Clinical trial NCT05274698: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

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

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 2 month
Secondary outcomes:
measure: Goniometer
timeFrame: 2 month
Other outcomes:
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: 2 month
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical Therapy
state: Giza
Study officials:
affiliation: teaching assistant of physical therapy cairo university
name: faculty of physical therapy
role: STUDY_DIRECTOR
References: