Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06091709 |
| Other study ID # |
MEET-R for dentists with WRLBP |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2023 |
| Est. completion date |
March 1, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Universiti Sains Malaysia |
| Contact |
Junaid Amin, MHPE,DPT |
| Phone |
+966580931017 |
| Email |
junaid768[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. 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.
Description:
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
This study will include registered and practicing dentists with non-specific low back pain
from private and public clinics, university clinics, and hospitals who participated in
another cross-sectional study on the prevalence of MSDs in dentists in Pakistan and agreed to
be contacted and participate in the trial.
Sample size calculation A sample size of 180 patients will be required for this study based
on the highest sample size calculated for the primary objectives. This sample size estimation
is based on the calculation of sample size in the subsequent section.
Sampling method
The participants will be selected using a simple random sampling method from a list of
respondents mentioned in the sampling frame.
Randomization
Randomization will be employed to ensure that the two groups are comparable at the start of
the study, and reducing the risk of selection bias. Computer-based online software
(https://www.randomizer.org/) will be used to allocate the participants into intervention and
control groups with a 1:2 ratio. The rationale for the ratio is described in the control
group heading number 3.4.10.
Matching
In addition to randomization, matching will be used to ensure that baseline characteristics
respect to the inclusion and exclusion criteria are similar between the groups. Dentists in
the experimental and control groups will be matched based on variables that might affect low
back pain, such as age, BMI, and severity of pain at the start of the study. Matching can
help control for these variables, reducing their potential impact on the results.
Blinding The study participants will be aware of their treatment but neither intervention nor
control groups will be unaware of the treatment of the other. The clinical assessment and
intervention will be performed by the same investigator. That investigator will be blinded
from knowing the identity of study participants by assigning codenames to the latter, derived
by another investigator, and addressing them by it throughout the study. Bias and blinding
are controlled by deriving different codenames for the clinical assessment and delivery of
the intervention. The participants will be informed of the lack of personal address in
communication during the interactive sessions. The data analyst will also be blinded to group
assignments and treatment information to ensure the integrity of data analysis.
Data collection method
Step 1: (Recruitment of patients) A list of subjects identified as having low back pain
including their contact information will be obtained from another (ongoing) cross-sectional
study. The subjects will be approached using their contact information (WhatsApp, email, and
mobile numbers) to screen their interest to participate in the trial and based on the study
inclusion criteria.
Step 2 (online screening to 'confirm' diagnosis) Those meeting the first screening stage will
undergo a second screening for the exclusion criteria (Irvine et al., 2015). Information on
demographics, workplaces, and possible medical risk factors will also be collected.
Step 3: (Online meeting to perform physical examination) For patients who pass the second
screening, an expert and registered physiotherapist will seek further a detailed history,
conduct a remote physical musculoskeletal examination in an online meeting which will take 30
minutes, and assess the pain score using the NRS (Laskowski et al., 2020; Mani et al., 2017).
Only patients who will meet the screening above will continue to the next step.
Step 4: (Informed consent and Baseline measurements) Each study participant will be informed
about the study objective and the methods before verbal and written informed consent is
sought (Figure 3). Then, the baseline assessment of the subjects will be performed to assess
the primary outcomes including pain, disability levels, and posture by using the Numeric
Rating Scale (NRS), Roland-Morris Disability Questionnaire, and Rapid Entire Body Assessment
(REBA), respectively. In addition, the participants will be asked to complete the Patient
Specific Functional Scale (PSFS) and European quality of life 5 dimensions 5 level (EQ-5D-5L)
questionnaire to assess their functional status and quality of life.
Step5 (Allocation to intervention and control groups)
The subjects will be randomly assigned to the intervention and control groups (Figure 3). The
intervention group will be given the link to the MEET-R which will be accessible for up to 6
weeks through a mobile application TeleHab® (VALD Health, Newstead, QLD, Australia, which is
a freely available exercise prescription and tracking platform. They will be asked to follow
the instruction of MEET-R throughout the 6 weeks. The MEET-R intervention included
instruction on exercises, education, and ergonomics instructions in the form of an e-booklet
that contains details of the instructions of their treatment protocol and a link to a video
of the same information. Subsequently, reinforcement will be given periodically every week to
the patients to improve their compliance and motivation by sending regular messages and
telephone calls during the study period. The services provided will be free of charge
throughout the study period of 6 weeks.
The control group will receive no intervention from the study and asked to continue with
their existing self-care management of LBP. They will be given access to the MEET-R module
after the completion of the trial.
Step 6 (Follow-up and Analysis) All the assessments made at baseline will be reassessed
online after 6 weeks (Figure 3). In addition, the exercise adherence rating scale (EARS), and
the Telehealth usability questionnaire (TUQ) will be assessed following the intervention. Any
changes observed in the self-care management of the control group after the baseline
assessment will also be recorded.
Pilot study A pilot study will also be conducted on 20 participants of the total sample to
evaluate the technical, administrative, or logistic feasibility before the main trail. The
justification of the pilot study is also to foresee the issues of data collection and
protocol adherence. RCT will be followed by the pilot study and participants of the pilot
study will be included in the RCT.
Data analysis
The data will be coded and analyzed using SPSS version 27 (PSS, Inc., Chicago, IL, USA). The
categorical data will be presented in the form of frequency and percentages while continuous
data will be presented as mean and standard deviation (SD). The data will be presented in the
form of bar charts and pie charts. A Chi-squared test will be used to analyze associations
between categorical variables. A histogram and the test of normality will be used to examine
the data distribution. A paired t-test will be used for comparing pre-and post-intervention
and an independent t-test for comparing intervention and control groups for normally
distributed data. The significance level will be 5% for all analyses and a P-value < 0.05
will be considered a significance level.
