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临床试验/NCT04656158
NCT04656158已完成不适用

Comparative Effects of Therapeutic Horticulture and Handiwork on Anterior Cingulate Cortex Activation in People With Chronic Low Back Pain : A Randomized Cross-over Controlled Pilot Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Change in the activity of the anterior cingulate cortex

研究概览

简要总结

Chronic low back leads to a significant socio-economic burden. It is associated with physical and psychosocial deconditioning. Even a short "nature experience" has positive effects on the affective and cognitive factors involved in chronic pain. In the brain, the anterior cingulate cortex plays an important role in both pain and emotions. Exposure to a natural environment may decrease activation of the anterior cingulate cortex.

The main objective of this study is to evaluate the effectiveness of therapeutic horticulture on the decrease of activation of the anterior cingulate cortex in people with chronic low back pain participating in 2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork.

The investigators hypothesize that therapeutic horticulture may reduce the activation of the anterior cingulate cortex. The effects of therapeutic horticulture may be mediated through the double exposure to both nature and physical activity.

详细描述

Non-specific low back pain is the first cause of years lived with a disability in the world. The network of biological, psychological and social contributors to chronic low back pain is complex. Within this network, physical and mental deconditioning are a key point and a privileged therapeutic target of multidisciplinary training programs.

Physical exercise improves pain and function in people with chronic low back pain. Nevertheless, its benefits decrease if it is not practiced regularly. The pleasure doing physical exercises and the possibility of integrating them into daily life are important factors of adherence. Gardening meets well the expectations of the physical treatment of chronic low back pain as it involves exercises aiming to increase spinal flexibility, strength and endurance of spine and lower limbs muscles, proprioception. Gardening is associated with the notion of pleasure and can be practiced in a group thus promoting the social bond. Moreover, therapeutic horticulture is suitable for the long term and can even be practiced in urban environment. Painful sensations are modulated by the affective and emotional state. Within the neuromatrix of pain, the cortex plays an important role in encoding pain and associated emotions. Several studies suggest an impact on several physiological parameters of an "experience of nature", even on a short time. A randomized controlled trial compared in 38 healthy volunteers, the effect of a 90-minute walk in nature (forest) and in urban setting (city), on the activation of the anterior cingulate cortex (specifically its subgenual part) assessed using variation in blood perfusion on MRI, and on rumination, assessed using a self-administered questionnaire. The authors showed that neural activation in the subgenual prefrontal cortex and rumination scores were lower in the group of healthy volunteers exposed to nature. Little is known about the impact of a "nature experience" on chronic low back pain. A non-randomized controlled study has shown that adding 7 sessions of therapeutic horticulture to a standardized pain management program improved health status, anxiety and coping strategies in patients with chronic pain.

By its nature and physical component, therapeutic horticulture could constitute a non-pharmacological accurate intervention in people with chronic low back pain, targeting both the neurobiological and physical aspects of deconditioning syndrome. Therapeutic horticulture was introduced in October 2017 in the multidisciplinary training program dedicated to chronic low back pain in our department. However, its effects have not yet been evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults of working-age (18 to 70 years),
  • •Chronic non-specific low back pain,
  • •Patient waiting for a short functional restoration program in the rehabilitation department,
  • •Failure of first-line treatment,
  • •Up-to-date DTP vaccination,
  • •Patients able to walk 2 km,
  • •Health insurance,
  • •Informed written consent.

排除标准

  • •Specific low back pain,
  • •Contraindication to MRI,
  • •Current stoppage or for more than 3 months during the last year,
  • •Lack of paid employment,
  • •Participation in another research on low back pain,
  • •Inability to fluently speak and/or read French language,
  • •Free state medical assistance
  • •People under tutorship or curatorship, and protected adults.

研究组 & 干预措施

Therapeutic horticulture

Experimental

handling (gardening equipment) and gardening task (outdoor and greenhouse tasks)

干预措施: Physical activity involving exposure to nature: Therapeutic horticulture (Other)

Handiwork

Active Comparator

Handling tasks (materials) and handiwork (manufacturing of piece of wooden furniture)

干预措施: Physical activity involving exposure to nature: Therapeutic horticulture (Other)

结局指标

主要结局

Change in the activity of the anterior cingulate cortex

时间窗: 3 weeks

The variation in the activity of the anterior cingulate cortex will be measured by the change in blood perfusion in ml / 100 g tissue / min using MRI.

次要结局

  • Variation in the catastrophizing score(3 weeks)
  • Variation in the rumination score(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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