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NCT00608530 · ClinicalTrials.gov registry record · NA
Telehealth Outreach for Chronic Back Pain
A NA study of Pain and Back Pain, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 127
- Enrollment target
- 1
- Study location
NCT00608530: Completed NA study of Pain and Back Pain, sponsored by VA Office of Research and Development.
NCT00608530 is a NA study of Pain and Back Pain that has completed, run by VA Office of Research and Development. The registered enrollment target is 127 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00608530, a NA study of Pain and Back Pain, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 127 participants
- Enrollment target
- 1
- Study location
Study Summary
Two separate double double blind, randomized, parallel groups, two-arm, 8 week clinical trials with 6-moth follow-up were conducted using identical inclusion/exclusion criteria and assessment batteries. In both studies patients had chronic low back pain of non-neoplastic origin. In both studies patients were randomized to one of two conditions, either a Cognitive Behavioral-based Therapy or a control condition, a supportive (Rogerian) psychotherapy. Both the cognitive-behavioral and supportive psychotherapy conditions consisted of home-based, telephone supported treatment, with 10 hours of contact time delivered over 8 weeks. In the first study (Study 1) the behavioral and Rogerian interventions were delivered by a licensed psychologist. In the second (Study 2) the interventions were delivered by a medical primary care nurse.
Primary Outcome
The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase "because of my back pain" (e.g., "Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often"). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy-Psychologist-Delivered
- BEHAVIORAL Supportive Psychotherapy-Psychologist-Delivered
- BEHAVIORAL Cognitive Behavioral Therapy Nurse-Delivered
- BEHAVIORAL Supportive Psychotherapy-Nurse-Delivered
Study Locations (1)
California
- VA San Diego Healthcare System, San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2008-03 |
| Est. Completion | 2015-12-31 |
| Phase | NA |
What the finished NCT00608530 record still lists
NCT00608530 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 4 interventions - of which Cognitive Behavioral Therapy-Psychologist-Delivered is the first listed.
NCT00608530 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00608530 about?
NCT00608530 is a clinical study titled "Telehealth Outreach for Chronic Back Pain". Two separate double double blind, randomized, parallel groups, two-arm, 8 week clinical trials with 6-moth follow-up were conducted using identical inclusion/exclusion criteria and assessment batteries. In both studies patients had chronic low back pain of non-neoplastic origin. In both studies pati...
What is the current status of trial NCT00608530?
This trial is currently completed. It is a NA study. The enrollment target is 127 participants. The study started on 2008-03. Estimated completion is 2015-12-31.
What conditions does trial NCT00608530 study?
This clinical trial studies the following conditions: Pain, Back Pain.
What interventions are being tested in trial NCT00608530?
The interventions under investigation include: Cognitive Behavioral Therapy-Psychologist-Delivered (BEHAVIORAL), Supportive Psychotherapy-Psychologist-Delivered (BEHAVIORAL), Cognitive Behavioral Therapy Nurse-Delivered (BEHAVIORAL), Supportive Psychotherapy-Nurse-Delivered (BEHAVIORAL).
Who is sponsoring clinical trial NCT00608530?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00608530 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00608530's enrollment target sits among peer trials
127 129th of 374 higher than 246 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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