FibromyalgiaPhase 1/2NCT00086060
Pain Management Techniques for Fibromyalgia
A Phase 1/2 study testing Exercise regimen and Relaxation training in people with Fibromyalgia, run by University of Michigan at 1 site in United States.
Trial summary
Pain management techniques may influence how the brain processes pain and may help patients with fibromyalgia (FM), a chronic pain condition. This study will train patients with FM to use pain management techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Exercise regimen and Relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Feb 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of fibromyalgia based on the criteria outlined by the American College of Rheumatology
- Standard medical care for fibromyalgia with the referring physician for at least the past 3 months
Who cannot join
- Severe physical impairment that would prevent the participant from receiving either of the nondrug interventions (e.g., complete blindness, deafness, paraplegia) or coexisting physical impairments that could be harmed by light exercise (e.g., sprained ankle, neck injury)
- Morbid obesity
- Autoimmune disease
- Cardiopulmonary disorders (e.g., angina, congestive heart failure, COPD, chronic asthma)
- Uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes)
- Cancer within the past 2 years
- Current psychiatric disorder involving a history of psychosis (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder), current suicide risk or suicide attempt within 2 years of study entry, or substance abuse within 2 years of study entry. Participants with mood disorders will not be excluded.
- Any pending or active disability associated with fibromyalgia (e.g., SSI, Workers' Compensation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Chronic Pain and Fatigue Research Center, University of Michigan
Ann Arbor, Michigan, 48106
About this study
Official title: Locus of Pain Control: Neural Substrates and Modifiability
Pain management techniques may influence how the brain processes pain and may help patients with fibromyalgia (FM), a chronic pain condition. This study will train patients with FM to use pain management techniques. Investigators will use brain scanning (functional magnetic resonance imaging, or fMRI) technology to identify changes in how a patient's brain processes pain over time. This study is primarily interested in examining cortical response to different behavioral interventions.
Read the detailed description
FM is a chronic pain condition that has no cure, and drugs are only partially successful in managing its symptoms. Many people with FM utilize nondrug management methods, such as exercise, for symptom relief. Nondrug methods can be quite effective, but some patients find it difficult to use these methods consistently. This study will determine which nondrug methods relieve FM symptoms by examining patients' brains after exercise or relaxation techniques. Preliminary data indicate that beliefs about one's personal ability to control pain result in use of differential neural mechanisms to process pain. This study will use fMRI, a tool for visualizing pain-processing patterns, to gain insights into how exercise and relaxation techniques modify pain processing in patients with FM.
There are four arms in this study. All participants with FM will be randomly assigned to one of three study arms. Participants in Arm 1 will receive relaxation training to supplement standard care for FM. Arm 2 participants will be prescribed an exercise regimen to supplement standard care. Participants in Arm 3 will receive standard care only. Arm 4 is a healthy control group, which will be followed during the 8-week intervention period.
At baseline, all participants will undergo blood collection and physical examination and will complete questionnaires about demographics, treatment history, symptoms, functional status, affective status, and beliefs about pain. They will also undergo a baseline fMRI imaging study, combined with evoked pressure pain testing, to evaluate differences in neural mechanisms involved in pain processing. Patients in Arms 1 and 2 will then attend one face-to-face training session with a therapist, followed by phone contact over the next 8 weeks. Participants will be asked to record pain and adherence to treatment on an electronic diary. After 8 weeks, all study participants will undergo a second fMRI scan, blood collection, and physical examination, and will complete questionnaires similar to those completed at baseline.
- Conditions
- Fibromyalgia
- Being tested
- Exercise regimen, Relaxation training, Standard Care
- Keywords
- Internal-External Control, Magnetic Resonance Imaging, fMRI, Exercise, Relaxation
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise regimenBehavioural
Aerobic Exercise is a self-management technique that increases personal control over pain by enhancing physical fitness. Patients will be encouraged to choose activities best suited to their tastes and current lifestyle, incorporating lifestyle physical activities (climbing stairs, household chores, etc) and more traditional exercise activities (walking, cycling, etc.). Subjects will use ratings of perceived exertion (RPE) to guide their effort. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for exercise, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
Relaxation trainingBehavioural
Relaxation is a self-management technique that increases personal control over pain by relaxing tense muscles, allowing the body to rest, and improving mental clarity through concentration and attention and has a great deal of empirical research supporting its effectiveness as a means of pain management. A variety of relaxation skills will be taught with some being based on muscle relaxation, and others focused more on cognitive relaxation and imagery. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for relaxation, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
Standard CareBehavioural
Participants in the standard care control group will not receive any additional intervention beyond that which they are receiving from their routine health care professional.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Relaxation Training | Experimental | Participants will receive relaxation training and standard care for FM Receives: Behavioral: Relaxation training |
| 2 Exercise Regimen | Experimental | Participants will receive an exercise regimen and standard care for FM Receives: Behavioral: Exercise regimen |
| 3 Standard Care | Active comparator | Participants will receive standard of care for FM Receives: Behavioral: Standard Care |
| 4 Health Controls | No intervention | Health participants will act as a control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical pain
Measured: Measured at Week 8
Change in activation pattern in fMRI
Measured: Measured at Week 8
Change in locus of control
Measured: Measured at Week 8
Secondary outcomes (3)
Improvement in symptoms
Measured: Measured at Week 8
Improvement in function
Measured: Measured at Week 8
Improvement in mood
Measured: Measured at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2004 (estimated)
- Study startMay 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, David A. Williams, University of Michigan
- Investigators
- David A. Williams, PhD, Principal investigator, Chronic Pain and Fatigue Research Center, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086060
- Sponsor's protocol ID
- NIAMS-121
- Other IDs
- R01AR050044-01A1
- Status last verified
- Oct 2011
- First submitted
- 22 Jun 2004
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locus of Pain Control: Neural Substrates and Modifiability
- ClinicalTrials.gov ID
- NCT00086060
- Acronym / sponsor ID
- NIAMS-121
- Conditions
- Fibromyalgia
- Keywords
- Internal-External Control, Magnetic Resonance Imaging, fMRI, Exercise, Relaxation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- May 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 23 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain management techniques may influence how the brain processes pain and may help patients with fibromyalgia (FM), a chronic pain condition. This study will train patients with FM to use pain management techniques. Investigators will use brain scanning (functional magnetic resonance imaging, or fMRI) technology to identify changes in how a patient's brain processes pain over time. This study is primarily interested in examining cortical response to different behavioral interventions.
