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

NCT06630208 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005235
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Postsurgical Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Forced vital capacity (FVC)

  5 days

• Forced expiratory volume at one second (FEV1)

  5 days

• FEV1/FVC

  5 days

• 6-min walk test (6 MWT)

  5 days

• Katz Index of Independence in Activities of Daily Living (ADL)

  5 days

Study Arms (2)

Myofascial release + Breathing exercises + Pharmacological treatment

EXPERIMENTAL

It will include 30 patients, who will receive myofascial release for 5 days, with breathing exercises in addition to pharmacological treatment.

Other: Myofascial release; Other: Breathing exercises; Drug: Pharmacological treatment

Pharmacological treatment

ACTIVE COMPARATOR

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

Drug: Pharmacological treatment

Interventions

Myofascial release OTHER

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.

Myofascial release + Breathing exercises + Pharmacological treatment

Breathing exercises OTHER

Following the 3 phases of myofascial release, breathing exercises will be done for patients.

Myofascial release + Breathing exercises + Pharmacological treatment

Pharmacological treatment DRUG

Patients will take pharmacological treatment prescribed by the cardiologist.

Myofascial release + Breathing exercises + Pharmacological treatment; Pharmacological treatment

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Myofascial Release Therapy; Breathing Exercises; Drug Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mind-Body Therapies; Exercise Movement Techniques

Study Officials

• Ahmad Mahdi Ahmad, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mayar Kamal Shehata Madian, B.Sc

CONTACT

01000681254; Mayar.kamal1@outlook.com

Salma Ibrahim Alghitany, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: December 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

EG (1)