Frozen Shoulder (Scapular Mobilization Versus Scapular PNF)

July 2, 2024 updated by: Mohamed Mahmoud El morsy, Cairo University

SCAPULAR MOBILIZATION VERSUS SCAPULAR PROPRIOCEPTIVE NEURO MUSCULAR FACILITATION ON FROZEN SHOUDER

This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Enas F Youssef, PhD

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- All the patients refferd from orthopaedic surgeon with diagnosis of adhesive capsulitis. Patients will be included in this study if they fulfil the following criteria

  1. Case diagnosed with adhesive capsulitis, both primary and secondary.
  2. Both males and females of the age group 40 to 60 years.
  3. Limited active and passive movement of the shoulder joint movements, as well as difficulties with ADLs.

4- The onset of symptoms between 3 to 12 months. 5. Unilateral adhesive capsulitis.

Exclusion Criteria:

  • 1. History of shoulder surgery or manipulation under anaesthesia, local corticosteroid injection administration to the affected shoulder within the last 6 months, 2. Neurological deficit affecting the shoulder function during daily activities, 3. Pathology of the shoulder joint other than adhesive capsulitis including rotator cuff tear, tendonitis at the shoulder and neck region, malignancies, history of trauma or accidental injuries of the upper limb.

    4- Other pathological conditions including, a history of stroke, history of mastectomy and coronary artery bypass grafting (CABG).

    5. Rheumatoid arthritis, osteoporosis, or disorders of the cervical spine, elbow, wrist or hand.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group A

Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks.

Mulligan Mobilization with Movement for peripheral joints combines sustained manual application of 'gliding' force to a joint, with the aim of repositioning the positional faults with concurrent physiological motion of the joint, either performed actively by the subject or passively by the therapist
Other: Group A SCAPULAR MOBILIZATION

Two treatment groups will receive interventions as follows:

Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks.

Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.

Other Names:
  • GROUP B SCAPULAR PNF
Experimental: group B

Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.

Scapular PNF incorporates functional or diagonal patterns (anterior elevation - posterior depression and posterior elevation - anterior depression) for performing the exercises and can be used to stretch or strengthen the muscles selectively. These techniques help the muscles to relearn the normal timing of recruitment and the amount of activation to sustain the balance between different groups of muscles
Other: Group A SCAPULAR MOBILIZATION

Two treatment groups will receive interventions as follows:

Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks.

Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.

Other Names:
  • GROUP B SCAPULAR PNF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shoulder disability
Time Frame: 4 weeks

Shoulder Pain and Disability Index (SPADI)

The translated version of SPADI in the Arabic language showed excellent internal consistency and test-retest reliability. Validity was shown by substantial correlations between SPADI and Quick DASH, NRS, and active shoulder ROM. The Arabic SPADI is recommended for the evaluation of patients with shoulder dysfunction
4 weeks
Shoulder range of motion
Time Frame: 4 weeks
A goniometer is a device used to measure the range of motion (in degrees) of joints for either active or passive range. Shoulder flexion, extension, abduction adduction, internal rotation and external rotation will be assessed by Goniometer
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Scapular upward rotation
Time Frame: 4 weeks
The Plurimeter-V gravity inclinometer will be used effectively and reliably for measuring upward rotation of the scapula in all ranges of shoulder abduction in the coronal plane
4 weeks
Lateral scapular slide test
Time Frame: 4 weeks
The three test positions will be used. For test position one (LSST-1), the subjects were instructed to keep their upper extremities relaxed at their sides. For test position two (LSST-2), the subjects were instructed to actively place both hands on the ipsilateral hips, and consequently, the humerus was positioned in medial rotation at 45° of abduction in the coronal plane. For test position three (LSST-3), the subjects were instructed to actively extend both elbows and to elevate both upper extremities to 90° in the coronal plane with maximal internal rotation. In this procedure, the distance between inferior aspect of the inferior angle of the scapula and the closest spinous process in the same horizontal plane was measured bilaterally with a tape measure for all three positions. A difference of 1.5 cm or more in any of the three positions was considered a positive result of the LSST
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mona M ibrahim, Cairo university
  • Study Director: mahmoud alsehemy, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Frozen shoulder

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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