NCT03990324

Brief Summary

Cervical range of motion (ROM) is necessary to perform normal activities of daily living and deficits are associate with various pathologies. Currently, its unclear if specific myofascial stretches will improve cervical range of motion and decrease myofascial sensitivity. After a single session of the manual stretching procedure, participants immediately demonstrated increased cervical ROM and pressure pain thresholds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

June 14, 2019

Last Update Submit

June 19, 2019

Conditions

Cervical Shortening

Keywords

range of motionmuscle sensitivitymuscle stretching

Outcome Measures

Primary Outcomes (1)

  • Range of Motion

    CROM including flexion, extension, side bending left, side bending right, rotation left, and rotation right

    1 minute post-intervention

Secondary Outcomes (1)

  • Pressure pain thresholds

    1 minute post-intervention

Study Arms (2)

Control group

NO INTERVENTION

The control group did not received intervention and sat on a table for approximately 5 minutes

Stretching group

EXPERIMENTAL

The stretching group received a standardized manual stretching protocol

Procedure: Manual stretching

Interventions

Manual stretchingPROCEDURE

Manual stretching for the upper trapezius and levator scapulae muscle

Stretching group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages of 18-60
  • active cervical flexion, right lateral flexion OR left cervical lateral flexion \<45˚

You may not qualify if:

  • minors
  • prisoners
  • individuals with cognitive impairments
  • recent neck surgeries
  • pre-existing neck injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

Study Officials

  • William J Hanney, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor of dependent variables was blinded to group assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 18, 2019

Study Start

January 26, 2018

Primary Completion

September 18, 2018

Study Completion

January 25, 2019

Last Updated

June 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)