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NCT04971616 Clinical Trial

Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.

Low Back Pain Clinical Trial

Official title:
Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04971616
Other study ID # M2020342
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date August 1, 2023

Study information
Verified date July 2021
Source Peking University Third Hospital
Contact Jian-quan Wang, M.D.
Phone 13801076267
Email keny1417@vip.sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression.

Description:

The purpose of this study is to design a self-assessment scheme for clinical assessment of shoulder, neck and lower back function and compare the consistency between clinical assessment and self-assessment. The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices, evaluating the risk factors of shoulder, neck and lower back discomfort.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date August 1, 2023
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria - 20-40 year of age with symptoms of shoulder - Neck and lower back discomfort Exclusion Criteria - Red flag sign of the neck

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Demographic data and range of motion.
The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices. The range of motion of neck and waist was collected through hand-held devices.

Locations
Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Range of motion (ROM) of the neck Patients' range of motion of the neck in all directions are measured using hand-held devices. at least 2-week monitoring by wearable devices
Primary Oswestry Disability Index (ODI) Oswestry Disability Index of the neck is collected for the evaluation of neck functions. at least 2-week monitoring by wearable devices
Primary Visual Analogue Scale (VAS) Visual Analogue Scale is collected for pain assessment. at least 2-week monitoring by wearable devices
Primary Roland-Morris Disability Questionnaire (RDQ) Roland-Morris Disability Questionnaire is collected for the evaluation of lower back functions. at least 2-week monitoring by wearable devices
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