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Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Active Release Technique
Graston Technique Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral Epicondylitis, Graston Technique, Active Release Technique, Grip Strength

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rawal General Hospital Rawalpindi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active Release Technique Group

Graston Technique Group

Arm Description

Patients in this group will receive Active Release Technique along with conventional therapy

Patients in this group will receive Instrumental Assisted Soft Tissue Mobilization along with conventional therapy

Outcomes

Primary Outcome Measures

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.
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)
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)

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
April 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05070559
Brief Title
Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis
Official Title
Comparison of Active Release Technique and Graston Technique In Patients With Chronic Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
lateral Epicondylitis, Graston Technique, Active Release Technique, Grip Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Release Technique Group
Arm Type
Experimental
Arm Description
Patients in this group will receive Active Release Technique along with conventional therapy
Arm Title
Graston Technique Group
Arm Type
Experimental
Arm Description
Patients in this group will receive Instrumental Assisted Soft Tissue Mobilization along with conventional therapy
Intervention Type
Other
Intervention Name(s)
Active Release Technique
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Graston Technique Group
Intervention Description
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)
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
4 Weeks
Title
Hand Dynamometer
Description
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)
Time Frame
4 Weeks
Title
Patient-Rated Tennis Elbow Evaluation
Description
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)
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajjad Ali, Ms-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rawal General Hospital Rawalpindi
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Active Release Technique and Graston Technique in Patients With Lateral Epicondylitis

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