Postoperative Nausea and VomitingPhase 1/2NCT00387361
Osteopathic Manipulative Treatment for Post-Operative Nausea and Vomiting
A Phase 1/2 study testing Osteopathic Manipulative Treatment in people with Postoperative Nausea and Vomiting, run by University of North Texas Health Science Center.
Trial summary
The purpose of this study is to determine if Osteopathic Manipulative Treatment (OMT) is effective in reducing nausea and vomiting experienced by patients recovering from anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Feb 2008
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery Type: orthopedic surgical procedures of the extremities (including, but not limited to, shoulder, elbow, wrist, hip, knee, and ankle) with estimated blood loss < 250 cc
- Surgery Duration: 30-180 minutes
- Anesthesia Type: General
- Procedure to be conducted at John Peter Smith Hospital
- Age: 18-75
- American Society of Anesthesiologists Classification < 3
Who cannot join
- Presence or likelihood of joint sepsis
- Confirmed or suspected pregnancy
- *Increased intracranial pressure, skull fracture, or head trauma within 3 months prior to surgery (by history)
- *Oxygen dependence at home (by history)
- *Active or chronic hepatitis B or C (by history)
- *Hepatocellular carcinoma (by history)
- *Disruption of Blood-Brain barrier: uncontrolled HTN, tumor (current or history of), meningitis or encephalitis (within 3 months prior to surgery), epilepsy (by history)
About this study
Official title: Osteopathic Manipulative Treatment (OMT) as Possible Prophylaxis Against Post-Operative Nausea and Vomiting (PONV) in Patients Receiving Inhalational Anesthesia
The purpose of this study is to determine if Osteopathic Manipulative Treatment (OMT) is effective in reducing nausea and vomiting experienced by patients recovering from anesthesia. OMT is a treatment in which the physician places his hands on areas of the body and applies pressure to correct disturbances in one area that may be related to a problem in another area of the body. Osteopathic Manipulative Medicine is a specialty for a physician who uses OMT.
The hypothesis of this study is when OMT is combined with standard-of-care prophylactic anti-emetic therapy in patients following administration of inhalational anesthesia, in comparison to a control group receiving only standard-of-care anti-emetic prophylaxis there will be a reduction in the incidence and severity of PONV.
Read the detailed description
This research study is a prospective, randomized, single-blinded, controlled, clinical trial under the principal investigator, Hollis King, DO, PhD with the University of North Texas - Health Science Center, Texas College of Osteopathic Medicine. The purpose of this study is to determine the effectiveness of osteopathic manipulative treatment (OMT) as an adjunctive modality to standard medical care for reduction of post-operative nausea and vomiting (PONV). This is the first attempt to study the treatment of PONV utilizing OMM; this study is being conducted as a pilot study
The hypothesis of this study is when OMT is combined with standard-of-care prophylactic anti-emetic therapy in patients following administration of inhalational anesthesia, in comparison to a control group receiving only standard-of-care anti-emetic prophylaxis there will be a reduction in the incidence and severity of PONV.
Two aims will guide this study toward evaluation of the hypothesis:
AIM I: To demonstrate the effect of OMT and standard care on the number of episodes of emesis experienced post-operatively by subjects having undergone anesthesia utilizing inhalational anesthesia (alone or in combination with intravenous anesthetics). All subjects will receive the treatment or "no-treat" protocol to which they are randomized. Data will be collected prior to discharge from the post-anesthesia care unit (PACU) to enumerate the episodes of emesis experienced by each study subject. Subjects will be asked to complete the Ambulatory Surgery-Rhodes Index of Nausea, Vomiting, and Retching (AS-RINVR) 24-48 hours following surgery when a post-study questionnaire is completed.1
AIM II: To demonstrate the effect of OMT and standard care on the intensity of nausea experienced post-operatively by subjects having undergone anesthesia utilizing inhalational anesthesia (alone or in combination with intravenous anesthetics). Following a subject's completion of the treatment protocol (or "no-treat" if so randomized), the nausea visual analog scale (VAS) validated by Boogaerts will be employed at 30 minutes, 1 hour, and 24-36 hours following their post-operative, post-anesthesia treatment protocol. Results will be compared between the control and experimental group for differences.
Osteopathic manipulative medicine (OMM) and OMT seek, in general, to facilitate a more optimal and often faster return to health and homeostasis. Though individuals largely seek out OMT for alleviation of structural and musculoskeletal complaints, its uses have been speculated and discovered to have effects also on physiologic mechanisms. Osteopathic manipulative treatment maneuvers to the head, neck, and upper thoracic spine may impart postulated mechanisms for PONV.3 Successful treatment will be measured by the reduction of PONV, as evaluated on several outcome measures, in a group of subjects receiving post-operative OMT along with standard-of-care treatment over those in the control group only receiving standard-of-care treatment for their PONV. Successful completion of all of the above specific aims will not only validate the hypothesis of this study but will also establish the study's effect and feasibility for future study. Additionally, this pilot study will establish the statistical trends needed to establish effect size data which is needed for power analysis and sample size estimates for future studies.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Osteopathic Manipulative Treatment
- Keywords
- Post-Operative Nausea, Nausea, Anesthesia, Osteopathic Manipulative Treatment, Osteopathic Manipulative Medicine, Manipulation, Osteopathic, Osteopathy, Texas College of Osteopathic Medicine
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
20 minute post-operative osteopathic manipulation as described in the protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Osteopathic Manipulative Treatment |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the episodes of emesis
Reduction in the intensity of nausea
Secondary outcomes (1)
Post-anesthesia recollection of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Investigators
- Hollis H King, DO, PhD, Principal investigator, UNTHSC - TCOM, Department of OMM; Osteopathic Research CenterSimon L Schrick-Senasac, OMS-IV, PDF, Study director, UNTHSC-TCOM, Department of OMM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387361
- Sponsor's protocol ID
- 2006-56
- Status last verified
- Jan 2011
- First submitted
- 12 Oct 2006
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Fetzer SJ, Hand MC, Bouchard PA, Smith H, Jenkins MB. Evaluation of the Rhodes Index of Nausea and Vomiting for ambulatory surgery patients. J Adv Nurs. 2004 Jul;47(1):74-80. doi: 10.1111/j.1365-2648.2004.03067.x.
PubMed 15186470Scuderi PE, Conlay LA. Postoperative nausea and vomiting and outcome. Int Anesthesiol Clin. 2003 Fall;41(4):165-74. doi: 10.1097/00004311-200341040-00012. No abstract available.
PubMed 14574220Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
PubMed 10757584Willard FH. Autonomic nervous system. In: Ward, Robert C., D.O., F.A.A.O., ed. Foundations for Osteopathic Medicine. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 2003:90.
American Society of Anesthesiologists. ASA Physical Status Classification System. Available at: http://www.asahq.org/clinical/physicalstatus.htm. Accessed May 11, 2006.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment (OMT) as Possible Prophylaxis Against Post-Operative Nausea and Vomiting (PONV) in Patients Receiving Inhalational Anesthesia
- ClinicalTrials.gov ID
- NCT00387361
- Acronym / sponsor ID
- 2006-56
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Post-Operative Nausea, Nausea, Anesthesia, Osteopathic Manipulative Treatment, Osteopathic Manipulative Medicine, Manipulation, Osteopathic, Osteopathy, Texas College of Osteopathic Medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Oct 2006 (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.
The purpose of this study is to determine if Osteopathic Manipulative Treatment (OMT) is effective in reducing nausea and vomiting experienced by patients recovering from anesthesia. OMT is a treatment in which the physician places his hands on areas of the body and applies pressure to correct disturbances in one area that may be related to a problem in another area of the body. Osteopathic Manipulative Medicine is a specialty for a physician who uses OMT.
The hypothesis of this study is when OMT is combined with standard-of-care prophylactic anti-emetic therapy in patients following administration of inhalational anesthesia, in comparison to a control group receiving only standard-of-care anti-emetic prophylaxis there will be a reduction in the incidence and severity of PONV.
Detailed description
This research study is a prospective, randomized, single-blinded, controlled, clinical trial under the principal investigator, Hollis King, DO, PhD with the University of North Texas - Health Science Center, Texas College of Osteopathic Medicine. The purpose of this study is to determine the effectiveness of osteopathic manipulative treatment (OMT) as an adjunctive modality to standard medical care for reduction of post-operative nausea and vomiting (PONV). This is the first attempt to study the treatment of PONV utilizing OMM; this study is being conducted as a pilot study
The hypothesis of this study is when OMT is combined with standard-of-care prophylactic anti-emetic therapy in patients following administration of inhalational anesthesia, in comparison to a control group receiving only standard-of-care anti-emetic prophylaxis there will be a reduction in the incidence and severity of PONV.
