Mindfulness Intervention to Reduce Low Back Pain Among Academicians

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06214884
• Other study ID #: 304/CIPPT/6315622
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: Universiti Sains Malaysia
• Contact: Eva N Zamri, PhD
• Phone: +60192184647
• Email: evazamri[@]usm.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Mindfulness for All
Experimental: The MFA will take place in a group setting with 10-15 participants per cluster. Due to participants' convenience, the delivery mode of each intervention session would be conducted online. At the end of session, they will be provided the task and supplementary materials (e-book, short audio, and video) to be apply after the session. The modules will be delivered by two trainees. Both trainees have received the certificates from the mindfulness-based strategic awareness training course. Participants in the intervention group will be joining the modules for 5 sessions weekly for 60-minute/session. Details on the modules can be referred in the Supplement material.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low back pain occurrence	The questions about musculoskeletal pain focused on seven anatomical sites will be adapted based on the Nordic Musculoskeletal Questionnaire. The seven anatomical sites include low back, neck, right or/and left shoulder, right or/and left elbow, right or/and left wrist/hand and right or left knee, and right or left ankle with the binary response (yes/no). The instrument has an acceptable psychometric property and widely applied in Malaysian working population.; During the screening process, participants will be asked whether they had experienced on low back pain during the past months that had lasted for longer than a day which were illustrated diagrammatically.; After the intervention, the occurrence of low back pain pain will be re-assessed by asking whether they had experienced pain for each anatomical site, during the past months that had lasted for longer than a day which were illustrated diagrammatically.	Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Primary	Low back pain intensity	Visual Analogue Scale (VAS) will be used to measure the participants' pain intensity during the pre and post-test. A VAS is commonly presented with unidimensional line, usually 100-mm long, starts from 0 'no pain' to 100 'severe intolerable pain'. Participants who reported pain at each anatomical site will be further asked to indicate which point along the line best represents their pain intensity.	Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Secondary	Psychological symptoms (anxiety)	A Malay translated version of Beck Anxiety Inventory (BAI) consists of 21 items will be utilized in this study to assess the anxiety symptoms. The participants need to respond each item on a four-point Likert scale, ranging from 0 "not at all" to 3 "severely". The range of total scores is from 0 to 63, with higher numbers suggesting greater degrees of anxiety. The recommended clinical classification of scoring results are as follows: 0-7 suggests minimal anxiety, 8-15 suggests mild anxiety, 16-25 suggests moderate anxiety, and 26-63 suggests severe anxiety. According to the manual, the suggested cut-off for clinically significant anxiety on the BAI is 16. Previous local study has shown that the BAI-Malay version has excellent internal consistency (a=.92) and high test-retest reliability (r=.75).	Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Secondary	Psychological symptoms (depression)	A Malay translated version of Beck Depression Inventory (BDI) will be used to assess the depression symptoms. It consists of 21 items and for each item need to answer on a four-point Likert scale, ranging from 0 to 3. Each item were asked about the unique symptoms of depression which more reflective of the diagnostic criteria that are described by the American Psychiatric Association (APA). The possible range of total score is between 0 - 63. Then, the total score can be categorized into three group which reflect the severity levels: 0-10 points for "not depressed", 11-17 points for "mild to moderately depressed", and 18-63 points for "clinically relevant depression". Previous study indicated that the current Malay version of the BDI-II is psychometrically strong and appropriate for use in assessing depressive symptomatology among Malaysian.	Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Secondary	Absenteeism and Presenteeism	This study adapted an instrument known as Work Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire. There are five items (Q1 -Q5) and aimed to measure work productivity namely absenteeism and presenteeism. Absenteeism is defined as the percentage of time miss from work because of LBP and is calculated by the formula Q2/(Q2 + Q4) × 100%. Presenteeism is measured by the degree LBP which affect productivity while working during the past month on a rating scale ranging from 0 " LBP had no effect on my working" to 10 "LBP completely prevented the me from working". Presenteeism is calculated by the formula (Q5/10) × 100%. Outcomes absenteeism and presenteeism are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Pre (week 0), Post intervention (week 5) and Follow-up (week 18)