N/A
N=328
Chronic Pain Skills Study
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02653664 ↗Enrolled (actual)
328
Serious AEs
15.9%
Results posted
Oct 2021
Primary outcome: Primary: Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment) — -.57; -.61; -.85 score on a scale — p=.39
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PsychoEducation (Behavioral); Self-Hypnosis Training (Behavioral); Mindfulness Meditation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment) |
-.57; -.61; -.85 | .39 |
Summary
Chronic pain is a significant problem for many Veterans, including new Veterans returning from Iraq and Afghanistan. It is also associated with a number of other significant problems, such as post-traumatic stress disorder and sleep problems. All of these can have significant negative effects of the quality of life of Veterans
Three different types of treatment that have been used to treat chronic pain in the general population include self-hypnosis, education about chronic pain, and teaching individuals how to be more mindful. The purpose of this study is to see if these three treatments can help decrease pain in Veterans. Additionally, the researchers want to determine if each of these treatments can help reduce the negative consequences associated with pain, such as changes in mood, sleep, and enjoyment of life.
Different types of treatment that include self-hypnosis, education about chronic pain, and learning skills on how to change how a person perceives his/her pain have been used to treat chronic pain the general population.
The purpose of this study of this study is to see if these different treatments can help decrease pain and improve quality of life in Veterans with chronic pain, and determine how and why these treatments are effective. A subject must have a Veteran status, have chronic pain, speak English and be at least 18 years old to participate.
Sleep Sub-Study
Chronic pain and sleep problems are common among Veterans. Study researchers believe the treatment interventions provided as part of the main study will help improve pain and sleep. However, the main study does not include a "real time" measurement of sleep nor does it include any specific strategies for examining the relationship between sleep and pain.
Previous research has shown that adequate sleep has been linked to improvements in pain reports. Adversely, sleep deprivation has been found to increase pain perception since it decreases a person's ability to disengage from pain. Therefore, the purpose of this sub-study is to measure sleep in order to learn more about how it interacts with chronic pain.
All of the subjects in this sub-study will be Veterans recruited from VA Puget Sound who experience moderate-to-severe chronic pain on a regular basis and who have enrolled in the main study. Study investigators will enroll up to 135 subjects into the sub-study.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older;
- Veteran eligible for services through Veteran Health Affairs;
- experience moderate to severe chronic pain on a regular basis; and
- able to read, speak and understand English.
Exclusion Criteria
- severe cognitive impairment;
- current or history of psychiatric or behavioral issues that require immediate attention and/or prevent the subject from participating effectively in the study;
- reported use of a high dose of an opioid(s).
Data sourced from ClinicalTrials.gov (NCT02653664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.