Clinical trial NCT07002853: Nature-based Intervention for Chronic Pain in Older People
Official title: Nature-based Intervention Program for Sustainable Health in Older People Living With Chronic Non-specific Lower Back Pain (PARC Project 2) - A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Chronic Pain (Back / Neck)
Older Adults (65 Years and Older)
Keywords: Aging
Chronic pain
Non-specific low back pain
Nature-based interventions
Falls
Forest bathing
Shinrin-yoku
Social
Nature connectedness
Functionning
Physical activity
Mindfulness
Meditation
Rehabilitation
Postural control
Strength
Quality of life
Balance
Lead sponsor: Université du Québec à Chicoutimi
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: FUQAC
First posted: 2025-06-04
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a nature-based intervention program has positive effects on the physical and psychosocial health in a group of older participants with chronic non-specific lower back pain. The main questions it aims to answer are:

Will the program improve:

* The physical outcomes such as mobility, strength and balance?
* The psychosocial health outcomes?

Participants will:

* Be assessed before and after the program;
* Participate in one session per week of the intervention.

Detailed description: Nonspecific chronic low back pain is defined as persistent pain located between the lower ribs and the gluteal fold, with no identifiable pathoanatomical cause. It is associated with decreased quality of life, mental well-being, increased work absenteeism, and represents a significant economic burden for both individuals and the healthcare system. In the scientific literature, physical activity remains the primary recommended intervention. Recently, nature-based interventions have also been explored as a potential multidisciplinary ally for the management of chronic pain.

The objective of this study is to examine the effects of outdoor physical activity (i.e. walking, general back mobility and strengthening) combined with other nature interventions (i.e. shinrin-yoku, meditation, gardening and pain education) in a group of older adults living with chronic non-specific lower back pain. The intervention will consist of an 8-week group program, conducted once a week for 2 hours. A total of 15 participants will take part in the program to evaluate its impact on both physical and mental health.

Data collection will include both quantitative and qualitative measures. Quantitative outcomes will assess pain disability, quality of life, kinesiophobia (fear of movement), fear of falling, pain catastrophisation, pain beliefs, well-being, depression, nature connectedness, and physical function through standardized tests (e.g., 5 Times Sit to Stand Test), postural control, and gait patterns. Statistical analyses will be performed to compare pre- and post-intervention outcomes, as well as to explore associations between clinical variables, using SPSS software.

Qualitative data will be collected through individual interviews conducted before and at the end of the program to provide a richer understanding of participants' experiences of pain and perceived effects of the program. Interview transcripts will be analyzed using NVivo software.

It is anticipated that this type of intervention will have positive effects for this population and may be considered a promising rehabilitation approach for the management of chronic low back pain in older adults.

Eligibility criteria: Inclusion Criteria:

* Aged 65 years +
* Having low back pain for 3 months or more
* Being able to walk independently
* Mental state \>25/30 in the MMSE questionnaire
* Frailty score \<3/5 (Fried criterias)

Exclusion Criteria:

* Presenting other severe musculoskeletal, cardiovascular, or neurological conditions, or systemic diseases (e.g., cancer).

Primary outcomes:
measure: Postural control
timeFrame: change from baseline at 0 to 8 weeks
measure: Trunk postural control on wobble chair
timeFrame: change from baseline at 0 to 8 weeks
measure: Walking
timeFrame: change from baseline at 0 to 8 weeks
measure: Well-being state (WHO-5)
timeFrame: change from baseline at 0 to 8 weeks
measure: Depression state (PHQ-9)
timeFrame: change from baseline at 0 to 8 weeks
measure: Connection to nature (CNS)
timeFrame: change from baseline at 0 to 8 weeks
measure: Social Loneliness and Isolation (ÉSUL)
timeFrame: change from baseline at 0 to 8 weeks
measure: Interoceptive Awareness (MAIA-Fr)
timeFrame: change from baseline at 0 to 8 weeks
measure: Pain measures
timeFrame: change from baseline at 0 to 8 weeks
measure: Social Provisions (SPS-10)
timeFrame: change from baseline at 8 to 12 weeks
measure: Disability related to low back pain (RMDQ)
timeFrame: change from baseline at 0 to 8 weeks
measure: Mood states (POMS-SF)
timeFrame: Before and after each intervention session
Secondary outcomes:
measure: Functional mobility test (TUG)
timeFrame: change from baseline at 0 to 8 weeks
measure: 5 times Sit-To-Stand (FTSTS)
timeFrame: change from baseline at 0 to 8 weeks
measure: Grip strength
timeFrame: change from baseline at 0 to 8 weeks
measure: Walking speed on 10 metres
timeFrame: change from baseline at 0 to 8 weeks
measure: Pain catastrophisation (PCS)
timeFrame: change from baseline at 0 to 8 weeks
measure: Kinesiophobia (TSK)
timeFrame: change from baseline at 0 to 8 weeks
measure: Fear and beliefs regarded pain (FABQ)
timeFrame: change from baseline at 0 to 8 weeks
Other outcomes:
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: change from baseline at 0 to 8 weeks
measure: Cognitive status
timeFrame: Only at baseline from Sample characterization
measure: Frailty criteria from Fried
timeFrame: Only at baseline from Sample characterization
Locations:
city: Saguenay
country: Canada
facility: Université du Québec à Chicoutimi
state: Quebec
Study officials:
affiliation: Université du Québec à Chicoutimi
name: Rubens A. da Silva, Ph.D.
role: STUDY_DIRECTOR
affiliation: Université du Québec à Chicoutimi
name: Marie-Ève Langelier, MD
role: STUDY_CHAIR
affiliation: Université du Québec à Chicoutimi
name: Émilie Fortin, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Guillaume Léonard, Ph.D.
role: STUDY_CHAIR
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