SurgeryPhase 4NCT02694991
Osteopathic Manipulative Treatment Efficacy in Postoperative Pain
A Phase 4 study testing Osteopathic Manipulative Treatment in people with Surgery and Pain, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent artery bypass grafting (CABG)
- Recent valve replacement or repair
- Recent ascending aorta surgery
Who cannot join
- Heart surgery using mini-thoracotomy.
- Heart transplantation
- Implant of a ventricular assistance device
- Diabetes mellitus
- Rheumatoid arthritis
- Autoimmune diseases
- Altered cognitive capacities
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Don C. Gnocchi ; Istituto S. Maria Nascente IRCCS
Milan, 20148
About this study
Official title: Osteopathic Manipulative Treatment Efficacy in Sternal Pain Management After Heart Surgery
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.
Read the detailed description
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
- Being tested
- Osteopathic Manipulative Treatment
- Keywords
- surgery, outcome, pain, osteopathic manipulative treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
Also called OMT
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.
| Study group | Role | What they receive |
|---|---|---|
| OMT Group | Experimental | Osteopathic Manipulative Treatment 15 minutes once a day for 8 days Receives: Other: Osteopathic Manipulative Treatment |
| Control Group | No intervention | No intervention, only usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity relief
Pain intensity measured with visual analogic scale (VAS)
Measured: 21 days
Secondary outcomes (5)
Functional capacity improvement
Distance in meters walked in six minutes
Measured: 21 days
Respiratory function
Inspiratory volume variation measured as mL of air inspired
Measured: 21 days
Hospitalization length
Number of days of hospitalisation
Measured: 21 days
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS) score
Measured: 21 days
Analgesic drug consumption.
Number of analgesic drug doses taken
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Mocarelli, Prof, Study chair, Fondazione Don C. Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694991
- Sponsor's protocol ID
- 0001-2013
- Status last verified
- Feb 2016
- First submitted
- 19 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: to upload the data base file of all results of the present trial
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment Efficacy in Sternal Pain Management After Heart Surgery
- ClinicalTrials.gov ID
- NCT02694991
- Acronym / sponsor ID
- 0001-2013
- Keywords
- surgery, outcome, pain, osteopathic manipulative treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT Group | Experimental | Other: Osteopathic Manipulative TreatmentOsteopathic Manipulative Treatment 15 minutes once a day for 8 days |
| Control Group | No intervention | –No intervention, only usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recent artery bypass grafting (CABG)
- Recent valve replacement or repair
- Recent ascending aorta surgery
Key exclusion criteria (7 listed)
- Heart surgery using mini-thoracotomy.
- Heart transplantation
- Implant of a ventricular assistance device
- Diabetes mellitus
- Rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentAlso: OMTThe 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 | OMT Group |
Primary outcome
Pain intensity relief
Time frame: 21 days
Pain intensity measured with visual analogic scale (VAS)
5 secondary outcomes
Functional capacity improvement
Time frame: 21 days
Respiratory function
Time frame: 21 days
Hospitalization length
Time frame: 21 days
Anxiety and Depression
Time frame: 21 days
Analgesic drug consumption.
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Individual participant dataSharing planned: Yes. to upload the data base file of all results of the present trial
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Mocarelli, Prof study chair
Fondazione Don C. Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Osteopathic Manipulative Treatment in people with Surgery and Pain, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity relief (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.