Nature-based Intervention for Chronic Pain in Older People

NCT07002853 | Recruiting

• 1 other identifier: 2025-1991
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• Postural control

  Measures of center of pressure (COP) using a force platform during different balance tasks

  change from baseline at 0 to 8 weeks

• Trunk postural control on wobble chair

  This test measures trunk postural balance during a sitting balance task on an unstable chair where only lumbar spine movements are allowed to restore balance. Briefly, the base of the chair consists of a pivot at its center and four springs that can be arranged and fixed at a distance varying between 6.0 and 21 cm from the center, allowing the system's level of stability to be varied. The system allows only forward/backward and lateral tilting.

  change from baseline at 0 to 8 weeks

• Walking

  Gait parameters from GaitRite measurement: The participants will be asked to walk at normal and fast speeds on a GaitRite treadmill (GAI-TRite® Platinum Plus System 16' - 4.876 m, SN: Q209, CIR Systems Inc., Franklin, NJ, USA). Participants will perform each task twice. Main gait parameters will be used as main outcomes such as velocity in m/s.

  change from baseline at 0 to 8 weeks

• Well-being state (WHO-5)

  The World Health Organization Well-Being Index (WHO-5) is a widely used self-reported questionnaire designed to measure subjective well-being. It assesses the individual's overall psychological well-being and quality of life. The WHO-5 consists of five simple questions that ask respondents to rate their well-being over the past two weeks. The questions cover aspects such as positive mood, vitality, and general interest in life.The questionnaire is scored on a scale from 0 to 100, with higher scores indicating better well-being.

  change from baseline at 0 to 8 weeks

• Depression state (PHQ-9)

  The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, monitor, and measure the severity of depression. It consists of nine questions based on the diagnostic criteria for major depressive disorder in the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition).Respondents rate how often they have experienced each symptom over the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). The scores are then added together to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms

  change from baseline at 0 to 8 weeks

• Connection to nature (CNS)

  The Connectedness to Nature Scale (CNS) is a psychological assessment tool designed to measure an individual's subjective connection to nature. It evaluates the degree to which people perceive themselves as a part of the natural world and the extent to which they appreciate and value nature in their lives. Respondents are asked to rate their agreement with each statement on a Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The scores are then totaled to provide an overall measure of an individual's connection to nature.

  change from baseline at 0 to 8 weeks

• Social Loneliness and Isolation (ÉSUL)

  The Échelle de Solitude de l'Université Laval (ÉSUL) is a French-language adaptation of the UCLA Loneliness Scale, developed and validated in Quebec. It is a 20-item self-report questionnaire designed to assess perceived loneliness and social isolation. Each item is rated on a 4-point Likert scale ranging from "Never" to "Often," with higher scores indicating greater feelings of loneliness. The ESUL is commonly used in research and clinical settings involving French-speaking populations.

  change from baseline at 0 to 8 weeks

• Interoceptive Awareness (MAIA-Fr)

  The Multidimensional Assessment of Interoceptive Awareness - French version (MAIA-Fr) is a validated French-language adaptation of the original MAIA questionnaire. It consists of 32 self-report items grouped into eight subscales that assess different dimensions of interoceptive body awareness, such as Noticing, Emotional Awareness, Self-Regulation, and Body Listening. Items are rated on a 6-point Likert scale ranging from "never" to "always," with higher scores indicating greater interoceptive awareness.

  change from baseline at 0 to 8 weeks

• Pain measures

  Pain measurement will be done using the Brain pain inventory (BPI) questionnaire. The interference items will be presented with 0-10 scales, with 0=no interference and 10=interferes completely.

  change from baseline at 0 to 8 weeks

• Social Provisions (SPS-10)

  The Social Provisions Scale-10 (SPS-10) is a shorter version of the original Social Provisions Scale (SPS). It is a brief self-report questionnaire designed to measure perceived social support across five dimensions. The SPS-10 is derived from the longer SPS but consists of a subset of items that capture key aspects of social support. Similar to the original SPS, respondents rate their agreement with each item on a Likert scale, ranging from 1 (strongly disagree) to 4 (strongly agree). The SPS-10 provides a quick and efficient way to assess an individual's perceived social support network and their satisfaction with various aspects of their social relationships.

  change from baseline at 8 to 12 weeks

• Disability related to low back pain (RMDQ)

  The Roland-Morris Disability Questionnaire (RMDQ) is a widely used self-report measure designed to assess physical disability due to low back pain. It consists of 24 yes/no items related to daily physical activities and functional limitations caused by back pain. Each affirmative response scores one point, for a total score ranging from 0 (no disability) to 24 (maximum disability). Higher scores indicate greater functional impairment.

  change from baseline at 0 to 8 weeks

• Mood states (POMS-SF)

  The Profile of Mood States - Short Form (POMS-SF), French Version is a validated self-report questionnaire used to assess short-term changes in mood states. This version consists of 20 items rated on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely"), and measures six mood dimensions: Anxiety (ANX), Depression (DEP), Anger (COL), Vigor (VIG), Fatigue (FAT), and Confusion (CON). Subscale scores are summed separately, with higher scores indicating greater intensity of the respective mood state, except for Vigor, where higher scores reflect better mood. This version, adapted and validated in French by Fillion \& Gagnon (1999), is administered before and after each intervention session to assess immediate psychological effects.

  Before and after each intervention session

Secondary Outcomes (7)

• Functional mobility test (TUG)

  change from baseline at 0 to 8 weeks

• 5 times Sit-To-Stand (FTSTS)

  change from baseline at 0 to 8 weeks

• Grip strength

  change from baseline at 0 to 8 weeks

• Walking speed on 10 metres

  change from baseline at 0 to 8 weeks

• Pain catastrophisation (PCS)

  change from baseline at 0 to 8 weeks

Other Outcomes (3)

• Falls Efficacy Scale-International (FES-I)

  change from baseline at 0 to 8 weeks

• Cognitive status

  Only at baseline from Sample characterization

• Frailty criteria from Fried

  Only at baseline from Sample characterization

Study Arms (1)

Nature-based intervention

EXPERIMENTAL

Nature-based intervention group of once a week (2 hours) for 8 weeks

Other: Nature-based Intervention

Interventions

Nature-based Intervention OTHER

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.

Nature-based intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Université du Québec à Chicoutimi: lead
• Fonds de la Recherche en Santé du Québec: collaborator
• FUQAC: collaborator

Study Sites (1)

Université du Québec à Chicoutimi

Saguenay, Quebec, G7H 2B1, Canada

RECRUITING

Related Publications (31)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.2022.10671. Epub 2022 Jun 19.

  PMID: 35722759 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Irvine KN, Fisher D, Currie M, Colley K, Warber SL. A Nature-Based Intervention for Promoting Physical Activity in Older Adults: A Qualitative Study Using the COM-B Model. Int J Environ Res Public Health. 2024 Jun 27;21(7):843. doi: 10.3390/ijerph21070843.

  PMID: 39063420 BACKGROUND

• Frumkin H, Bratman GN, Breslow SJ, Cochran B, Kahn PH Jr, Lawler JJ, Levin PS, Tandon PS, Varanasi U, Wolf KL, Wood SA. Nature Contact and Human Health: A Research Agenda. Environ Health Perspect. 2017 Jul 31;125(7):075001. doi: 10.1289/EHP1663.

  PMID: 28796634 BACKGROUND

• Zhang SK, Gu ML, Zhang T, Xu H, Mao SJ, Zhou WS. Effects of exercise therapy on disability, mobility, and quality of life in the elderly with chronic low back pain: a systematic review and meta-analysis of randomized controlled trials. J Orthop Surg Res. 2023 Jul 19;18(1):513. doi: 10.1186/s13018-023-03988-y.

  PMID: 37468931 BACKGROUND

• Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.

  PMID: 21665125 BACKGROUND

• Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1.

  PMID: 30546064 BACKGROUND

• Dionne CE, Dunn KM, Croft PR. Does back pain prevalence really decrease with increasing age? A systematic review. Age Ageing. 2006 May;35(3):229-34. doi: 10.1093/ageing/afj055. Epub 2006 Mar 17.

  PMID: 16547119 BACKGROUND

• da Silva RA, Vieira ER, Carvalho CE, Oliveira MR, Amorim CF, Neto EN. Age-related differences on low back pain and postural control during one-leg stance: a case-control study. Eur Spine J. 2016 Apr;25(4):1251-7. doi: 10.1007/s00586-015-4255-9. Epub 2015 Oct 1.

  PMID: 26428907 BACKGROUND

• Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.

  PMID: 27745712 BACKGROUND

• Lee I, Choi H, Bang KS, Kim S, Song M, Lee B. Effects of Forest Therapy on Depressive Symptoms among Adults: A Systematic Review. Int J Environ Res Public Health. 2017 Mar 20;14(3):321. doi: 10.3390/ijerph14030321.

  PMID: 28335541 RESULT

• Berman MG, Jonides J, Kaplan S. The cognitive benefits of interacting with nature. Psychol Sci. 2008 Dec;19(12):1207-12. doi: 10.1111/j.1467-9280.2008.02225.x.

  PMID: 19121124 RESULT

• Vanti C, Andreatta S, Borghi S, Guccione AA, Pillastrini P, Bertozzi L. The effectiveness of walking versus exercise on pain and function in chronic low back pain: a systematic review and meta-analysis of randomized trials. Disabil Rehabil. 2019 Mar;41(6):622-632. doi: 10.1080/09638288.2017.1410730. Epub 2017 Dec 5.

  PMID: 29207885 RESULT

• White MP, Alcock I, Grellier J, Wheeler BW, Hartig T, Warber SL, Bone A, Depledge MH, Fleming LE. Spending at least 120 minutes a week in nature is associated with good health and wellbeing. Sci Rep. 2019 Jun 13;9(1):7730. doi: 10.1038/s41598-019-44097-3.

  PMID: 31197192 RESULT

• Simone C. Gafner A-VB. Test de 10 mètres de marche 10-Meter Walking Test Kinésithérapie, la Revue. 2022;22(248-249):46-9.

  RESULT

• Bohannon RW. Reference values for the five-repetition sit-to-stand test: a descriptive meta-analysis of data from elders. Percept Mot Skills. 2006 Aug;103(1):215-22. doi: 10.2466/pms.103.1.215-222.

  PMID: 17037663 RESULT

• Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

  PMID: 8455963 RESULT

• Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment. 1995;7(4):524-32.

  RESULT

• French DJ, Roach PJ, Mayes S. Peur du mouvement chez des accidentes du travail: l'Echelle de Kinesiophobie de Tampa (EKT). CANADIAN JOURNAL OF BEHAVIOURAL SCIENCE. 2002;34:28-33.

  RESULT

• Steigen AM, Bergh D. The Social Provisions Scale: psychometric properties of the SPS-10 among participants in nature-based services. Disabil Rehabil. 2019 Jul;41(14):1690-1698. doi: 10.1080/09638288.2018.1434689. Epub 2018 Feb 5.

  PMID: 29402143 RESULT

• Orpana HM, Lang JJ, Yurkowski K. Validation of a brief version of the Social Provisions Scale using Canadian national survey data. Health Promot Chronic Dis Prev Can. 2019 Dec;39(12):323-332. doi: 10.24095/hpcdp.39.12.02.

  PMID: 31825785 RESULT

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 RESULT

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 RESULT

• Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.

  PMID: 6222486 RESULT

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 RESULT

Related Links

• PARC project 1 for Parkinson Disease

MeSH Terms

Conditions

Chronic Disease; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Rubens A. da Silva, Ph.D.

  Université du Québec à Chicoutimi

  STUDY DIRECTOR

• Marie-Ève Langelier, MD

  Université du Québec à Chicoutimi

  STUDY CHAIR

• Émilie Fortin, M.Sc

  Université du Québec à Chicoutimi

  PRINCIPAL INVESTIGATOR

• Guillaume Léonard, Ph.D.

  Université de Sherbrooke

  STUDY CHAIR

Central Study Contacts

Rubens A. da Silva, Ph.D.

CONTACT

418 545-5011; rubens.dasilva@uqac.ca

Émilie Fortin, M.Sc

CONTACT

5818828598; emilie.fortin7@uqac.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director researcher

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 4, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)