I would like to bring to everyones attention a study that has been ongoing at NIH for a number of years. The drug they are studying in Neurotropin. It is a double blind, crossover ,placebo study. I participated 5 yrs ago with great results. They need more people who have had rsd for less than 1 yr. All expenses are paid, airfare, hotel, cab or bus and $20.00 for food. Please go to the NIH website and see if you might be interested then call them for more info. This has been used in Japan for over 20 yrs and without enough people to complete the study it may never be approved. They have even taken people from Canada into the study, so if you live outside of this country I would still give it a try if you want to. Thanks for considering this and let your doctors know and other people you might know about this study. I will be glad to tell you more if you are interested. Thanks again Marilyn

Protocol Number: 00-NR-0200


Title: Neurotropin for Acute Dental Pain and for Chronic Neuropathic Pain Number: 00-NR-0200 Summary: This study will examine the effectiveness of the drug neurotropin in treating chronic pain after injury to a limb or a large nerve. Two groups of patients will participate in this study: patients with complex regional pain syndrome type 1, or CRPS-I (also called reflex sympathetic dystrophy) and patients with complex regional pain syndrome type 2, or CRPS-II. CRPS-I is pain that develops after relatively minor injury to an arm or leg, but lasts much longer and is much more severe than would normally be expected. CRPS-II is pain resulting from injury to a large nerve. Candidates will have a history and physical examination, blood tests, and electrocardiogram. Participants will undergo the following tests and procedures:
Patients with CRPS I and II will receive an individualized regimen of physical therapy and standard treatment to control their pain. In addition, they will receive neurotropin or placebo tablets for 5 weeks, then no trial medicine for at least 1 week, and then the other trial drug for the next 5 weeks. That is, patients who took placebo the first 5 weeks will take neurotropin the second 5 weeks and vice versa. Neither the patients nor the doctors will know who received which drug during the two intervals until the study is over. Patients will complete questionnaires about their pain, quality of life, and ability to perform daily living activities. They will have various tests to measure pain (such as sensitivity to heat and cold, to an electric current, to a mild pin prick, etc.); to provide information about changes in their condition (such as tests of range of motion of joints and limb size); to measure blood circulation and sweating in the arm or leg (such as measurements of blood flow to the limb, skin temperature, and sweat production), and other procedures.

Sponsoring Institute: National Institute of Nursing Research (NINR) Recruitment Detail Type: Participants currently recruited/enrolled Gender: Male & Female Referral Letter Required: No Population Exclusion(s): Pregnant or Nursing
Eligibility Criteria:

INCLUSION CRITERIA
Dental outpatients undergoing elective removal of impacted third molars based on a preoperative diagnosis of the type and number of teeth to be extracted. The difficulty of extraction will be classified based on clinical exam and a panoramic radiograph as simple extraction (1), soft tissue impaction (2), partial boney impaction (3), or full boney impaction (4). Both lower teeth to be extracted should be similarly boney impacted, and the score for each of the two lower teeth should be 3 to 4. Uppers are usually in soft tissue. The diagnosis for each tooth will be confirmed by the oral surgeon after the procedure based on the surgical procedure actually performed.

CRPS patients are referred with a diagnosis of CRPS-I or CRPS-II in one limb only, based on pain (1) that is post-traumatic and spread beyond the region of the injury; (2) has persisted for more than 2 weeks; and (3) is associated with swelling, altered skin color or skin temperature, altered sweating, allodynia or hyperesthesia or limitation of active movement. Atrophic changes in skin, hair loss or nail changes, or disuse atrophy of skeletal muscle may be present.

Both sexes are to be studied.

Children can participate, if they can provide adequate self-ratings.

All ethnic and racial groups can participate.

Patients must be willing to return to NIH for follow-up evaluation under this protocol.

EXCLUSION CRITERIA

Dental outpatients must not be taking any medications chronically (with the exception of oral contraceptive agents).

Pregnant and lactating women are excluded.

Based on the oral surgeon's postoperative diagnosis, any extraction which is classified as producing unusual surgical trauma will result in exclusion from the remainder of the study.

Dental subjects will also be excluded if they are not adequately sedated by midazolam alone and require intraoperative administration of an opioid drug such as fentanyl, administration of greater than 14.4 ml of local anesthetic (2% lidocaine with 1:100,000 epinephrine), or postoperative administration of a steroid for possible injury to the inferior alveolar nerve.

Patients referred with CRPS-I or CRPS II who have abnormal screening test results or who have non-tramatic disorders to which pain may be attributed (gout, malignancy, arthritis, etc.) will be excluded.

