Efficacy of Multimodal Exercises and Education Tele-Rehabilitation (MEET-R) for Low Back Pain Managment

NCT06091709 | Unknown DMC

• 1 other identifier: MEET-R for dentists with WRLBP
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to test the MEET-R module (Multimodal Exercises and Education Tele-Rehabilitation) for improving pain, disability, and posture of dentists with work-related non-specific chronic low back pain. The main question is "Is MEET-R, a telerehabilitation multimodal exercises module, effective for managing pain, disability, and posture of Pakistani dentists with low back pain?" It aims to To assess the efficacy of MEET-R module for improving pain, disability, and posture of dentists with work-related non-specific chronic low back pain in a randomized controlled trial by,

1. 1.comparing the mean difference in pain ( assessed using Numeric Rating Scale, NRS sores) before and after intervention between dentists with non-specific chronic low back pain receiving the MEET-R telerehabilitation and a control group.
2. 2.comparing the proportion of improvement in disability, defined as having at least 30% decrease in Roland-Morris Disability Questionnaire (RMQ) score, between dentists with non-specific chronic low back pain receiving the MEET-R telerehabilitation and a control group.
3. 3.comparing the mean difference in posture, assessed using the Rapid Entire Body Assessment (REBA) score, before and after intervention between dentists with non-specific chronic low back pain receiving the MEET-R telerehabilitation and a control group.

Conditions

Non-specific Low Back Pain

Keywords

Multimodal Exercises,Low back pain, Tele-Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Numeric Rating Scale (NRS)

  Roland-Morris Disability Questionnaire was designed to assess self-rated physical disability caused by low back pain (Jawaid et al., 2020). This validated self-report questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute, or chronic low back pain and assesses the physical, psychosocial, sleep and rest home management, and eating domains (Grotle, Brox, \& Vollestad, 2003).

  From enrollment to the end of treatment at 6 weeks

• Roland-Morris Disability Questionnaire

  The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale to measure the intensity of pain. The respondent selects a whole number and rates the pain from 0 (no pain) to 10 (worst pain). Respondents are most commonly asked to report pain intensity "in the last 24 hours". NRS is a valid and reliable scale with minimal language translation difficulties that supports the use of the NPRS across cultures and languages

  From enrollment to the end of treatment at 6 weeks

• Rapid Entire Body Assessment (REBA)

  The REBA score represents the level of MSDs risk for the job task being evaluated. The minimum REBA score = 1, and the maximum REBA score = 15. As the Risk Index increases, the level of MSDs risk increases correspondingly. REBA score 1 =negligible risk, 2-3= low risk, 4-7= medium risk, 8-10= high risk, and 11 or above very high risk.

  From enrollment to the end of treatment at 6 weeks.

Secondary Outcomes (4)

• Patient-Specific Functional Scale (PSFS):

  From enrollment to the end of treatment at 6 weeks

• European quality of life (EQ-5D-5L) questionnaire

  From enrollment to the end of treatment at 6 weeks

• The Exercise Adherence Rating Scale (EARS)

  From enrollment to the end of treatment at 6 weeks.

• Telehealth usability questionnaire (TUQ)

  From enrollment to the end of treatment at 6 weeks.

Study Arms (2)

MEET-R Group

EXPERIMENTAL

Participants will follow the MEET-R that will include stretching, strengthening and core stabilization exercises, and education material pertaining to the proper posture during work.

Other: Multimodal Exercises and Education delivered through tele rehabilitation

Control Group

OTHER

The control group is allowed to opt for self-care management of back pain in the form of medications, rest, conventional physiotherapy, and a home exercise plan. They are also allowed to change their self-care management during the study period; information about the use of the alternative management will be recorded. The information on self-care management will be gathered after 6 weeks at the end of the intervention

Other: Selafcare

Interventions

Multimodal Exercises and Education delivered through tele rehabilitation OTHER

Participants will follow the MEET-R that will include stretching, strengthening and core stabilization exercises, and education material pertaining to the proper posture during work.

MEET-R Group

Selafcare OTHER

The control group is allowed to opt for self-care management of back pain in the form of medications, rest, conventional physiotherapy, and a home exercise plan. They are also allowed to change their self-care management during the study period; information about the use of the alternative management will be recorded. The information on self-care management will be gathered after 6 weeks at the end of the intervention

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Patients who are suffering from MSDs related to other medical conditions including
• Neurological disorders such as spinal tumors, IVDP, spinal surgery, infection, osteoporosis, cauda equina syndrome, lumbar spine fracture, spondylolisthesis, stroke, parkinsonism and
• Physical disability, spinal deformities (Scoliosis, lordosis, and kyphosis), pregnancy, mental disorders, and inflammatory joint diseases (rheumatoid arthritis, gout, ankylosing spondylitis).
• Patients who are suffering from low back pain from other causes:
• Back pain before practicing dentistry
• Has a history of trauma to the spine.
• Known or suspected to have serious spinal pathology.
• Currently undergoing a monitored exercise program or physiotherapy intervention for back pain.
• Any contraindication to exercise (etc. uncontrolled hypertension, respiratory and/or severe cardiac pathology)
• Having a BMI above 35.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Officials

• Basaruddin Ahmad, PhD

  Universiti Sains Malaysia

  STUDY DIRECTOR

• junaid Amin, PhD Student

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junaid Amin, MHPE,DPT

CONTACT

+966580931017; junaid768@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shahzada Junaid Amin

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 19, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10