Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Low back pain (LBP) is the fifth-most common disorder among older adults 60 years or older. The prevalence of LBP increases with age, with the highest prevalence occurring at 85 years old. Because many older individuals face various age-related life challenges (e.g., comorbidities, financial difficulties, and bereavement), the addition of chronic LBP (CLBP) to existing stressors may worsen their physical and psychological well-being. Unfortunately, CLBP is difficult to manage and is refractory to many existing treatments. Physiotherapy treatments alone show only modest improvements in LBP or LBP-related disability. Recent research has shown that proper pain self-management is crucial to reduce pain and disability in individuals with CLBP.
Acceptance and commitment therapy (ACT), a new mindfulness-based therapy, has been suggested for chronic pain management. ACT improves an individual's psychological flexibility, by improving their openness, awareness, and acceptance of the present moment (including pain). Combining ACT and exercise classes has the potential to improve the latter treatment's efficacy. Our recent pragmatic pilot, 2-arm cluster randomised controlled trial (RCT) on 40 older adults with CLBP revealed that eight weeks of ACT plus exercise and an 8-week back care education plus exercise program (control group) were safe, feasible, and well accepted by participants in elderly community centres. Moreover, compared to the control group, the ACT-plus-exercise group showed significantly greater improvements in pain intensity, LBP-related disability, health-related quality of life (HRQOL), and psychological flexibility immediately after treatment. These promising preliminary findings indicate that a fully powered clinical trial is warranted.
Building on our pilot study, we aim to conduct a pragmatic definitive cluster RCT in multiple elderly community centres to validate our findings immediately post-treatment and to explore its potential beneficial effects 3 and 6 months after treatment. Additionally, we will conduct a mediation analysis to explore potential mediation effects of psychological flexibility on the association between post-treatment changes in LBP-related disability and the corresponding changes in HRQOL in older adults with CLBP. Collectively, the project's results have the potential to help clinicians find a novel pragmatic approach to empower community-dwelling older adults to self-manage their CLBP.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-plus-exercise group | Experimental | 8-week ACT plus back exercise group |
|
| Exercise control group | Active Comparator | 8-week back care education plus exercise group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and commitment therapy (ACT) | Behavioral | Each 1.5-hour session will consist of a 1-hour ACT intervention and 30 minutes of exercise training. The ACT group was led by a trained ACT counsellor and a trained exercise trainer. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain intensity | Current, worst, least, and average LBP intensities in the last 24 hours will be assessed in four days within a week before each assessment using separate 11-point NPRS. The NPRS ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable". The average LBP intensity over the four days will be calculated as a composite score for data analysis. | Baseline, immediately after treatment, at the 3- and 6-month follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain-related disability | The Chinese version of the 24-item Roland-Morris Disability Questionnaire will be used to evaluate LBP-related disability in older adults.[21] It consists of 24 yes/no items concerning LBP-related functional limitations. The number of items with "yes" answers indicates the severity of the respondent's LBP-related disability. The maximum score is 24. | Baseline, immediately after treatment, and at the 3- and 6-month follow-ups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Arnold Wong Yu Lok | Contact | (852) 2766 6741 | arnold.wong@polyu.edu.hk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Recruiting | Hong Kong | Hong Kong |
Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
at baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Upon reasonable request to the principal investigator
Not provided
Not provided
Not provided
Not provided
double-blinded (participants and statistician)
| back exercise | Behavioral | 30-minute exercise class |
|
| back care education | Behavioral | 1-hour interactive lesson on back care |
|
| Change in Psychological flexibility | Participants' psychological flexibility will be measured by The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II). It comprises 7 statements, which respondents rate on a 7-point scale, where 1 means "never true" and 7 means "always true". The maximum total score is 49. Higher total scores indicate less flexibility. The AAQ-II has been cross-culturally adapted and validated among Chinese adolescents and has demonstrated satisfactory internal consistency and test-retest reliability. | Baseline, immediately after treatment, and at the 3- and 6-month follow-ups |
| Change in HRQOL | Participants' HRQOL will be measured by the Chinese version of the EQ-5D-5L. It comprises 5 items related to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each item has 5 response options ("no problem", "slight problems", "moderate problems", "severe problems", and "extreme problems/unable to"). It has been found to be useful in monitoring treatments' effects on HRQOL. | Baseline, immediately after treatment, and at the 3- and 6-month follow-ups |
| Change in Psychological factors | The Hong Kong Chinese version of the 21-item Depression Anxiety Stress Scales will be used to evaluate depression (7 items), anxiety (7 items), and stress (7 items) in older adults. Each item is rated on a 4-point scale ranging from 0 ("not at all") to 3 ("most of the time"). Higher scores imply more severe mental health issues. This questionnaire and its subscales have demonstrated excellent internal consistency for assessing depression, anxiety, and stress. | Baseline, immediately after treatment, and at the 3- and 6-month follow-ups |
| Change in falling risk | The Timed Up and Go test will be used to assess transfer skills and walking. It can identify community-dwelling older adults at risk of falling. | Baseline, immediately after treatment, and at the 3- and 6-month follow-ups |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided