Osteopathic Manipulative Treatment Efficacy in Postoperative Pain

NCT02694991 | Completed Phase 4

• 1 other identifier: 0001-2013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Pain

Keywords

surgery; outcome; pain; osteopathic manipulative treatment

Outcome Measures

Primary Outcomes (1)

• Pain intensity relief

  Pain intensity measured with visual analogic scale (VAS)

  21 days

Secondary Outcomes (5)

• Functional capacity improvement

  21 days

• Respiratory function

  21 days

• Hospitalization length

  21 days

• Anxiety and Depression

  21 days

• Analgesic drug consumption.

  21 days

Study Arms (2)

OMT Group

EXPERIMENTAL

Osteopathic Manipulative Treatment 15 minutes once a day for 8 days

Other: Osteopathic Manipulative Treatment

Control Group

NO INTERVENTION

No intervention, only usual care

Interventions

Osteopathic Manipulative Treatment OTHER

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.

Also known as: OMT

OMT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don C. Gnocchi ; Istituto S. Maria Nascente IRCCS

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Paolo Mocarelli, Prof

  Fondazione Don C. Gnocchi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 1, 2016
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 1, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)