search
Back to results

Comparative Effects of Myofascial Arm Pull and Post Isometric Relaxation Techniques in Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial arm pull technique
post isometric relaxation technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive Capsulitis, Pain, Shoulder, Joint Range of Motion

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Unilateral frozen shoulder male and female Age between 40 and 60 grade 2 frozen shoulder with pain lasting more than three month; capsular pattern of shoulder( External rotation, Abduction, Internal rotation) Exclusion Criteria: Acute inflammation Subjects with systemic disease Dislocation and fracture in and around the shoulder, Rheumatoid arthritis History of Subjects with diabetes mellitus, osteoporosis or malignancies in shoulder region Past surgery around shoulder

Sites / Locations

  • Hafeez clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Myofascial arm pull technique

Post Isomeric relaxation technique

Arm Description

subjects in this group will be treated with myofascial arm pull technique

subjects in this group will be treated with post isometric relaxation technique

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
An NPRS is described as an 11-point scale with scores from 0 to 10 and anchors of 0 = no pain and 10 = worst possible pain Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in cervical spine. The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
SPADI(shoulder pain and disability index)
The questionnaire consists of 13 items grouped into pain and disability subscales, the questions starting with "How severe is your pain." and "How much difficulty do you have.", respectively. Items mainly deal with various activities of daily living (ADL) that may or may not be problematic to the patient. Items are rated on visual analogue scales to produce a score for each subscale, and the means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst)

Secondary Outcome Measures

Universal Goniometer
The universal mechanical goniometer (Plastic Goniometer-360 Degree Head - 12 inch arms) is a high-resolution plastic goniometer that permits observation of the axis of motion and ROM of the joint being measured The goniometer generally consists of a stationary arm, movable arm and a fulcrum. The circular or semi-circular portion is the centerpiece, which is the body of goniometer with a protractor printed on its face and the fulcrum of movable arm at its center. Generally, the fulcrum of the goniometer is placed over the center of a joint during measurement.

Full Information

First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05915689
Brief Title
Comparative Effects of Myofascial Arm Pull and Post Isometric Relaxation Techniques in Adhesive Capsulitis
Official Title
Comparative Effects of Myofascial Arm Pull and Post Isometric Relaxation Techniques on Pain, Range of Motion and Functional Disability in Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

