Phase 3
Completed N=134
Combined Behavioral and Analgesic Trial for Fibromyalgia
Source: ClinicalTrials.gov NCT01598753 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function — 24; 13; 21; 15 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a randomized control study that involves a combination of a drug treatment, behavioral health, and placebo controls.
Some participants will receive a medication approved by the Food and Drug Administration for treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive an inactive pill, called a placebo. There will also be 2 different types of behavioral health treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have been recommended for the treatment of patients with FM by the American Pain Society.
There are 4 possible study treatment combinations:
1. Tramadol + CBT,
2. Tramadol + HE,
3. Placebo + CBT,
4. Placebo + HE.
Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there have been no studies that have evaluated the combination of medication and a behavioral health treatment. The primary purpose of this study is to compare the benefits of the 4 combinations listed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function |
24; 13; 21; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Males and Females 21-70
- Diagnosis of Fibromyalgia
- Current primary care physician
- Fluent in English
Exclusion Criteria
- Rheumatologic disorders
- Drug and alcohol abuse in the past year
- Psychiatric hospitalization in the past 6 months
- Current use of Tramadol
- Certain antidepressant and other pain medications
Data sourced from ClinicalTrials.gov (NCT01598753). 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. Informational only — not medical advice.