Effectiveness of Pain Science Education and Therapeutic Exercise in Adults With Musculoskeletal Pain. A Randomized Controlled Experimental Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Numeric Pain Rating Scale
研究概览
简要总结
This randomized controlled pilot trial evaluated the effectiveness of adding pain neuroscience education (PNE) to a therapeutic exercise program in adults with chronic musculoskeletal pain. Participants were randomly allocated in a 1:1 ratio to an experimental group receiving therapeutic exercise plus PNE or to a control group receiving therapeutic exercise alone. The intervention lasted 8 weeks. The primary objective was to evaluate the effect of the intervention on pain intensity. Secondary objectives included evaluating its effects on kinesiophobia, fear-avoidance beliefs, and muscle strength, as well as assessing the feasibility of the study protocol to inform the design of a future larger-scale randomized controlled trial.
详细描述
This randomized controlled pilot trial was designed to evaluate the added effect of pain neuroscience education (PNE) when incorporated into a structured therapeutic exercise program in adults with chronic musculoskeletal pain.
Participants were randomly allocated in a 1:1 ratio to an experimental group or a control group. Both groups participated in the same 8-week therapeutic exercise program. The experimental group additionally received a structured PNE intervention consisting of four educational sessions delivered every two weeks. The PNE program aimed to facilitate the reconceptualization of pain through accessible explanations of the neurophysiological mechanisms involved in pain perception and modulation.
The therapeutic exercise program was delivered in supervised group sessions and was primarily focused on strength training, with an additional aerobic exercise component. Exercise frequency, intensity, duration, and progression were individualized according to each participant's characteristics and abilities.
The study was designed as a pilot trial to estimate the effects of adding PNE to therapeutic exercise and to assess the feasibility of the study protocol, with the aim of informing the design of a future larger-scale randomized controlled trial.
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 (Outcomes Assessor)
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 years.
- •Chronic musculoskeletal pain lasting more than 3 months, regardless of pain location.
- •Provision of written informed consent to participate in the study.
排除标准
- •Psychiatric or psychological condition that could interfere with the performance or understanding of the therapeutic exercise program or the educational intervention.
- •Degenerative neurological disease or neurological disease affecting the central nervous system.
- •Recent surgery.
- •Pregnancy.
结局指标
主要结局
Numeric Pain Rating Scale
时间窗: Baseline and Week 9
Pain Intensity. Pain intensity was assessed using the Numeric Pain Rating Scale (NPRS), based on the maximum pain experienced during the previous 7 days.
次要结局
- Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia (TSK-11)(Baseline and Week 9)
- Fear-Avoidance Beliefs Assessed With the Fear-Avoidance Beliefs Questionnaire (FABQ)(Baseline and Week 9)
- Muscle Strength Assessed Using a Linear Velocity Transducer(Baseline and Week 9)
- Recruitment Feasibility(Through completion of the recruitment period)
- Adherence to the Intervention(Up to 8 weeks)
- Dropout Rate(Up to 8 weeks)
- Safety of the Intervention(Up to 8 weeks)
研究者
Irimia Mollinedo Cardalda
Professor
University of Vigo