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

July 11, 2021 updated by: Peking University Third Hospital
Identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20-40 year of age with shoulder, neck and lower back discomfort

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Patients with shoulder, neck and lower back discomfort
Patients with shoulder, neck and lower back discomfort.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Chair: Jian-quan Wang, M.D., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 11, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 11, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2020342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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