Quantitative Assessment of Shoulder Proprioception in Pat... | NCT04263389

Studies
Quantitative Assessment of Shoulder Proprioception in Patients With Chronic Mechanical Cervical Pain

NCT04263389

Sponsor

Hamada Ahmed

Status

Completed

Last Update Posted

Jul 22, 2022Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Cervical Pain

Interventions

Not provided

Countries

Egypt

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

Feb 2020

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

Apr 1, 2019Actual

Primary Completion Date

Nov 15, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Jan 24, 2020

First Submission Date that Met QC Criteria

Feb 7, 2020

First Posted Date

Feb 10, 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

Jul 19, 2022

Last Update Posted Date

Jul 22, 2022Actual

Name	Class
Cairo University	OTHER

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 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.

Detailed Description

The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include two 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. Test was applied using an isokinetic dynamometer device at angle 30° for both shoulder internal and external rotation on both sides with an angular velocity 30°/sec.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group		control group is a normal matched group.
study group		study group is a group of chronic mechanical cervical pain

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wael Shendy, PhD	Associate professor Faculty of Physical Therapy-Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Physical Therapy, Cairo University		Giza	Cairo Governorate	12613	Egypt

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
D019547	Neck Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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