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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05070559
Other study ID # Iqra Shabbir
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date February 16, 2022

Study information

Verified date April 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Lateral epicondylitis is an injury caused by overusing the elbow. It is characterized by tenderness and pain over the lateral epicondyle of the elbow. It is not exactly a condition involving inflammation rather a chronic degeneration of the tendon. The major symptom of lateral epicondylitis is presentation or complaint of sharp pain at the lateral side of the elbow with swelling


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 16, 2022
Est. primary completion date February 16, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 40 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Acute/ sub-acute lateral epicondylitis - Any cervical spine or any other upper limb dysfunction - Any other neurological disease, cardiovascular disease, osteoporosis - Bilateral complaints

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active Release Technique
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)
Graston 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)

Locations

Country Name City State
Pakistan Rawal General Hospital Rawalpindi Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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