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

The main aim of this study is to investigate the effectiveness of Myofascial release in patients with chronic sternotomy pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Postsurgical Pain
• Intervention / Treatment: Other: Myofascial release; Other: Breathing exercises; Drug: Pharmacological treatment

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mayar Kamal Shehata Madian, B.Sc; Phone Number: 01000681254; Email: Mayar.kamal1@outlook.com
• Study Contact Backup: Name: Salma Ibrahim Alghitany, PhD

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University
    • Contact: Mayar Kamal Shehata Madian, B.Sc; Phone Number: 01000681254; Email: Mayar.kamal1@outlook.com
    • Contact: Salma Ibrahim Alghitany, PhD
    • Principal Investigator: Ahmad Mahdi Ahmad, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS)	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	It will be obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers.	5 days
Lower chest expansion	It will be obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers.	5 days
Pressure pain threshold	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

Outcome Measure	Measure Description	Time Frame
Forced vital capacity (FVC)	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)	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	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)	The total distance walked in meters will be measured.	5 days
Katz Index of Independence in Activities of Daily Living (ADL)	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)	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)	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)	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

• Sponsor: Cairo University
• Investigators: Study Chair: Ahmad Mahdi Ahmad, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID 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