Nature-based Intervention for Chronic Pain in Older People
- Conditions
- Chronic DiseaseChronic Pain (Back / Neck)Older Adults (65 Years and Older)
- Registration Number
- NCT07002853
- Lead Sponsor
- Université du Québec à Chicoutimi
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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)
- Presenting other severe musculoskeletal, cardiovascular, or neurological conditions, or systemic diseases (e.g., cancer).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Functional mobility test (TUG) change from baseline at 0 to 8 weeks To assess mobility. Equipment: A stopwatch. Directions: Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
5 times Sit-To-Stand (FTSTS) change from baseline at 0 to 8 weeks The Five Times Sit to Stand Test (5xSTS) is a standardized functional assessment used to evaluate lower limb strength, balance, and functional mobility. Participants are instructed to rise from a standard chair and sit back down five times as quickly as possible without using their arms. The total time to complete the five repetitions is recorded in seconds. This measure is commonly used to assess physical function and fall risk in older adults.
Grip strength change from baseline at 0 to 8 weeks Jamar dynamometer to assess maximal isometric hand grip strength and frailty criteria. 3 trials of maximal contraction up 5 seconds. The best value is retained and corrected by body mass index from Fried classification.
Walking speed on 10 metres change from baseline at 0 to 8 weeks Walking speed executed in 10 meter walking test. 2 trials and the best value in time seconds is retained for analysis.
Pain catastrophisation (PCS) change from baseline at 0 to 8 weeks The Pain Catastrophizing Scale (PCS) is a validated self-report questionnaire designed to assess catastrophic thinking related to pain. It consists of 13 items that measure three dimensions: rumination, magnification, and helplessness. Participants rate each item on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("all the time"). The total score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. The PCS is widely used in both clinical and research settings to evaluate psychological responses to pain.
Kinesiophobia (TSK) change from baseline at 0 to 8 weeks The Tampa Scale of Kinesiophobia (TSK) is a validated self-report questionnaire used to assess fear of movement and re-injury related to physical activity. It consists of 17 items rated on a 4-point Likert scale, ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Total scores range from 17 to 68, with higher scores indicating greater fear of movement. The TSK is commonly used in populations with chronic pain to evaluate the psychological impact of pain on physical activity and rehabilitation outcomes.
Fear and beliefs regarded pain (FABQ) change from baseline at 0 to 8 weeks The Fear and Beliefs Questionnaire (FBQ) is a self-administered questionnaire designed to assess fear-avoidance beliefs and perceptions related to low back pain. It evaluates how individuals perceive the harmfulness of movement and physical activity, and how these beliefs may influence their behavior and functional limitations. The FBQ includes items rated on a Likert scale, with higher scores reflecting stronger fear-avoidance beliefs. It is commonly used in clinical and research settings to better understand the psychosocial factors contributing to chronic pain and disability.
Trial Locations
- Locations (1)
Université du Québec à Chicoutimi
🇨🇦Saguenay, Quebec, Canada