Nature-based Intervention for Chronic Pain in Older People

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Postural control — change from baseline at 0 to 8 weeks
  Measures of center of pressure (COP) using a force platform during different balance tasks
• Trunk postural control on wobble chair — change from baseline at 0 to 8 weeks
  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.
• Walking — change from baseline at 0 to 8 weeks
  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.
• Well-being state (WHO-5) — change from baseline at 0 to 8 weeks
  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.
• Depression state (PHQ-9) — change from baseline at 0 to 8 weeks
  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
• Connection to nature (CNS) — change from baseline at 0 to 8 weeks
  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.
• Social Loneliness and Isolation (ÉSUL) — change from baseline at 0 to 8 weeks
  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.
• Interoceptive Awareness (MAIA-Fr) — change from baseline at 0 to 8 weeks
  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.
• Pain measures — change from baseline at 0 to 8 weeks
  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.
• Social Provisions (SPS-10) — change from baseline at 8 to 12 weeks
  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.
• Disability related to low back pain (RMDQ) — change from baseline at 0 to 8 weeks
  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.
• Mood states (POMS-SF) — Before and after each intervention session
  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.

Trial sites (1)

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