Detailed description
FM is a chronic pain condition that has no cure, and drugs are only partially successful in managing its symptoms. Many people with FM utilize nondrug management methods, such as exercise, for symptom relief. Nondrug methods can be quite effective, but some patients find it difficult to use these methods consistently. This study will determine which nondrug methods relieve FM symptoms by examining patients' brains after exercise or relaxation techniques. Preliminary data indicate that beliefs about one's personal ability to control pain result in use of differential neural mechanisms to process pain. This study will use fMRI, a tool for visualizing pain-processing patterns, to gain insights into how exercise and relaxation techniques modify pain processing in patients with FM.
There are four arms in this study. All participants with FM will be randomly assigned to one of three study arms. Participants in Arm 1 will receive relaxation training to supplement standard care for FM. Arm 2 participants will be prescribed an exercise regimen to supplement standard care. Participants in Arm 3 will receive standard care only. Arm 4 is a healthy control group, which will be followed during the 8-week intervention period.
At baseline, all participants will undergo blood collection and physical examination and will complete questionnaires about demographics, treatment history, symptoms, functional status, affective status, and beliefs about pain. They will also undergo a baseline fMRI imaging study, combined with evoked pressure pain testing, to evaluate differences in neural mechanisms involved in pain processing. Patients in Arms 1 and 2 will then attend one face-to-face training session with a therapist, followed by phone contact over the next 8 weeks. Participants will be asked to record pain and adherence to treatment on an electronic diary. After 8 weeks, all study participants will undergo a second fMRI scan, blood collection, and physical examination, and will complete questionnaires similar to those completed at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 - Relaxation Training | Experimental | Behavioral: Relaxation trainingParticipants will receive relaxation training and standard care for FM |
| 2 Exercise Regimen | Experimental | Behavioral: Exercise regimenParticipants will receive an exercise regimen and standard care for FM |
| 3 Standard Care | Active comparator | Behavioral: Standard CareParticipants will receive standard of care for FM |
| 4 Health Controls | No intervention | –Health participants will act as a control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of fibromyalgia based on the criteria outlined by the American College of Rheumatology
- Standard medical care for fibromyalgia with the referring physician for at least the past 3 months
Key exclusion criteria (8 listed)
- Severe physical impairment that would prevent the participant from receiving either of the nondrug interventions (e.g., complete blindness, deafness, paraplegia) or coexisting physical impairments that could be harmed by light exercise (e.g., sprained ankle, neck injury)
- Morbid obesity
- Autoimmune disease
- Cardiopulmonary disorders (e.g., angina, congestive heart failure, COPD, chronic asthma)
- Uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise regimenAerobic Exercise is a self-management technique that increases personal control over pain by enhancing physical fitness. Patients will be encouraged to choose activities best suited to their tastes and current lifestyle, incorporating lifestyle physical activities (climbing stairs, household chores, etc) and more traditional exercise activities (walking, cycling, etc.). Subjects will use ratings of perceived exertion (RPE) to guide their effort. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for exercise, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call. | Behavioural | 2 Exercise Regimen |
| Relaxation trainingRelaxation is a self-management technique that increases personal control over pain by relaxing tense muscles, allowing the body to rest, and improving mental clarity through concentration and attention and has a great deal of empirical research supporting its effectiveness as a means of pain management. A variety of relaxation skills will be taught with some being based on muscle relaxation, and others focused more on cognitive relaxation and imagery. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for relaxation, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call. | Behavioural | 1 - Relaxation Training |
| Standard CareParticipants in the standard care control group will not receive any additional intervention beyond that which they are receiving from their routine health care professional. | Behavioural | 3 Standard Care |
Primary outcome
Change in clinical pain
Time frame: Measured at Week 8
Change in activation pattern in fMRI
Time frame: Measured at Week 8
Change in locus of control
Time frame: Measured at Week 8
3 secondary outcomes
Improvement in symptoms
Time frame: Measured at Week 8
Improvement in function
Time frame: Measured at Week 8
Improvement in mood
Time frame: Measured at Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2011.
Related trials for Fibromyalgia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Williams, PhD principal investigator
Chronic Pain and Fatigue Research Center, University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exercise regimen and Relaxation training in people with Fibromyalgia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical pain (time frame: Measured at Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2011.