Clinical trial NCT06214884: Mindfulness Intervention to Reduce Low Back Pain Among Academicians
Official title: Study Protocol: A Randomized Controlled Trial of a Mindfulness Intervention to Reduce Low Back Pain, Psychological Symptoms and Enhance Work Productivity Among Academic Staff in Malaysian Tertiary Education
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: mindfulness
low back pain
work productivity
anxiety
depression
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 86
Sex: ALL
Minimum age (years): 28
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single blind, parallel cluster randomized controlled trial will be conducted on 86 academic staff working in the tertiary education in Northern Region, West Coast of Peninsular Malaysia. At baseline, all participants must undergo the screening criteria for inclusion which are academic staff with moderate to severe symptom of anxiety with cut-off score of 16, mild to severe symptoms of depression with cut-off score of 16, and pain intensity of LBP should be at least \>35mm using Visual analogue scale (VAS). Participants will be randomized at cluster level to receive either mindfulness intervention or control group. The intervention will be given for 5 sessions weekly for 60 minute/session. Outcome measures such as LBP, depression and anxiety symptoms, and work productivity will be measured at baseline and after 5-weeks. The control group will be given delayed treatment for 2 weeks after the trial ended.
Primary purpose: PREVENTION

Brief summary: Mindfulness interventions are a well-known approach for improving mental health. Nevertheless, the available evidence regarding their efficacy in addressing musculoskeletal pain (MSP) is limited, despite numerous studies demonstrating an association between psychological factors and MSP. Both mental health issues and MSP are prevalent among academicians, yet there is a scarce study on the application of mindfulness interventions to these specific concerns. Therefore, this study aimed to provide a study protocol that will focus on assessing the impact of mindfulness interventions on alleviating low back pain (LBP) symptoms, psychological symptoms, and improving work productivity among academic staff.

Detailed description: This study acknowledges the significance of mindfulness interventions, primarily introduced by Jon Kabat-Zinn. Mindfulness, rooted in various religious traditions, has been associated with improved well-being. The efficacy of mindfulness interventions in addressing anxiety and mood disorders is supported by meta-analyses, indicating moderate effectiveness. The focus then shifts to workplace interventions, noting a rising trend in research on mindfulness from 2012 to 2022. Studies highlight its efficacy not only in mental health aspects among employees but also in reducing musculoskeletal disorders.

Previous studies revealing the positive impact of mindfulness on chronic musculoskeletal pain, psychological well-being, and overall health-related quality of life among nurses. Another study in Denmark combines mindfulness with physical and cognitive elements, demonstrating reductions in pain intensity across various body regions. While mindfulness in the workplace is well-explored, its application in academia, particularly among university teachers, is relatively new. Previous scoping review explores various psychological interventions, including Mindfulness-Based Interventions, cognitive behavioural therapy (CBT), and yoga, to reduce stress and burnout among teachers, but cautions against generalizing these findings to academicians due to the heterogeneity of their work nature.

Based on the fact mentioned above, it is imperative to initiate mindfulness interventions among the academicians targeting to reduce low back pain, psychological symptoms and enhance work productivity. As of our latest information, there are no existing programs accessible for this specific implementation in Malaysia. The specific objectives for this trial were as follows

1. To identify the efficacy of the mindfulness intervention in reducing the pain intensity of LBP among academic staffs.
2. To identify the efficacy of the mindfulness intervention in reducing depression and anxiety symptoms among academic staffs.
3. To identify the efficacy of the mindfulness intervention in improving work productivity among academic staffs.

Eligibility criteria: Inclusion criteria

* All academic staff aged 28-50 years old
* Able to understand Malay language
* Reported moderate to severe symptom of anxiety with cut-off score of 16,
* Reported mild to severe symptoms of depression with cut-off score of 16
* Presence of LBP during past month with pain intensity should be at least \>35mm using Visual analogue scale (VAS).

Exclusion Criteria:

* Pregnancy or had planned to become pregnant in the coming months,
* History of trauma or accidents in the spinal region
* Medically diagnosed with congenital anomaly of the spine, rheumatoid arthritis, infections of the spine or discs, ankylosing spondylitis, spondylolisthesis, spondylosis, spinal tumor, systemic lupus erythymatosus, or osteoporosis.
* Had performed either spinal, intra-abdominal or femoral surgery.

Primary outcomes:
measure: Low back pain occurrence
timeFrame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
measure: Low back pain intensity
timeFrame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Secondary outcomes:
measure: Psychological symptoms (anxiety)
timeFrame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
measure: Psychological symptoms (depression)
timeFrame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
measure: Absenteeism and Presenteeism
timeFrame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Other outcomes:
Locations:
Study officials:
affiliation: Universiti Sains Malaysia
name: Eva N Zamri, PhD
role: PRINCIPAL_INVESTIGATOR
References: