NCT02797002

Brief Summary

Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's societies. Cervical muscles endurance has been commonly associated with the development of NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical therapists to evaluate muscle structure, function and activation patterns. The aim of this study is if change in muscle thickness can correlate with the results of the endurance testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

June 3, 2016

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (6)

  • Flexor and Extensor cervical muscles holding time (second)

    6 months

  • Anteroposterior diameter of the flexor and extensor cervical muscles (mm)

    6 months

  • Mediolateral diameter of the flexor and extensor cervical muscles (mm)

    6 months

  • Cross section area of the flexor and extensor cervical muscles (cm2)

    6 months

  • Neck disability questionnaire score

    6 months

  • Visual analogue scale score

    6 months

Secondary Outcomes (1)

  • Pearson correlation coefficient of the cervical muscles holding time with Anteroposterior and border and cross section area of the flexor and extensor cervical muscles

    6 months

Study Arms (2)

Chronic non specific neck pain

Experiencing neck pain for at least 3 months in the last year

Other: Assessment

Without neck pain (asymptomatic)

No history of neck pain

Other: Assessment

Interventions

Chronic non specific neck painWithout neck pain (asymptomatic)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects with and without neck pain

You may qualify if:

  • Subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.
  • Healthy subjects: no history of neck pain

You may not qualify if:

  • History of cervical discopathy
  • Any surgery on neck
  • Traumatic neck injury
  • Any congenital disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Social Welfare and Rehabilitation Sciences

Tehran, 1985713831, Iran

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 13, 2016

Study Start

March 1, 2015

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations