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NCT Number: NCT05698108

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sikander Medical Complex

Guiranwala, Pujab, 52250, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Instrument Assisted Soft Tissue Mobilization (IASTM)

Device

Tools designed for soft tissue mobilization

Other names: Ergon Tools

Conventional physical therapy

Other

Moist Hot pack, Ultrasound, Deep Friction Massage, Stretching and Strengthening Exercises.

Other names: Traditional Physical Therapy

Primary outcomes

  1. 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

  2. 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.

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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