Clinical trial NCT02694991: Osteopathic Manipulative Treatment Efficacy in Postoperative Pain
Official title: Osteopathic Manipulative Treatment Efficacy in Sternal Pain Management After Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Pain
Keywords: surgery
outcome
pain
osteopathic manipulative treatment
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Recent artery bypass grafting (CABG)
* Recent valve replacement or repair
* Recent ascending aorta surgery

Exclusion Criteria:

* Heart surgery using mini-thoracotomy.
* Heart transplantation
* Implant of a ventricular assistance device
* Diabetes mellitus
* Rheumatoid arthritis
* Autoimmune diseases
* Altered cognitive capacities

Primary outcomes:
measure: Pain intensity relief
timeFrame: 21 days
Secondary outcomes:
measure: Functional capacity improvement
timeFrame: 21 days
measure: Respiratory function
timeFrame: 21 days
measure: Hospitalization length
timeFrame: 21 days
measure: Anxiety and Depression
timeFrame: 21 days
measure: Analgesic drug consumption.
timeFrame: 21 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione Don C. Gnocchi ; Istituto S. Maria Nascente IRCCS
Study officials:
affiliation: Fondazione Don C. Gnocchi
name: Paolo Mocarelli, Prof
role: STUDY_CHAIR
References: