Pain, Postoperative Clinical Trial
Official title:
Quantifying Pain and Narcotic Usage Following Orthopedic Surgery Using a Text-Messaging Robot
NCT number | NCT03991546 |
Other study ID # | 201412701 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 3, 2016 |
Est. completion date | June 17, 2019 |
Verified date | August 2019 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to 1) observe the course of pain, 2) utilization of opioid pain medication, and 3) possible effect of a behavioral intervention delivered via an automated mobile phone messaging robot in patients undergoing surgical treatment of a traumatic orthopaedic injury.
Status | Completed |
Enrollment | 82 |
Est. completion date | June 17, 2019 |
Est. primary completion date | June 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Must have their own personal phone capable of sending and receiving text messages - Must be familiar with sending and receiving text messages - Must have a traumatic upper or lower extremity fracture - Must be indicated for primary operative fixation of their orthopaedic injury Exclusion Criteria: - Any open orthopaedic injuries - Current or previous infection at the injury site - Cause of injury is self inflicted non-accidental trauma - Active diagnosis of a pain syndrome or chronic condition requiring long-term pain medication usage - Indication for fracture temporization using external fixation. - Indication for revision surgery for non-union or hardware failure - Bilateral upper extremity injuries impeding patient's ability to use a mobile phone - Orthopaedic injuries limited to the distal hand and/or foot - Preoperative admission to an intensive care unit (ICU) - Active cancer diagnosis or history of malignancy receiving treatment within the last 5 years - Presence of altered mental status, intellectual disability, or dementia, which impedes a patient from ethically providing consent. - Indication for primary arthroplasty treatment of the traumatic injury |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Christopher Anthony | Orthopaedic Trauma Association |
United States,
Anthony CA, Lawler EA, Glass NA, McDonald K, Shah AS. Delivery of Patient-Reported Outcome Instruments by Automated Mobile Phone Text Messaging. Hand (N Y). 2017 Nov;12(6):614-621. doi: 10.1177/1558944716672201. Epub 2016 Oct 6. — View Citation
Anthony CA, Lawler EA, Ward CM, Lin IC, Shah AS. Use of an Automated Mobile Phone Messaging Robot in Postoperative Patient Monitoring. Telemed J E Health. 2018 Jan;24(1):61-66. doi: 10.1089/tmj.2017.0055. Epub 2017 Jun 16. — View Citation
Anthony CA, Peterson AR. Utilization of a text-messaging robot to assess intraday variation in concussion symptom severity scores. Clin J Sport Med. 2015 Mar;25(2):149-52. doi: 10.1097/JSM.0000000000000115. — View Citation
Anthony CA, Polgreen LA, Chounramany J, Foster ED, Goerdt CJ, Miller ML, Suneja M, Segre AM, Carter BL, Polgreen PM. Outpatient blood pressure monitoring using bi-directional text messaging. J Am Soc Hypertens. 2015 May;9(5):375-81. doi: 10.1016/j.jash.2015.01.008. Epub 2015 Jan 21. — View Citation
Anthony CA, Volkmar A, Shah AS, Willey M, Karam M, Marsh JL. Communication with Orthopedic Trauma Patients via an Automated Mobile Phone Messaging Robot. Telemed J E Health. 2018 Jul;24(7):504-509. doi: 10.1089/tmj.2017.0188. Epub 2017 Dec 20. — View Citation
Day MA, Anthony CA, Bedard NA, Glass NA, Clark CR, Callaghan JJ, Noiseux NO. Increasing Perioperative Communication With Automated Mobile Phone Messaging in Total Joint Arthroplasty. J Arthroplasty. 2018 Jan;33(1):19-24. doi: 10.1016/j.arth.2017.08.046. Epub 2017 Sep 19. — View Citation
Dindo L, Zimmerman MB, Hadlandsmyth K, StMarie B, Embree J, Marchman J, Tripp-Reimer T, Rakel B. Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. J Pain. 2018 Oct;19(10):1211-1221. doi: 10.1016/j.jpain.2018.04.016. Epub 2018 May 17. — View Citation
Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10. — View Citation
Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses. Clin J Pain. 2017 Jun;33(6):552-568. doi: 10.1097/AJP.0000000000000425. Review. — View Citation
Jones J Jr, Southerland W, Catalani B. The Importance of Optimizing Acute Pain in the Orthopedic Trauma Patient. Orthop Clin North Am. 2017 Oct;48(4):445-465. doi: 10.1016/j.ocl.2017.06.003. Review. — View Citation
Nicholls JL, Azam MA, Burns LC, Englesakis M, Sutherland AM, Weinrib AZ, Katz J, Clarke H. Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. Patient Relat Outcome Meas. 2018 Jan 19;9:49-64. doi: 10.2147/PROM.S121251. eCollection 2018. Review. — View Citation
Rathbone AL, Prescott J. The Use of Mobile Apps and SMS Messaging as Physical and Mental Health Interventions: Systematic Review. J Med Internet Res. 2017 Aug 24;19(8):e295. doi: 10.2196/jmir.7740. Review. — View Citation
Tofte JN, Anthony CA, Polgreen PM, Buckwalter JA, Caldwell LS, Fowler TP, Ebinger T, Hanley JM, Dowdle SB, Holte AJ, Arpey NC, Lawler EA. Postoperative care via smartphone following carpal tunnel release. J Telemed Telecare. 2018 Nov 14:1357633X18807606. doi: 10.1177/1357633X18807606. [Epub ahead of print] — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of opioid pain medication tablets consumed | Amount of outpatient opioid pain medication consumed by participating subjects during the study period. Recorded as tablets consumed allowing for the calculation of morphine milliequivalents. Collected via a pill count in clinic or over the phone. | Measurement of outcome obtained on postoperative day fourteen. | |
