NCT05358054

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

April 28, 2022

Last Update Submit

April 28, 2022

Conditions

Keywords

Mobilization with movement, PRE, PRTEE, VAS, HD.

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.The VAS is pain numeric scale to find out pain intensity and pain level perceived by patients. The VAS is a subjective type pain scale measured the acute and chronic level pain. Score are marked between no pain and worst pain ( zero to 10)

    1st Day

  • Patients Related Tennis Elbow Evaluation

    Measurements the patient functional status its 15 questionnaires In PRTEE First subscale is The Pain Subscale detail is 5 items Maximum or best score is 0 and worst score is 50 The Second Subscale or PRTEE is The Specific Activities detail is 6 items with finest score is 0 and least score is 60 The third one subscale of PRTEE the Usual Activities sub part 4 items with superior score is 0 and least score is 40. Third Fourth Part of PRTEE is The Function Subscale detail is performance bases specific activities and usual or regular activities Add up to specific or regular activities divided by 2 Maximum best score or prime score is 0 and least score is 50 Total detail Score of PRTEE is = Pain Subscale + Function Subscale Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score)

    1st Day

  • Hand Dynamometer Maximum Grip Strength

    A dynamometer with high accuracy and sensitivity has recently been developed to assess grip strength. It provides maximal isometric grip strength measured.Many sports activities hand dynamometer is used to find out athlete performance around hand and forearm muscle strength. Sports, like baseball and tennis, where the hand is utilized for tossing or lifting make use of dynamometers to test hand strength

    1st day

Study Arms (2)

GROUP A

EXPERIMENTAL

GROUP A

Other: Mobilization with movement lateral Glides and Conventional PhysiotherapyOther: Progressive Resistance Exercises and Conventional Physiotherapy

GROUP B

EXPERIMENTAL

GROUP B

Other: Mobilization with movement lateral Glides and Conventional PhysiotherapyOther: Progressive Resistance Exercises and Conventional Physiotherapy

Interventions

(The Mobilization with movement technique is(lateral glide) applied to the patient by a physiotherapist to patients at supine level position. First we identify pain free region each patients. The lateral humerus above the condyle of elbow joint are fixed by therapist. Then therapist ask to patients perform the active movement ten times. The same procedure repeats number of 3 sets, 10 number of repetition. The rest of interval fifteen to twenty seconds with in the sets Grip strength (pain Free Strength ) was evaluated in kilogram using a dynamometer. The measurements using dynamometer patients posture is erect sit position , the elbow at 90 degree flexion , shoulder would be abducted , rest of joint forearm and wrist in neutral during measurements. conventional therapy list of conventional physiotherapy are therapeutic ultrasound , deep transverse friction massage and stretching

GROUP AGROUP B

4 STEPS Progressive resistive EXERCISES have a 4 step to application Step 1 Clenching fist strongly, resisted wrist Flexion, Extension, wrist rotation with a stick) Step 2 The therapeutic band exercised performed at wrist Flexion(WF), Wrist Extension(WE), Wrist Ulnar Deviation(WED) , and Wrist Radial Deviation(WRD).Step 3 Patient asked to perform combined wrist rotatory movements using e.g. table top as a support. Step 4 Soft ball compressing exercises, Transferring buttons from cup into another, Twisting a towel into the roll, Hand Rotating both directions at table AND CONVENTIONAL PHYSIOTHERAPY and list of conventional physiotherapy are therapeutic ultrasound , deep transverse friction massage and stretching

GROUP AGROUP B

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bone and joints centre

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (31)

  • 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.

    PMID: 30255288BACKGROUND
  • 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.

    PMID: 19801110BACKGROUND
  • 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.

    PMID: 26381484BACKGROUND
  • 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.

    PMID: 29398988BACKGROUND
  • 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.

    PMID: 31104005BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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. .

    BACKGROUND
  • 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.

    PMID: 29706713BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29705077BACKGROUND
  • MacDermid JC. The Patient-Rated Tennis Elbow Evaluation (PRTEE) User Manual. Hamilton, Canada: School of Rehabilitation Science, McMaster University. 2007

    BACKGROUND
  • Cassar M-P. Handbook of clinical massage: Churchill Livingstone; 2004.

    BACKGROUND
  • 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.

    PMID: 27294996BACKGROUND
  • 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.

    PMID: 19707766BACKGROUND
  • 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.

    PMID: 29794282BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 19188560BACKGROUND
  • 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.

    PMID: 23997125BACKGROUND
  • 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.

    PMID: 29901918BACKGROUND
  • 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.

    BACKGROUND
  • )-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.

    BACKGROUND
  • 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.

    PMID: 28828509BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 11527456BACKGROUND
  • 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.

    PMID: 16235324BACKGROUND
  • Khan MK. Effectiveness of Autologous Blood Injection in Patients with Lateral Epicondylitis (Tennis Elbow). Ophthalmology. 2014;12(2):159.

    BACKGROUND
  • 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.

    PMID: 11869609BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Lal Gul Khan, MScPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 3, 2022

Study Start

June 30, 2020

Primary Completion

January 20, 2021

Study Completion

February 26, 2021

Last Updated

May 3, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations