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Lack of new inclusions due to a significant change in surgery technique. An endoscopic a-traumatic coronary artery bypass (endo-ACAB) approach is now used.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Patients following the outpatient cardiac rehabilitation program. |
|
| Usual care and Osteopathic treatment | Experimental | Patients following the outpatient cardiac rehabilitation program and receiving osteopathic treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline in McNew quality of life questionnaire at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gert Roncada, DO, MSc | Heart Centre Hasselt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac rehabilitation centre at the Jessa Hospital Hasselt | Hasselt | Limburg | 3500 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15804805 | Background | Kristjansdottir A, Ragnarsdottir 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. doi: 10.1080/14017430410016396. | |
| 15204235 | Background | Kristjansdottir A, Ragnarsdottir 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. doi: 10.1080/14017430410028492. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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|
|
| Osteopathic treatment | Other | 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:
|
|
McNew questionnaire will be done at 3 and 12 weeks after surgery.
| 3 weeks postoperative (baseline) and 12 weeks postoperative |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Changes in thoracic mobility at 4, 12 and 52 weeks postoperative. | Osteopathic clinical examination of the thorax. | 4, 12 and 52 weeks postoperative |
| 16106113 | Background | Ragnarsdottir M, Kristinsdottir EK. Breathing movements and breathing patterns among healthy men and women 20-69 years of age. Reference values. Respiration. 2006;73(1):48-54. doi: 10.1159/000087456. Epub 2005 Aug 11. |
| 15204247 | Background | Ragnarsdottir M, KristjAnsdottir A, Ingvarsdottir 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. doi: 10.1080/14017430310016658. |
| 12855337 | Background | 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. doi: 10.1016/s0304-3959(03)00017-4. |
| 11576042 | Background | Kalso E, Mennander S, Tasmuth T, Nilsson E. Chronic post-sternotomy pain. Acta Anaesthesiol Scand. 2001 Sep;45(8):935-9. doi: 10.1034/j.1399-6576.2001.450803.x. |
| 2392792 | Background | Locke TJ, Griffiths TL, Mould H, Gibson GJ. Rib cage mechanics after median sternotomy. Thorax. 1990 Jun;45(6):465-8. doi: 10.1136/thx.45.6.465. |
| 21955825 | Background | 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. No abstract available. |
| 11576043 | Background | 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. doi: 10.1034/j.1399-6576.2001.450804.x. |
| 21561786 | Background | 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. |
| 21044253 | Background | 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. |
| 12693792 | Background | 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. doi: 10.1053/rmed.2002.1424. |
| 16336009 | Background | 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. doi: 10.2165/00007256-200535120-00005. |
| 15894562 | Background | Alston RP, Pechon P. Dysaesthesia associated with sternotomy for heart surgery. Br J Anaesth. 2005 Aug;95(2):153-8. doi: 10.1093/bja/aei152. Epub 2005 May 13. |
| 16055882 | Background | 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. doi: 10.1183/09031936.05.00034805. No abstract available. |
| 32825989 | Derived | Roncada G. Osteopathic treatment leads to significantly greater reductions in chronic thoracic pain after CABG surgery: A randomised controlled trial. J Bodyw Mov Ther. 2020 Jul;24(3):202-211. doi: 10.1016/j.jbmt.2020.03.004. Epub 2020 Mar 17. |
| 27884147 | Derived | Roncada G. Effects of osteopathic treatment on pulmonary function and chronic thoracic pain after coronary artery bypass graft surgery (OstinCaRe): study protocol for a randomised controlled trial. BMC Complement Altern Med. 2016 Nov 25;16(1):482. doi: 10.1186/s12906-016-1468-3. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |