Osteopathic Manipulative Treatment Efficacy in Postoperative Pain

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.

Study Overview

• Status: Completed
• Conditions: Pain; Surgery
• Intervention / Treatment: Other: Osteopathic Manipulative Treatment

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20148
    • Fondazione Don C. Gnocchi ; Istituto S. Maria Nascente IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OMT Group; Osteopathic Manipulative Treatment 15 minutes once a day for 8 days	Other: Osteopathic Manipulative Treatment; The thoracic wall is gently manipulated in conscious subjects in a supine position in order to facilitate greater diaphragmatic excursion. The thorax is palpated by applying a low pressure load directly on the skin in the direction of resistance, without any sliding over the skin or forcing of the subcutaneous tissue until it begins to yield and there is a sensation of softening. Sterile procedures are used when touching the patients near the surgical site. The treatment consists of a fixed and preordained sequence of three sessions, beginning with the costal arch on the diaphragm and then moving to the sternal area and, finally, the region of the thoracic outlet. The first two phases are performed from the right side, and the third from the head of the bed.; Other Names: OMT
No Intervention: Control Group; No intervention, only usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity relief	Pain intensity measured with visual analogic scale (VAS)	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity improvement	Distance in meters walked in six minutes	21 days
Respiratory function	Inspiratory volume variation measured as mL of air inspired	21 days
Hospitalization length	Number of days of hospitalisation	21 days
Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS) score	21 days
Analgesic drug consumption.	Number of analgesic drug doses taken	21 days

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Study Chair: Paolo Mocarelli, Prof, Fondazione Don C. Gnocchi

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 1, 2016

Study Record Updates

• Last Update Posted (Estimate): March 1, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: pain; surgery; outcome; osteopathic manipulative treatment
• Other Study ID Numbers: 0001-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: to upload the data base file of all results of the present trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No