the condition being commonly referred to as tennis elbow, tennis players make up only 10% of the patient population. Half of the tennis players develop pain around the elbow, of which 75% represent true tennis elbow.

Diagnosis of Lateral Epicondylitis is based on the palpation around lateral elbow region , found local tenderness around lateral epicondyle region and Cozen test , Mill,s test.

Literature review: A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines and the key words used were Lateral Epicondylitis , Tennis Elbow, PRE, Strengthening exercises ,VAS, exercises programme for tennis elbow, .The purpose of the literature review is to find out the pre-existing literature regarding the mobilization with movement and PRE interventions for Lateral Epicondylitis .

In 2020, The Effects of Mulligan's Mobilization with movement technique in patients with lateral epicondylitis. MWM is secure and shows efficacy in terms of outcomes at elbow pain (VAS) , Functional Capacity( FC) PRTEE, and Pain less maximized grip strength, these all parameters showed significant improvement.

An experimental study was conducted in 2017 Effects of progressive strengthening exercises in chronic lateral epicondylitis. The group receiving PRE showed significant improvement in study variables (VAS, PRTEE, Grip Strength). The group which performed PRE and conventional physiotherapy showed greater improvement than alone conventional treatment for lateral epicondylitis .

RCT was conducted in 2016 MWM compared to supervised exercises in patients with lateral epicondylitis. This study showed that the group with mulligan technique's showed effectiveness in term of reduction of pain and improved Grip Hand Strength (GHS) as compared with supervised exercise program group.

An Intervention Comparative study was conducted in 2013 Effectiveness of MWM compared with manipulation of wrist in lateral epicondylitis . The variables were pain , Functional disability recorded by VAS, PRTEE, and Hand Dynamo-meter .This study showed that mulligan mobilization plus conventional treatment was much more effective in treatment of tennis elbow .

RCT was conducted in 2012 MWM as adjunct to conventional physiotherapy in treatment of chronic lateral epicondylitis stated that Mobilization with movement group showed significant improvement in pain reduction at VAS and improved Pain Free Grip Strength .

Eligibility criteria: Inclusion Criteria:

* During Palpation found local tenderness over lateral side of epicondyle.
* Diagnosed clinically minimum 3 month duration from orthopedic doctors/ department.
* Positive Mills test or Cozen test.

Exclusion Criteria:

