Low Back PainHORTICARENCT04656158
Therapeutic Effects of Horticulture on Anterior Cingulate Cortex Activation in People With Chronic Low Back Pain
A study testing Physical activity involving exposure to nature: Therapeutic horticulture in people with Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Physical activity involving exposure to nature: Therapeutic horticulture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2021to 29 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Cochin hospital - Department of Physical and Rehabilitation Medicine,
Paris, 75014
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Physical activity involving exposure to nature: Therapeutic horticulture
- Keywords
- Low back pain, Chronic pain, therapeutic horticulture, anterior cingulate cortex, subgenual prefrontal cortex
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity involving exposure to nature: Therapeutic horticultureOther
2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic horticulture | Experimental | handling (gardening equipment) and gardening task (outdoor and greenhouse tasks) Receives: Other: Physical activity involving exposure to nature: Therapeutic horticulture |
| Handiwork | Active comparator | Handling tasks (materials) and handiwork (manufacturing of piece of wooden furniture) Receives: Other: Physical activity involving exposure to nature: Therapeutic horticulture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (2)
Variation in the rumination score
The variation in the rumination score will be measured by means of the self-administered Rumination-Reflection Questionnaire
Measured: 3 weeks
Variation in the catastrophizing score
The catastrophizing score is a sub-scale of the self-administered Coping strategy questionnaire
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start25 May 2021
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christelle NGUYEN, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656158
- Sponsor's protocol ID
- APHP191119
- Other IDs
- 2019-A02988-49
- Acronym
- HORTICARE
- Status last verified
- Sep 2025
- First submitted
- 30 Nov 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39689109
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04656158
- Acronym / sponsor ID
- HORTICARE / APHP191119
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Chronic pain, therapeutic horticulture, anterior cingulate cortex, subgenual prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 May 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic horticulture | Experimental | Other: Physical activity involving exposure to nature: Therapeutic horticulturehandling (gardening equipment) and gardening task (outdoor and greenhouse tasks) |
| Handiwork | Active comparator | Other: Physical activity involving exposure to nature: Therapeutic horticultureHandling tasks (materials) and handiwork (manufacturing of piece of wooden furniture) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity involving exposure to nature: Therapeutic horticulture2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork | Other | Handiwork, Therapeutic horticulture |
Primary outcome
Change in the activity of the anterior cingulate cortex
Time frame: 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.
2 secondary outcomes
Variation in the rumination score
Time frame: 3 weeks
Variation in the catastrophizing score
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 39689109Roren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle NGUYEN, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity involving exposure to nature: Therapeutic horticulture in people with Low Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the activity of the anterior cingulate cortex (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.