Effectiveness of Myofascial Release in Patients With Chronic Post Sternotomy Pain Syndrome

October 4, 2024 updated by: Mayar Kamal Shehata Madian, Cairo University
The main aim of this study is to investigate the effectiveness of Myofascial release in patients with chronic sternotomy pain.

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

Post-sternotomy pain syndrome (PSPS) is a prevalent disorder affecting a substantial proportion of patients who have undergone sternotomy surgery, with incidence rates ranging from 10% to 40%. Several mechanisms have been proposed to be responsible for the development of PSPS; for example, intercostal neuralgia from scar-entrapped neuroma, brachial plexus injury, ribs or costal fractures with incomplete healing, sternal wound infections and even hypersensitivity reaction to sternal wire. chronic post sternotomy pain (CPSP) can compromise quality of life, affecting their sleep patterns and impairing their working ability.

During the first week after coronary artery bypass grafting (CABG) surgery, vital capacity (VC) decreases by 30-60% and even up to 1 year this remains reduced by 12%. Reduced VC has a negative effect on exercise tolerance (Vo2max) and therefore it is important to optimize pulmonary function after CABG surgery. The decreased thoracic mobility after CABG still presents 12 months after surgery. Thoracic mobility and vital capacity were affected more when the left internal thoracic artery (LITA)-retractor was used and reduced thoracic mobility is related to diminished pulmonary function.

New therapeutic-rehabilitative proposals have been tried in cardiac patients. After cardiac surgery, it was found that the responses of the cardiovascular, and respiratory systems get better after neuromuscular manual therapy. The strong correlation between manual therapy and its effects, suggests that a central control mechanism could be activated by manual therapy.

Using Myofascial release (MFR) techniques may be beneficial for patients post-CABG and off-pump coronary artery bypass grafting (OPCAB) surgery. The advantages of MFR techniques are gentleness and non-invasiveness. During therapy one works with fascia structures, thus, not influencing bone structures directly, These techniques are comfortable and safe, they may be applied in acute conditions.

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.
60

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: Salma Ibrahim Alghitany, PhD

Study Locations

  • Egypt
      • Giza, Egypt
        • Cairo University
        • Contact:
        • Contact:
          • Salma Ibrahim Alghitany, PhD
        • Principal Investigator:
          • Ahmad Mahdi Ahmad, PhD

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic Post-sternotomy pain (CPSP), defined as discomfort at the thorax after cardiac surgery, persisting for at least 2 months, and without apparent cause (I.e., such as infection or the underlying disease that motivated the surgery).
  • Age between 55 to 65 years old.
  • All patients will be under full medical supervision.
  • Adherence to informed consent.
  • Cardiac sternotomy intervention

Exclusion Criteria:

  • Neuromuscular disorders.
  • Any Active hemorrhage.
  • The presence of an unstable cardiac, pulmonary or cerebral pathology.
  • Poor cognition and mentality.
  • Patients with active contagious skin conditions
  • Any Cardiopulmonary problems (eg. Uncontrolled hypertension, Heart Failure, Arrhythmia)
  • Patients with malignancy.
  • Any acute viral infection.
  • Patients with ascites or end-stage liver or kidney failure.
  • Patients will participate in other physiotherapy programs rather than the prescribed protocol.
  • Chest infection in last 3 months.
  • Patients with musculoskeletal problems like any bone fracture
  • Osteoporotic patients.
  • Any recent open wound in the chest are.
  • Hemodynamic instability.

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: Single

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: Myofascial release + Breathing exercises + Pharmacological treatment
It will include 30 patients, who will receive myofascial release for 5 days, with breathing exercises in addition to pharmacological treatment.
Other: Myofascial release
The experimental group will undergo a 5-day consecutive myofascial release treatment, administered as Osteopathic Manipulative Treatment (OMT), with each session lasting a maximum of 15 minutes. The treatment will consist of three phases targeting the entire mediastinum: Thoracic Inlet (Indirect) Myofascial Release, Rib Raising with continued stretch of the paraspinal muscles to the L2 vertebral level, and Soft Tissue Cervical Paraspinal Muscle Stretch with Suboccipital Muscle Release. Participants will be positioned in a supine posture to enhance diaphragmatic excursion, with each session following a fixed, prearranged sequence of these techniques.
Other: Breathing exercises
Following the 3 phases of myofascial release, breathing exercises will be done for patients.
Drug: Pharmacological treatment
Patients will take pharmacological treatment prescribed by the cardiologist.
Active Comparator: Pharmacological treatment
It will include 30 patients, who will receive pharmacological treatment only.
Drug: Pharmacological treatment
Patients will take pharmacological treatment prescribed by the cardiologist.

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
Visual analog scale (VAS)
Time Frame: 5 days
Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
5 days
Upper chest expansion
Time Frame: 5 days
It will be obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers.
5 days
Lower chest expansion
Time Frame: 5 days
It will be obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers.
5 days
Pressure pain threshold
Time Frame: 5 days
Pressure algometers are useful for quantifying the pressure pain thresholds of muscles. The pressure pain threshold of a patient is judged to be abnormal when the pressure pain threshold was lower than the normal value or if the pressure pain threshold of a certain site was lower than that of the opposite site by at least 2 kg/cm2, or if it was less than 3 kg/cm2.
5 days

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
Forced vital capacity (FVC)
Time Frame: 5 days
It will be assessed by a spirometer before and after treatment. The patient will be asked to take a deep inspiration to expire forcefully and rapidly as much as possible through the mouthpiece.
5 days
Forced expiratory volume at one second (FEV1)
Time Frame: 5 days
It will be assessed by a spirometer before and after treatment. The patient will be asked to take a deep inspiration to expire forcefully and rapidly as much as possible through the mouthpiece.
5 days
FEV1/FVC
Time Frame: 5 days
The ratio between the forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) will be calculated before and after treatment.
5 days
6-min walk test (6 MWT)
Time Frame: 5 days
The total distance walked in meters will be measured.
5 days
Katz Index of Independence in Activities of Daily Living (ADL)
Time Frame: 5 days
The Katz ADL index measures the self-care tasks which include bathing, dressing, toileting, transferring to and from a chair, maintaining continence and feeding. Answers are given in a dichotomous manner - yes or no for each task. The scores indicate the levels of functional impairments; total score of 6 - full function, 3 to 5 - moderate functional impairment, and 2 or less - severe functional impairment.
5 days
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 5 days
The PSQI was designed to evaluate overall sleep quality in these clinical populations. Each of the questionnaire's 19 self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
5 days
Arabic version of the 12-item short-form health survey (SF-12)
Time Frame: 5 days
It will be used to assess the quality of life. The Arabic version of the SF-12 is a reliable, easy-to-use, and valid tool to measure health-related quality of life in the general population.
5 days
The Readiness for Return to Work (RRTW)
Time Frame: 5 days
The Readiness for Return to Work (RRTW) model attempts to describe the intricate process of returning to work after a long-term sickness absence. The scale comprises 22 questions, which are divided into 13 questions for those who are not back to work yet, and 9 questions for those who are currently back at work.
5 days

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 Chair: Ahmad Mahdi Ahmad, PhD, 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 (Estimated)

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.
December 15, 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.
February 15, 2025

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.
March 1, 2025

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 4, 2024

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 4, 2024

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 8, 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.
October 8, 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.
October 4, 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.
October 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.
  • P.T.REC/012/005235

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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