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Clinical Trials/NCT06630208
NCT06630208
Not yet recruiting
Not Applicable

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

Cairo University1 site in 1 country60 target enrollmentDecember 15, 2024

Overview

Phase
Not Applicable
Intervention
Myofascial release
Conditions
Chronic Postsurgical Pain
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Visual analog scale (VAS)
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2024
End Date
March 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mayar Kamal Shehata Madian

Principal Investigator

Cairo University

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: Myofascial release

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.

Intervention: Breathing exercises

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.

Intervention: Pharmacological treatment

Pharmacological treatment

It will include 30 patients, who will receive pharmacological treatment only.

Intervention: Pharmacological treatment

Outcomes

Primary Outcomes

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).

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.

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.

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.

Secondary Outcomes

  • Forced vital capacity (FVC)(5 days)
  • Forced expiratory volume at one second (FEV1)(5 days)
  • FEV1/FVC(5 days)
  • Katz Index of Independence in Activities of Daily Living (ADL)(5 days)
  • 6-min walk test (6 MWT)(5 days)
  • Pittsburgh Sleep Quality Index (PSQI)(5 days)
  • Arabic version of the 12-item short-form health survey (SF-12)(5 days)
  • The Readiness for Return to Work (RRTW)(5 days)

Study Sites (1)

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