Chronic Pain Clinical Trial
Official title:
Operant Learning Versus Energy Conservation Activity Pacing Interventions in a Sample of Fibromyalgia Patients: A Randomized Controlled Trial
Verified date | August 2015 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Activity pacing (AP) is a commonly used treatment for people with chronic pain. Many people with pain try to continue their daily activities at the same level as they were able to manage before they had pain. This way of coping causes increases in their pain; they become discouraged and give up on their activities. AP treatments involve helping them regulate their activity level so that they can achieve important life goals. Although AP is widely used, its effectiveness is still unproven. There are two key approaches: The operant learning (OL) approach uses quotas related to time or goals the person sets. The energy conservation (EC) approach focuses on balancing patient energy expenditure. Both of these treatments have often been used with people with Fibromyalgia Syndrome (FMS), a common pain condition. We will examine the effects of these treatments on pain, fatigue, quality of life, physical functioning and mental well-being. We will also investigate whether other factors influence treatment effectiveness (e.g., a person's readiness to change, pain intensity level). 120 FMS patients will be randomly assigned to receive OL, EC, Delayed-OL or Delayed-EC. Data will be collected at baseline, at the end of treatment and at 3, 6 and 12 month follow-ups. FMS patients will be recruited consecutively from Rheumatologists at St. Joseph's Health Care London. OL and EC treatment manuals will be developed by experts in the field and both interventions will be given by two occupational therapists over a 3 month period as "stand-alone" interventions (10 sessions of 120 min). All sessions will be recorded in order to assess intervention fidelity. This study will be the first to base AP interventions on a clearly delineated theoretical framework. It will clarify whether AP strategies benefit individuals with FMS and whether either of these two approaches is more effective. Our results will help to direct clinical resources and funding toward the most beneficial interventions.
Status | Completed |
Enrollment | 69 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Aged 18 years or over - Presenting a formal diagnosis of FMS meeting either the American College of Rheumatology 1990 criteria or the 2010 clinical diagnostic criteria - Able to provide informed consent - Able to read, understand and answer questionnaires in English - Available for follow-up booster sessions during a 12 months period Exclusion Criteria: - Have previously participated in a formal activity pacing intervention - Present psychological comorbidity that might interfere with the activity pacing group sessions - Present cognitive impairment that would prevent benefiting from the activity pacing group sessions |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Health Care London | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Coping Strategies Questionnaire (CSQ) (Short-Form 2 items) | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No | |
Other | Multidimensional Pain Readiness to Change Questionnaire (MPRCQ2) - Pacing scale | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No | |
Other | Survey of Pain Attitudes (SOPA) (Short-Form 2 items) | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No | |
Other | Patterns of Activity - Pain (POAM-P) | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No | |
Other | Patients' Global Impression of Change (PGIC) | PretreatmentPost-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No | |
Primary | Pain ratings (0-10 numerical rating scale assessing average pain over the last 7 days) | This study used multiple primary endpoints (pain and fatigue) as we consider both variables as important on a clinical point of view. Both measures are rate or a 0 to 10 numerical scale where 0= no pain or no fatigue and 10=worst pain or worst fatigue as bad as they can imagine. Significant clinical changes of both pain and fatigue are consider to be 1) minimal if the reduction on the scale is between 1 or 2 points, 2) moderate if the reduction is = 3 points, and 3) substantial improvement if the reduction is = 5 points. Change in pain will be calculated by subtracting the earlier time point (T0) from each of the subsequent time points(T1 to T4). | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No |
Primary | Fatigue ratings (0-10 numerical rating scale assessing average fatigue over the last 7 days) | This study used multiple primary endpoints (pain and fatigue) as we consider both variables as important on a clinical point of view. Both measures are rate or a 0 to 10 numerical scale where 0= no pain or no fatigue and 10=worst pain or worst fatigue as bad as they can imagine. Significant clinical changes of both pain and fatigue are consider to be 1) minimal if the reduction on the scale is between 1 or 2 points, 2) moderate if the reduction is = 3 points, and 3) substantial improvement if the reduction is = 5 points. Change in fatigue will be calculated by subtracting the earlier time point (T0) from each of the subsequent time points(T1 to T4) | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No |
Secondary | Socio-demographic questionnaire | Information on sex, age, ethnicity, civil status, education, work status, income, will be collected | Pretreatment (T0). | No |
Secondary | Brief Pain Inventory | Questionnaire measuring pain interference in different life aspects. | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No |
Secondary | Brief Fatigue Inventory | Questionnaire measuring fatigue interference in different life aspects. | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No |
Secondary | SF36v2 Health Survey | Questionnaire measuring quality of life. | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No |
Secondary | Medical Outcomes Study (MOS) - Sleep scale | Questionnaire measuring sleep problems. | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No |
Secondary | Hospital Anxiety and Depression Scale (HADS) | Pretreatment (up to 3 months, T0), post-treatment (3 months, T1), and three follow-ups (3 months (T2), 6 months (T3) and 12 months (T4)). | No | |
Secondary | Structured Assessment | Information on current medications and health care utilization, fibromyalgia characteristics (symptoms, duration etc.), chronic pain and fatigue family history as well as comorbid mental and physical condition. | Pretreatment (T0) | No |
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