Resilience Skills Self-Management for Chronic Pain.

Fibromyalgia Clinical Trial

Official title:

Resilience Skills Self-Management for Chronic Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304613
• Other study ID #: HUM00124722
• Secondary ID: 5R01NR017096-05
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: March 21, 2023

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will conduct a randomized controlled trial of an 8-week resilience-enhanced CBT online self-management program for chronic pain plus usual care (PRISM), standard e-CBT self-management plus usual care (e-CBT), and usual care alone. Thus, 300 individuals with chronic pain will undergo a comprehensive pre-intervention assessment that includes a blood draw (T1). Participants will then be randomized 2:2:1 as follows: e-CBT (n=120), PRISM (n=120) and usual care (n = 60). Immediately post-intervention (T2) and at 6 months (T3) and 12 months (T4) after that, participants undergo the same in-person assessment including blood draw. Telomerase activity will be assessed at T1, T2 and T3; and telomere length at T1 and T4

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 21, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• Primary back or spine pain diagnosis from the Back & Pain Center at University of Michigan.
• High scores on the 2011 survey criteria for Fibromyalgia. The survey criteria for FM consist of an assessment of widespread pain and symptom severity.

Exclusion Criteria:

• Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus erythematosus.
• Medical conditions that can impair health status independent of spine pain and FM, including cardiopulmonary disorders (e.g. CHF, COPD), uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes), or malignancy within the preceding 2 years
• Current psychotic disorder (schizophrenia, etc.), dissociative identity disorder, untreated bipolar disorder, active suicide risk, or current alcohol / drug dependence.
• Planned major surgery in the next 12 months;
• Pregnancy or taking steroid medications
• Recent pain interventions =6 weeks prior to study (e.g., back surgery, epidural steroid injections) or planned interventions for the study period (e.g., surgery scheduled). Ongoing physical therapy will be allowed and new physical therapy or exercise regimen will be addressed during data analysis;
• Cognitive impairment or dementia (inability to give consent or meaningfully participate);
• Pending or recently received (within 1 years) pain-related disability or Workman's Compensation;
• Unable to read or fluently converse in English;
• Planning to move from the area in next 14 months;
• In the judgment of the PIs the individual would not be able to meaningfully participant.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Spine Pain
• Fibromyalgia

Intervention

Behavioral:
• Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management
Already noted.
• Promoting Resilience through Innovative Self-Management
Already noted.

Locations

Country	Name	City	State
United States	Back & Pain Center, University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire-Revised (FIQ-R)	The Fibromyalgia Impact Questionnaire-Revised (FIQR) assesses the total spectrum of problems and responses to therapy. The 2009 revised version contains 21 items assessing broad domains such as physical function, overall impact, and a wide range of symptoms. The measure is self-report with a recall period of the past week and requires only several minutes to complete.	At 8-week assessment point
Secondary	Brief Pain Inventory (BPI)	The BPI is a 15-item self-report measure that has been validated for use in a wide variety of pain states. The BPI assesses for the presence of pain, pain intensity (i.e., worst, least, average, current) and functional interference from pain.	At 8-week assessment point
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a widely used, valid and reliable measure of global sleep quality and sleep-related symptoms.149 The 19-items yield 7 component-scores that reflect common sleep problems such as subjective sleep quality, sleep disturbance and use of sleep medication.	At 8-week assessment point
Secondary	PROMIS Fatigue-Short Form	The PROMIS Fatigue-Short Form consists of 8 items that assess the impact and experience of fatigue in the past week. It uses a 5-point Likert-like scale with response options that range from "Not at all" to "Very much." A raw score is calculated by summing scores across items then a conversion table is used to calculate T-scores with higher scores indicating greater fatigue.	At 8-week assessment point
Secondary	Multidimensional Inventory of Subjective Cognitive Impairment (MISCI)	The MISCI is a 10-item measure based upon items developed for PROMIS that assesses perceived difficulties within 5 domains: mental clarity, memory, language, executive functioning, and attention/concentration.	At 8-week assessment point
Secondary	Subjective well-being	Subjective well-being has at least three components: positive affective appraisal, negative affective appraisal, and life satisfaction. Composite scores for well-being will be calculated using scores obtained on Positive and Negative Affect Schedule (PANAS) and the Satisfaction with Life Scale (SWLS).	At 8-week assessment point
Secondary	Pain Catastrophizing Scale (PCS)	. Catastrophizing will be measured using the Pain Catastrophizing Scale (PCS).144 The PCS contains 13 statements regarding various beliefs about pain. A total score is obtained by summing the responses to all items.	At 8-week assessment point
Secondary	Patient Health Questionnaire 9-item (PHQ-9):	The PHQ-9 is a 9-item multipurpose instrument that has utility for screening, diagnosing, monitoring, and measuring the severity of depression.	At 8-week assessment point
Secondary	Generalized Anxiety Disorder 7-item (GAD-7)	The GAD-7 is a 7-item measure of anxiety. It has good reliability, criterion, construct, and factorial validity. It has a sensitivity of 89% and specificity of 82% for generalized anxiety disorder.	At 8-week assessment point
Secondary	Perceived Stress Scale (PSS)	The 10-item PSS will be used evaluate an individual's assessment of stress. Participants rate stress on a numeric rating scale from 0 to 10 where higher scores reflect higher levels of stress. Total scores range from 0 to 100.	At 8-week assessment point
Secondary	Six-Minute Walk Test (6MWT)	The 6MWT measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. Participants are instructed to walk as far as possible, but allowed to self-pace and rest as needed.	At 8-week assessment point
Secondary	Sit-to-Stand Test	Patients are instructed to stand up 5 times from a chair without arms as fast as possible. The test is repeated twice as this improves reliability. Average time is calculated in seconds.	At 8-week assessment point
Secondary	Telomerase activity as measured by the Droplet Digital PCR (ddPCR) method	The Blackburn lab collaborated with Biorad to develop a highly sensitive, quantitative and high throughput droplet digital PCR (ddPCR) method to measure telomerase activity in unstimulated PBMCs. This new method has over 10-fold increased sensitivity and over 5-fold increased throughput compared to the currently used gel method.	At 8-week assessment point
Secondary	Telomere length	The DNA will then be analyzed for telomere length using a quantitative polymerase chain reaction (PCR) measurement assay adapted from the methods described by Cawthon with modifications by Lin (Co-I).	At 1 year assessment point