A Telephone Feedback System for Prevention of Chronic Pain Relapse
NCT ID: NCT00266773
Last Updated: 2013-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2005-11-30
2012-01-31
Brief Summary
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Detailed Description
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* an automated daily questionnaire for self-monitoring
* a review of coping skills
* guided behavioral rehearsals of CST coping skills
* personalized monthly feedback messages recorded onto TIVR by the therapist
All four components can be accessed remotely by patients via any touch-tone phone. In a small pilot study, people with severe, chronic musculoskeletal pain received 11 weeks of either CST alone or CST with TIVR access and therapist feedback. Those who used TIVR had better pain outcomes than those who did not. This study will compare the effectiveness of TIVR with or without therapist feedback to a control group not using TIVR at all.
To be eligible for this study, participants must have just completed an 11-week course of CST through the University of Vermont College of Medicine's MindBody Medicine Clinic. At study entry, participants will be randomly assigned to one of three groups. Group 1 is a control group that will not receive any intervention through this study. Group 2 participants will receive full access to TIVR and will get a minimal monthly message from their therapist, who will not use the participant's daily questionnaire data. Group 3 participants will receive full access to TIVR and will get personalized monthly messages from their therapist based on the participant's daily questionnaire data. Messages for participants will include any trends the therapist has noted in a participant's stress, sleep, mood, pain levels, coping, and activity, as reported through TIVR. All study participants may continue to receive treatment from their regular physician or take part in other pain management techniques during this study, but such treatment will not be provided through this study.
Upon completing the 11 weeks of CST, all participants will be asked to complete a packet of questionnaires about their chronic pain. At the start of this study, participants in Groups 2 and 3 will have a 30-minute training session on how to use and access TIVR. At Months 4, 8, and 12, participants from all three groups will have follow-up interviews and will complete additional questionnaires.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Control - standard care only
No interventions assigned to this group
2
Attention Control - standard care plus 6 months TIVR receiving minimal monthly feedback
Chronic pain therapeutic interactive voice response (TIVR) system
Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls
3
Standard care plus 6 months TIVR receiving detailed monthly feedback
Chronic pain therapeutic interactive voice response (TIVR) system
Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls
Interventions
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Chronic pain therapeutic interactive voice response (TIVR) system
Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls
Eligibility Criteria
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Inclusion Criteria
* At least 6 months of musculoskeletal pain caused by back, neck, or shoulder pain; osteoarthritis; or fibromyalgia
* Meet study threshold for pain severity with a Typical Pain score of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire (80)
* Receiving ongoing standard pain management from a physician (typically involving oral analgesic medication and physical therapy, with or without anesthetic or steroid injections)
Exclusion Criteria
* Cancer that causes or influences patient's chronic pain
* Cancer requiring radiation or chemotherapy or metastatic cancer of any type
* Reflex sympathetic dystrophy (RSD)
* Neuropathic pain
* Awaiting a pain-related surgical procedure
* Involved in pain-related litigation or awaiting disability determination
* Behavioral problems or psychotic disorders that may interfere with the study
* Inability to use telephone-based TIVR due to cognitive or hearing impairment
* At risk for suicide
18 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Vermont Medical Center
OTHER
University of Vermont
OTHER
Responsible Party
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Magdalena Naylor, MD, PhD
Magdalena R. Naylor, MD, PhD
Principal Investigators
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Magdalena R. Naylor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont College of Medicine - MindBody Medicine Clinic
Locations
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University of Vermont College of Medicine - MindBody Medicine Clinic
Burlington, Vermont, United States
Countries
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References
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Keefe FJ, Rumble ME, Scipio CD, Giordano LA, Perri LM. Psychological aspects of persistent pain: current state of the science. J Pain. 2004 May;5(4):195-211. doi: 10.1016/j.jpain.2004.02.576.
Naylor MR, Helzer JE, Naud S, Keefe FJ. Automated telephone as an adjunct for the treatment of chronic pain: a pilot study. J Pain. 2002 Dec;3(6):429-38. doi: 10.1054/jpai.2002.129563.
Related Links
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Click here for the University of Vermont College of Medicine - MindBody Medicine Clinic Web site
Other Identifiers
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