Osteopathic Manipulative Treatment Efficacy in Postoperative Pain

D

Don Carlo Gnocchi Onlus Foundation

Status and phase

Completed
Phase 4

Conditions

Surgery
Pain

Treatments

Other: Osteopathic Manipulative Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02694991
0001-2013

Details and patient eligibility

About

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.

Full 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

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

OMT Group
Experimental group
Description:
Osteopathic Manipulative Treatment 15 minutes once a day for 8 days
Treatment:
Other: Osteopathic Manipulative Treatment
Control Group
No Intervention group
Description:
No intervention, only usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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