* Traumatic injury
* Any Positive history of ligament or tendon tear grade 3
* Any kind of surgery around elbow past two months
* Any History of systemic diseases
* Any kind of neurological conditions like stroke, MS, CVA.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1st Day
measure: Patients Related Tennis Elbow Evaluation
timeFrame: 1st Day
measure: Hand Dynamometer Maximum Grip Strength
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Bone and joints centre
state: Punjab
Study officials:
affiliation: Riphah International University
name: Lal Gul Khan, MScPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwapisz A, Prabhakar S, Compagnoni R, Sibilska A, Randelli P. Platelet-Rich Plasma for Elbow Pathologies: a Descriptive Review of Current Literature. Curr Rev Musculoskelet Med. 2018 Dec;11(4):598-606. doi: 10.1007/s12178-018-9520-1.
citation: Greenberg JA. Endobutton repair of distal biceps tendon ruptures. J Hand Surg Am. 2009 Oct;34(8):1541-8. doi: 10.1016/j.jhsa.2009.05.021.
citation: Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.
citation: Degen RM, Conti MS, Camp CL, Altchek DW, Dines JS, Werner BC. Epidemiology and Disease Burden of Lateral Epicondylitis in the USA: Analysis of 85,318 Patients. HSS J. 2018 Feb;14(1):9-14. doi: 10.1007/s11420-017-9559-3. Epub 2017 Jun 5.
citation: Reyhan AC, Sindel D, Dereli EE. The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2020;33(1):99-107. doi: 10.3233/BMR-181135.
citation: Upadhyay S, Shukla Y, Patel KK. Effects of progressive strengthening exercises in chronic lateral epicondylitis. Int J Health Sci Res. 2017;7(4):244-57.
citation: Rahman H, Chaturvedi PA, Apparao P, Srithulasi PR. Effectiveness of mulligan mobilisation with movement compared to supervised exercise program in subjects with lateral epicondylitis. Int J Physiotherapy Res. 2016;4(2):1394-400.
citation: Patel N. Effectiveness of mobilization with movement of elbow compared with manipulation of wrist in patients of lateral epicondylitis. Int J Physiother Res. 2013;1(4):177-82.
citation: Anap D, Shende M, Khatri S. Mobilization with movement technique as an adjunct to conventional physiotherapy in treatment of chronic lateral epicondylits-a comparative study. J Nov Physiother. 2012;2(121):2. .
citation: Lee JH, Kim TH, Lim KB. Effects of eccentric control exercise for wrist extensor and shoulder stabilization exercise on the pain and functions of tennis elbow. J Phys Ther Sci. 2018 Apr;30(4):590-594. doi: 10.1589/jpts.30.590. Epub 2018 Apr 20.
citation: Kim LJ, Choi H, Moon D. Improvement of pain and functional activities in patients with lateral epicondylitis of the elbow by mobilization with movement: a randomized, placebo-controlled pilot study. Journal of Physical Therapy Science. 2012;24(9):787-90.
citation: Basak T, Pal TK, Saha MB, Agarwal S, Das T. Comparative Efficacy of Wrist Manipulation, Progressive Exercises and Both Treatments in Patients with Tennis Elbow. International Journal of Health Sciences and Research. 2018;8(4):87-94.
citation: Soonsuwan W, Rangkla S. Comparison between effects of radial extracorporeal shock wave therapy and progressive resistive exercise in treatments of chronic lateral elbow tendinosis. Chulalongkorn Medical Journal. 2017;61(2):193-204.
citation: Lucado AM, Dale RB, Vincent J, Day JM. Do joint mobilizations assist in the recovery of lateral elbow tendinopathy? A systematic review and meta-analysis. J Hand Ther. 2019 Apr-Jun;32(2):262-276.e1. doi: 10.1016/j.jht.2018.01.010. Epub 2018 Apr 26.
citation: MacDermid JC. The Patient-Rated Tennis Elbow Evaluation (PRTEE) User Manual. Hamilton, Canada: School of Rehabilitation Science, McMaster University. 2007
citation: Cassar M-P. Handbook of clinical massage: Churchill Livingstone; 2004.
citation: Cadenas-Sanchez C, Sanchez-Delgado G, Martinez-Tellez B, Mora-Gonzalez J, Lof M, Espana-Romero V, Ruiz JR, Ortega FB. Reliability and Validity of Different Models of TKK Hand Dynamometers. Am J Occup Ther. 2016 Jul-Aug;70(4):7004300010. doi: 10.5014/ajot.2016.019117.
citation: Altan L, Ercan I, Konur S. Reliability and validity of Turkish version of the patient rated tennis elbow evaluation. Rheumatol Int. 2010 Jun;30(8):1049-54. doi: 10.1007/s00296-009-1101-6. Epub 2009 Aug 26.
citation: Thong ISK, Jensen MP, Miro J, Tan G. The validity of pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand J Pain. 2018 Jan 26;18(1):99-107. doi: 10.1515/sjpain-2018-0012.
citation: Amro A, Diener I, Isra'M H, Shalabi AI, Dua'I I. The effects of Mulligan mobilisation with movement and taping techniques on pain, grip strength, and function in patients with lateral epicondylitis. Hong Kong Physiotherapy Journal. 2010;28(1):19-23
citation: Rees JD, Maffulli N, Cook J. Management of tendinopathy. Am J Sports Med. 2009 Sep;37(9):1855-67. doi: 10.1177/0363546508324283. Epub 2009 Feb 2.
citation: Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.
citation: Kongmalai P, Chanlalit C. Demographic Causes of Chronic Lateral Elbow Pain along Arthroscopic Criteria. J Med Assoc Thai. 2016 Nov;99 Suppl 8:S79-S83.
citation: Fekri L, Rezvani A, Karimi N, Ezzati K. The Effect of Low-Power and High-Power Laser Therapy on Pain, Tenderness and Grip Force of the Patients with Tennis Elbow. Pharma-cophores. 2019;10(3):89-95.
citation: )-Padasala M, Sharmila B, Bhatt H, D'Onofrio R. Comparison of efficacy of the eccentric concentric training of wrist extensors with static stretching versus eccentric concentric training with supinator strengthening in patients with tennis elbow: A randomized clinical trial.
citation: Uygur E, Aktas B, Ozkut A, Erinc S, Yilmazoglu EG. Dry needling in lateral epicondylitis: a prospective controlled study. Int Orthop. 2017 Nov;41(11):2321-2325. doi: 10.1007/s00264-017-3604-1. Epub 2017 Aug 21.
citation: Shaheen H, Alarab A, Ahmad MS. Effectiveness of therapeutic ultrasound and kinesio tape in treatment of tennis elbow. J Nov Physiother Rehabil. 2019;3:25-33.
citation: Abbott JH, Patla CE, Jensen RH. The initial effects of an elbow mobilization with movement technique on grip strength in subjects with lateral epicondylalgia. Man Ther. 2001 Aug;6(3):163-9. doi: 10.1054/math.2001.0408.
citation: Buchbinder R, Green SE, Youd JM, Assendelft WJ, Barnsley L, Smidt N. Shock wave therapy for lateral elbow pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003524. doi: 10.1002/14651858.CD003524.pub2.
citation: Khan MK. Effectiveness of Autologous Blood Injection in Patients with Lateral Epicondylitis (Tennis Elbow). Ophthalmology. 2014;12(2):159.
citation: Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.