NCT05039827

Brief Summary

Lateral epicondylitis or tennis elbow is one of the most common lesions of the arm. This injury is a major challenge, as it is difficult to treat, prone to recurrence and may last for several weeks or months, with an average duration of a typical episode which has been reported to be between six months to two years. This is an RCT study. Subjects who fulfilled inclusion criteria will be taken for the study. Before conducting the actual method for subjects, lateral epicondylitis evaluation is done. First day before treatment, pain evaluation were done by using Numeric Pain Rating Scale. Muscle power was assessed by MMT (Manual Muscle Testing) and the function level are tested by Patient-Related Tennis Elbow Evaluation (PRTEE) questionnaire and asked to mark the results. Subjects will be divided into 2 groups randomly by lottery method. Each group consists of 15 patients. Group A will be given MWM; Group B will be given soft tissue mobilization. Both groups will be given with the above said methods for alternative days in a week as per 3 sessions per week for 4 weeks. At the end of program subjects will be reassessed by recording muscle strength, pain intensity and functional level. Finally pre and post recordings will be compared and analyzed statistically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

October 14, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

September 1, 2021

Last Update Submit

September 1, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

    4 Week

  • Grip Strength

    Manual muscle testing as used to test grip strength. It involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly\[1\]: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance

    4 week

  • Functional activity

    Patient Related Tennis Elbow Evaluation (PRTEE) was used.The PrTEEQ is a 15-item questionnaire, it's designed to measure forearm pain and disability in patients with lateral epicondylitis. The patients have to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales. There is the pain subscale (0 = no pain, 10 = worst imaginable) en the function subscale (0 = no difficulty, 10 = unable to do)

    4 weeks

Study Arms (2)

MWM GROUP

EXPERIMENTAL

Mobilization with movement with wrist extension

Other: Mobilization with movement

SOFT TISSUE MOBILIZATION GROUP

ACTIVE COMPARATOR

Parallel and perpendicular soft tissue massage at common extensor origin

Other: Soft Tissue Mobilization

Interventions

Heating fermentation was done for 10 minutes as baseline treatment. MWM with wrist extension was given for alternative days in a week as per 3 sessions per week for 4 weeks.

MWM GROUP

Heating fermentation was done for 10 minutes as baseline treatment. Parallel and longitudinal massage was given for alternative days in a week as per 3 sessions per week for 4 weeks

SOFT TISSUE MOBILIZATION GROUP

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Tennis players.
  • Age group between 15-30 years.
  • Positive specific tests.(cozen and mills test)
  • Subjects having lateral epicondylitis pain for at least 4 weeks, muscle power for wrist muscle should be increase with activity against resistance, average pain level of 3-cm or more on a 10-cm Numerical pain rating scale

You may not qualify if:

  • Any neurological disorder.
  • Other elbow deformity or joint pathology. fracture of upper limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hidayat Gillani Orthopedic Complex Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

Location

Related Publications (5)

  • Bisset L, Paungmali A, Vicenzino B, Beller E. A systematic review and meta-analysis of clinical trials on physical interventions for lateral epicondylalgia. Br J Sports Med. 2005 Jul;39(7):411-22; discussion 411-22. doi: 10.1136/bjsm.2004.016170.

    PMID: 15976161BACKGROUND
  • Castillo-Lozano R, Casuso-Holgado MJ. Incidence of musculoskeletal sport injuries in a sample of male and female recreational paddle-tennis players. J Sports Med Phys Fitness. 2017 Jun;57(6):816-821. doi: 10.23736/S0022-4707.16.06240-X. Epub 2016 Feb 12.

    PMID: 26954572BACKGROUND
  • 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
  • Ahmed A, Ibrar M, Arsh A, Wali S, Hayat S, Abass S. Comparing the effectiveness of Mulligan mobilization versus Cyriax approach in the management of patients with subacute lateral epicondylitis. J Pak Med Assoc. 2021 Jan;71(1(A)):12-15. doi: 10.47391/JPMA.186.

    PMID: 33484510BACKGROUND
  • Coombes BK, Connelly L, Bisset L, Vicenzino B. Economic evaluation favours physiotherapy but not corticosteroid injection as a first-line intervention for chronic lateral epicondylalgia: evidence from a randomised clinical trial. Br J Sports Med. 2016 Nov;50(22):1400-1405. doi: 10.1136/bjsports-2015-094729. Epub 2015 Jun 2.

    PMID: 26036675BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Movement

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sidra Shafique, tDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 10, 2021

Study Start

October 14, 2020

Primary Completion

June 30, 2021

Study Completion

July 15, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations