Pain Clinical Trial
Official title:
Osteopathic Manipulative Treatment Efficacy in Sternal Pain Management After Heart Surgery
Effectively controlling sternal pain during cardiac rehabilitation after heart surgery is
very important as it reduces the risk of postoperative complications.
However, the contraindications and side effects of analgesic drugs may induce physicians to
use them so cautiously that pain may actually be under-treated.
The aim of this open label, controlled study is to assess whether osteopathic manipulative
treatment (OMT) can contribute to pain relief and improve rehabilitation outcomes.
The currently predominant means of controlling postoperative pain is the peri-operative
administration of opioid or non-opioid (acetaminophen) analgesics, alone or in combination,
and non-steroidal anti-inflammatory drugs (NSAIDs). However, anti-inflammatory drugs are
contraindicated for many patients because they may impair renal function, interact with
platelet aggregation, and increase the risk of gastrointestinal damage and bleeding. The
spectrum of available options is narrow.
Osteopathic manipulative Treatment (OMT) intervenes in the process that transforms
nociceptive information into the subjective experience and it may be useful.
It has been found to be effective in controlling pain after abdominal surgery, it has a
beneficial effect on patients recovering coronary artery by-pass surgery and also improves
cardiac function The aim of this study was to assess whether complementary OMT is an
effective means of reducing post-surgical sternal pain and improving rib cage mobility after
heart surgery involving sternotomy, and to investigate its advantages during in-patient
rehabilitation in terms of functional recovery, and perceived anxiety and depression.
This open, randomised, semi-blinded, controlled trial involves inclusion of 80 adult
patients of both genders consecutively admitted as in-patients to cardiac rehabilitation
unit after undergoing elective coronary artery by-pass grafting (CABG), valve replacement or
repair and/or ascending aorta surgery with sternotomy, and capable of voluntarily providing
their written informed consent. The patients are divided in 2 groups, the intervention group
receiving OMT and the control group. Both groups are following the same rehabilitation
programme and receiving usual care.
All of the subjects taking part in the study are receiving standard care in accordance with
the international guidelines for in-patient cardiac rehabilitation; the only experimental
intervention is the addition of OMT
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|