Any patients who have had ablative procedures for treatment of their neuropathic pain disorder will not be eligible for inclusion in this study.

Subjects with impaired mental capacity that precludes informed consent and children who cannot provide adequate self-ratings are excluded.

Patients who have a positive HIV result will be excluded.

Special Instructions:

Currently Not Provided

Keywords: Analgesia Causalgia CRPS Neuropathic Pain Oral Surgery Reflex Sympathetic Dystrophy Sympathetic Nervous System Chronic Regional Pain Syndrome Recruitment Keyword(s): None Condition(s): Causalgia Reflex Sympathetic Dystrophy Investigational Drug(s): Neurotropin Investigational Device(s): None Intervention(s): Drug: Neurotropin Supporting Site: National Institutes of Nursing Research Contact(s): Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793
Electronic Mail:prpl@mail.cc.nih.gov Citation(s): Reflex sympathetic dystrophy: changing concepts and taxonomy IASP diagnostic criteria for complex regional pain syndrome: a preliminary empirical validation study International Association for the Study of Pain External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria International Association for the Study of Pain
If you have:

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Flippinout, yes, this is the study. Thank you so much for posting this. I am pretty computer illiterate and had no idea how to do what you did. Thank you so much. Also, at the end of the study I was given a choice of which test med I wanted to continue for another 5 weeks. No brainer for me, my body knew which one worked. Marilyn

This isn't going to help me due to having it for too long but I would like to know how it continued to help you. Did it just help with the pain or did it help with other side effects of the RSD.

Maybe some of the people on here that will check it out.

Ada

I applied for this study and was turned down because not only have I had RSD longer than 1 year, but I have also been diagnosed with Fibromyalgia, Osteoporosis, and MS on top of it.....I was WAY out of their ballpark....hahahahaha. Oh well, maybe one day!!
Hope someone here is able to do this study and will let us know the status of the outcome.

Make it an Amazing Day!

Love, Peace & Blessings,
Marla

Ada, It helped with all of it. For the first time in 11 months I was able to take a shower and a bath with hot water. Before that I propped my foot on the side of the tub as I could not stand the feel of the water. I was able to cook for my family and clean my own home. I was able to drive again and walk through all the stores without my scooter or my cane. I walked the entire border of our 10 acre farm! I was able to eliminate the Vicodin, I needed regular Tylenol every now and then. I still continued the Neurontin and the oral Ketamine. I could sleep in bed with the sheets and blankets on my foot. I was able to wear tennis shoes and boots again. Breezes and ceiling fans no longer bothered me. I even started wearing crop pants and walking barefoot in the grass. My favorite pasttime, never knew how great that feel is until you can no longer do it! My toes which were frozen and pointed up began to bend. I still have a problem with my big toe bending but the other 4 bend normally now. I needed no blocks or changes in meds for 3 yrs after the study. It has only been in the last year that I have needed the blocks and have had additional meds added to control my pain. At the end of the study you are able to choose which med you would like to continue for an additional 5 weeks. Of course no one knows what you are taking, however, you cannot have any doubt when the improvement is so drastic and is documented through your physical exams that they give you. They gave me the paperwork to get an IND number through the FDA so I could obtain the med under the Compassionate Use clause. The med costs $80.00 from the manufacturer. Unfortunately, even though the liason tried to work with the doctor I had at the time I was unable to get the doctor to follow through. To this day I have not been able to get any physician to do this for me, liability I guess. This med has been used in Japan for over 20 yrs for shingles, back pain and several pain conditions. It is not addictive and has very few side effects, I experienced no side effects. I was told that 2 people who were in the study were able to get it, however, they are nurses and had a doctor friend who did it for them. The other person is from Canada and they were able to get it also. I sure would like to know if anyone out there knows of a doctor who would be willing to do this for me. I will travel anywhere, even on a regular basis, just to be able to get this again. I have all the paperwork. The only thing I am missing is a physician who has enough compassion to take me and fill out the paperwork. Like I said, I will travel anywhere, even monthly, please if anyone can help me would you please let me know? Thanks for asking and thank you to all who are willing to help me. Marilyn

For answering this for me. It sounds like it helped a lot. It's too bad they can't find enough people to follow through with the research.

I love going barefoot. Unfortunely, here in Co. if I try it, I end up with all of those stickers in my feet. LOL I can remember when we first moved here, Susan was about 4 and we had to sit down and pull all of those stickers out of her feet. We sure had to learn how different Co. and Ky. was. LOL I go barefoot in the house all of the time.

I am glad you found such relief and I wish you could find that Dr. out there to help you.

Thanks again for the reply.
Ada