Fibromyalgia
Conditions
Brief 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.
Interventions
DRUGTramadol
50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day. Minimum accepted dose of 200mg per day
DRUGPlacebo
Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
BEHAVIORALCognitive Behavior Therapy for FM
Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.
BEHAVIORALHealth Education
Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function | Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline). | The primary outcome is a reduction of at least 30% on the pain score (mean for 5-day daily pain diary) or improvement of 20% physical function (FIQR) from baseline (pre-treatment) to post-treatment. Individuals who achieve such decrease in pain or increase in function are labeled responders. |
Countries
United States
Participant flow
Recruitment details
Participants with fibromyalgia (FM) were enrolled at 2 sites, the University of Washington in Seattle WA and the University of Rochester in Rochester NY.
Pre-assignment details
Participants underwent a physical exam to rule out conflicting medical conditions and confirm a diagnosis of FM (1990 ACR criteria). A 5-day baseline diary was distributed and required a mean daily pain score ≥ 4 and ≤ 9. A urine drug test with no illicit drugs and a negative urine pregnancy test (when applicable) were also required at baseline.
Participants by arm
| Arm | Count |
|---|---|
| Placebo and Health Education Participants received a matching placebo and 8 weekly 50 minute sessions of health education on Fibromyalgia. | 37 |
| Tramadol and Health Education Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia. | 31 |
| Placebo and Cognitive Behavioral Therapy Participants received matching placebo and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients. | 32 |
| Tramadol and Cognitive Behavioral Therapy Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of Cognitive Behavioral Therapy that had been specifically tailored for Fibromyalgia patients. | 34 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 9 | 1 | 7 |
| Overall Study | Lost to Follow-up | 4 | 3 | 7 | 5 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 7 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo and Health Education | Tramadol and Health Education | Placebo and Cognitive Behavioral Therapy | Tramadol and Cognitive Behavioral Therapy | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 12.9 | 51.2 years STANDARD_DEVIATION 10.8 | 48.9 years STANDARD_DEVIATION 13.1 | 44.64 years STANDARD_DEVIATION 13.1 | 48.7 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 29 Participants | 30 Participants | 33 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 35 Participants | 25 Participants | 29 Participants | 28 Participants | 117 Participants |
| Sex: Female, Male Female | 34 Participants | 28 Participants | 30 Participants | 31 Participants | 123 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 31 | 0 / 32 | 0 / 34 |
| other Total, other adverse events | 23 / 37 | 27 / 31 | 21 / 32 | 25 / 34 |
| serious Total, serious adverse events | 0 / 37 | 0 / 31 | 0 / 32 | 0 / 34 |
Outcome results
Primary
Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function
The primary outcome is a reduction of at least 30% on the pain score (mean for 5-day daily pain diary) or improvement of 20% physical function (FIQR) from baseline (pre-treatment) to post-treatment. Individuals who achieve such decrease in pain or increase in function are labeled responders.
Time frame: Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo and Health Education | Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function | 24 Participants |
| Tramadol and Health Education | Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function | 13 Participants |
| Placebo and Cognitive Behavioral Therapy | Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function | 21 Participants |
| Tramadol and Cognitive Behavioral Therapy | Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function | 15 Participants |