Efficacy Of Muscle Energy Technique On Shoulder Adhesive Capsulitis Post Mastectomy

The purpose of the study is to evaluate the effect of muscle energy technique on adhesive capsulitis post mastectomy.

Study Overview

• Status: Recruiting
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Behavioral: muscle energy technique; Behavioral: 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.

Detailed Description

1. 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.

2. 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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: samah fakhry, master; Phone Number: 01129688461; Email: samah_gameil@yahoo.com
• Study Contact Backup: Name: samia fakhry, bachelor; Phone Number: 01553387357; Email: samiagamil58@gmail.com

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12611
      • Recruiting
      • Faculty of Physical Therapy
      • Contact: faculty of physical therapy; Phone Number: 0237617691; Email: Info@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Behavioral: muscle energy technique; 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.; Behavioral: 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.; 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
OTHER: 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.	Behavioral: 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goniometer	( From supine lying position ,the measurements will be taken for shoulder flexion, abduction, and external rotation).	2 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Shoulder Pain and Disability Index (SPADI)	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	2 month

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: faculty of physical therapy, teaching assistant of physical therapy cairo university

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (ACTUAL): March 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: P.T.REC/012/003434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No