Primary | Change in reported pain intensity score (PROMIS Pain Intensity 1A) | Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 1A short form scores collected from all participating subjects. PROMIS Pain Intensity 1A short form is a 1 question survey measuring an individual's average pain over the past 7 days. It utilizes a scale of 0 (no pain) to 10 (worst imaginable pain). Higher values represent worse pain outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net. |
Measurements assessed in person via the standardized forms listed above on the day of surgery (enrollment) and on postoperative day fourteen, in clinic or via telephone. | |
Primary | Change in reported pain intensity score (PROMIS Pain Intensity 3A) | Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 3A short form scores collected from all participating subjects. PROMIS Pain Intensity 3A short form is a 3 question survey measuring an individual's pain over the past 7 days. It utilizes a scale of 1 (no pain) to 5 (very severe pain) for all questions. The scores for the 3 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 30.7 to 71.8 for the PROMIS Pain Intensity 3A instrument. Higher t-score values represent worse pain outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net. |
Measurements assessed in person via the standardized forms listed above on the day of surgery (enrollment) and on postoperative day fourteen, in clinic or via telephone. | |
Primary | Change in reported pain interference score | Patient-reported outcomes measurement information system (PROMIS) Pain Interference 8A short form scores collected from all participating subjects. The PROMIS Pain Interference 8A short form is an 8 question survey that measures how much pain has interfered in the respondent's life over the past 7 days. It utilizes a scale of 1 (not at all) to 5 (very much) for all questions. The scores for all 8 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 40.7 to 77.0 for the PROMIS Pain Interference 8A instrument. Higher t-score values represent worse pain interference outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net. |
Measurements assessed in person via the standardized forms listed above on the day of surgery (enrollment) and on postoperative day fourteen, in clinic or via telephone. | |
Primary | Change in reported emotional distress (anxiety) score. | Patient-reported outcomes measurement information system (PROMIS) Emotional Distress-Anxiety 8A short form scores collected from all participating subjects. The PROMIS Emotional Distress-Anxiety 8A short form is an 8 statement survey that measures how much emotional distress, specifically due to anxiety, a respondent has experienced over the past 7 days. It utilizes a scale of 1 (never) to 5 (always) for all the statements. The scores for all 8 statements are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 37.1 to 83.1 for the PROMIS Emotional Distress-Anxiety 8A instrument. Higher t-score values represent worse anxiety caused emotional distress outcomes. More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net. |
Measurements assessed in person via the standardized forms listed above on the day of surgery (enrollment) and on postoperative day fourteen, in clinic or via telephone. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05480111 -
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
|
Phase 4 | |
Completed |
NCT06129305 -
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
|
||
Completed |
NCT04401826 -
Micro-surgical Treatment of Gummy Smile
|
N/A | |
Recruiting |
NCT04020133 -
the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.
|
N/A | |
Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
Completed |
NCT03652103 -
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
|
Phase 4 | |
Completed |
NCT03546738 -
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
|
N/A | |
Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
Terminated |
NCT03261193 -
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
|
Phase 3 | |
Completed |
NCT02525133 -
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
|
Phase 3 | |
Completed |
NCT03244540 -
Regional Analgesia After Cesarean Section
|
Phase 4 | |
Enrolling by invitation |
NCT05316168 -
Post Operative Pain Management for ACL Reconstruction
|
Phase 3 | |
Recruiting |
NCT04130464 -
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
|
Phase 4 | |
Enrolling by invitation |
NCT04574791 -
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
|
N/A | |
Completed |
NCT04073069 -
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
|
Phase 4 | |
Completed |
NCT04526236 -
Influence of Aging on Perioperative Methadone Dosing
|
Phase 4 | |
Recruiting |
NCT05351229 -
Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
|
Phase 4 | |
Enrolling by invitation |
NCT05543109 -
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
|
N/A | |
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04919317 -
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
|
Phase 2 |