NCT04263389

Brief Summary

The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include 2 groups, 40 subjects with mechanical chronic cervical pain and 40 healthy subjects representing the control group. The primary outcome measure was the shoulder proprioception test of both upper limbs during active repositioning and quantified with angular displacement error.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Last Updated

July 22, 2022

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

January 24, 2020

Last Update Submit

July 19, 2022

Conditions

Keywords

chronic mechanical cervical pain, shoulder proprioception,

Outcome Measures

Primary Outcomes (1)

  • Absolute angular error (AAE) of shoulder joint

    The AAE is an angle that was measured using the isokinetic dynamometer to indicate the sense of position for shoulder joint. Two measurements were performed; AAE for external rotation range and AAE for internal rotation range for both right and left arms.

    during the procedure

Study Arms (2)

control group

control group is a normal matched group.

study group

study group is a group of chronic mechanical cervical pain

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

For the control group they are normal subjects. For the group with cervical pain, participants had a chronic mechanical cervical pain started from three to 12 months with a score of 3 to 65 according to the short-form of the McGill Pain Questionnaire (SF-MPQ).

You may qualify if:

  • The age ranged from 20 to 35 years.
  • Body Mass Index (BMI) between 18 and less than 30.
  • Sufficient cognitive abilities that enables them to understand and follow instructions with a score more than 24 in the Mini-Mental State Examination (MMSE) scale.
  • For the group with cervical pain, participants had a chronic mechanical cervical pain started from three to 12 months.
  • Participants with chronic pain with a score of 3 to 65 according to the short-form of the McGill Pain Questionnaire (SF-MPQ).

You may not qualify if:

  • Shoulder problems.
  • Previous cervical or shoulder surgery.
  • Shoulder or cervical trauma.
  • Cervical radiculopathy.
  • Sever visual and/or auditory problems.
  • Cognitive impairment (a score less than 24 according to MMSE).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wael Shendy, PhD

    Associate professor Faculty of Physical Therapy-Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 24, 2020

First Posted

February 10, 2020

Study Start

April 1, 2019

Primary Completion

November 15, 2019

Study Completion

December 30, 2019

Last Updated

July 22, 2022

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations