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Efficacy Of Muscle Energy Technique On Shoulder Adhesive Capsulitis Post Mastectomy

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
muscle energy technique
conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • • Female patients with age range between 40-60 years.

    • Shoulder ROM restriction.
    • Shoulder pain more than 3 months.
    • Patients with adhesive capsulitis abduction test and external rotation test positive.
    • Patients referral adhesive capsulitis with MRI

Exclusion Criteria:

  • • Disease such as rheumatoid arthritis

    • Diabetes mellitus.
    • History of trauma or accidental injuries.
    • Neurological involvement (stroke, Parkinsonism, radiating pain to arm).
    • History of surgery on particular shoulder

Sites / Locations

  • Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A (Experimental group):

Group B (Control group):

Arm Description

This group includes 30 patients with adhesive capsulitis who will receive muscle energy techniques 1 session per day, 5 days a week for 8 weeks in addition to their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises).

This group includes 30 patients with adhesive capsulitis who will receive their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.

Outcomes

Primary Outcome Measures

Visual analogue scale (VAS)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Secondary Outcome Measures

Goniometer
( From supine lying position ,the measurements will be taken for shoulder flexion, abduction, and external rotation).

Full Information

First Posted
March 2, 2022
Last Updated
March 21, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05274698
Brief Title
Efficacy Of Muscle Energy Technique On Shoulder Adhesive Capsulitis Post Mastectomy
Official Title
Efficacy Of Muscle Energy Technique On Shoulder Adhesive Capsulitis Post Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the effect of muscle energy technique on adhesive capsulitis post mastectomy.
Detailed Description
Subjects: Sixty patients who have adhesive capsulitis post- mastectomy will participate in this study .Their ages will range from 40 to 60 years. The participants will be selected from National Cancer Institute, Cairo University and randomly distributed into two equal groups. 1.1 Design of the study: In this study the patients will be randomly assigned into two equal groups (30 patients for each group): 1.1(a) Group A (Experimental group): This group includes 30 patients with adhesive capsulitis who will receive muscle energy techniques 1 session per day, 5 days a week for 8 weeks in addition to their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises). 1.1(b) Group B (Control group): This group includes 30 patients with adhesive capsulitis who will receive their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks. Equipment: 2.1- Measurement equipment: 2.1.a-Visual analogue scale (VAS): The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. 2.1.b-Goniometer : One of the most common assessment methods is measuring range of motion (ROM) of the joint using a goniometer. This method has been used for almost 90 years. Baseline limitation on ROM of a patient can be obtained before treatment, and changes induced in this motion after therapeutic interventions is easily determined. Reliability studies on ROM measurement of the joint using goniometer have been studied in depth, and have shown high reliability 2.1.c-Shoulder Pain and Disability Index (SPADI): Is a self-administered questionnaire that aims to measure pain and disability associated with shoulder disease .The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability . 2. 2-Therapeutic equipment and tools: 3-Procedures of the study: 3.1-Measurement procedures: 3.1.a-A Visual Analogue Scale (VAS): VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, as illustrated in Fig. (1).The patient will mark on the line the point that they feel represents their perception of their current state. The VAS score will be determined by measuring in millimetres from the left hand end of the line to the point that the patient mark . 3.1.b- Goniometer: ( From supine lying position ,the measurements will be taken for shoulder flexion, abduction, and external rotation).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group A (Experimental group):
Arm Type
Experimental
Arm Description
This group includes 30 patients with adhesive capsulitis who will receive muscle energy techniques 1 session per day, 5 days a week for 8 weeks in addition to their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises).
Arm Title
Group B (Control group):
Arm Type
Other
Arm Description
This group includes 30 patients with adhesive capsulitis who will receive their conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
muscle energy technique
Intervention Description
It is a manual treatment in which a patient produces a contraction in a precisely controlled position and direction against a counterforce applied by a manual therapist .Muscle energy techniques (MET) were originally developed to treat soft tissue, mobilize joints, stretch tight muscles and fascia, reduce pain and to improve circulation and lymphatic drainage.
Intervention Type
Behavioral
Intervention Name(s)
conventional physical therapy program (Mobilization exercises, Posterior capsule stretching, and Range of motion exercises) 1 session per day, 5 days a week for 8 weeks.
Intervention Description
Joint mobilization, specifically glenohumeral joint distraction, glenohumeral joint caudal glide, glenohumeral joint posterior glide, and glenohumeral joint anterior glide, will be applied with patients. Posterior capsule stretching will be applied with patients in side lying position. The scapula will be stabilized at the lateral side with the arm at 90° flexion. Stretching will be applied from the elbow with a downward force. The stretch will be repeated 10 times for 20 s each. A 30-s break will be given between each stretching . Range of motion exercises: Codman/ pendulum exercise ,Wall climbing exercise and Shoulder wheel exercise Circumduction of the shoulder joint clockwise and anticlockwise using shoulder wheel
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
2 month
Secondary Outcome Measure Information:
Title
Goniometer
Description
( From supine lying position ,the measurements will be taken for shoulder flexion, abduction, and external rotation).
Time Frame
2 month
Other Pre-specified Outcome Measures:
Title
The Shoulder Pain and Disability Index (SPADI)
Description
The SPADI consists of two dimensions (pain and disability) with a total of 13 questions. The pain dimension consists of five questions pertaining to the severity of an individual's pain. Disability will be assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living requiring the use of the upper extremities. To answer the questions, the patients will place a mark on a 10-cm VAS for each question. Verbal anchors for the pain dimension will be 'no pain at all' and 'worst pain imaginable' and those for the disability dimension were 'no difficulty' and 'so difficult it requires help'. Scores from both dimensions will be averaged to derive a total percentage score. Higher scores reflected more pain and greater disability
Time Frame
2 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Female patients with age range between 40-60 years. Shoulder ROM restriction. Shoulder pain more than 3 months. Patients with adhesive capsulitis abduction test and external rotation test positive. Patients referral adhesive capsulitis with MRI Exclusion Criteria: • Disease such as rheumatoid arthritis Diabetes mellitus. History of trauma or accidental injuries. Neurological involvement (stroke, Parkinsonism, radiating pain to arm). History of surgery on particular shoulder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
samah fakhry, master
Phone
01129688461
Email
samah_gameil@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
samia fakhry, bachelor
Phone
01553387357
Email
samiagamil58@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
faculty of physical therapy
Organizational Affiliation
teaching assistant of physical therapy cairo university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Dokki
State/Province
Giza
ZIP/Postal Code
12611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of physical therapy
Phone
0237617691
Email
Info@pt.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
l

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy Of Muscle Energy Technique On Shoulder Adhesive Capsulitis Post Mastectomy

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