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

Overview

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.

Interventions

• Other Nature-based Intervention
  Combination of activities in nature such as walking, exercises (strengthening, mobility, balance), mindfulness, guided meditation, forest bathing or Shinrin-Yoku, interpretation of nature, gardening and pain education.

Primary outcome measures

• Postural control [Time frame: change from baseline at 0 to 8 weeks]
• Trunk postural control on wobble chair [Time frame: change from baseline at 0 to 8 weeks]
• Walking [Time frame: change from baseline at 0 to 8 weeks]
• Well-being state (WHO-5) [Time frame: change from baseline at 0 to 8 weeks]
• Depression state (PHQ-9) [Time frame: change from baseline at 0 to 8 weeks]
• Connection to nature (CNS) [Time frame: change from baseline at 0 to 8 weeks]
• Social Loneliness and Isolation (ÉSUL) [Time frame: change from baseline at 0 to 8 weeks]
• Interoceptive Awareness (MAIA-Fr) [Time frame: change from baseline at 0 to 8 weeks]
• Pain measures [Time frame: change from baseline at 0 to 8 weeks]
• Social Provisions (SPS-10) [Time frame: change from baseline at 8 to 12 weeks]

Secondary outcome measures (7)

• Functional mobility test (TUG) [Time frame: change from baseline at 0 to 8 weeks]
• 5 times Sit-To-Stand (FTSTS) [Time frame: change from baseline at 0 to 8 weeks]
• Grip strength [Time frame: change from baseline at 0 to 8 weeks]
• Walking speed on 10 metres [Time frame: change from baseline at 0 to 8 weeks]
• Pain catastrophisation (PCS) [Time frame: change from baseline at 0 to 8 weeks]
• Kinesiophobia (TSK) [Time frame: change from baseline at 0 to 8 weeks]
• Fear and beliefs regarded pain (FABQ) [Time frame: change from baseline at 0 to 8 weeks]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Université du Québec à Chicoutimi — Saguenay

Publications

• Suh JH, Kim H, Jung GP, Ko JY, Ryu JS. The effect of lumbar stabilization and walking exercises on chronic low back pain: A randomized controlled trial. Medicine (Baltimore). 2019 Jun;98(26):e16173. doi: 10.1097/MD.0000000000016173. PMID 31261549
• Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2. PMID 34580864
• Fernandez-Rodriguez R, Alvarez-Bueno C, Cavero-Redondo I, Torres-Costoso A, Pozuelo-Carrascosa DP, Reina-Gutierrez S, Pascual-Morena C, Martinez-Vizcaino V. Best Exercise Options for Reducing Pain and Disability in Adults With Chronic Low Back Pain: Pilates, Strength, Core-Based, and Mind-Body. A Network Meta-analysis. J Orthop Sports Phys Ther. 2022 Aug;52(8):505-521. doi: 10.2519/jospt.2022.1067 PMID 35722759
• Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010 Jun;10(6):514-29. doi: 10.1016/j.spinee.2010.03.032. PMID 20494814
• Brumitt J, Matheson JW, Meira EP. Core stabilization exercise prescription, part I: current concepts in assessment and intervention. Sports Health. 2013 Nov;5(6):504-9. doi: 10.1177/1941738113502451. PMID 24427424
• Han JW, Choi H, Jeon YH, Yoon CH, Woo JM, Kim W. The Effects of Forest Therapy on Coping with Chronic Widespread Pain: Physiological and Psychological Differences between Participants in a Forest Therapy Program and a Control Group. Int J Environ Res Public Health. 2016 Feb 24;13(3):255. doi: 10.3390/ijerph13030255. PMID 26927141
• Li Q, Morimoto K, Kobayashi M, Inagaki H, Katsumata M, Hirata Y, Hirata K, Shimizu T, Li YJ, Wakayama Y, Kawada T, Ohira T, Takayama N, Kagawa T, Miyazaki Y. A forest bathing trip increases human natural killer activity and expression of anti-cancer proteins in female subjects. J Biol Regul Homeost Agents. 2008 Jan-Mar;22(1):45-55. PMID 18394317
• Li Q. Effects of forest environment (Shinrin-yoku/Forest bathing) on health promotion and disease prevention -the Establishment of "Forest Medicine". Environ Health Prev Med. 2022;27:43. doi: 10.1265/ehpm.22-00160. PMID 36328581

Identifiers

NCT: NCT07002853 · 2025-1991

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