The Impact of a Sleep and Circadian Intervention Program (SCIP) in Chronic Musculoskeletal Pain (CMP) Rehabilitation: a Feasibility PILOT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Opioid consumed dose
研究概览
简要总结
Musculoskeletal pain has become in a major problem related to its prevalence, treatment cost, absenteeism, quality of life impairment, disability and drugs consumption. The difficulty in musculoskeletal pain control ends in the abuse of drugs by these patients, including opioids. This drugs consumption has become a health problem in the United States and around the world related to their increasing abuse mainly between 2002 and 2011 and has had an impact in the numbers of deaths caused by opioids prescription (reaching 16,651 deaths in United States in 2010). Pain is clearly associated with sleep disturbances (50-80% of these patients suffer from a sleep problem), and in turn poor sleep quality leads to increased pain sensitivity. There is evidence showing that improving sleep disturbance co-occurring pain would improve, and some may reduce the use of opioids in specific patients on long-term opioid therapy. In spite of this reciprocal relationship between sleep and pain only few programs take into account the management of sleep disorders as a non-pharmacological measure for pain control. The hypothesis is: "to address sleep and circadian disorders (SCD) using a Sleep and Circadian Intervention Program (SCIP) in patients treated with rehabilitation by chronic musculoskeletal pain (CMP) optimizes the rehabilitation outcomes and reduces opioids consumption".
Main goal:
The aim of this PILOT study is to evaluate the feasibility of the protocol of the present study that aims to assess the improvement in rehabilitation outcomes and decrease in opioid consumption, through the management of sleep disorders.
Methodology Using a randomised (1:1) controlled feasibility study, 50 men and women will be included to evaluate methodology and identify the potential outcome of the main project. Subjects older than 18 years included in a rehabilitation program by musculoskeletal lumbar pain lasting more than three months will be recruited. Basal Visit (BV): After the signature of informed consent, a medical history, physical exam, evaluation of the pain perception (EQ5D5L), quality of life evaluation (SF36 and FOSQ), mood and anxiety (HADS y PASS20), circadian rhythm study and drugs consumption will be evaluated in both groups. Patients will be randomized to control group (usual rehabilitation program) or intervention group (usual rehabilitation program + sleep circadian intervention program-SCIP). The patient in the SCIP program will received the next intervention: 1) Educational and circadian rhythm intervention: general sleep hygiene recommendation and promotion of daily physical activity. 2) Sleep studies for sleep quality and sleep disorders diagnosis: full polysomnography 3) Sleep questionnaires for another sleep disorders. Based on the results of the studies, patients will be treated according to current guidelines for the management of sleep disorders. 6 month after the SCIP starts patients will be evaluated in the End of Study Visit (EOS) as in the BV and also in their functional improvement and health resources consumption.
详细描述
Hypothesis: to address sleep and circadian disorders (SCD) using a Sleep and Circadian Intervention Program (SCIP) in patients treated with rehabilitation by chronic musculoskeletal pain (CMP) optimizes the rehabilitation outcomes and reduces opioids consumption.
The Main Objective of this PILOT study is to evaluate the feasibility of the protocol of the present study that aims to assess the improvement in rehabilitation outcomes and decrease in opioid consumption, through the management of sleep disorders.
Secondary objectives of the PILOT study:
- To identify the primary outcome to evaluate the hypothesis. Evaluate relevance and observed change of the main outcome for the main study. It will allow investigators to evaluate the effect size and variability of the SCIP in the opioids consumption in a sample of our population to determine if this is the potential outcome for the main project.
- To determine the patient inclusion rhythm (recruitment rate) and, if necessary, the reasons for non-recruitment.
- To determine the follow-up rate and reasons for loss to follow-up.
- To test the sleep circadian study's methodology in this type of population.
- To assess the acceptability, implementation and preliminary efficacy of the SCIP.
- To evaluate adherence and fidelity to the SCIP through recruitment and retention.
- To determine the data acquisition rate, amount of missing data and reasons for loss.
- To evaluate the safety of the program.
- To characterize the effect observed in the intervention in order to properly calculate the sample size necessary for the main study.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Subjects older than 18 years
- •Inclusion in a rehabilitation program by lumbar musculoskeletal pain lasting more than three months
- •Patients have no severe reading or learning difficulty
- •Signature of informed consent.
排除标准
- •Severe psychopathological co-morbidity (e.g. the presence of schizophrenia, bipolar disorders…)
- •Co-morbid malignant/terminal diseases (e.g. HIV/AIDS, cancer)
- •Shift-workers and people who work making transmeridian travels.
结局指标
主要结局
Opioid consumed dose
时间窗: 12 months
Quantification of decrease dose opioids consumption related through the management of sleep disorders.
次要结局
- Number of patients lost in follow up.(12 months)
- Opioids urine drugs test to assess opioids consumption(12 months)
- Number of patients that complete the SCIP(12 months)
- Determine inclusion rhythm.(6 months)
- Determine data acquisition.(18 months)
- Number of participants with SCIP-related adverse events as assessed(12 months)
- Number of patients needed related to the SCIP effect size.(12 months)
- Sleep circadian study's methodology(12 months)
- Number of patients the developed the EOS visit(12 months)
研究者
OlgaMediano
Principal Investigator
Consorcio Centro de Investigación Biomédica en Red (CIBER)