Research: Post-Amputation Pain Study

Post-Amputation Pain Study: A Controlled Clinical Trial

Patient Information

What is post-amputation pain?

Post-amputation pain is persistent pain after amputation of a body part. In the case of a limb, this may include pain in the region of the stump or phantom pain. Phantom pain is a painful sensation felt in the missing body part. The reported pain can vary in the intensity, frequency or duration of episodes and in the type of pain experienced. Phantom limb pain is usually described as burning, crushing or squeezing. Both stump pain and phantom pain may influence a person's ability to tolerate the use of prosthetic devices.

What are the current available medical treatments for it?

Post-amputation pain is often difficult to treat and available treatments, both medical and surgical, are not effective in a number of patients.

What is the Post-Amputation Pain Study?

The physicians at the Johns Hopkins Hospital are now conducting a study to determine the effectiveness of two drugs for the treatment of phantom pain and associated stump pain. This study is sponsored by the National Institutes of Health. Patients will be enrolled over a four-year period and each patient will be followed for a period of about six months. During this period, three different medications will be given to the patient, each for a period of two months.

What is required of the patient?

After being included in the study, patients will undergo tests for three days when different medications will be given intravenously (IV). During the rest of the study, medications will be given by mouth. There will be about seven scheduled follow-up clinic visits during which there will be blood tests and tests to monitor the level of pain and disability. In addition, there will be telephone contacts twice a week to adjust medication dosage, assess the pain level and check for any side effects of the medications.

What are the risks and discomforts involved?

The extent of pain relief achieved with the different pills may vary. Throughout the study period you will be permitted to use over-the-counter drugs such as Tylenol or Motrin, in addition to the study medications as needed. If the pain is severe, you are free to choose either to quit the study or to continue the study with a different pill. The medications that will be studied have been used for other pain conditions and have been tolerated by most patients.

What are the benefits?

You will receive free consultations and remain under close supervision by a physician throughout the study period. The study medications and any procedures done for the purposes of the study will be at no charge to you. At the end of the study, you will have the opportunity to continue on the medication that is most beneficial for your pain. This research study will help determine which medications can be effectively used in the management of severe and often intractable pain following amputation.

For more information, please call 410-614-2010 or write to:

Srinivasa N. Raja, M.D.
Johns Hopkins Hospital
600 N. Wolfe Street, Osler 292
Baltimore, MD 21287