Effect of Diaphragmatic Release on Upper Crossed Syndrome

March 22, 2023 updated by: Zeinab Mohamed Abd El-Rahem, Cairo University
the study aims to investigate the effectiveness of diaphragmatic release on upper crossed syndrome

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Poor posture typically causes upper cross syndrome, resulting in neck pain. Neck pain is the most common reason for patients to visit healthcare professionals. This syndrome can cause dysfunctional tone in posture and muscular disparity of the head, neck, and shoulder region . Evidence suggests that 6-48% of the upper crossed syndrome population complain of pain in the shoulder girdle and cervicothoracic region.

Many disorders are linked with the upper crossed syndrome, including migraine headaches; chronic headaches; Subacromial impingement; biceps tendinitis; thoracic outlet syndrome; degeneration of the cervical spine; and joint dysfunction at the C1-C2 segment, C4-C5 segment, cervicothoracic joint, and T4-T5 segment.

Upon the available research studies, there is no study conducted to investigate the effect of diaphragmatic release on upper crossed syndrome patients.

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 (Anticipated)

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.
30

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

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

17 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ranged from 17 to 22 years .
  • Body Mass Index from 20 to 25 kg/m².
  • All participants have an intensity of neck pain on VAS (4-8) (moderate cases).
  • The subjects were chosen from both sexes.
  • All participants have kyphosis angle ≥42°
  • All participants have mechanical neck pain and FHP (craniovertebral angle CVA < 49).

Exclusion Criteria:

  • Malignancy
  • Fractures of the cervical spine
  • Cervical radiculopathy or myelopathy
  • Vascular syndromes such as vertebrobasilar insufficiency
  • Rheumatoid arthritis
  • Neck or upper back surgery
  • Taking anticoagulants
  • Local infection
  • Whiplash injury

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: Double

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: GroupA diaphragmatic release + conventional

Group A: diaphragmatic release +conventional The patients will be positioned in the supine position. The therapist stood at the head of the patient contact thoracic cage and ask the patient to take inspiration and move laterally then ask the patient to expire.

conventional Subjects will form the letter 'Y' with their arms then they will flex their elbows and move into a position of shoulder extension so that their arms will form the letter 'w L to Y Exercise: Subjects will begin with arms abducted to 90° and elbows flexed to 90° Chin tucks: Subjects will length the neck by pushing the chin into the table in an entirely posterior motion stretch the pectoral area from the supine lying position
Other: effect of diaphragmatic release on upper crossed syndrome

The patients will be positioned in the supine position. The therapist stood at the head of the patient.therapist make manual contact of ribs and ask patient to inspire the move ribs laterally and then expire

conventional exercise Subjects will form the letter 'Y' with their arms then they will flex their elbows and move into a position of shoulder extension, so that their arms will form the letter 'w L to Y Exercise: Subjects will begin with arms abducted to 90° and elbows flexed to 90° Chin tucks : Subjects will length the neck by pushing the chin into the table in an entirely posterior motion stretch pectoral area from supine lying position
Experimental: Group B: conventional
Group B: conventional posture correction exercises Subjects will form the letter 'Y' with their arms then they will flex their elbows and move into a position of shoulder extension, so that their arms will form the letter 'w L to Y Exercise: Subjects will begin with arms abducted to 90° and elbows flexed to 90° Chin tucks : Subjects will length the neck by pushing the chin into the table in an entirely posterior motion stretch pectoral area from supine lying position
Other: effect of diaphragmatic release on upper crossed syndrome

The patients will be positioned in the supine position. The therapist stood at the head of the patient.therapist make manual contact of ribs and ask patient to inspire the move ribs laterally and then expire

conventional exercise Subjects will form the letter 'Y' with their arms then they will flex their elbows and move into a position of shoulder extension, so that their arms will form the letter 'w L to Y Exercise: Subjects will begin with arms abducted to 90° and elbows flexed to 90° Chin tucks : Subjects will length the neck by pushing the chin into the table in an entirely posterior motion stretch pectoral area from supine lying position

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
chest expansion with tape measurement
Time Frame: up to four weeks
using tape to measure chest expansion during inspiration and expiration at axillary level and at the level of T10
up to four 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
pain intensity with pain numerical scale scale
Time Frame: up to four weeks
The subject was instructed to place a vertical mark on the line to indicate his/her pain which zero is no pain and ten being severe pain.
up to four 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

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 (Anticipated)

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.
March 20, 2023

Primary Completion (Anticipated)

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.
April 20, 2023

Study Completion (Anticipated)

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.
April 20, 2023

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).
October 15, 2022

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.
October 15, 2022

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.
October 19, 2022

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.
March 23, 2023

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.
March 22, 2023

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.
March 1, 2023

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.
  • p.tREC/012/003917

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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