NCT04656158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

November 30, 2020

Last Update Submit

November 17, 2025

Conditions

Low Back Pain

Keywords

Low back painChronic paintherapeutic horticultureanterior cingulate cortexsubgenual prefrontal cortex

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 weeks

Secondary Outcomes (2)

  • Variation in the rumination score

    3 weeks

  • Variation in the catastrophizing score

    3 weeks

Study Arms (2)

Therapeutic horticulture

EXPERIMENTAL

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

Other: Physical activity involving exposure to nature: Therapeutic horticulture

Handiwork

ACTIVE COMPARATOR

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

Other: Physical activity involving exposure to nature: Therapeutic horticulture

Interventions

Physical activity involving exposure to nature: Therapeutic horticultureOTHER

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

HandiworkTherapeutic horticulture

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin hospital - Department of Physical and Rehabilitation Medicine,

Paris, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 39689109RESULT

MeSH Terms

Conditions

Low Back PainChronic Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christelle NGUYEN, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

May 25, 2021

Primary Completion

March 29, 2022

Study Completion

March 29, 2022

Last Updated

November 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)