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

Lateral Epicondylitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05698108
• Other study ID #: ULahore Shazal Nazir
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2023
• Source: University of Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 1, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Device:
• Instrument Assisted Soft Tissue Mobilization (IASTM)
Tools designed for soft tissue mobilization

Other:
• Conventional Physical Therapy
Moist Hot pack, Ultrasound, Deep Friction Massage, Stretching and Strengthening Exercises.

Locations

Country	Name	City	State
Pakistan	Sikander Medical Complex	Gujranwala	Pujab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Primary	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.	4 weeks
Primary	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)	4 weeks