Effects of Multimodal Exercises Integrated With Cognitive-behavioral Therapy in Subjects With Chronic Neck Pain: a Randomized Controlled Study With One Year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Change from Baseline Tampa Scale of Kinesiophobia at 10 weeks and 12 months
研究概览
简要总结
The etiology of cervical pain is multifactorial and studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. Over time, the use of multidisciplinary interventions for chronic vertebral pain (instead of segmental treatments) has grown in order to improve disability, pain and proactive behaviors towards the problem manifested. To date, the evidence relating to the effects of multidisciplinary approaches is inconclusive and lacking. In light of these premises, it appears necessary to deepen the conduct of studies aimed at evaluating the efficacy of a multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy based on kinesiophobia with specific exercises, in the treatment of chronic neck pain of working subjects.
详细描述
Background The etiology of cervical pain is multifactorial and includes age, gender, incongruous postures, repeated efforts. Studies based on the bio-psychosocial model also link chronic neck pain to psychological factors. Among them, kinesiophobia has been reported as an important determinant. It is debatable whether interventions targeting cognitive processes and pain-associated behaviors can lead to clinically significant changes in terms of disability, pain and quality of life of these individuals.
Furthermore, there is uncertainty about the effectiveness of the types of exercises to be proposed. This makes it difficult to choose between general exercises (aimed at improving cervical muscle and joint skills) and motor-oriented (or task-oriented) exercises (aimed at cervical functional recovery in an ecological context). Over time, the use of multidisciplinary interventions for chronic vertebral pain (instead of segmental treatments) has grown in order to improve disability, pain and proactive behaviors towards the problem manifested. To date, the evidence relating to the effects of multidisciplinary approaches is inconclusive and lacking. In light of these premises, it appears necessary to deepen the conduct of studies aimed at evaluating the efficacy of a multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy based on kinesiophobia with specific exercises, in the treatment of chronic neck pain of working subjects.
Hypothesis The hypothesis is that a multidisciplinary rehabilitation program induces clinically significant and long-term improvements in the disability, pain and quality of life of working subjects with chronic neck pain.
Objectives of the study Verify the effectiveness of a multidisciplinary program in inducing clinically significant and long-term improvements in the disability, pain and quality of life of working subjects suffering from chronic neck pain. Evaluate the work discomfort linked to the condition of chronic neck pain.
Study procedure The subjects eligible for the study will be assigned to one of two treatment programs (multidisciplinary or general) using a permuted block randomization procedure.
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
- Double (Investigator, 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
- •diagnosis of chronic non-specific neck pain
- •documented history of pain lasting more than 3 months
- •good knowledge of the Italian language
- •age over 18.
排除标准
- •acute and subacute neck pain
- •cognitive impairment
- •presence of specific causes of neck pain (history of spinal surgery, spinal deformity, herniated disc, infection, fracture, myelopathy or malignancy, whiplash injury, systemic or neuromuscular disease, cognitive impairment) evaluated by medical history and diagnostics for images
- •have previously undergone cognitive-behavioral therapy.
结局指标
主要结局
Change from Baseline Tampa Scale of Kinesiophobia at 10 weeks and 12 months
时间窗: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Tampa Scale of Kinesiophobia is a self-report questionnaire that assesses pain beliefs and pain-related fear of movement/reinjury in subjects with musculoskeletal complaints. the 13-item Italian version ranges from 13 (best health status) to 52 (worst health status).
Change from Baseline Neck Disability Index at 10 weeks and 12 months
时间窗: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Neck Disability Index, a self-administered 10-item questionnaire concerning neck pain disability, rates the intensity of pain and its disabling effects on typical daily activities. The score, expressed as a percentage, ranges from 0 (no disability) to 100 (maximum disability). Investigators used the Italian version which proved to be reliable and valid
Change from Baseline Numerical Rating Scale at 10 weeks and 12 months
时间窗: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Numerical Rating Scale assesses pain intensity using an 11-pointnumerical rating scale ranging from 0 (no pain) to10 (the worst imaginable pain).
Change from Baseline Pain Catastrophizing Scale at 10 weeks and 12 months
时间窗: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Pain Catastrophizing Scale assesses catastrophizing in subjects with musculoskeletal complaints, and consists of a 13-item self-report questionnaire. The total score ranges from 0 to 52 with 52 indicating the worst health status. Investigators used the Italian version which proved to be reliable and valid.
Change from Baseline Global Perceived Effect at 10 weeks and 12 months
时间窗: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Global Perceived Effect is a self-administered measure of treatment satisfaction consisting of a five-level Likert scale (1=helped a lot, 2=helped, 3=helped only a little, 4=did not help, 5=made things worse).
Change from Baseline Short-Form Health Survey Questionnaire at 10 weeks and 12 months
时间窗: Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).
Quality of life is assessed using the Italian version of the self-report Short-Form Health Survey with its eight domain scores ranging from 0 (the worst perceived quality of life) to 100 (the best perceived quality of life).
次要结局
- Change from Baseline Work Ability Index at 10 weeks and 12 months(Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).)
- Change from Baseline of Anamnestic survey of the upper limbs and spine's pathologies at 10 weeks and 12 months(Questionnaires will be administered before treatment, ten weeks after (post-treatment) and 12 months after the end of treatment (follow-up).)
研究者
Marco Monticone
Professor
University of Cagliari