Chronic Pain Clinical Research Trial

Randomized Controlled Trial of a Novel 8-Week Interdisciplinary Chronic Pain Self-Rehabilitation Program for Opioid Users


Who is doing the study?

Centura Health, Colorado's largest health network, is conducting a high-quality clinical trial of a new educational program for patients with chronic pain who currently take opioid medications. We're looking for up to 120 participants. Our instructor and principal investigator is Jay E. Valusek, M.Ed., a chronic pain self-management specialist with Centura Health Integrative Medicine at Longmont United Hospital.

What is the purpose of the study?

This study is being done to determine if a unique mix of medication-free pain self-management strategies will improve certain aspects of your life more than traditional treatment for chronic pain. We also want to learn if this approach will reduce the severity of your pain and begin to reduce your dependence on opioid medications.

Where will the research take place?

Participants will be assigned to one of the following two locations where they will complete their sessions. Locations will be assigned with participants’ residence in mind to limit burden of travel.

Longmont United Hospital
1950 Mountain View Avenue
Longmont, CO 80501

84th Avenue Neighborhood Health Center
2552 W. 84th Avenue
Westminster, CO 80031

pain

To participate in this study, you must attend one of our free information sessions.

These information sessions will last about 90 minutes. Our principal investigator will describe the study, go through the informed consent and registration forms, answer questions, and offer you the chance to enroll if you meet the eligibility criteria. You are under no obligation to enroll in the study if you attend one of these information sessions. You should not join the study until all your questions are answered to your satisfaction.

Space is limited. To attend a free information session, you must RSVP:

Register for a Session

More About the Study

The main goal of any research study is to gain insight and understanding, which may help other patients in the future. This study is an educational research study, not medical research or medical treatment. No experimental drugs, devices, vaccines or medical procedures will be involved. The objective is to teach you how to restore (or "rehabilitate") yourself as much as possible to health and well-being, even if your chronic pain does not go away. The strategies are taken from four different approaches to pain self-management, which previous research has proven effective. However, this particular combination of techniques has not yet been studied.

  • Who is eligible to take part in the study?

    You may participate in this research study if you:

    • Are at least 18 years of age
    • Have suffered from chronic non-cancer pain for at least one year (12 months)
    • Are currently using one or more opioid medications to help manage your pain
    • Are willing to be randomly assigned either to a pain self-management education group or a wait-list control group (if you are assigned to the control group, you will be able to receive the same training after the education group is finished)
    • Are able to attend all eight of the class sessions at one of our research study sites

    Are willing and able to understand and sign an informed consent form at one of our free public information sessions

  • What will happen if you participate in the study?

    If you are eligible to participate in this study, you will be required to attend one of our information sessions, and sign an informed consent form. Next, you will fill out a participant registration form, which provides your contact information and limited personal and medical information. Once we have registered enough research volunteers (ideally 120 people), you will be randomly assigned either to the pain self-management education group or wait-list control group.

    Pain Self-Management Education Group:
    If you are randomly assigned to the pain self-management education group, you will attend eight class sessions of 2.5 hours each, for a total of 20 in-class hours. Classes will be offered multiple days of the week at different times each day, in an effort to accommodate your schedule. You will have homework to complete between class sessions, which may include physical activity, psychological techniques, highly personalized action plans, or keeping a pain diary. You will also complete self-report assessments to track changes to your pain level that may occur during the 8-week program.

    Wait-List Control Group:
    If you are randomly assigned to the wait-list control group, you will meet once at the beginning and once at the end of the eight-week training period for about one hour each session, to complete self-report assessments. After the pain self-management education group sessions have been completed, you will be offered the opportunity to go through the same training, which will take another eight weeks. However, you are not required to go through the pain self-management education classes.

    Compensation:
    All research study participants will receive up to $80 compensation. If you are assigned to the pain self-management education group, you will receive $10 for each completed class session. If you are assigned to the wait-list control group, you will receive $40 for each completed assessment session. If you do not complete the study, you will be compensated only for the sessions you completed.

  • What risks or discomforts are involved with participating in the study?

    If you are assigned to the pain self-management educational group, or elect to participate in these classes you may experience some discomforts. Because this is an educational research study, and it does not involve any drugs, medical tests or procedures, the risks you may experience are minimal.

    • Attending class for 2.5 hours may cause some physical discomfort. We will take regular breaks, you may bring comfort items to class, and you may stand up, move around, or even lie down during sessions, as needed.
    • You may accidentally overdo a physical activity or exercise outside of class, which may cause a flare-up of your pain. You will be provided instructions on how to plan and carry out new activities by taking small steps.
    • If you decide to reduce your opioid medications too quickly, you may experience some withdrawal symptoms and other unpleasant side effects (e.g. nausea). You will be provided guidelines on how to slowly and safely taper opioid usage, ideally with assistance from your primary care provider. However, you are not required to change your medications.
    • Certain pain self-management techniques may cause some emotional discomfort, especially if you begin to face challenges you have previously been avoiding. Part of the training program involves simple techniques to calm psychological distress and reactivity to pain. The principal investigator is also a registered psychotherapist with experience handling emotions.
  • Are there benefits to participating in the study?

    Although this study cannot promise any specific outcomes, you may gain some of the following benefits if you are part of the pain self-management group:

    • In the pain self-management education group, you will be exposed to a number of highly personalized pain self-management strategies, which may help you gain a new understanding of why you hurt and effective tools on how to manage that pain. You may be able to maintain these strategies after the end of the study, since they will be based mostly on your own choices, actions and discovery of new coping strategies.
    • During class sessions with other people who understand and live with chronic pain, you may feel a sense of belonging, social connection, engagement, and support.
    • Your overall quality of life, emotional well-being, self-confidence, motivation, and hope for the future may improve while you are in this study. The intensity of your pain and dependence of opioid medication may be reduced.

    Although this study cannot promise any specific outcomes, you may gain some of the following benefits if you are part of the wait-list control group:

    • If you only participate in the control group (and choose not to go through the 8-week program), the results of this study may help other people who suffer from chronic pain in the future. You may benefit from knowing that you will be helping us gain new knowledge and insight in the emerging field of chronic pain self-management and self-rehabilitation.