Role of Emotion Regulation on Low Back Pain Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Emotion regulation abilities
研究概览
简要总结
This study will advance understanding on the mechanisms that mediate improved outcomes for chronic low back pain and provide specific directions for optimizing physical activity interventions for this population.
详细描述
In this study, participants with chronic low back pain will be randomized to receive a 12-week physical activity intervention (2 times per week with encouragement for home practice). The experimental condition will entail physical activity with components for strengthening emotion regulation skills, behaviors, and attitudes while the control condition will entail physical activity alone.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
We will employ blinding whenever possible. Assessments, evaluations, and data analysis will be conducted without knowledge of participants' assigned group. Study personnel will be blinded to the assigned condition of subjects when conducting data collection by using unique study identification numbers, by following a strict script to refrain from discussing participant activities, and by using different members of the study team to coordinate assigned condition activities and to collect data. De-identified data with codes for assigned condition will facilitate blinded data analysis.
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
- •- Age > 18;
- •Report of low back pain >3 of last 6 months;
- •Willing to attend 12-weeks of yoga or stretching (twice per week);
- •Willing to complete 4 assessments;
- •English Literacy;
- •No changes in pain treatments in the past month;
- •Willing to not change pain treatments during study unless medically necessary;
- •Have not practiced yoga > 2x in the last 12 months;
排除标准
- •- back surgery within the last 1 year;
- •back pain due to specific systemic problem (e.g., lupus);
- •lower extremity weakness (motor strength 4/5 of the quads, gluts, hamstrings, EHL);
- •sciatica or (+) straight leg raise (SLR);
- •coexisting chronic pain problem (migraine headaches, fibromyalgia);
- •Serious or unstable psychiatric illness (e.g. psychosis, mania, history of suicide attempt);
- •major coexisting medical illness (e.g., cancer, COPD, morbid obesity);
- •Positive Romberg test (with or without sensory neuropathy).
研究组 & 干预措施
Physical activity + emotion regulation group
Participants randomized to the experimental group attend two group-based class sessions per week, each 1.25hours long, that are led by certified instructors who guide participants through various exercises. Participants are encouraged to practice the activities at home for 20 minutes each day.
干预措施: Physical activity + emotion regulation intervention (Behavioral)
Physical activity control group
Participants randomized to the control group attend two group-based class sessions per week, each 1.25hours long, that are led by trained therapists who guide participants through a series of stretching exercises. Participants are encouraged to practice the activities at home for 20 minutes each day.
干预措施: Physical activity control intervention (Behavioral)
结局指标
主要结局
Emotion regulation abilities
时间窗: Baseline and 6 weeks and 3 months and 6 months
Difficulties in Emotion Regulation Scale - Change over time; range is 36-120, a higher score reflects less emotion regulation
次要结局
- Pain severity/interference(Baseline and 6 weeks and 3 months and 6 months)
- Pain sensitization(Baseline and 6 weeks and 3 months and 6 months)
研究者
Crystal Park
Professor
University of Connecticut