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

Primary Purpose

Lateral Epicondylitis, Tennis Elbow

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Instrument Assisted Soft Tissue Mobilization (IASTM)
Conventional Physical Therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring IASTM, Lateral Epicondylitis, tennis elbow, pain, grip strength, functional activity

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sikander Medical Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Physcial Therapy Group

IASTM Group

Arm Description

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

Participants received Instrument Assisted Soft Tissue Mobilization Treatment 2 times a week for 4 weeks using Ergon IASTM tools.

Outcomes

Primary Outcome Measures

Pain (mild to severe)
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
Grip Strength
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.
Functional Activity
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)

Secondary Outcome Measures

Full Information

First Posted
November 26, 2022
Last Updated
January 13, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05698108
Brief Title
Effects Of Instrument Assisted Soft Tissue Mobilization on Pain, Grip Strength and Functional Activity in Patients With Lateral Epicondylitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Tennis Elbow
Keywords
IASTM, Lateral Epicondylitis, tennis elbow, pain, grip strength, functional activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
The study was single-blinded as the assessor was blinded
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physcial Therapy Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
IASTM Group
Arm Type
Experimental
Arm Description
Participants received Instrument Assisted Soft Tissue Mobilization Treatment 2 times a week for 4 weeks using Ergon IASTM tools.
Intervention Type
Device
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization (IASTM)
Other Intervention Name(s)
Ergon Tools
Intervention Description
Tools designed for soft tissue mobilization
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Other Intervention Name(s)
Traditional Physical Therapy
Intervention Description
Moist Hot pack, Ultrasound, Deep Friction Massage, Stretching and Strengthening Exercises.
Primary Outcome Measure Information:
Title
Pain (mild to severe)
Description
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
Time Frame
4 weeks
Title
Grip Strength
Description
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.
Time Frame
4 weeks
Title
Functional Activity
Description
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)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shazal Nazir, DPT
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sikander Medical Complex
City
Gujrānwāla
State/Province
Pujab
ZIP/Postal Code
52250
Country
Pakistan

12. IPD Sharing Statement

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

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