NCT05274698

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 2, 2022

Last Update Submit

March 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Goniometer

    2 month

Other Outcomes (1)

  • The Shoulder Pain and Disability Index (SPADI)

    2 month

Study Arms (2)

Group A (Experimental group):

EXPERIMENTAL

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 techniqueBehavioral: 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.

Group B (Control group):

OTHER

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.

Interventions

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.

Group A (Experimental group):

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

Group A (Experimental group):Group B (Control group):

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Dokki, Giza Governorate, 12611, Egypt

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • faculty of physical therapy

    teaching assistant of physical therapy cairo university

    STUDY DIRECTOR

Central Study Contacts

samah fakhry, master

CONTACT

samia fakhry, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistant of physical therapy ,Cairo university

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 10, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations