Interdisciplinary Active Coping Program for Chronic Pain in the Physiotherapy Unit in Primary Care - Teruel Health Sector (Aragón, Spain)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline in Health-Related Quality of Life as Measured by the SF-36 v2 at End of Program and 6-Month Follow-Up
研究概览
简要总结
The goal of this observational intervention study is to evaluate the impact of a multidisciplinary active coping program for chronic back pain in adults referred from Primary Care to the Physiotherapy Unit of Teruel Ensanche. The main questions it aims to answer are:
- Does the program improve physical function, measured through gait speed, balance, and chair stand tests?
- Does it reduce pain-related psychological factors such as kinesiophobia, catastrophizing, anxiety, and depression?
- Does it improve quality of life and sleep quality, and reduce analgesic medication use?
Participants will attend group sessions on pain neuroscience education, followed by sessions on healthy habits, nutrition and sleep hygiene and group psychological intervention focused on emotional wellbeing tools, and will complete therapeutic exercise sessions over the course of the program. They will also complete validated questionnaires and physical assessments at three timepoints: at baseline, at the end of the program, and at a 6-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult (18 years or older)
- •Diagnosis of non-oncological chronic back pain
- •Referred from Primary Care to the Physiotherapy Unit of Teruel Ensanche . (UFAP) from one of the following basic health zones: Teruel Centro, Teruel Ensanche, Albarracín, Alfambra, Cella, or Villel
- •Able to provide voluntary written informed consent
排除标准
- •Oncological pain
- •Cognitive impairment that prevents following the program
- •Spinal surgery in the last year
- •Internal electrostimulator device (e.g. pacemaker, spinal cord stimulator)
研究组 & 干预措施
Multidisciplinary Active Coping Program
All participants receive the full sequential multidisciplinary intervention comprising four components delivered across four phases.
干预措施: Pain Neuroscience Education (PNE) (Behavioral)
Multidisciplinary Active Coping Program
All participants receive the full sequential multidisciplinary intervention comprising four components delivered across four phases.
干预措施: Healthy Habits and Psychological Intervention (Behavioral)
Multidisciplinary Active Coping Program
All participants receive the full sequential multidisciplinary intervention comprising four components delivered across four phases.
干预措施: Therapeutic Exercise (Behavioral)
结局指标
主要结局
Change from Baseline in Health-Related Quality of Life as Measured by the SF-36 v2 at End of Program and 6-Month Follow-Up
时间窗: Baseline, end of program, 6-month follow-up
The SF-36 measures health-related quality of life across 8 dimensions: physical function, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100, where 0 indicates the worst possible health state and 100 indicates the best possible health state.
次要结局
- Change from Baseline in Functional Disability as Measured by the Roland-Morris Disability Questionnaire at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Physical Performance as Measured by the Short Physical Performance Battery (SPPB) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Dynamic Balance as Measured by the Timed Up and Go Test (TUG) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Lower Limb Strength and Balance as Measured by the 30-Second Sit-to-Stand Test at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Gait Speed and Exercise Tolerance as Measured by the 6-Minute Walk Test at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Kinesiophobia as Measured by the Tampa Scale for Kinesiophobia (TSK-11SV) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (ECD) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Central Sensitization Symptoms as Measured by the Central Sensitization Inventory (CSI) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Analgesic and Co-adjuvant Medication Use as Recorded by Medication Registry at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Frequency of Primary Care Consultations (Medical and Physiotherapy) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Anxiety as Measured by the State-Trait Anxiety Inventory (STAI) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Depressive Symptoms as Measured by the Beck Depression Inventory II (BDI-II) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
- Change from Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) at End of Program and 6-Month Follow-Up(Baseline, end of program, 6-month follow-up)
研究者
Sandra León-Herrera
Trainee Research and Teaching Staff
Universidad de Zaragoza