Effectiveness of a Multidisciplinary Treatment for Patients with Chronic Low Back Pain (PAINDOC Protocol): Randomized, Parallel-group, Two-arm, Single-blind Clinical Trial (PAINDOC Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Pain Intensity. Changes from baseline to 6 months.
研究概览
简要总结
PAINDOC is a treatment program that includes 4 disciplines that, separately, have demonstrated their effectiveness in the treatment of chronic low back pain: education in pain neuroscience, therapeutic education (Empowered Relief®), psychotherapy based on cognitive-behavioral therapy and therapeutic exercise.
The primary objective of the study is to evaluate the effectiveness of the PAINDOC multidisciplinary treatment program in reducing pain intensity and improving quality of life in persons with chronic low back pain referred to the pain unit of the Hospital Clinic of Barcelona, compared to usual care treatment.
As secondary objectives, the present study aims to evaluate the effect of the PAINDOC program on:
- The reduction of pain-related disability.
- The reduction of pain catastrophizing.
- The improvement in perceived social support.
- The improvement in perceived autonomy (self-efficacy).
- The reduction of analgesic, anti-inflammatory and adjuvant analgesic medication.
The main questions it aims to answer are:
- Is the proposed multidisciplinary treatment effective in improving pain-related outcomes?
- Is the proposed multidisciplinary treatment effective in reducing analgesic medication?
Participants will receive either usual care (pharmacological control) or the PAINDOC program, which consists of 7 multidisciplinary sessions within 2 months. There will be one therapeutic education session called Empowered Relief®, 2 pain neuroscience education sessions, one pain psychology session and 3 therapeutic education sessions. Besides, participants will be assessed using written questionnaires before treatment, at 3 months and at 6 months.
Researchers will assess the effectiveness of the multidisciplinary treatment group comparing both groups to see if there is any difference in several pain-related outcomes.
详细描述
Despite improving pharmacological and surgical medical treatment options, chronic low back pain is the most frequent pain disorder and a leading cause of disability. Over the past decades, clinicians have acknowledged that a broader view of disease and disability is needed in chronic conditions treatment. Therefore, biological, psychological and social factors must be addressed to improve such conditions.
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
- •Patients over 18 years of age.
- •Patients with primary chronic low back pain (non-specific chronic low back pain) of axial predominance.
- •Experiencing pain at least 50% of the time over the last 6 months.
- •Average weekly pain intensity equal or greater than 4 out of 10 on a verbal numerical scale.
- •Be agreeable to receiving active, non-pharmacological and non-surgical treatment.
排除标准
- •Inflammatory low back pain.
- •History of cancer in the last 5 years.
- •Unexplained and unintentional weight loss of 10 Kg or more over the preceding 12-month period.
- •Lack of control of bowel and bladder function (cauda equina).
- •Difficulty in performing the sessions due to severe physical disability.
- •Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).
- •Strong prescription opioid or parenteral medication addiction disorders.
- •Technical-logistical problems (inability to attend treatment sessions or inability to fill out assessment questionnaires).
- •Problems in understanding the content of the sessions (language barrier, severe hearing loss or severe cognitive impairment).
- •Have sought compensation or entered into litigation in the preceding 12-month period.
研究组 & 干预措施
Pharmacological control
The subjects in the control group will be treated following a pharmacological approach according to the latest clinical guidelines for patients with chronic low back pain. Thus, the pharmacological options to be considered in each patient will be those included in the first and second analgesic steps of the WHO (preferably without including minor opioids).
干预措施: Usual Care (Drug)
PAINDOC program
The PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 7 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over 2 months. It consists of a therapeutic education session (Empowered Relief®) given by a physician from the unit, a pain psychology session given by a psychologist, and 2 pain neuroscience education sessions and 3 therapeutic exercise sessions given by a physiotherapist. This program is already part of the pain unit's routine care practice, so it is considered that the sessions of this program do not represent an additional and specific visit for the patients.
干预措施: Multidisciplinary and multimodal intervention (Behavioral)
结局指标
主要结局
Pain Intensity. Changes from baseline to 6 months.
时间窗: Baseline, 3 months, 6 months
Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = worst imaginable pain. The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in low back pain patients. For patients with subacute or chronic low back pain, the minimum clinically relevant change is considered to be at least 20 mm on a VAS.
Health-related quality of life. Changes from baseline to 6 months.
时间窗: Baseline, 3 months, 6 months
The spanish version of the Euro Quality of Life 5D-5L (EQ-5D-5L) was used to assess the health related quality of life (HRQL).(10) The EQ-5D-5L consists in two pages: the first one is based on a descriptive system that defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories: no problems, slight problems, moderate problems, severe problems, extreme problems.(10) A health state is composed by taking one level for each dimension, and a preference-based scoring function is used to convert the descriptive system to a summary index score (ranging from states worse than dead \<0 to full health 1).
次要结局
- Pain-related Disability. Changes from baseline to 6 months.(Baseline, 3 months, 6 months)
- Pain Catastrophizing. Changes from baseline to 6 months.(Baseline, 3 months, 6 months)
- Perceived Social Support. Changes from baseline to 6 months.(Baseline, 3 months, 6 months)
- Self-efficacy. Changes from baseline to 6 months.(Baseline, 3 months, 6 months)
- Consumption of analgesic, anti-inflammatory and coadjuvant analgesic drugs(Baseline, 3 months, 6 months)
研究者
Anna Dalmau Roig
Principal Investigator
University of Barcelona