N/A
N=60
Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management
Chronic Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT03927846 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity — 4.4; 4.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nurse-guided Web-based Cognitive Behavioral Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity |
4.4; 4.7 | — |
| PRIMARY PROMIS Pain Interference |
57.4; 57.3 | — |
| SECONDARY Completed Phone Calls |
3.5; 0 | — |
| SECONDARY Completed Learning Modules Per Treatment Arm |
7; 8 | — |
Summary
To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints.
Eligibility Criteria
Inclusion Criteria: -
- patients at the primary care or rheumatology clinic with daily pain for 6 months or longer affecting the low back, neck, hip, knee or widespread pain;
- at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24;
- at least 18 years of age;
- reliable phone (landline or cell), and
- have home computer with reliable internet access.
Exclusion Criteria
- planned elective surgery during the study period;
- very severe symptoms of depression (i.e., The eight-item Patient Health Questionnaire depression scale (PHQ8) score of ≥ 20);
- ongoing unresolved disability claims;
- inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.);
- cancer-related musculoskeletal pain;
- history of bipolar disorder or schizophrenia; and
- takes daily opioid for more than one year.
Data sourced from ClinicalTrials.gov (NCT03927846). 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.