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NCT03927846

Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management

Completed NA Results posted Last updated 19 November 2024
What this trial tests

NA trial testing Nurse-guided Web-based Cognitive Behavioral Therapy in Chronic Musculoskeletal Pain in 60 participants. Completed in 18 January 2021.

Timeline
17 July 2019
Primary endpoint
18 January 2021
18 January 2021

Quick facts

Lead sponsorWake Forest University Health Sciences
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment60
Start date17 July 2019
Primary completion18 January 2021
Estimated completion18 January 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Chronic Musculoskeletal Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity Primary · Up to Week 16

Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome

GroupValue95% CI
Nurse Support4.4± 0.3
Control4.7± 0.2
PROMIS Pain Interference Primary · Up to Week 16

PROMIS pain interference is a questionnaire that measures interference of pain on subject's life. The possible raw score range is 6-30. The raw score has been converted into a T score. The T score range is from 41.6 to 75.6. A t-score indicates the number of standard deviations away from the mean. A t-score of 50 is equal to the mean of a reference population. Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population.

GroupValue95% CI
Nurse Support57.4± 0.9
Control57.3± 0.9
Completed Phone Calls Secondary · Up to Week 16

The number of completed phone calls by the nurse will be recorded.

GroupValue95% CI
Nurse Support3.52 – 5
Control00 – 0
Completed Learning Modules Per Treatment Arm Secondary · Week 16

The number of completed learning modules per treatment arm will be recorded.

GroupValue95% CI
Nurse Support71 – 8
Control81 – 8
BPI Pain Interference Secondary · Up to Week 16

This is a questionnaire that shows a subject's perceived interference of pain in his/her daily life. The BPI pain interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference).A pain interference score is calculated from the mean of the seven pain interference items.

GroupValue95% CI
Nurse Support3.5± 0.3
Control3.5± 0.3

Sponsor's own description

To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Chronic Musculoskeletal Pain

Currently open trials in the same condition.

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03927846.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing