NCT05566418

Brief Summary

This study will help to determine the immediate and long term effects of Mulligan mobilization with and without myofascial release on pain, grip strength and function in patients with lateral epicondylitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

September 28, 2022

Last Update Submit

October 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • change from baseline in pain at week 4th

    Numeric pain rating scale will be used to assess the pain level. A score of 0 means there is no pain, while a score of 10 means the worst pain

    baseline and 4th week

Other Outcomes (2)

  • change from baseline in grip strength at week 4th

    baseline and 4th week

  • change from baseline in functional ability at week 4th

    baseline and 4th week

Study Arms (2)

Group A

NO INTERVENTION

Group A will get standard therapy and the Mulligan mobilization technique for 12 sessions. A Mulligan mobilization belt will be wrapped around the subject's proximal forearm, close to the elbow joint line, and then wrapped around the therapist's shoulder. This will be done with the therapist's other hand on the distal humerus. The belt will give the subject's forearm a 10-to 15-second lateral glide. The patient will be instructed to constantly extend their wrists while the therapist applies manual resistance to their attempts, and the therapist will continue to work on the patient. When the user can fully extend their wrist without discomfort, the lateral glide will be abolished. Three repeats will be performed, each separated by a fifteen-to twenty-second interval.

Group B

EXPERIMENTAL

In addition to the standard treatment, Group B participants will receive 12 sessions of myofascial release technique and Mulligan mobilization. Participants will be instructed to lie supine on the plinth with the afflicted arm internally rotated, elbow slightly flexed and pronated, and palm of hand on the plinth. While standing on the side of the body affected by the ailment being treated, the therapist turned their body to face the affected hand. Myofascial release will be performed on the patient The therapeutic session will last five minutes and will be repeated twice.

Other: mulligan mobilizationOther: myofascial release

Interventions

Mulligan mobilization belt will be wrapped around the subject's proximal forearm, close to the elbow joint line, and then wrapped around the therapist's shoulder. This will be done with the therapist's other hand on the distal humerus. The belt will give the subject's forearm a 10-to 15-second lateral glide.

Also known as: transcutaneous electric nerve stimulation,Cryo-therapy, Ultrasonic therapy, strengthening exercises
Group B

Myofascial release will be performed on the patient, commencing at the common extensor origin and progressing all the way to the extensor retinaculum in the wrist. The periosteum will be engaged with the fingertips, with contact progressing inferiorly to the common extensor tendon and then to the wrist's extensor retinaculum

Group B

Eligibility Criteria

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

You may qualify if:

  • Age group 20 years to 40 years ,both males and females
  • Diagnosed cases of lateral epicondylitis by senior physiotherapist
  • Acute and sub-acute cases
  • Numeric Pain Rating Scale 4 and above
  • Positive cozen test, Mills test, middle finger extension test

You may not qualify if:

  • H/o
  • Active medications.
  • Dermatitis, malignancy or hazardous to myofascial release.
  • Recent trauma, fracture
  • Prior surgeries of elbow, tendon ruptures
  • Any Neurological conditions like nerve compression
  • Swelling around the elbow joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sumra Riaz

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Ultrasonic TherapyMyofascial Release Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeuticsMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sumra Riaz, MS-PTM

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study will be single blinded. Patients will be assessed by a senior Physiotherapist then divided into two groups for treatments. The assessor will be unaware of the treatment given to both groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel designed randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 4, 2022

Study Start

October 13, 2021

Primary Completion

August 16, 2022

Study Completion

September 16, 2022

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations