NCT04971616

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

June 27, 2021

Last Update Submit

July 11, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Visual Analogue Scale (VAS)

    Visual Analogue Scale is collected for pain assessment.

    at least 2-week monitoring by wearable devices

  • 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

Study Arms (1)

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.

Interventions

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.

Group 1: Patients with shoulder, neck and lower back discomfort

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • year of age with symptoms of shoulder
  • Neck and lower back discomfort

You may not qualify if:

  • Red flag sign of the neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Low Back PainNeck PainShoulder Pain

Interventions

DemographyRange of Motion, Articular

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jian-quan Wang, M.D.

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Jian-quan Wang, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 21, 2021

Study Start

August 1, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2023

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations