AzTrials
AzTrials

Lateral EpicondylitisNCT05358054

Mobilization With Movement and Progressive Strengthening Exercises in Lateral Epicondylitis

A study testing Mobilization with movement lateral Glides and Conventional Physiotherapy and Progressive Resistance Exercises and Conventional Physiotherapy in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Lateral Epicondylitis
What is being tested?
Mobilization with movement lateral Glides and Conventional Physiotherapy and Progressive Resistance Exercises and Conventional Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
30 Jun 2020to 26 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Bone and joints centre

    Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

Official title: Comparison of Mulligan Mobilization With Movement and Progressive Strengthening Exercises in Patients With Lateral Epicondylitis

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.

Read the 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 .

Being tested
Mobilization with movement lateral Glides and Conventional Physiotherapy, Progressive Resistance Exercises and Conventional Physiotherapy
Keywords
Mobilization with movement, PRE, PRTEE, VAS, HD.
Medical subject headings
Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobilization with movement lateral Glides and Conventional PhysiotherapyOther

    (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

  • Progressive Resistance Exercises and Conventional PhysiotherapyOther

    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

Study groups in NCT05358054
Study groupRoleWhat they receive
GROUP AExperimentalGROUP A
Receives: Other: Mobilization with movement lateral Glides and Conventional Physiotherapy; Other: Progressive Resistance Exercises and Conventional Physiotherapy
GROUP BExperimentalGROUP B
Receives: Other: Mobilization with movement lateral Glides and Conventional Physiotherapy; Other: Progressive Resistance Exercises and Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1st Day

  2. 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)

    Measured: 1st Day

  3. 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

    Measured: 1st day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start30 Jun 2020
  3. Primary completion20 Jan 2021
  4. Study completion26 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
RCT
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05358054
Sponsor's protocol ID
REC/00769 Amman Ullah Nazir
Status last verified
Apr 2022
First submitted
28 Apr 2022
Last updated
3 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30255288
  • 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.

    PubMed 19801110
  • 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.

    PubMed 26381484
  • 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.

    PubMed 29398988
  • 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.

    PubMed 31104005
  • 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.

  • 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.

  • 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.

  • 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. .

  • 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.

    PubMed 29706713
  • 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.

  • 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.

  • 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.

  • 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Mobilization with movement lateral Glides and Conventional Physiotherapy and Progressive Resistance Exercises and Conventional Physiotherapy in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: 1st Day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05358054, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in