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NCT Number: NCT02694991

Osteopathic Manipulative Treatment Efficacy in Postoperative Pain

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.

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Key information

Conditions

Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Milan, 20148, Italy

About this study

The currently predominant means of controlling postoperative pain is the peri-operative administration of opioid or non-opioid (acetaminophen) analgesics, alone or in combination, and non-steroidal anti-inflammatory drugs (NSAIDs). However, anti-inflammatory drugs are contraindicated for many patients because they may impair renal function, interact with platelet aggregation, and increase the risk of gastrointestinal damage and bleeding. The spectrum of available options is narrow.

Osteopathic manipulative Treatment (OMT) intervenes in the process that transforms nociceptive information into the subjective experience and it may be useful.

It has been found to be effective in controlling pain after abdominal surgery, it has a beneficial effect on patients recovering coronary artery by-pass surgery and also improves cardiac function The aim of this study was to assess whether complementary OMT is an effective means of reducing post-surgical sternal pain and improving rib cage mobility after heart surgery involving sternotomy, and to investigate its advantages during in-patient rehabilitation in terms of functional recovery, and perceived anxiety and depression.

This open, randomised, semi-blinded, controlled trial involves inclusion of 80 adult patients of both genders consecutively admitted as in-patients to cardiac rehabilitation unit after undergoing elective coronary artery by-pass grafting (CABG), valve replacement or repair and/or ascending aorta surgery with sternotomy, and capable of voluntarily providing their written informed consent. The patients are divided in 2 groups, the intervention group receiving OMT and the control group. Both groups are following the same rehabilitation programme and receiving usual care.

All of the subjects taking part in the study are receiving standard care in accordance with the international guidelines for in-patient cardiac rehabilitation; the only experimental intervention is the addition of OMT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: OMT

Primary outcomes

  1. Pain intensity relief

    Time frame: 21 days

    Pain intensity measured with visual analogic scale (VAS)

Secondary outcomes

  1. Functional capacity improvement

    Time frame: 21 days

    Distance in meters walked in six minutes

  2. Respiratory function

    Time frame: 21 days

    Inspiratory volume variation measured as mL of air inspired

  3. Hospitalization length

    Time frame: 21 days

    Number of days of hospitalisation

  4. Anxiety and Depression

    Time frame: 21 days

    Hospital Anxiety and Depression Scale (HADS) score

  5. Analgesic drug consumption.

    Time frame: 21 days

    Number of analgesic drug doses taken

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Osteopathic Manipulative Treatment Efficacy in Sternal Pain Management After Heart Surgery

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 1, 2016
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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