Osteopathic Manipulative Treatment Efficacy in Postoperative Pain
- Conditions
- SurgeryPain
- Interventions
- Other: Osteopathic Manipulative Treatment
- Registration Number
- NCT02694991
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Recent artery bypass grafting (CABG)
- Recent valve replacement or repair
- Recent ascending aorta surgery
- Heart surgery using mini-thoracotomy.
- Heart transplantation
- Implant of a ventricular assistance device
- Diabetes mellitus
- Rheumatoid arthritis
- Autoimmune diseases
- Altered cognitive capacities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OMT Group Osteopathic Manipulative Treatment Osteopathic Manipulative Treatment 15 minutes once a day for 8 days
- Primary Outcome Measures
Name Time Method Pain intensity relief 21 days Pain intensity measured with visual analogic scale (VAS)
- Secondary Outcome Measures
Name Time Method Respiratory function 21 days Inspiratory volume variation measured as mL of air inspired
Anxiety and Depression 21 days Hospital Anxiety and Depression Scale (HADS) score
Functional capacity improvement 21 days Distance in meters walked in six minutes
Analgesic drug consumption. 21 days Number of analgesic drug doses taken
Hospitalization length 21 days Number of days of hospitalisation
Trial Locations
- Locations (1)
Fondazione Don C. Gnocchi ; Istituto S. Maria Nascente IRCCS
🇮🇹Milano, Italy