Mindfulness Intervention to Reduce Low Back Pain Among Academicians

NCT06214884 | Unknown DMC

• 1 other identifier: 304/CIPPT/6315622
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Keywords

mindfulness; low back pain; work productivity; anxiety; depression

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Psychological symptoms (anxiety)

  Pre (week 0), Post intervention (week 5) and Follow-up (week 18)

• Psychological symptoms (depression)

  Pre (week 0), Post intervention (week 5) and Follow-up (week 18)

• Absenteeism and Presenteeism

  Pre (week 0), Post intervention (week 5) and Follow-up (week 18)

Study Arms (2)

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.

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.

Behavioral: Mindfulness for All

Interventions

Mindfulness for All BEHAVIORAL

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.

Mindfulness for All (MFA) Group; Wait-list control group

Eligibility Criteria

• Age: 28 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

MeSH Terms

Conditions

Low Back Pain; Anxiety Disorders; Depression

Interventions

Mindfulness; Proto-Oncogene Proteins c-raf

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; raf Kinases; MAP Kinase Kinase Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins

Study Officials

• Eva N Zamri, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva N Zamri, PhD

CONTACT

+60192184647; evazamri@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Eligible participants were invited to participate in the interventional study. Their participation must be voluntarily. Those who agreed to participate will be randomized either to the intervention and wait-list control group. The participants will remain unaware of their group assignment, as the randomization sequence will be generated using computer-based randomization. This is known as single-blind study. Allocation will follow a 1:1 ratio, overseen by a researcher with no other involvement in this trial. The participants' names will be matched with the random number sequence. Clusters of participants were in the same workplace to avoid contamination of the intervention and enhance compliance within the intervention group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 22, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: tentatively May 2024 after publication
• Access Criteria: Study Protocol and Supplement Material (Module for Mindfulness for All intervention) will be shared after publication. If other researchers have no access to retrieve the documents, they can request via Principal Investigator's email: evazamri@usm.my