Chronic Postsurgical PainNCT06630208
Effectiveness of Myofascial Release in Patients With Chronic Post Sternotomy Pain Syndrome
A study testing Myofascial release, Breathing exercises and Pharmacological treatment in people with Chronic Postsurgical Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The main aim of this study is to investigate the effectiveness of Myofascial release in patients with chronic sternotomy pain. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Chronic Postsurgical Pain
- What is being tested?
- Myofascial release, Breathing exercises and Pharmacological treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Salma Ibrahim Alghitany, PhD contact
Egypt1 site
Cairo University
Giza
Mayar Kamal Shehata Madian, B.Sc, 01000681254, Mayar.kamal1@outlook.com
Salma Ibrahim Alghitany, PhD
About this study
The main aim of this study is to investigate the effectiveness of Myofascial release in patients with chronic sternotomy pain.
Read the 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.
- Conditions
- Chronic Postsurgical Pain
- Being tested
- Myofascial release, Breathing exercises, Pharmacological treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial releaseOther
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.
Breathing exercisesOther
Following the 3 phases of myofascial release, breathing exercises will be done for patients.
Pharmacological treatmentDrug
Patients will take pharmacological treatment prescribed by the cardiologist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Myofascial release; Other: Breathing exercises; Drug: Pharmacological treatment |
| Pharmacological treatment | Active comparator | It will include 30 patients, who will receive pharmacological treatment only. Receives: Drug: Pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 days
Upper chest expansion
It will be obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers.
Measured: 5 days
Lower chest expansion
It will be obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers.
Measured: 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.
Measured: 5 days
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 5 days
6-min walk test (6 MWT)
The total distance walked in meters will be measured.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postsurgical PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayar Kamal Shehata Madian, Cairo University
- Investigators
- Ahmad Mahdi Ahmad, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630208
- Sponsor's protocol ID
- P.T.REC/012/005235
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Myofascial Release in Patients With Chronic Post Sternotomy Pain Syndrome
- ClinicalTrials.gov ID
- NCT06630208
- Acronym / sponsor ID
- P.T.REC/012/005235
- Conditions
- Chronic Postsurgical Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial release + Breathing exercises + Pharmacological treatment | Experimental | Other: Myofascial release, Other: Breathing exercises, Drug: Pharmacological treatmentIt will include 30 patients, who will receive myofascial release for 5 days, with breathing exercises in addition to pharmacological treatment. |
| Pharmacological treatment | Active comparator | Drug: Pharmacological treatmentIt will include 30 patients, who will receive pharmacological treatment only. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial releaseThe 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 | Myofascial release + Breathing exercises + Pharmacological treatment |
| Breathing exercisesFollowing the 3 phases of myofascial release, breathing exercises will be done for patients. | Other | Myofascial release + Breathing exercises + Pharmacological treatment |
| Pharmacological treatmentPatients will take pharmacological treatment prescribed by the cardiologist. | Drug | Myofascial release + Breathing exercises + Pharmacological treatment, Pharmacological treatment |
Primary outcome
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.
8 secondary outcomes
Forced vital capacity (FVC)
Time frame: 5 days
Forced expiratory volume at one second (FEV1)
Time frame: 5 days
FEV1/FVC
Time frame: 5 days
6-min walk test (6 MWT)
Time frame: 5 days
Katz Index of Independence in Activities of Daily Living (ADL)
Time frame: 5 days
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 5 days
Arabic version of the 12-item short-form health survey (SF-12)
Time frame: 5 days
The Readiness for Return to Work (RRTW)
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salma Ibrahim Alghitany, PhD contact
Ahmad Mahdi Ahmad, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release, Breathing exercises and Pharmacological treatment in people with Chronic Postsurgical Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayar Kamal Shehata Madian, B.Sc (01000681254, Mayar.kamal1@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.