Night Pain in Patients With Rotator Cuff Syndrome

NCT03894761 | Completed DMC

• 1 other identifier: 13.06.18/69
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the factors that may be associated with night pain in patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Shoulder Tendinitis; Rotator Cuff Tear

Keywords

Pain; Shoulder; Rotator Cuff

Outcome Measures

Primary Outcomes (1)

• Night pain: visual analogue scale

  The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during night for the last one week were inquired.

  7 day

Secondary Outcomes (22)

• Demographic datas

  1 day

• Daytime pain: visual analogue scale

  7 day

• Range of Motion of the Shoulder

  1 day

• Pathology in magnetic resonance imaging

  1 day

• The Shoulder Pain and Disability Index

  7 days

Study Arms (1)

Patients with Rotator Cuff Syndrome

OTHER

The patients diagnosed with rotator cuff syndrome by clinical and magnetic resonance imaging.

Other: Night Pain in Patients with Rotator Cuff Syndrome

Interventions

Night Pain in Patients with Rotator Cuff Syndrome OTHER

The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during night for the last one week were inquired.

Patients with Rotator Cuff Syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be diagnosed with rototor cuff pathology by magnetic resonance imaging
• Age range between 18-65 years old
• To be literate and cooperative

You may not qualify if:

• Having shoulder pathology other than rototor cuff pathology (Glenohumeral instability, Bisipital tendon lesions, Glenohumeral joint osteoarthritis, Acromioclavicular joint osteoarthritis, Milwaukee shoulder)
• Having complete rotator cuff tear
• Patients with a history of shoulder or cervical surgery
• The presence of cervical pathology
• Patients with a history of fracture in the shoulder with pain
• Local corticosteroid injection history for the shoulder (over the last 6 months) and using painkiller regularly
• Physical therapy history for the shoulder (in the last 3 months)
• The presence of systemic inflammatory disease
• Malignancy
• Pregnancy
• A history of any psychiatric disorders

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Alper Mengi

Çanakkale, 17100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Rotator Cuff Injuries; Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries

Study Officials

• Alper Mengi, M.D.

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Physiatrist

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 29, 2019
• Study Start: March 21, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)