Ultrasonographic Parameters and Life Quality in Nocturnal Shoulder Pain

March 8, 2018 updated by: Çiğdem Aydoğan, Suleyman Demirel University

Comparison of Clinical and Ultrasonographic Parameters of Rotator Cuff Tendinopathy Patients With and Without Nocturnal Pain

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty patients with nocturnal pain, 30 patients without nocturnal pain, and 30 healthy subjects were included in the study. The demographic characteristics and body mass indexes of the patients were recorded. The visual analogue scale was used to determine pain severity. The American Shoulder and Elbow Surgeons Scale Assessment, Short Form-36 and Beck Depression Inventory were used to determine patients' shoulder function, general quality of life and depression levels, respectively. The peak systolic velocity and resistive index of anterior circumflex humeral artery was assessed with power doppler ultrasonography.The peak systolic velocity and resistive index of anterior circumflex humeral artery values of the affected and unaffected sides were compared.

Study Type

Observational

Enrollment (Actual)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients aged over 18 years diagnosed with rotator cuff tendinopathy

Exclusion Criteria:

  • 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
  • Antiinflammatory drugs or received physical therapy within the last 3 months
  • Beck depression score of higher than 13.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group C
Healthy controls
Device: Ultrasonography
Ultrasonographic examination of shoulder
Group A
Thirty patients with nocturnal shoulder pain
Device: Ultrasonography
Ultrasonographic examination of shoulder
Group B
Thirty patients without nocturnal shoulder pain
Device: Ultrasonography
Ultrasonographic examination of shoulder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior circumflex humeral artery peak systolic velocity
Time Frame: 1 week
Ultrasonographic examination
1 week
Anterior circumflex humeral artery resistive index
Time Frame: 1 week
Ultrasonographic examination
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Investigators

  • Principal Investigator: Çiğdem Aydoğan, Suleyman Demirel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

October 15, 2017

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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