NCT05070559

Brief Summary

This study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 36 participants will be taken. Patients will be divided into two groups by sealed envelop method. Patients in group A will receive Active Release Technique along with conventional therapy while Patients in group B will receive instrument assisted soft tissue mobilization along with conventional therapy. The study includes intervention protocol of 4 weeks. The sessions will be given 3 times a week for 4 weeks. The outcome measures Numeric pain rating scale(NPRS), Hand Dynamometer and Patient-Rated Tennis Elbow Evaluation (PRTEE) will be measured at baseline and at the end of 4th week. Data will be analyzed by SPSS 25

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 7, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

September 27, 2021

Last Update Submit

April 15, 2022

Conditions

Keywords

lateral EpicondylitisGraston TechniqueActive Release TechniqueGrip Strength

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale that is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (no pain) to '10' representing the other pain extreme (or "worst pain imaginable"). The intrarater reliability with ICC = 0.67.

    4 Weeks

  • Hand Dynamometer

    hand dynamometer is the most reliable and acceptable tool for measuring grip strength. It detects and quantitatively determines the degree of weak grip strength. (ICC = 0.99)

    4 Weeks

  • Patient-Rated Tennis Elbow Evaluation

    The Patient-Rated Tennis Elbow Evaluation questionnaire is a specific questionnaire available for assessing the functional status of patients with lateral epicondylitis. (ICC = 0.96)

    4 Weeks

Study Arms (2)

Active Release Technique Group

EXPERIMENTAL

Patients in this group will receive Active Release Technique along with conventional therapy

Other: Active Release Technique

Graston Technique Group

EXPERIMENTAL

Patients in this group will receive Instrumental Assisted Soft Tissue Mobilization along with conventional therapy

Other: Graston Technique Group

Interventions

Patients in this group will receive Active Release Technique along with conventional therapy. ART will be given with patient seated, elbow flexed and resting on the treatment table, forearm in midprone \& wrist in neutral position and then the therapist will work on the common extensor tendon by applying pressure to the tendon distal to their attachment at the elbow. The patient will start with the elbow bent and wrist straight. As the therapist hold the muscles, the patient will extend the elbow and pronate and flex the wrist while the therapist move the pressure proximally, attempting to release adhesions around and between muscle planes. Total of 15 repetitions for of 10 minutes. CONVENTIONAL THERAPY: * Hot pack for 15 minutes * TENS for 15 minutes * Ultrasound (pulsed mode, 1MHz at 1.5 W/cm2 for 5 minutes)

Active Release Technique Group

Patients in this group will receive IASTM along with conventional therapy. In graston technique proper application of GT3 which include application of a cream to the common extensor tendon. The GT3will be then used to common extensor tendon. In areas of increased tissue restriction, more required pressure with GT3 is applied using increased force and shorter strokes over the areas of restriction. Ice will be offered as needed for pain management after each session. The study includes interventional protocol of 4 weeks. The sessions will be given 3 times a week for 4 weeks. CONVENTIONAL THERAPY: * Hot pack for 15 minutes * TENS for 15 minutes * Ultrasound (pulsed mode, 1MHz at 1.5 W/cm2 for 5 minutes)

Graston Technique Group

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Chronic lateral epicondylitis, complaints for at least 3 months or more
  • Pain intensity level between 3 to 6 on 0-10 point numerical pain rating scale

You may not qualify if:

  • Acute/ sub-acute lateral epicondylitis
  • Any cervical spine or any other upper limb dysfunction
  • Any other neurological disease, cardiovascular disease, osteoporosis
  • Bilateral complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawal General Hospital Rawalpindi

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Sajjad Ali, Ms-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 27, 2021

First Posted

October 7, 2021

Study Start

November 1, 2021

Primary Completion

February 16, 2022

Study Completion

February 16, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations