Osteopathic Manipulative Treatment Improves Heart Surgery Outcomes, A Randomized Controlled Trial

Participants

• Number: 80 people (34 female and 46 male)
• Criteria of inclusion: adults (age ≥ 18 years), consecutively admitted to the cardiac rehabilitation unit after coronary artery bypass graft (CABG) surgery, valve replacement or repair, ascending aorta surgery with sternotomy, able to sign informed consent
• Criteria of exclusion: heart surgery using minithoracotomy, heart transplantation or implantation of ventricular assistance devices (specific pharmacological and rehabilitation treatments are required), diabetes mellitus (diabetes affects the presentation of pain), autoimmune diseases (require steroidal drugs), impaired cognitive abilities
• Group of study: 2 groups obtained through randomization
  • Group 1: standardized cardiorespiratory rehabilitation program with the addition of OMT, 40 people (16 female and 24 male, mean age 67.8 years)
    • 2 people had experienced sternal wound complications
  • Group 2: standardized cardiorespiratory rehabilitation program alone, 10 people (18 female and 22 male, mean age 64.2 years)
    • 4 people had experienced sternal wound complications
  • The main comorbidities have been: chronic obstructive pulmonary disease, prostatic hypertrophy and chronic kidney failure

Interventions and evaluations

• Complete cardiac assessment and comorbidity research on admission
• Evaluation of functional capacity on admission and at the time of hospital discharge
  • evaluation of respiratory function as volume inspired with the aid of an incentivator device, holding the breath for at least 5 seconds
  • evaluation of the submaximal functional cardiorespiratory capacity through distance covered in a 6-minute walk test
• Evaluation of pain using a 10-cm VAS (ranging from “no pain at all”, or 0, to “unbearable pain”, or 10) at the beginning and at the end of the study
• Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale at the beginning and end of the study
• Evaluation of the drugs used as daily number of equivalent doses
• 5 daily sessions of cardiorespiratory rehabilitation
• 5 15-minute OMT daily sessions
• Cardiorespiratory rehabilitation program: started within 24 hours of admission and lasted throughout hospitalization, exercise bike at 70% of maximum heart rate, up to 50 minutes per week, assisted respiratory training
• OMT: patient in a supine position to facilitate the diaphragmatic excursion, standardized three-phase treatment scheme (diaphragm rib arch, sternal area and thoracic outlet) of 5 minutes each
• OMT administered by an expert physiotherapist-osteopath
• When needed, patients could be prescribed analgesics, anti-inflammatory and other drugs by doctors blind to their allocation between the two groups
  • among the various drugs the following ones were used: analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), benzodiazepines

Results

• Primary outcomes: although the pain decreased in both groups, OMT favored a statistically significant reduction in pain measured by VAS (median VAS of 1 in the OMT group versus median VAS of 3 in the control group)
• Secondary outcomes: in regard to functional capacity, although improved in both groups, it increased more in the group with OMT. In particular, the respiratory volume was greater in the group with OMT compared to the group with only cardiorespiratory rehabilitation in a statistically significant way. The cardiorespiratory capacity (walk test) increased in both groups, but not in a different way. The same result occurred for anxiety and depression: decreased in both groups, but not differently.

Hospitalization was lower in the OMT group (19.1 ± 4.8 days) than in the rehabilitation group (21.7 ± 6.3) in a statistically significant way.
Drug use was not found to be different between the two groups.

Adverse effects (nausea, vomiting, dizziness, difficulty concentrating, drowsiness, light-headidness,, abdominal discomfort, constipation, dry mouth, itching, rash, blurred vision) were detected in 9 patients per group.

Discussion

OMT as an additional treatment compared to cardiorespiratory rehabilitation showed to be able to significantly reduce pain and hospitalization (by about 2 days) in a statistically significant way, as well as improving respiratory capacity.

Potentially, the reduced hospitalization may be due to the improvement of the respiratory capacity and the reduction of the sternal pain, typical consequence of various surgical interventions to the heart, taking into account that the very breathing capacity is affected by sternal pain – less pain leads to better breathing: nonetheless, patients with less post-surgical pain also have fewer lung infections.

Pain reduction may have been due to an action of osteopathic techniques on nociceptors, action that may have led to fewer muscle spasms.
By reducing pain, OMT may also reduce the use of analgesics, although the study showed no results in this sense.

Finally, although the sample was too small to carry out specific sub-analyses of the different types of intervention to which the patients recruited were subjected, it does not seem that sternal wound complications dependent on the interventions received have influenced the outcome: in fact, by removing from the analysis the 6 patients who presented this problem, the effects of the OMT on pain, respiratory function and hospitalization have remained statistically significant.