NCT03466307

Brief Summary

This study aimed to investigate the effects of nocturnal pain on clinical and ultrasonographic parameters in patients with rotator cuff tendinopathy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

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

January 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

February 21, 2018

Last Update Submit

March 8, 2018

Conditions

Musculoskeletal Pain

Keywords

Nocturnal painshoulder painultrasonographyresistive indexquality of lifeanterior circumflex humeral artery

Outcome Measures

Primary Outcomes (2)

  • Anterior circumflex humeral artery peak systolic velocity

    Ultrasonographic examination

    1 week

  • Anterior circumflex humeral artery resistive index

    Ultrasonographic examination

    1 week

Study Arms (3)

Group A

Thirty patients with nocturnal shoulder pain

Device: Ultrasonography

Group B

Thirty patients without nocturnal shoulder pain

Device: Ultrasonography

Group C

Healthy controls

Device: Ultrasonography

Interventions

UltrasonographyDEVICE

Ultrasonographic examination of shoulder

Group AGroup BGroup C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged over 18 years diagnosed with rotator cuff tendinopathy attending our physical medicine and rehabilitation outpatient clinic and healthy volunteers

You may qualify if:

  • Patients aged over 18 years diagnosed with rotator cuff tendinopathy

You may not qualify if:

  • Severe limitation and pain in head and neck movements
  • Loss of strength
  • Sensation and reflexes loss in the upper extremity
  • Limitation in passive shoulder movements on physical examination
  • Systemic rheumatic disease
  • Diabetes mellitus
  • Malignant disease
  • Active infection
  • Intraarticular injection
  • Trauma
  • Dementia
  • History of surgery
  • Bilateral should pain
  • Psychiatric discomfort
  • Smoking history
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal PainShoulder Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Çiğdem Aydoğan

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor in Physical Medicine and Rehabilitation Clinic

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 15, 2018

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

October 15, 2017

Last Updated

March 15, 2018

Record last verified: 2018-03