Therapeutic Effects of Horticulture on Anterior Cingulate Cortex Activation in People With Chronic Low Back Pain (HORTICARE)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity involving exposure to nature: Therapeutic horticulture
Sponsored by
About this trial
This is an interventional basic science trial for Low Back Pain focused on measuring Low back pain, Chronic pain, therapeutic horticulture, anterior cingulate cortex, subgenual prefrontal cortex
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Cochin hospital - Department of Physical and Rehabilitation Medicine,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Therapeutic horticulture
Handiwork
Arm Description
handling (gardening equipment) and gardening task (outdoor and greenhouse tasks)
Handling tasks (materials) and handiwork (manufacturing of piece of wooden furniture)
Outcomes
Primary Outcome Measures
Change in the activity of the anterior cingulate cortex
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.
Secondary Outcome Measures
Variation in the rumination score
The variation in the rumination score will be measured by means of the self-administered Rumination-Reflection Questionnaire
Variation in the catastrophizing score
The catastrophizing score is a sub-scale of the self-administered Coping strategy questionnaire
Full Information
NCT ID
NCT04656158
First Posted
November 30, 2020
Last Updated
May 20, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04656158
Brief Title
Therapeutic Effects of Horticulture on Anterior Cingulate Cortex Activation in People With Chronic Low Back Pain
Acronym
HORTICARE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Chronic pain, therapeutic horticulture, anterior cingulate cortex, subgenual prefrontal cortex
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic horticulture
Arm Type
Experimental
Arm Description
handling (gardening equipment) and gardening task (outdoor and greenhouse tasks)
Arm Title
Handiwork
Arm Type
Active Comparator
Arm Description
Handling tasks (materials) and handiwork (manufacturing of piece of wooden furniture)
Intervention Type
Other
Intervention Name(s)
Physical activity involving exposure to nature: Therapeutic horticulture
Intervention Description
2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork
Primary Outcome Measure Information:
Title
Change in the activity of the anterior cingulate cortex
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Variation in the rumination score
Description
The variation in the rumination score will be measured by means of the self-administered Rumination-Reflection Questionnaire
Time Frame
3 weeks
Title
Variation in the catastrophizing score
Description
The catastrophizing score is a sub-scale of the self-administered Coping strategy questionnaire
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christelle NGUYEN, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Cochin hospital - Department of Physical and Rehabilitation Medicine,
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Effects of Horticulture on Anterior Cingulate Cortex Activation in People With Chronic Low Back Pain
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