Chronic Pain Clinical Trial
Official title:
Digital Self-Management of Chronic Pain
NCT number | NCT04865263 |
Other study ID # | US3 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | August 1, 2022 |
Verified date | February 2023 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators aim to validate if a digital tool for increased self-management of chronic pain can improve the quality of life for patients with chronic pain. The validation is based on the change in pain interference (Quality of life), pain intensity, physical functioning, depression, and anxiety based on self-reported information from baseline to study end.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 18 years of age - > 3 months low back or neck pain - Average daily numeric rating scale (NRS) score of 4 in the low back or neck Back or neck pain is the primary area of pain (NRS scores < 4 in other areas of pain) - Agree to using the web-based application on a daily basis for 12 weeks - No anticipated plans for back or neck surgery for at least 6 months - Have the knowledge and proficiency and access to use a smart phone, tablet or computer in the English language - Physically able to engage in basic physical activity (e.g. ambulation, light exercise, physical therapy exercises, etc.) - Agree to remain on stable doses of medication and a stable treatment regimen Exclusion Criteria: - Low back pain requiring surgical intervention in the next 6 months - Severe or acute psychiatric illness, severe anxiety or depression - Current history of substance use disorder - Serious illness in active treatment - Pain related to malignancy - Other areas of pain exceeding the level/intensity of low back or neck pain - Currently involved in a lawsuit or pending litigation in relation to the low back or neck pain |
Country | Name | City | State |
---|---|---|---|
United States | Newton-Wellesley Hospital- Ambulatory Pain Service | Newton | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Lund University | Newton-Wellesley Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain interference | Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 6a . Measure of the amount of interference pain causes in life; range 6-30; higher is worse | 6 and 12 weeks from baseline | |
Secondary | Pain severity | Change from Baseline in the 7 day average pain intensity. Measured by NRS using an 11-point Pain Intensity Numerical Rating Scale (NRS) (0=no pain, 10=pain as bad as you can imagine) | 6 and 12 weeks from baseline | |
Secondary | Physical function | Change from baseline in physical function, measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Physical function 10a. Measure of the impact of a condition on physical function; range 4-20; higher is worse |
6 and 12 weeks from baseline | |
Secondary | Depression | Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression 4a. Measures the extent to which patients experience depressive symptoms over the past 7 days. Raw scores range from 4-20 with lower scores representing less endorsement of depression |
6 and 12 weeks from baseline | |
Secondary | Anxiety | Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety 4. Measures the extent to which patients experience anxiety symptoms over the past 7 days. Raw scores range from 4-20 with lower scores representing less endorsement of anxiety. |
6 and 12 weeks from baseline | |
Secondary | Pain Catastrophizing | The Pain Catastrophizing Scale (PCS) is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing The theoretical range of the instrument is between 0 and 52, with low scores indicating low catastrophizing, and high values showing high catastrophizing. | 6 and 12 weeks from baseline | |
Secondary | Chronic Pain Acceptance | Chronic Pain Acceptance Questionnaire-8 (CPAQ-8) CPAQ-8 is an 8-question survey that measures the level of patient acceptance of pain. The scale ranges from 0-48 and where a higher scores corresponds to greater acceptance of pain. | 6 and 12 weeks from baseline |
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