FibromyalgiaNCT00423631
Web-based Education to Enhance Fibromyalgia Management
A study of Fibromyalgia and Fibrositis, run by University of Michigan at 1 site in United States.
Trial summary
Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard care in order to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia, Fibrositis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Apr 2008
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to travel to Sioux Falls, SD for study visits.
- All subjects must fulfill the diagnostic criteria for fibromyalgia as established by the American College of Rheumatology (ACR) in 1990 (Wolfe et al., 1990)
- Be 18 years of age
- All subjects must have been in standard medical care with a physician for at least 3 months.
- Subjects must have a home computer or access to a computer with the following features:
- An Internet browser that is Internet Explorer version 5.0 or higher.
Show all 16Show fewer
- Printer
- Speakers or headphones
- Ability to use e-mail and access to the Internet
- Subjects must be able to perform the following screening test designed to assess computer ability:
- Go to a webpage Log in to a website
- Click on an icon
- Click on a radio button to answer a multiple choice question
- Fill a name into a text box
- Click on a submit button
- Print a document
Who cannot join
- Subjects will be excluded from participation if they have any of the following:
- A severe physical impairment that precludes receiving/using the website or using the CBT skills contained on the website (e.g. complete blindness)
- Co-morbid medical illnesses capable of causing a worsening of physical functional status independent of fibromyalgia (e.g. morbid obesity, autoimmune diseases,) cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), and malignancy within 2 years.
- Any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), current suicide risk or attempt within 2 years of the study, or substance abuse within 2 years. Note: Subjects with mood disorders will not be excluded.
- Prior face to face CBT for pain management.
- Receiving or applying for or considering seeking disability payments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: Internet-Enhanced Management of Fibromyalgia
Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard care in order to obtain better outcomes in terms of improved functional status and symptom reduction. While the addition of CBT to standard care has been shown to be beneficial, it is not a form of therapy that is widely available to patients with FMS. CBT includes a variety of skills that can be taught to patients to help in the management of chronic illnesses. This protocol will examine the relative merits of providing these CBT skills to patients via an informational website. The website will contain the content of CBT, a social support capability, and data transfer capabilities. The addition of this website to standard care will be compared to standard care alone. This study is interested in assessing improvements in physical functional status, the symptoms of FMS, and the relative costs of the interventions as compared to the savings in health care utilization over a 6-month period.
Primary Hypothesis The primary hypothesis of this study is that the number of patients with fibromyalgia who are able to achieve clinically meaningful improvements in physical function will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website.
Read more
Secondary Hypotheses
- The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website
- The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in mood and beliefs about pain will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website
Read the detailed description
Cognitive-Behavioral Therapy is a therapeutic approach that uses specific techniques to produce behavioral and cognitive change. CBT is not a singular approach to all problems; rather it is a set of techniques that can be tailored for specific problems. The techniques falling under the rubric of CBT have in common a scientific foundation based in learning and cognitive principles. The techniques used to change behavior are based on principles of classical and operant conditioning (e.g. extinction, positive and negative reinforcement, shaping, prompts), and observational learning. The techniques used to produce cognitive change are based largely on the development of problem solving skills and principles of attributional change (Craighead, Craighead, Kazdin, \& Mahoney, 1994).
Cognitive behavioral therapy has been shown to be effective in the management of symptoms for a wide range of chronic medical illnesses (Compas, Haaga, Keefe, Leitenberg, \& Williams, 1998; Emmelkamp \& van Oppen, 1993; Gil et al., 1996)(1994; Emmelkamp et al., 1993; Turner \& Romano, 1990; Gil et al., 1996; Keefe, 1996) including Fibromyalgia (Bradley, 1989; Nielson, Walker, \& McCain, 1992; White \& Nielson, 1995; Goldenberg, Kaplan, \& Nadeau, 1994; Nielson et al., 1992; White et al., 1995; Goldenberg et al., 1994) and related conditions such as chronic fatigue syndrome (Sharpe et al., 1996; Deale, Chalder, Marks, \& Wessely, 1997; Deale, Chalder, Marks, \& Wessely, 1997). The rationale for using CBT with FMS stems from the assumption that pain and suffering is the result of a complex integration of pathophysiology, cognition, affect, and behavior (Keefe, 1996). Modification of any one of these four factors can positively or negatively impact the course of the persistent medical condition.
When applied to patients having fibromyalgia, CBT has been shown to be associated with both short-term (3 weeks) and long-term (30 months) improvements in pain, distress, and perceived control over pain (Nielson et al., 1992; White et al., 1995; White et al., 1995). Several other investigations of CBT have demonstrated improvements in depression, pain behaviors, and tenderness (Nicassio et al., 1997), as well as knowledge of fibromyalgia and coping with pain (Vlaeyen et al., 1996). While the latter two studies did not demonstrate a superiority of CBT over educational approaches, a meta-analytic review concluded that psychological interventions for fibromyalgia in general produced effect sizes that exceeded those of physical therapy or pharmacological interventions for outcomes such as symptoms, mental health, and physical functioning (Rossy et al., 1999). The latter outcome, a sustained improvement in physical functioning, was the most difficult outcome to achieve for patients with fibromyalgia using any form of intervention. One recent study however demonstrated that 1-year sustained improvements in physical functional status were three times more likely in patients that attended a brief course of CBT than if they received only symptom-based pharmacological care (Williams, 2002).
New Advances in CBT Delivery Despite the demonstrated effectiveness of combining pharmacological interventions with CBT, integration of CBT into mainstream clinical practice for FMS has been slow. Barriers have not been due to lack of demonstrated efficacy, but rather to economic and administrative issues such as the lack of CPT codes for applying a psychological intervention for a physical illness, difficulties administering a time-intensive psychological intervention to populations that must travel long distances each week to obtain the intervention, and the lack of sufficient numbers of trained professionals to deliver the intervention on a large scale (Muehrer, 2000).
A current technology, Internet websites, has been implemented in an effort to overcome some of the barriers that have prevented the delivery of clinical services to FMS populations.
Healthcare Websites E-learning, the use of a website for education without the use of a live instructor, has become a popular method for educating the lay-public, for offering classes for credit and for continuing education online, and for training employees new job skills. Numerous websites exist that purport to improve health. Some of these sites simply provide information about illness, others provide interactive preprogrammed advice, and some send tailored health messages to patients.
The current study will seek to evaluate the effectiveness of using traditional standard care with standard care plus Internet web-based educational programming. This will be one of the largest randomized controlled trials to use web-based learning and should help to identify the feasibility of using this modality to augment standard care for the FMS community.
- Conditions
- Fibromyalgia, Fibrositis
- Being tested
- Standard care and web, Standard Care
- Keywords
- Pain, Fibromyalgia, Internet
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care and webBehavioural
A static web site containing cognitive and behavioral self management instructions.
Standard CareBehavioural
Standard care delivered by the primary care provider.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care and Web | Experimental | Standard care plus a web site based on cognitive behavioral principals. Receives: Behavioral: Standard care and web |
| Standard Care | Active comparator | Subject recieve standard care from their primary care provider. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically meaningful improvements in physical function (as measured by the SF-36).
Measured: baseline to 6 months
Clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties (as measured by the McGill, MFI and MASQ).
Measured: baseline to 6 months
Clinically meaningful improvements in mood and beliefs about pain (as measured by the CES-D, STPI, CSQ and BPCQ)
Measured: baseline to 6 months
Secondary outcomes (3)
To determine whether treatment adherence is superior in one of the treatment arms of the study, and whether adherence is related to improved outcomes.
Measured: baseline to 6 months
To determine whether treatment satisfaction is superior in one of the treatment arms of the study, and whether that satisfaction is related to improved outcomes
Measured: Baseline to 6 months
To determine post hoc, the characteristics of the individuals that achieved treatment success versus those that did not, to better identify the factors that contribute to positive outcomes in this spectrum of illness.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Williams, University of Michigan
- Investigators
- David A Williams, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423631
- Sponsor's protocol ID
- DAMD 17-002-0018, A-9356.1
- Status last verified
- Oct 2011
- First submitted
- 17 Jan 2007
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8. doi: 10.1001/jama.280.11.981.
PubMed 9749480Clauw DJ, Chrousos GP. Chronic pain and fatigue syndromes: overlapping clinical and neuroendocrine features and potential pathogenic mechanisms. Neuroimmunomodulation. 1997 May-Jun;4(3):134-53. doi: 10.1159/000097332.
PubMed 9500148Clauw DJ. Fibromyalgia: more than just a musculoskeletal disease. Am Fam Physician. 1995 Sep 1;52(3):843-51, 853-4.
PubMed 7653424Crofford LJ, Engleberg NC, Demitrack MA. Neurohormonal perturbations in fibromyalgia. Baillieres Clin Rheumatol. 1996 May;10(2):365-78. doi: 10.1016/s0950-3579(96)80022-7.
PubMed 8911654Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28. doi: 10.1002/art.1780380104.
PubMed 7818567Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
PubMed 2306288Yunus MB. Towards a model of pathophysiology of fibromyalgia: aberrant central pain mechanisms with peripheral modulation. J Rheumatol. 1992 Jun;19(6):846-50. No abstract available.
PubMed 1404119Carette S, Bell MJ, Reynolds WJ, Haraoui B, McCain GA, Bykerk VP, Edworthy SM, Baron M, Koehler BE, Fam AG, et al. Comparison of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia. A randomized, double-blind clinical trial. Arthritis Rheum. 1994 Jan;37(1):32-40. doi: 10.1002/art.1780370106.
PubMed 8129762Godfrey RG. A guide to the understanding and use of tricyclic antidepressants in the overall management of fibromyalgia and other chronic pain syndromes. Arch Intern Med. 1996 May 27;156(10):1047-52.
PubMed 8638990Compas BE, Haaga DA, Keefe FJ, Leitenberg H, Williams DA. Sampling of empirically supported psychological treatments from health psychology: smoking, chronic pain, cancer, and bulimia nervosa. J Consult Clin Psychol. 1998 Feb;66(1):89-112. doi: 10.1037//0022-006x.66.1.89.
PubMed 9489263Emmelkamp PM, van Oppen P. Cognitive interventions in behavioral medicine. Psychother Psychosom. 1993;59(3-4):116-30. doi: 10.1159/000288656.
PubMed 8416088Gil KM, Wilson JJ, Edens JL, Webster DA, Abrams MA, Orringer E, Grant M, Clark WC, Janal MN. Effects of cognitive coping skills training on coping strategies and experimental pain sensitivity in African American adults with sickle cell disease. Health Psychol. 1996 Jan;15(1):3-10. doi: 10.1037//0278-6133.15.1.3.
PubMed 8788535The Persian Gulf experience and health. NIH Technology Assessment Workshop Panel. JAMA. 1994 Aug 3;272(5):391-6. No abstract available.
PubMed 8028172Bradley LA. Cognitive-behavioral therapy for primary fibromyalgia. J Rheumatol Suppl. 1989 Nov;19:131-6.
PubMed 2691672White KP, Nielson WR. Cognitive behavioral treatment of fibromyalgia syndrome: a followup assessment. J Rheumatol. 1995 Apr;22(4):717-21.
PubMed 7791170
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
- Internet-Enhanced Management of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00423631
- Acronym / sponsor ID
- DAMD 17-002-0018, A-9356.1
- Conditions
- Fibromyalgia, Fibrositis
- Keywords
- Pain, Fibromyalgia, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Jan 2007 (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.
Fibromyalgia (FMS) a condition marked by pain, fatigue, and memory complaints, is considered a chronic condition and is most commonly treated or managed using medications. Previous studies have found benefit in adding cognitive-behavioral therapy (CBT), a non-medication intervention, to standard care in order to obtain better outcomes in terms of improved functional status and symptom reduction. While the addition of CBT to standard care has been shown to be beneficial, it is not a form of therapy that is widely available to patients with FMS. CBT includes a variety of skills that can be taught to patients to help in the management of chronic illnesses. This protocol will examine the relative merits of providing these CBT skills to patients via an informational website. The website will contain the content of CBT, a social support capability, and data transfer capabilities. The addition of this website to standard care will be compared to standard care alone. This study is interested in assessing improvements in physical functional status, the symptoms of FMS, and the relative costs of the interventions as compared to the savings in health care utilization over a 6-month period.
Primary Hypothesis The primary hypothesis of this study is that the number of patients with fibromyalgia who are able to achieve clinically meaningful improvements in physical function will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website.
Secondary Hypotheses
- The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website
- The proportion of patients with fibromyalgia who are able to achieve clinically meaningful improvements in mood and beliefs about pain will be greater when standard symptom-based pharmacological care is augmented by CBT skills delivered through an educational website
Detailed description
Cognitive-Behavioral Therapy is a therapeutic approach that uses specific techniques to produce behavioral and cognitive change. CBT is not a singular approach to all problems; rather it is a set of techniques that can be tailored for specific problems. The techniques falling under the rubric of CBT have in common a scientific foundation based in learning and cognitive principles. The techniques used to change behavior are based on principles of classical and operant conditioning (e.g. extinction, positive and negative reinforcement, shaping, prompts), and observational learning. The techniques used to produce cognitive change are based largely on the development of problem solving skills and principles of attributional change (Craighead, Craighead, Kazdin, \& Mahoney, 1994).
Cognitive behavioral therapy has been shown to be effective in the management of symptoms for a wide range of chronic medical illnesses (Compas, Haaga, Keefe, Leitenberg, \& Williams, 1998; Emmelkamp \& van Oppen, 1993; Gil et al., 1996)(1994; Emmelkamp et al., 1993; Turner \& Romano, 1990; Gil et al., 1996; Keefe, 1996) including Fibromyalgia (Bradley, 1989; Nielson, Walker, \& McCain, 1992; White \& Nielson, 1995; Goldenberg, Kaplan, \& Nadeau, 1994; Nielson et al., 1992; White et al., 1995; Goldenberg et al., 1994) and related conditions such as chronic fatigue syndrome (Sharpe et al., 1996; Deale, Chalder, Marks, \& Wessely, 1997; Deale, Chalder, Marks, \& Wessely, 1997). The rationale for using CBT with FMS stems from the assumption that pain and suffering is the result of a complex integration of pathophysiology, cognition, affect, and behavior (Keefe, 1996). Modification of any one of these four factors can positively or negatively impact the course of the persistent medical condition.
When applied to patients having fibromyalgia, CBT has been shown to be associated with both short-term (3 weeks) and long-term (30 months) improvements in pain, distress, and perceived control over pain (Nielson et al., 1992; White et al., 1995; White et al., 1995). Several other investigations of CBT have demonstrated improvements in depression, pain behaviors, and tenderness (Nicassio et al., 1997), as well as knowledge of fibromyalgia and coping with pain (Vlaeyen et al., 1996). While the latter two studies did not demonstrate a superiority of CBT over educational approaches, a meta-analytic review concluded that psychological interventions for fibromyalgia in general produced effect sizes that exceeded those of physical therapy or pharmacological interventions for outcomes such as symptoms, mental health, and physical functioning (Rossy et al., 1999). The latter outcome, a sustained improvement in physical functioning, was the most difficult outcome to achieve for patients with fibromyalgia using any form of intervention. One recent study however demonstrated that 1-year sustained improvements in physical functional status were three times more likely in patients that attended a brief course of CBT than if they received only symptom-based pharmacological care (Williams, 2002).
New Advances in CBT Delivery Despite the demonstrated effectiveness of combining pharmacological interventions with CBT, integration of CBT into mainstream clinical practice for FMS has been slow. Barriers have not been due to lack of demonstrated efficacy, but rather to economic and administrative issues such as the lack of CPT codes for applying a psychological intervention for a physical illness, difficulties administering a time-intensive psychological intervention to populations that must travel long distances each week to obtain the intervention, and the lack of sufficient numbers of trained professionals to deliver the intervention on a large scale (Muehrer, 2000).
A current technology, Internet websites, has been implemented in an effort to overcome some of the barriers that have prevented the delivery of clinical services to FMS populations.
Healthcare Websites E-learning, the use of a website for education without the use of a live instructor, has become a popular method for educating the lay-public, for offering classes for credit and for continuing education online, and for training employees new job skills. Numerous websites exist that purport to improve health. Some of these sites simply provide information about illness, others provide interactive preprogrammed advice, and some send tailored health messages to patients.
The current study will seek to evaluate the effectiveness of using traditional standard care with standard care plus Internet web-based educational programming. This will be one of the largest randomized controlled trials to use web-based learning and should help to identify the feasibility of using this modality to augment standard care for the FMS community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care and Web | Experimental | Behavioral: Standard care and webStandard care plus a web site based on cognitive behavioral principals. |
| Standard Care | Active comparator | Behavioral: Standard CareSubject recieve standard care from their primary care provider. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ability to travel to Sioux Falls, SD for study visits.
- All subjects must fulfill the diagnostic criteria for fibromyalgia as established by the American College of Rheumatology (ACR) in 1990 (Wolfe et al., 1990)
- Be 18 years of age
- All subjects must have been in standard medical care with a physician for at least 3 months.
- Subjects must have a home computer or access to a computer with the following features:
Key exclusion criteria (6 listed)
- A severe physical impairment that precludes receiving/using the website or using the CBT skills contained on the website (e.g. complete blindness)
- Co-morbid medical illnesses capable of causing a worsening of physical functional status independent of fibromyalgia (e.g. morbid obesity, autoimmune diseases,) cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), and malignancy within 2 years.
- Any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), current suicide risk or attempt within 2 years of the study, or substance abuse within 2 years. Note: Subjects with mood disorders will not be excluded.
- Prior face to face CBT for pain management.
- Receiving or applying for or considering seeking disability payments.
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 |
|---|---|---|
| Standard care and webA static web site containing cognitive and behavioral self management instructions. | Behavioural | Standard Care and Web |
| Standard CareStandard care delivered by the primary care provider. | Behavioural | Standard Care |
Primary outcome
Clinically meaningful improvements in physical function (as measured by the SF-36).
Time frame: baseline to 6 months
Clinically meaningful improvements in symptoms of FMS such as pain, fatigue, and perceived cognitive difficulties (as measured by the McGill, MFI and MASQ).
Time frame: baseline to 6 months
Clinically meaningful improvements in mood and beliefs about pain (as measured by the CES-D, STPI, CSQ and BPCQ)
Time frame: baseline to 6 months
3 secondary outcomes
To determine whether treatment adherence is superior in one of the treatment arms of the study, and whether adherence is related to improved outcomes.
Time frame: baseline to 6 months
To determine whether treatment satisfaction is superior in one of the treatment arms of the study, and whether that satisfaction is related to improved outcomes
Time frame: Baseline to 6 months
To determine post hoc, the characteristics of the individuals that achieved treatment success versus those that did not, to better identify the factors that contribute to positive outcomes in this spectrum of illness.
Time frame: Baseline to 6 months
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.
- Background: PubMed 9749480Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8. doi: 10.1001/jama.280.11.981.
- Background: PubMed 9500148Clauw DJ, Chrousos GP. Chronic pain and fatigue syndromes: overlapping clinical and neuroendocrine features and potential pathogenic mechanisms. Neuroimmunomodulation. 1997 May-Jun;4(3):134-53. doi: 10.1159/000097332.
- Background: PubMed 7653424Clauw DJ. Fibromyalgia: more than just a musculoskeletal disease. Am Fam Physician. 1995 Sep 1;52(3):843-51, 853-4.
- Background: PubMed 8911654Crofford LJ, Engleberg NC, Demitrack MA. Neurohormonal perturbations in fibromyalgia. Baillieres Clin Rheumatol. 1996 May;10(2):365-78. doi: 10.1016/s0950-3579(96)80022-7.
- Background: PubMed 7818567Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28. doi: 10.1002/art.1780380104.
- Background: PubMed 2306288Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
- Background: PubMed 1404119Yunus MB. Towards a model of pathophysiology of fibromyalgia: aberrant central pain mechanisms with peripheral modulation. J Rheumatol. 1992 Jun;19(6):846-50. No abstract available.
- Background: PubMed 8129762Carette S, Bell MJ, Reynolds WJ, Haraoui B, McCain GA, Bykerk VP, Edworthy SM, Baron M, Koehler BE, Fam AG, et al. Comparison of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia. A randomized, double-blind clinical trial. Arthritis Rheum. 1994 Jan;37(1):32-40. doi: 10.1002/art.1780370106.
- Background: PubMed 8638990Godfrey RG. A guide to the understanding and use of tricyclic antidepressants in the overall management of fibromyalgia and other chronic pain syndromes. Arch Intern Med. 1996 May 27;156(10):1047-52.
- Background: PubMed 9489263Compas BE, Haaga DA, Keefe FJ, Leitenberg H, Williams DA. Sampling of empirically supported psychological treatments from health psychology: smoking, chronic pain, cancer, and bulimia nervosa. J Consult Clin Psychol. 1998 Feb;66(1):89-112. doi: 10.1037//0022-006x.66.1.89.
- Background: PubMed 8416088Emmelkamp PM, van Oppen P. Cognitive interventions in behavioral medicine. Psychother Psychosom. 1993;59(3-4):116-30. doi: 10.1159/000288656.
- Background: PubMed 8788535Gil KM, Wilson JJ, Edens JL, Webster DA, Abrams MA, Orringer E, Grant M, Clark WC, Janal MN. Effects of cognitive coping skills training on coping strategies and experimental pain sensitivity in African American adults with sickle cell disease. Health Psychol. 1996 Jan;15(1):3-10. doi: 10.1037//0278-6133.15.1.3.
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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
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 study of Fibromyalgia and Fibrositis, 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 16 inclusion and 6 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.
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?
Clinically meaningful improvements in physical function (as measured by the SF-36). (time frame: baseline to 6 months). 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?
On the ClinicalTrials.gov record for NCT00423631, which also lists 47 linked publications.
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.