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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol | Active Comparator |
| |
| Placebo | Placebo Comparator |
| |
| Cognitive Behavior Therapy for FM | Active Comparator |
| |
| Health Education | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | United States | |||
| University of Washington |
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 with fibromyalgia (FM) were enrolled at 2 sites, the University of Washington in Seattle WA and the University of Rochester in Rochester NY.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo and Health Education | Participants received a matching placebo and 8 weekly 50 minute sessions of health education on Fibromyalgia. |
| FG001 | Tramadol and Health Education | Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo and Health Education | Participants received a matching placebo and 8 weekly 50 minute sessions of health education on Fibromyalgia. |
| BG001 | Tramadol and Health Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | Posted | Count of Participants | Participants | Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline). |
|
Adverse events were reported from signing the informed consent until the completion of the 6-month follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo and Health Education | Participants received a matching placebo and 8 weekly 50 minute sessions of health education on Fibromyalgia. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis C. Turk, Ph.D. | University of Washington | (206)616-2626 | turkdc@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2014 | Jun 24, 2019 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo | Drug | Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg |
|
| Cognitive Behavior Therapy for FM | Behavioral | Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients. |
|
| Health Education | Behavioral | Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia |
|
| Seattle |
| Washington |
| 98195 |
| United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia.
| OG002 | 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. |
| OG003 | 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. |
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 23 |
| 37 |
| EG001 | Tramadol and Health Education | Participants received between 200mg and 400mg of Tramadol daily and 8 weekly 50 minute sessions of health education on Fibromyalgia. | 0 | 31 | 0 | 31 | 27 | 31 |
| EG002 | 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. | 0 | 32 | 0 | 32 | 21 | 32 |
| EG003 | 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. | 0 | 34 | 0 | 34 | 25 | 34 |
| Skin abrasions | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Blood in stool | Renal and urinary disorders | Systematic Assessment |
|
| Blurry vision | Nervous system disorders | Systematic Assessment |
|
| Body ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bruise | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Change in respiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Chills | Endocrine disorders | Systematic Assessment |
|
| Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cramps | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased taste sensation | Nervous system disorders | Systematic Assessment |
|
| Dental pain | General disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Difficulty concentrating | Nervous system disorders | Systematic Assessment |
|
| Difficulty swallowing | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dissociative state | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
|
| Dry eyes | Eye disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dry nose | General disorders | Systematic Assessment |
|
| Emesis | Gastrointestinal disorders | Systematic Assessment |
|
| Extra emotional | Psychiatric disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Fever | Nervous system disorders | Systematic Assessment |
|
| Flatus | Gastrointestinal disorders | Systematic Assessment |
|
| Flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fogginess | Nervous system disorders | Systematic Assessment |
|
| Foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | Systematic Assessment |
|
| Goosebumps | Nervous system disorders | Systematic Assessment |
|
| Hair loss | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hot flashes | Endocrine disorders | Systematic Assessment |
|
| Hypersensitivity to smell | Nervous system disorders | Systematic Assessment |
|
| Increased urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Increased irritability | Psychiatric disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Jaw pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| Thumb pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Left elbow mass resected | General disorders | Systematic Assessment |
|
| Light headed | Nervous system disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Night sweats | Endocrine disorders | Systematic Assessment |
|
| Arm pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hand pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Pins and needles | Nervous system disorders | Systematic Assessment |
|
| Poor balance | Nervous system disorders | Systematic Assessment |
|
| Prostatitis | Renal and urinary disorders | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Runny nose | General disorders | Systematic Assessment |
|
| Scalp lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sedation | Nervous system disorders | Systematic Assessment |
|
| Sensitivity to noise | Nervous system disorders | Systematic Assessment |
|
| Shakiness | Nervous system disorders | Systematic Assessment |
|
| Burning pain through urethra | Renal and urinary disorders | Systematic Assessment |
|
| Shocking sensation | Nervous system disorders | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sinus infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| Sunburn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sweats | Endocrine disorders | Systematic Assessment |
|
| Swelling | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thoughts of self mutilation | Psychiatric disorders | Systematic Assessment |
|
| Tingling | Nervous system disorders | Systematic Assessment |
|
| TMJ pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tremors | Nervous system disorders | Systematic Assessment |
|
| Twitching | Nervous system disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Vivid dreams | Nervous system disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Wisdom tooth infection | Infections and infestations | Systematic Assessment |
|
| Yeast infection | Renal and urinary disorders | Systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |