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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04971616
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Neck Pain; Shoulder Pain	Other: Demographic data and range of motion.

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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Range of motion (ROM) of the neck [at least 2-week monitoring by wearable devices]

   Patients' range of motion of the neck in all directions are measured using hand-held devices.

2. Oswestry Disability Index (ODI) [at least 2-week monitoring by wearable devices]

   Oswestry Disability Index of the neck is collected for the evaluation of neck functions.

3. Visual Analogue Scale (VAS) [at least 2-week monitoring by wearable devices]

   Visual Analogue Scale is collected for pain assessment.

4. Roland-Morris Disability Questionnaire (RDQ) [at least 2-week monitoring by wearable devices]

   Roland-Morris Disability Questionnaire is collected for the evaluation of lower back functions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• 20-40 year of age with symptoms of shoulder

• Neck and lower back discomfort

Exclusion Criteria

• Red flag sign of the neck

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing		China

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04971616
• Other Study ID Numbers: M2020342
• First Posted: Jul 21, 2021
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shoulder Pain; Low Back Pain; Neck Pain

Study Results

No Results Posted as of Jul 21, 2021