Effects Of Instrument Assisted Soft Tissue Mobilization on Pain, Grip Strength and Functional Activity in Patients With Lateral Epicondylitis

January 13, 2023 updated by: University of Lahore

Effects Of Instrument Assisted Soft Tissue Mobilization Using Ergon Technique on Pain, Grip Strength and Functional Activity in Patients With Lateral Epicondylitis: A Randomized Controlled Trial

This study aimed to find the effects of Instrument Assisted Soft Tissue Mobilization (IASTM) using Ergon Tools on pain, grip strength and functional activity among patients diagnosed with Lateral epicondylitis.

The study concluded that IASTM is effective in improving pain, grip strength and functional activity in patients with lateral epicondylitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Lateral Epicondylitis is a type of "repetitive strain injury" that causes pain on the lateral portion of the elbow, especially while gripping and applying resistance to the forearm's extensor muscles, both men and women are equally affected by it. Traditional Physical Therapy has failed to improve the disorders caused by LE, Instrument Assisted Soft Tissue Mobilization is a new approach for its treatment a lot of tools are being used and Ergon Tools are among one of them, very less data is available for its efficacy in lateral epicondylitis patients.

Objective: To compare the effects of Instrument Assisted Soft Tissue Mobilization using Ergon Technique on pain, grip strength and functional activity in patients with lateral epicondylitis.

Methodology: 72 individuals with lateral epicondylitis pre-diagnosed by an orthopedic surgeon, are assessed from Sikander Medical Complex, Gujranwala. After fulfilling the inclusion criteria, the participants are randomly divided into two groups, 36 participants receiving IASTM using Ergon Tools and 36 participants received conventional physical therapy. Both groups receive treatment 2 times a week for 4 weeks. Outcome measures are pain (VAS), grip strength (handheld dynamometer), and functional mobility (PRTEE) collected at the baseline, 1st week, and 4th week.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Pujab
      • Gujrānwāla, Pujab, Pakistan, 52250
        • Sikander Medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both Male and Female Patients
  • Patients between the age group 20-50 years
  • Sub-acute Patients having symptoms for > 6 weeks and < 3 months.
  • Patients who had pain rating from 5 to 9 in VAS will be included
  • Patients with Positive Cozens test, Mill's test

Exclusion Criteria:

  • Patients with any surgical or trauma history of the elbow
  • Rheumatoid Arthritis and Malignancies
  • Cervical Radiculopathy patients who have referred pain in the elbow
  • Loss of Passive ROM in extension
  • Active infections such as, Bursitis, Calcification of the soft tissues, Fragile skin, Hyper Mobility & Joint Effusion
  • Hemophilic Patients
  • Osteoporosis
  • Patients with history of getting treatment with Steroid Injections will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Physcial Therapy Group
All participants received treatment 2 times a week for 4 weeks. Pre-treatment included a Moist hot pack for 10 minutes and traditional physical therapy included Cyriax Deep Friction Massage (DFM), Ultrasound therapy as well as strengthening and stretching exercises
Other: Conventional Physical Therapy
Moist Hot pack, Ultrasound, Deep Friction Massage, Stretching and Strengthening Exercises.
Other Names:
  • Traditional Physical Therapy
Experimental: IASTM Group
Participants received Instrument Assisted Soft Tissue Mobilization Treatment 2 times a week for 4 weeks using Ergon IASTM tools.
Device: Instrument Assisted Soft Tissue Mobilization (IASTM)
Tools designed for soft tissue mobilization
Other Names:
  • Ergon Tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (mild to severe)
Time Frame: 4 weeks
Visual Analogue Scale The score is calculated by measuring the distance (mm) between the "no pain" anchor and the patient's mark on a 10-cm line with a ruler, yielding a range of 0-100. A higher score implies that the pain is more intense and a lower score suggests the intensity of pain to be milder. VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain
4 weeks
Grip Strength
Time Frame: 4 weeks
Digital Hand Held Dynamometer The best result from several trials for each hand is recorded, with at least 15 seconds recovery between each effort. The values listed below (in kg and lbs) give a guide to expected scores for adults. These values are the average of the best scores of each hand. See more Hand Grip Strength Norms. Other protocols will just use the score from the dominant hand, or compare the left and right hand results. See also examples of some actual athlete results.
4 weeks
Functional Activity
Time Frame: 4 weeks
Patient Rated Tennis Elbow Evaluation It consists of pain subscale and functional subscale, total score is calculated by adding Pain Subscale and Function Subscale then calculated as, Best Score= 0 Worst Score = 100 (pain and disability contribute equally to score)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Shazal Nazir, DPT, University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULahore Shazal Nazir

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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