Stretching and Musculoskeletal Pain | NCT04617379

Studies
Stretching and Musculoskeletal Pain

NCT04617379

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

May 18, 2022Actual

Enrollment

190Actual

Phase

Not Applicable

Conditions

Musculoskeletal Pain

Interventions

Stretching

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2021Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Oct 30, 2020

First Submission Date that Met QC Criteria

Nov 4, 2020

First Posted Date

Nov 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess whether a daily, 15-minute stretching routine for one year reduces musculoskeletal pain and improves quality of life in personnel working in the radiology and cardiology departments at Mayo Clinics and Mayo Clinic Health System sites.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Treatment Group	Experimental	15 minutes daily stretch for 1 year	Behavioral: Stretching
Control Group	No Intervention	No stretches

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stretching	Behavioral	One-year stretching program for 15 minutes every day	Active Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the DASH index score	The DASH (Disability Arm, Shoulder, and Hand outcomes) is scored on a 0-100 scale. Higher score indicates greater disability. A change of 10 more points from baseline, noted at the end of the study will be considered significant	12 months
Change in ODI (Oswestry Disability Index)	The OSI is scored on a 0-100 scale, zero being with no disability and 100 with maximum disability possible. A change of 10 points from baseline will be considered significant	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A 15-minute daily stretching program will be implemented for 1 year.
Personnel working in the departments of Cardiology and Radiology at Mayo Rochester, - Mayo Scottsdale, and Mayo Jacksonville and Mayo Clinic Health System.
Willing to complete standardized questionnaires (DASH, ODI) to assess work-related pain at baseline and at 1 year.
Employees who respond to questionnaires at baseline and 1 year but don't participate in the stretching exercises will be controls for the study.
Willing and able to provide written, informed consent.

Exclusion Criteria:

Pregnancy.
Inability to participate in the stretching exercises for any reason.
Preexisting musculoskeletal problems that has required employees to seek active medical or orthopedic treatment.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mandeep Singh, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Scottsdale	Arizona	85259	United States
Mayo Clinic Florida

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059352	Musculoskeletal Pain

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D010146	Pain
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided