Operant Learning Versus Energy Conservation Activity Pacing Interventions in a Sample of Fibromyalgia Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Pain ratings (0-10 numerical rating scale assessing average pain over the last 7 days)
研究概览
简要总结
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.
详细描述
Rational:
Activity pacing (AP) can be defined as "the regulation of activity level and/or rate in the service of a goal or goals" (Nielson, Jensen et Vlaeyen, 2012). This general coping strategy is widely used in chronic pain (CP) management both as a stand-alone treatment and as a component of multimodal treatment programs. However its potential benefits remain unproven; in fact, there is evidence that in some contexts, pacing may be a maladaptive coping response (Gill et Brown, 2009). Thus, more knowledge regarding the effects of this coping strategy is needed in order to determine if (and for whom) it is an effective pain management treatment.
Two models of AP are currently in widespread use. The Operant Learning (OL) approach uses positively reinforced activity quotas that are time and/or goal contingent, rather than pain-contingent, and these are gradually increased using "activity-rest" cycling (Fordyce, 1976). In contrast, the Energy Conservation (EC) approach focuses on patient energy expenditure, and seeks to achieve a balance between accomplishing important day-to-day activities and resting in order to reduce or avoid pain and fatigue (Hammond, 2004). Despite the ubiquitous use of these two forms of AP in clinical settings, little is known about either their individual or relative efficacy. Similarly, each approach involves multiple elements, and it is unclear which of these elements might be responsible for putative treatment effects. Two recent studies (Murphy et al., 2011 ; van Koulil et al., 2010) have provided some data regarding AP, but described somewhat contradictory results and did not provide clear theoretical bases for their interventions. Future research concerning the effectiveness of AP should: (a) define the contents of interventions based on theory; (b) avoid confounding AP with non-AP treatment elements; (c) examine the relative efficacy of these two theoretically different AP methodologies; and (d) identify the clinical populations that are most likely to benefit from AP treatment.
Fibromyalgia Syndrome (FMS) is a condition with a general population prevalence of approximately 3-5% and is estimated to have one of the highest psychosocial and financial impacts of all rheumatic diseases and chronic pain conditions. The predominant symptoms of FMS are chronic widespread pain and fatigue. Although there are no disease-modifying treatments available for this condition, Cognitive Behavioural and Multidisciplinary Treatment Programs, usually including some form of AP, are evidence-based and widely recommended. Because FMS is common, causes considerable suffering (personal, social and economic) and has been the frequent target of AP methods, it is particularly important to understand the efficacy of AP - both alone and as a part of multimodal treatment packages. However, before this step is taken, it is important to assess the efficacy of AP as a stand-alone treatment.
Research objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pain ratings (0-10 numerical rating scale assessing average pain over the last 7 days)
时间窗: 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)).
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).
Fatigue ratings (0-10 numerical rating scale assessing average fatigue over the last 7 days)
时间窗: 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)).
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)
次要结局
- Socio-demographic questionnaire(Pretreatment (T0).)
- Brief Pain Inventory(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)).)
- Brief Fatigue Inventory(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)).)
- SF36v2 Health Survey(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)).)
- Medical Outcomes Study (MOS) - Sleep 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)).)
- 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)).)
- Structured Assessment(Pretreatment (T0))
研究者
Warren Nielson, PhD
Principal Investigator
Lawson Health Research Institute
