Effects of Osteopathic Treatment on Pulmonary Function After Coronary Artery Bypass Graft Surgery

Not Applicable

Terminated

• Conditions: Pain; Mechanical Complication of Coronary Artery Bypass Graft; Respiratory Depression; Quality of Life
• Interventions: Other: Usual care; Other: Osteopathic treatment

• Registration Number: NCT01714791
• Lead Sponsor: Hartcentrum Hasselt

Brief Summary

The purpose of this study is to determine the short and long term effects of osteopathic treatment on pulmonary function, pain and quality of life in patients after coronary artery bypass graft (CABG) surgery. The study is a randomized controlled trial.

Detailed Description

Coronary artery bypass graft (CABG) surgery is performed worldwide. Several studies have found that there is a decrease in pulmonary function, loss of thoracic mobility and a high prevalence of chronic poststernotomy pain (CPSP) after CABG. So far there is no effective treatment for these conditions. The OstinCare study aims to investigate whether osteopathic treatment has an added value in the treatment of these patients.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-26
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Planned Coronary Artery Bypass Graft (CABG) surgery at the Jessa Hospital Hasselt
• Planned Endoscopic Atraumatic Coronary Artery Bypass (endo ACAB) surgery at the Jessa Hospital
• Planned Minimal Invasive Aortic Valve Replacement (mini AVR) surgery at the Jessa Hospital

Exclusion Criteria

• Thoracic surgery in the past
• Redo CABG
• Complications after CABG, requiring long-term (more than 6 days) admission to intensive care
• Pathologies of the lungs
• Pathologies of the heart, other than the coronary artery disease
• Surgery in the sub diaphragmatic region: epigastric region, left and right hypochondriac region.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Patients following the outpatient cardiac rehabilitation program.
Usual care and Osteopathic treatment	Usual care	Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment.
Usual care and Osteopathic treatment	Osteopathic treatment	Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment.

Primary Outcome Measures

Name	Time	Method
Change from baseline in slow vital capacity (SVC) at 12 weeks.	preoperative (baseline) and 12 weeks postoperative	A Slow Vital Capacity (SVC) test will be performed at each time point.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in McNew quality of life questionnaire at 12 weeks.	3 weeks postoperative (baseline) and 12 weeks postoperative	McNew questionnaire will be done at 3 and 12 weeks after surgery.
Change from baseline in McNew quality of life questionnaire at 52 weeks.	3 weeks postoperative (baseline) and 52 weeks postoperative	McNew questionnaire will be done at 3, 12 and 52 weeks after surgery.
Change from baseline in slow vital capacity (SVC) at 52 weeks.	preoperative (baseline) and 52 weeks postoperative	A SVC test will be performed at each time point.
Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative.	3 weeks postoperative (baseline) and 12 weeks postoperative	Pain will be evaluated at 3 and 12 weeks after surgery.
Change in pain from baseline on VAS at 52 weeks postoperative.	3 weeks postoperative (baseline) and 52 weeks postoperative	Pain will be evaluated at 3, 12 and 52 weeks after surgery.
Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative.	3 weeks postoperative (baseline) and 12 weeks postoperative	Thoracic stiffness will be evaluated at 3, 12 weeks after surgery.
Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative.	3 weeks postoperative (baseline) and 52 weeks postoperative	Thoracic stiffness will be evaluated at 3, 12 and 52 weeks after surgery.

Trial Locations

Locations (1)

Cardiac rehabilitation centre at the Jessa Hospital Hasselt; 🇧🇪 Hasselt, Limburg, Belgium