Fibromyalgia is a difficult disease to endure, causing fatigue, muscle pain, and “tender points,” areas that hurt when touched. These may be on the neck, arms, legs, shoulders, backs and hips. Additional symptoms include insomnia, headache, stiffness in the morning, and memory and thinking problems. There is no cure and no understanding yet of the cause.
Fortunately, there are medications that can help with the symptoms. New medications for this disease are desired, and clinical trials are occurring in order to evaluate the efficacy and safety of these drugs. You should understand the steps to find and take part in these trials if you are interested in participating.
The Internet is an excellent tool for finding fibromyalgia medication trials, with a number of websites dedicated to such. Clinicaltrials.gov is excellent resource This provides a listing of the different clinical trials. Some involve medication and other involve other types of therapies. On the website, you will see the status (recruiting, not yet recruiting, etc.), the title, the conditions and the interventions that the study is testing. An example is the “Trial of Acupuncture in the Treatment of Fibromyalgia.”
You can click on the study for addition information. This will include the sponsor and a detailed purpose. It will include information on the study type and design. It will then give a detailed listing of the procedures involved in the clinical trial as well as whether any are designated a safety issue (i.e. filling out a questionnaire is safe). It will list eligibility such as age and gender and specific criteria. It will list the location and contact information.
You may want to next do research on whether you want to participate. Carefully consider the safety risks and potential benefits. You can contact the organization for more information. You also may want to contact your personal physician.
You should learn about what phase the trials are in. For instance, in stage 1, the safety of an intervention is assessed. The efficacy is tested in stage II. Stage III testing expands the study to many more participants. After this stage, the company can seek FDA approval. Stage IV testing looks for various things, such as a comparison with other drugs, long term efficacy, the medicine’s effect on the person’s life and more.
If you are interested in participating you can contact the organization that is conducting the trial. The exact next steps will depend on the actual trial. Generally you will first be asked some questions to make sure that you meet the criteria for the project. In many trials, you will then be assigned to one of two groups, the active or the placebo. You will often have to fill out a detailed questionnaire about your condition and symptoms. One group may be the placebo, in which you do not receive treatment or receive something ineffective against fibromyalgia. The other group will receive what they are testing, such as a new drug for the sleep problems associated with fibromyalgia. After the trials, any change may be accessed through physical examination or another questionnaire. The exact length and details of the fibromyalgia trial will range.
Fibromyalgia is a serious condition that affects many. New treatments can spell relief, and clinical trials are how these appear. The above information can help you partake in such a trial.
Resources:
http://www.nlm.nih.gov/medlineplus/fibromyalgia.html
http://www.centerwatch.com/ctrc/NationalFibromyalgia/
http://www.clinicalconnection.com/Clinical_Trials/Condition/Fibromyalgia.aspx
