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

Pain Clinical Trial

— OSTinCARE  

Official title:

Effect of Osteopathy on Pulmonary Function in Patients After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01714791
• Other study ID #: 09.07/cardio09.01
• Status: Terminated
• Phase: N/A
• First received: October 18, 2012
• Last updated: March 1, 2018
• Start date: January 2010
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Hartcentrum Hasselt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Complication of Coronary Artery Bypass Graft
• Pain
• Quality of Life
• Respiratory Depression
• Respiratory Insufficiency

Intervention

Other:
• Usual care
Patients exercise at a heart rate corresponding to 65% of baseline Vo2peak. Each exercise training session takes 40-60 minutes. Exercise time is apportioned as follows: 42% on the treadmill, 33% on the circle ergometer and 25% on the arm cranking device. All patients exercise under close supervision 3 days per week for a total duration of 12 weeks.
• Osteopathic treatment
Patients receive 4 osteopathic treatments (OT). OT is performed in week 4, 5, 8 and 12 postoperative. Depending on what is found in the patient, treatments consist mostly of one or more of the following approaches: Structural High Velocity Low Amplitude-techniques. Muscle Energy Techniques. General osteopathic mobilisations. Functional techniques (Sutherland-, Jones-techniques,…) including inhibition techniques. Fascia techniques. Soft tissue- and connective tissue techniques. Neurovisceral and neurolymphatic reflex techniques. Fluidal techniques (lymphatic manipulative techniques,...). Visceral manipulations. Neurocranial and viscerocranial techniques.

Locations

Country	Name	City	State
Belgium	Cardiac rehabilitation centre at the Jessa Hospital Hasselt	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Hartcentrum Hasselt

Country where clinical trial is conducted

Belgium, 

References & Publications (15)

Alston RP, Pechon P. Dysaesthesia associated with sternotomy for heart surgery. Br J Anaesth. 2005 Aug;95(2):153-8. Epub 2005 May 13. — View Citation

Bruce J, Drury N, Poobalan AS, Jeffrey RR, Smith WC, Chambers WA. The prevalence of chronic chest and leg pain following cardiac surgery: a historical cohort study. Pain. 2003 Jul;104(1-2):265-73. Erratum in: Pain. 2004 Dec;112(3):413. — View Citation

Hansen D, Dendale P, Berger J, Meeusen R. Rehabilitation in cardiac patients:what do we know about training modalities? Sports Med. 2005;35(12):1063-84. Review. — View Citation

Kalso E, Mennander S, Tasmuth T, Nilsson E. Chronic post-sternotomy pain. Acta Anaesthesiol Scand. 2001 Sep;45(8):935-9. — View Citation

Kristjánsdóttir A, Ragnarsdóttir M, Hannesson P, Beck HJ, Torfason B. Chest wall motion and pulmonary function are more diminished following cardiac surgery when the internal mammary artery retractor is used. Scand Cardiovasc J. 2004 Dec;38(6):369-74. — View Citation

Kristjánsdóttir A, Ragnarsdóttir M, Hannesson P, Beck HJ, Torfason B. Respiratory movements are altered three months and one year following cardiac surgery. Scand Cardiovasc J. 2004 May;38(2):98-103. — View Citation

Locke TJ, Griffiths TL, Mould H, Gibson GJ. Rib cage mechanics after median sternotomy. Thorax. 1990 Jun;45(6):465-8. — View Citation

Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. Review. — View Citation

Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4. — View Citation

Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. — View Citation

Ragnarsdóttir M, Kristinsdóttir EK. Breathing movements and breathing patterns among healthy men and women 20-69 years of age. Reference values. Respiration. 2006;73(1):48-54. Epub 2005 Aug 11. — View Citation

Ragnarsdóttir M, KristjAnsdóttir A, Ingvarsdóttir I, Hannesson P, Torfason B, Cahalin L. Short-term changes in pulmonary function and respiratory movements after cardiac surgery via median sternotomy. Scand Cardiovasc J. 2004 Mar;38(1):46-52. — View Citation

van Gulik L, Janssen LI, Ahlers SJ, Bruins P, Driessen AH, van Boven WJ, van Dongen EP, Knibbe CA. Risk factors for chronic thoracic pain after cardiac surgery via sternotomy. Eur J Cardiothorac Surg. 2011 Dec;40(6):1309-13. doi: 10.1016/j.ejcts.2011.03.039. Epub 2011 May 10. — View Citation

van Leersum NJ, van Leersum RL, Verwey HF, Klautz RJ. Pain symptoms accompanying chronic poststernotomy pain: a pilot study. Pain Med. 2010 Nov;11(11):1628-34. doi: 10.1111/j.1526-4637.2010.00975.x. — View Citation

Westerdahl E, Lindmark B, Bryngelsson I, Tenling A. Pulmonary function 4 months after coronary artery bypass graft surgery. Respir Med. 2003 Apr;97(4):317-22. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in maximal aerobic capacity (VO2max) at 12 weeks postoperative	All patients will perform a maximal cardiopulmonary exercise test on a cycle ergometer. The test will be performed at the cardiac rehabilitation centre by a trained operator and under supervision of a cardiologist.	3 weeks postoperative (baseline) and 12 weeks postoperative
Other	Changes in thoracic mobility at 4, 12 and 52 weeks postoperative.	Osteopathic clinical examination of the thorax.	4, 12 and 52 weeks postoperative
Primary	Change from baseline in slow vital capacity (SVC) at 12 weeks.	A Slow Vital Capacity (SVC) test will be performed at each time point.	preoperative (baseline) and 12 weeks postoperative
Secondary	Change from baseline in slow vital capacity (SVC) at 52 weeks.	A SVC test will be performed at each time point.	preoperative (baseline) and 52 weeks postoperative
Secondary	Change from baseline in McNew quality of life questionnaire at 12 weeks.	McNew questionnaire will be done at 3 and 12 weeks after surgery.	3 weeks postoperative (baseline) and 12 weeks postoperative
Secondary	Change from baseline in McNew quality of life questionnaire at 52 weeks.	McNew questionnaire will be done at 3, 12 and 52 weeks after surgery.	3 weeks postoperative (baseline) and 52 weeks postoperative
Secondary	Change in pain from baseline on Visual Analogue Scale (VAS) at 12 weeks postoperative.	Pain will be evaluated at 3 and 12 weeks after surgery.	3 weeks postoperative (baseline) and 12 weeks postoperative
Secondary	Change in pain from baseline on VAS at 52 weeks postoperative.	Pain will be evaluated at 3, 12 and 52 weeks after surgery.	3 weeks postoperative (baseline) and 52 weeks postoperative
Secondary	Change in thoracic stiffness from baseline on VAS at 12 weeks postoperative.	Thoracic stiffness will be evaluated at 3, 12 weeks after surgery.	3 weeks postoperative (baseline) and 12 weeks postoperative
Secondary	Change in thoracic stiffness from baseline on VAS at 52 weeks postoperative.	Thoracic stiffness will be evaluated at 3, 12 and 52 weeks after surgery.	3 weeks postoperative (baseline) and 52 weeks postoperative