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临床试验/NCT06091709
NCT06091709尚未招募不适用

Development, Evaluation, and Assessing the Efficacy of Multimodal Exercises and Education Tele-Rehabilitation (MEET-R) Module for Improving Pain, Posture, and Disability Level in Dentists With Work-related Low Back Pain.

Universiti Sains Malaysia0 个研究点目标入组 180 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
主要终点
Roland-Morris Disability Questionnaire

研究概览

简要总结

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. 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. 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. 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.

Intervention Group 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.

The Control Group 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

Researchers will compare MEET-R group and control group to see if there is difference in the efficacy of MEET-R module for improving pain, disability, and posture of dentists with work-related non-specific chronic low back pain compared in a randomized controlled trial.

详细描述

HYPOTHESIS It is hypothesized that an innovative telerehabilitation module MEET-R that is specifically developed for dentists with work-related nonspecific chronic low back pain and approved by panelists can improve back pain, physical disability, and postural symptoms and thus, improves health-related quality of life, functioning, and satisfaction.

Research design A randomized controlled parallel group trial will be conducted to evaluate the effectiveness of MEET-R in dentists with work-related low back pain. The study protocol will adhere to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Study area The study participants will receive the instruction for the intervention online and be performing the intervention in their home environment under the remote supervision of a qualified physiotherapist.

Reference population

Dentist with non-specific chronic low back pain. Target population

The dentists with non-specific chronic low back pain in Lahore, Pakistan. Sampling frame

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Roland-Morris Disability Questionnaire

时间窗: From enrollment to the end of treatment at 6 weeks

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

Numeric Rating Scale (NRS)

时间窗: From enrollment to the end of treatment at 6 weeks

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).

Rapid Entire Body Assessment (REBA)

时间窗: From enrollment to the end of treatment at 6 weeks.

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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Junaid Amin

Shahzada Junaid Amin

Universiti Sains Malaysia

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