A Feasibility Study of a Multidisciplinary Treatment for Patients with Chronic Low Back Pain: PAINDOC Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
The present feasibility study aims to evaluate the feasibility and adequacy of a multidisciplinary treatment program as a therapeutic option for patients with chronic low back pain referred to the pain unit of the Hospital Clinic of Barcelona. Secondarily, the present study will also evaluate the effect on pain-related outcomes to estimate the number of needed participants for a full trial.
The main questions it aims to answer are:
- Is the proposed multidisciplinary treatment feasible and adequate for chronic low back pain patients?
- Is the proposed multidisciplinary treatment effective in improving pain-related outcomes?
Participants will receive either usual care (pharmacological control) or eight multidisciplinary sessions within two months, composed of therapeutic patient education, mindfulness relaxation, cognitive-behavioural therapy and therapeutic exercise. Besides, participants will be assessed using written questionnaires before and after treatment and two months after treatment.
Researchers will assess the feasibility of the multidisciplinary treatment group and will compare 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, long-lasting 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.
The present study aims to evaluate the viability and adequacy of a multidisciplinary treatment program (PAINDOC Program) as a therapeutic option for patients with chronic low back pain referred to the pain unit of the Hospital Clínic of Barcelona. The secondary objectives are to evaluate the effect of the PAINDOC Program on the reduction of pain intensity, the improvement of pain-related disability, the improvement of quality of life, and the reduction of pain catastrophizing.
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)
盲法说明
Two armed, parallel groups, single blind, unicentric, randomized feasibility study
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 with primary chronic low back pain (non-specific chronic low back pain).
- •Predominantly axial pain, for at least 50% of the time during the last 6 months.
- •Average pain intensity equal or greater than 4 out of 10 on a verbal numerical scale, during the present week.
- •Predisposed to receive an active, non-pharmacological and non-surgical treatment.
排除标准
- •Inflammatory low back pain.
- •History of cancer in the past 5 years.
- •Unexplained and involuntary weight loss of 10 Kg during the last year.
- •Problems in the control of bowel and bladder function.
- •Difficulty attending sessions due to severe physical disability.
- •Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.).
- •Addiction disorder to parenteral drugs or strong prescription opioids. Technical-logistical problems (inability to attend treatment sessions, inability to complete evaluation questionnaires).
- •Seeking compensation or litigation in the last year.
- •Severe hearing loss or severe cognitive impairment.
研究组 & 干预措施
Usual Care (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 8 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over two months.
It consists of a therapeutic education (Empowered Relief) session given by a physician from the unit, a pain psychology session given by a psychologist, an introductory mindfulness meditation session given by an advanced practice nurse, and two pain neuroscience education sessions and three 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: PAINDOC Program (Other)
结局指标
主要结局
Recruitment rate
时间窗: 4 months prior to study start
To obtain this information, the number of participants included in the program for four consecutive months will be calculated. The number of eligible participants, the number of participants included and excluded, and the reasons for exclusion will be detailed.
Number of participants completing treatment
时间窗: 2 months
Acceptable compliance has been defined as at least 80% of participants included in the program completing all program sessions.
Follow-up rate
时间窗: 4 months
to determine the follow-up rate, the number of participants who complete the evaluations at each evaluation point in the study will be detailed.
Acceptance of treatment and detection of barriers
时间窗: 2 months
Treatment acceptance will be assessed through a qualitative approach, based on focus groups and content analysis. The study will have a phenomenological approach to understand and know directly the experiences of the participants. The research will be conducted from the interpretive paradigm, as it seeks to understand and interpret the deep meaning of the observed phenomena. In addition, it is based on an inductive methodology that starts from reality to generate theories, so the fieldwork does not start from a hypothesis.
次要结局
- Pain Catastrophizing. Changes from baseline to 2 months after treatment.(Baseline, 2 months, 4 months)
- Pain Intensity. Changes from baseline to 2 months after treatment.(Baseline, 2 months, 4 months)
- Health-related quality of life. Changes from baseline to 2 months after treatment.(Baseline, 2 months, 4 months)
- Pain-related disability. Changes from baseline to 2 months after treatment.(Baseline, 2 months, 4 months)
研究者
Marc Terradas Monllor
Principal Investigator
University of Vic - Central University of Catalonia