Two aims will guide this study toward evaluation of the hypothesis:
AIM I: To demonstrate the effect of OMT and standard care on the number of episodes of emesis experienced post-operatively by subjects having undergone anesthesia utilizing inhalational anesthesia (alone or in combination with intravenous anesthetics). All subjects will receive the treatment or "no-treat" protocol to which they are randomized. Data will be collected prior to discharge from the post-anesthesia care unit (PACU) to enumerate the episodes of emesis experienced by each study subject. Subjects will be asked to complete the Ambulatory Surgery-Rhodes Index of Nausea, Vomiting, and Retching (AS-RINVR) 24-48 hours following surgery when a post-study questionnaire is completed.1
AIM II: To demonstrate the effect of OMT and standard care on the intensity of nausea experienced post-operatively by subjects having undergone anesthesia utilizing inhalational anesthesia (alone or in combination with intravenous anesthetics). Following a subject's completion of the treatment protocol (or "no-treat" if so randomized), the nausea visual analog scale (VAS) validated by Boogaerts will be employed at 30 minutes, 1 hour, and 24-36 hours following their post-operative, post-anesthesia treatment protocol. Results will be compared between the control and experimental group for differences.
Osteopathic manipulative medicine (OMM) and OMT seek, in general, to facilitate a more optimal and often faster return to health and homeostasis. Though individuals largely seek out OMT for alleviation of structural and musculoskeletal complaints, its uses have been speculated and discovered to have effects also on physiologic mechanisms. Osteopathic manipulative treatment maneuvers to the head, neck, and upper thoracic spine may impart postulated mechanisms for PONV.3 Successful treatment will be measured by the reduction of PONV, as evaluated on several outcome measures, in a group of subjects receiving post-operative OMT along with standard-of-care treatment over those in the control group only receiving standard-of-care treatment for their PONV. Successful completion of all of the above specific aims will not only validate the hypothesis of this study but will also establish the study's effect and feasibility for future study. Additionally, this pilot study will establish the statistical trends needed to establish effect size data which is needed for power analysis and sample size estimates for future studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Osteopathic Manipulative Treatment |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Surgery Type: orthopedic surgical procedures of the extremities (including, but not limited to, shoulder, elbow, wrist, hip, knee, and ankle) with estimated blood loss < 250 cc
- Surgery Duration: 30-180 minutes
- Anesthesia Type: General
- Procedure to be conducted at John Peter Smith Hospital
- Age: 18-75
Key exclusion criteria (7 listed)
- Presence or likelihood of joint sepsis
- Confirmed or suspected pregnancy
- *Increased intracranial pressure, skull fracture, or head trauma within 3 months prior to surgery (by history)
- *Oxygen dependence at home (by history)
- *Active or chronic hepatitis B or C (by history)
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 Treatment20 minute post-operative osteopathic manipulation as described in the protocol | Procedure or surgery | 1 |
Primary outcome
Reduction in the episodes of emesis
Reduction in the intensity of nausea
1 secondary outcome
Post-anesthesia recollection of treatment
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 12 Jan 2011.
- Background: PubMed 15186470Fetzer SJ, Hand MC, Bouchard PA, Smith H, Jenkins MB. Evaluation of the Rhodes Index of Nausea and Vomiting for ambulatory surgery patients. J Adv Nurs. 2004 Jul;47(1):74-80. doi: 10.1111/j.1365-2648.2004.03067.x.
- Background: PubMed 14574220Scuderi PE, Conlay LA. Postoperative nausea and vomiting and outcome. Int Anesthesiol Clin. 2003 Fall;41(4):165-74. doi: 10.1097/00004311-200341040-00012. No abstract available.
- Background: PubMed 10757584Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
- BackgroundWillard FH. Autonomic nervous system. In: Ward, Robert C., D.O., F.A.A.O., ed. Foundations for Osteopathic Medicine. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 2003:90.
- BackgroundAmerican Society of Anesthesiologists. ASA Physical Status Classification System. Available at: http://www.asahq.org/clinical/physicalstatus.htm. Accessed May 11, 2006.
- Website of the American Osteopathic AssociationLink provided by the sponsor.
Related trials for Postoperative Nausea and Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Hollis H King, DO, PhD principal investigator
UNTHSC - TCOM, Department of OMM; Osteopathic Research Center
Simon L Schrick-Senasac, OMS-IV, PDF study director
UNTHSC-TCOM, Department of OMM
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Osteopathic Manipulative Treatment in people with Postoperative Nausea and Vomiting, run by University of North Texas Health Science Center.
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 6 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 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduction in the episodes of emesis. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00387361, which also lists 5 linked publications.
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 12 Jan 2011.