Efficacy of Acceptance and Commitment Therapy in Patients Scheduled for Lumbar Spine Surgery (SPINE-ACT Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
Objectives: (1) To analyze the effectiveness of adding a group-based form of Acceptance and Commitment Therapy (ACT) to the treatment as usual (TAU) for preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain at baseline and after psychological treatment. (2) To examine the effectiveness of ACT on the improvement of pain interference, pain-related and behavioral variables in degenerative lumbar pathology preoperative patients after lumbar spine surgery in comparison with TAU. (3) To measure the proximal and distal effects of ACT in preoperative patients with degenerative lumbar pathology who had the surgery after ACT program completion in comparison with proximal and distal TAU surgery effects on pain related variables.
Method: A 12-month randomized controlled trial (RCT) will be conducted at Hospital del Mar (Barcelona). Only those preoperative degenerative lumbar pathology patients with psychosocial risk factors for chronic post-surgical pain will be randomized to pre-surgical ACT group or to TAU. Evaluations will be completed before treatment (baseline), after ACT therapy (3 months), a first follow-up (6 months from baseline alias 3 months after surgery), second follow-up (9 months from baseline alias 6 months after surgery), and final follow-up (15 months from baseline alias 12 months from surgery).
Participants: 80 adult preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain will be randomly assigned to two arms: ACT + TAU vs TAU.
Primary outcome: Pain interference. Secondary outcomes: pain intensity, pain catastrophising, pain acceptance, pain disability, kinesiophobia, depression symptoms, anxiety symptoms, psychological flexibility, and quality of life.
Main statistical analyses: Intention-to-Treat analyses that will include all participants who undergo random allocation, using multiple imputation to replace missing values. General linear mixed-effects models will be performed using Restricted Maximum Likelihood to estimate the parameters. Calculation of between-groups effect sizes using Cohen's d and of the number-needed-to-treat.
详细描述
The Spine-ACT project's main objective is to determine the effectiveness of adding to the standard care (TAU) of preoperative patients with degenerative lumbar pathology plus psychosocial risk factors related to post-surgical chronic pain, a group-based form of ACT. In this regard, assessing patients' results after surgery at proximal or distal improvement on pain-related variables compared with TAU surgery patients would be addressed. The Spine-ACT project will assess the usefulness of ACT therapy applied before surgery to improve pain-related variables and quality of life in preoperative degenerative lumbar pathology patients with psychosocial risk factors of developing chronic or post-surgical pain. This project will significantly expand the limited knowledge available about preoperative pain-related improvement through ACT therapy and how this psychological therapy could prevent post-surgical chronic pain. Thus, it is expected that ACT therapy can improve the various pain-related and quality-of-life variables in developing chronic pain in preoperative patients diagnosed with degenerative lumbar pathology plus psychosocial risk factors of post-surgical chronic pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18- 80 years
- •Possess an adequate understanding of Spanish or Catalan
- •Meet the diagnostic criteria for lumbar pain/degenerative lumbar pathology candidates for surgical treatment.
- •Diagnoses:
- •Lumbar canal stenosis.
- •Foraminal stenosis.
- •Lumbar spondylolisthesis.
- •Lumbar degenerative disc disease.
- •Degenerative scoliosis.
- •Lumbar kyphosis.
- •Procedures:
- •Laminectomy. Foraminoplasty. Laminectomy and posterior arthrodesis. previous arthrodesis.
- •Presence of psychosocial risk factors for chronic post-surgical pain:
- •Mild-moderate anxiety/depression symptoms (HADS hospital anxiety and depression sub-scales≥11, see measurement instruments section) and/or
- •Presence of catastrophizing (PCS catastrophizing scale (0-52) ≥24, see measurement instruments section), and/or
- •Kinesiophobia base ≥27, see measurement instruments section)
- •Have an internet connection on a mobile phone, tablet, computer, etc. to be able to carry out group psychological therapy online.
- •Give authorization by signing an informed consent
排除标准
- •Cognitive impairment that in the clinician's judgment prevents you from participating in therapy
- •Presenting chronic pain not related to the diagnosis of low back pain that is a candidate for surgical treatment
- •NOT present psychosocial risk factors for chronic post-surgical pain (see inclusion criteria: anxiety, catastrophizing, depression, kinesiophobia)
- •Patients in litigation or who are pending legal claims for compensation
- •Severe or decompensated psychiatric disorder (depression, schizophrenia, bipolar disorder, personality disorder) that in the clinician's judgment prevents you from participating in therapy
- •Suicidal ideation
- •Consumption of toxic substances in abuse/dependence, except for smoking
- •Patients with a language barrier (Spanish/Catalan)
- •Patients who do not authorize it voluntarily and do not want to participate
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: Through study completion, an average of 2 years
It is a questionnaire that assesses chronic pain in a multidimensional way. It provides information on the intensity of the pain and on the degree of interference in the functioning and daily activities of the patients. It has 11 items. The first 4 items evaluate the intensity of pain in the last 24 hours. Subsequently, 7 items that report the degree of involvement of chronic pain in various areas of the person's functioning are evaluated. The higher the score in the areas of the questionnaire, the greater the intensity of perceived pain, as well as the greater degree of involvement of chronic pain in the functioning of the person in the various areas explored
次要结局
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 2 years)
- Pain Catastrophising Scale (PCS)(Through study completion, an average of 2 years)
- Psychological Inflexibility in Pain Scale (PIPS)(Through study completion, an average of 2 years)
- Tampa Kinesiophobia Scale (TSK-11SV)(Through study completion, an average of 2 years)
- Chronic Pain Acceptance Questionnaire (CPAQ-20)(Through study completion, an average of 2 years)
- Short Form 12 Health Survey (SF-12)(Through study completion, an average of 2 years)
- Oswestry Low Back Pain Disability Scale (OLBPDQ)(Through study completion, an average of 2 years)
研究者
Juan Ramon Castaño
Principal Investigator
Parc de Salut Mar