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
No

5. Study Description

Brief Summary
Adhesive capsulitis is defined as a condition characterized by pain and stiffness in shoulder which results in both active and passive movement loss. The purpose of this study is to investigate the effects of shoulder directed treatment approach using Myofascial arm pull technique on the pain, range of motion and quality of life in patients with adhesive capsulitis and compare its effectiveness with Post Isometric Relaxation technique.
Detailed Description
Frozen shoulder is a common debilitating disorder characterized by shoulder pain and progressive loss of shoulder movement. Frozen shoulder is frequently associated with other systemic conditions or occurs following periods of immobilization, and has a protracted clinical course, which can be frustrating for patients as well as health-care professionals .Loyd define secondary frozen shoulder as a condition resulting from painful spasm on shoulder which causes activity limitation and dependency on opposite arm. In general population, the prevalence rate of frozen shoulder is around 2% to 5% and it ranges from 11% to 30% in diabetic population. Women are affected more than male and approx. 70% cases of frozen shoulder are on female. Among all frozen shoulder cases; around 20% to 30% patients develop frozen shoulder on opposite shoulder. Most of the frozen shoulder cases develop on non dominant shoulder. Adhesive Capsulitis of Shoulder is seen commonly at age of 40-65 years. Traditionally, FS has been regarded as a self-limiting and benign disease with complete recovery of pain and ROM. However, this condition can sometimes last for years. In one study, 50% of patients were still experiencing pain or stiffness of the shoulder at a mean of 7 years from the onset of the condition, although only 11% reported functional limitation. Different Physical therapy interventions used in patients with frozen shoulder frequently include modalities, manual techniques, and therapeutic exercise. Exercises given in the treatment of adhesive capsulitis consists of active ROM, Codman's exercise, wall walks, shoulder wheel, pulley, active and passive stretching, and rotator cuff and scapular strengthening exercises, METs, Gong mobilization, Mulligan mobilization. Many strategies have been employed in clinical practice to improve range and strength in prior research. There are limited studies regarding comparisons between the effects of myofascial arm pull and post isometric relaxation techniques that give the evidence of improving end painful ranges of adhesive capsulitis for long term effect. This study will be conducted to check the positive effect of myofascial arm pull technique and post isometric relaxation to increase end range in adhesive capsulitis. The literature review was conducted using different databases and the eleven selected articles fulfilled the criteria and included in research. Conclusion: Addition of Myofascial release technique and post isometric relaxation technique both as an adjunct to conventional treatment will have better benefits and faster recovery in patients with frozen shoulder but there are limited studies about the comparison of myofascial arm pull and post isometric relaxation techniques on pain, range of motion and quality of life in adhesive capsulitis. I will conduct this study to determine which technique is better to gain painful end ranges in adhesive capsulitis. So that this study will provide different treatment strategies for frozen shoulder to improve end painful ranges.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive Capsulitis, Pain, Shoulder, Joint Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myofascial arm pull technique
Arm Type
Experimental
Arm Description
subjects in this group will be treated with myofascial arm pull technique
Arm Title
Post Isomeric relaxation technique
Arm Type
Experimental
Arm Description
subjects in this group will be treated with post isometric relaxation technique
Intervention Type
Other
Intervention Name(s)
Myofascial arm pull technique
Intervention Description
patient in supine position move the arm passively in abduction to the restricted barrier and pull the arm only enough traction was used to counterbalance the weight of the patient's arm. Stretch was hold until the fibers were released, and then, stretch was given again by increasing traction. This sequence was repeated until an end feel was reached. same procedure for flexion and scapular protraction and Horizontal-adduction. Repetition will be 4-5 reps. per set, 3 times per week for 18 sessions.
Intervention Type
Other
Intervention Name(s)
post isometric relaxation technique
Intervention Description
The therapist stood in front of the patient, then placed one hand over the top of the subject's involved shoulder. The therapist cups the gleno humeral joint to palpate for motion and the subjects are directed to press the elbow towards therapist hand for shoulder abduction, internal rotation and external rotation. Muscle energy technique was applied for five repetitions per set, five sets per session, one session per day, three days a week for six weeks with each repetition maintained for the duration of 7-10 second
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
An NPRS is described as an 11-point scale with scores from 0 to 10 and anchors of 0 = no pain and 10 = worst possible pain Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in cervical spine. The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
Time Frame
6 weeks
Title
SPADI(shoulder pain and disability index)
Description
The questionnaire consists of 13 items grouped into pain and disability subscales, the questions starting with "How severe is your pain." and "How much difficulty do you have.", respectively. Items mainly deal with various activities of daily living (ADL) that may or may not be problematic to the patient. Items are rated on visual analogue scales to produce a score for each subscale, and the means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Universal Goniometer
Description
The universal mechanical goniometer (Plastic Goniometer-360 Degree Head - 12 inch arms) is a high-resolution plastic goniometer that permits observation of the axis of motion and ROM of the joint being measured The goniometer generally consists of a stationary arm, movable arm and a fulcrum. The circular or semi-circular portion is the centerpiece, which is the body of goniometer with a protractor printed on its face and the fulcrum of movable arm at its center. Generally, the fulcrum of the goniometer is placed over the center of a joint during measurement.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Unilateral frozen shoulder male and female Age between 40 and 60 grade 2 frozen shoulder with pain lasting more than three month; capsular pattern of shoulder( External rotation, Abduction, Internal rotation) Exclusion Criteria: Acute inflammation Subjects with systemic disease Dislocation and fracture in and around the shoulder, Rheumatoid arthritis History of Subjects with diabetes mellitus, osteoporosis or malignancies in shoulder region Past surgery around shoulder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sana Hafeez, PhD*
Phone
03234195603
Email
Sana.hafeez@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Huma Shakeel, MS-OMPT*
Phone
03190428242
Email
humashakeel09@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sana Hafeez, PhD*
Organizational Affiliation
Riphah International University Lahore Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hafeez clinic
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
51310
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huma Shakeel, MS-OMPT
First Name & Middle Initial & Last Name & Degree
Sana hafeez, Phd*

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparative Effects of Myofascial Arm Pull and Post Isometric Relaxation Techniques in Adhesive Capsulitis

We'll reach out to this number within 24 hrs