Therapeutic Effects of Horticulture on Anterior Cingulate Cortex Activation in People With Chronic Low Back Pain

NCT ID: NCT04656158

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2022-03-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therapeutic horticulture

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

Group Type EXPERIMENTAL

Physical activity involving exposure to nature: Therapeutic horticulture

Intervention Type OTHER

2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork

Handiwork

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

Group Type ACTIVE_COMPARATOR

Physical activity involving exposure to nature: Therapeutic horticulture

Intervention Type OTHER

2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical activity involving exposure to nature: Therapeutic horticulture

2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christelle NGUYEN, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cochin hospital - Department of Physical and Rehabilitation Medicine,

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Roren A, Debacker C, Saghiah M, Bedin C, Fayolle A, Abdoul H, Lefevre-Colau MM, Rannou F, Oppenheim C, Nguyen C. Effects of horticultural therapy versus handiwork on anterior cingulate cortex activity in people with chronic low back pain: A randomized, controlled, cross-over, pilot study. PLoS One. 2024 Dec 17;19(12):e0313920. doi: 10.1371/journal.pone.0313920. eCollection 2024.

Reference Type RESULT
PMID: 39689109 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A02988-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP191119

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3h of PNE on BDNF and Pain Levels
NCT05736172 RECRUITING NA
Education on BDNF on Pain Levels
NCT05623579 RECRUITING NA