Clinical trial NCT06630208: Effectiveness of Myofascial Release in Patients With Chronic Post Sternotomy Pain Syndrome
Official title: Effectiveness of Myofascial Release in Patients With Chronic Post Sternotomy Pain Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Postsurgical Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 5 days
measure: Upper chest expansion
timeFrame: 5 days
measure: Lower chest expansion
timeFrame: 5 days
measure: Pressure pain threshold
timeFrame: 5 days
Secondary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 5 days
measure: Forced expiratory volume at one second (FEV1)
timeFrame: 5 days
measure: FEV1/FVC
timeFrame: 5 days
measure: 6-min walk test (6 MWT)
timeFrame: 5 days
measure: Katz Index of Independence in Activities of Daily Living (ADL)
timeFrame: 5 days
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 5 days
measure: Arabic version of the 12-item short-form health survey (SF-12)
timeFrame: 5 days
measure: The Readiness for Return to Work (RRTW)
timeFrame: 5 days
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Ahmad Mahdi Ahmad, PhD
role: STUDY_CHAIR
References: