Low Back PainNCT06214884
Mindfulness Intervention to Reduce Low Back Pain Among Academicians
A study testing Mindfulness for All in people with Low Back Pain, run by Universiti Sains Malaysia.
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. Read more about this study
- Who is it for?
- Ages 28 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Mindfulness for All
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- To identify the efficacy of the mindfulness intervention in reducing the pain intensity of LBP among academic staffs.
- To identify the efficacy of the mindfulness intervention in reducing depression and anxiety symptoms among academic staffs.
- To identify the efficacy of the mindfulness intervention in improving work productivity among academic staffs.
- Conditions
- Low Back Pain
- Being tested
- Mindfulness for All
- Keywords
- mindfulness, low back pain, work productivity, anxiety, depression
- Medical subject headings
- Low Back Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness for AllBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness for All (MFA) Group | Experimental | This intervention program named "MINDFULNESS FOR ALL (MFA)" developed on the conceptual basis of traditional mindfulness programs. Its formal structure resembles the traditional mindfulness programs, but it has been tailored to meet the needs and demands of employees.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. Receives: Behavioral: Mindfulness for All |
| Wait-list control group | Active comparator | The wait-list control group will receive their training two weeks after interventional group complete their training. There will be a 90-minute online training session aimed at introducing participants to mindfulness in general and encouraging them to practice mindfulness by teaching several techniques. There will be no potential harm occurs among the subjects in the wait-list control group. Receives: Behavioral: Mindfulness for All |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
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.
Measured: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Secondary outcomes (3)
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 (α=.92) and high test-retest reliability (r=.75).
Measured: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
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.
Measured: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
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.
Measured: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Zamri, Universiti Sains Malaysia
- Investigators
- Eva N Zamri, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214884
- Sponsor's protocol ID
- 304/CIPPT/6315622
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol together its supplement material will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06214884
- Acronym / sponsor ID
- 304/CIPPT/6315622
- Conditions
- Low Back Pain
- Keywords
- mindfulness, low back pain, work productivity, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To identify the efficacy of the mindfulness intervention in reducing the pain intensity of LBP among academic staffs.
- To identify the efficacy of the mindfulness intervention in reducing depression and anxiety symptoms among academic staffs.
- To identify the efficacy of the mindfulness intervention in improving work productivity among academic staffs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness for All (MFA) Group | Experimental | Behavioral: Mindfulness for AllThis intervention program named "MINDFULNESS FOR ALL (MFA)" developed on the conceptual basis of traditional mindfulness programs. Its formal structure resembles the traditional mindfulness programs, but it has been tailored to meet the needs and demands of employees.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. |
| Wait-list control group | Active comparator | Behavioral: Mindfulness for AllThe wait-list control group will receive their training two weeks after interventional group complete their training. There will be a 90-minute online training session aimed at introducing participants to mindfulness in general and encouraging them to practice mindfulness by teaching several techniques. There will be no potential harm occurs among the subjects in the wait-list control group. |
Who may qualify
- Ages
- 28 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness for AllExperimental: 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. | Behavioural | Mindfulness for All (MFA) Group, Wait-list control group |
Primary outcome
Low back pain occurrence
Time frame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
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.
Low back pain intensity
Time frame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
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.
3 secondary outcomes
Psychological symptoms (anxiety)
Time frame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Psychological symptoms (depression)
Time frame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Absenteeism and Presenteeism
Time frame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Yes. Study Protocol together its supplement material will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva N Zamri, PhD principal investigator
Universiti Sains Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness for All in people with Low Back Pain, run by Universiti Sains Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva N Zamri, PhD (+60192184647, evazamri@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain occurrence (time frame: Pre (week 0), Post intervention (week 5) and Follow-up (week 18)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.