NCT03958227

Brief Summary

The aim of the investigator's study is to compare the efficacy of manual therapy and exercise practices compared to exercise practice in patients with Glenohumeral Arthritis. Thirty volunteer patients will include into the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 2, 2020

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

April 11, 2019

Last Update Submit

December 30, 2019

Conditions

Glenohumeral Arthritis

Keywords

Glenohumeral ArthritisPainMobilisationPhysiotherapyRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Shoulder Range of Motion (ROM)

    The shoulder flexion, abduction, internal and external rotation ROM will be evaluated with digital goniometer while the patient will be in supine position.

    Evaluation will be performed first time at baseline and second time will be performed after 5 weeks rehabilitation program. After treatment "change" will be assessed.

Secondary Outcomes (6)

  • ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form

    Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

  • Visual Analogue Scale (VAS)

    Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

  • Manual Muscle Test

    Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

  • Short Form 12 (SF-12)

    Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

  • Global Rating of Change (GRC) Scale

    Evaluation will be performed after 5 weeks rehabilitation program.

  • +1 more secondary outcomes

Study Arms (2)

''Manuel Therapy group''

EXPERIMENTAL

This treatment group will be received Manuel Therapy techniques and exercise interventions.

Other: Manuel Therapy plus Exercise Intervention

''Exercise group''

EXPERIMENTAL

This treatment group will be received only exercise interventions.

Other: Exercise Intervention

Interventions

Manuel Therapy plus Exercise InterventionOTHER

Shoulder mobilization techniques include glenohumeral traction, anterior, posterior and inferior glide. We will also use anterior, posterior and inferior joint stretching exercises and scapular mobilization. Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.

''Manuel Therapy group''
Exercise InterventionOTHER

Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.

''Exercise group''

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older patients
  • To be diagnosed with GHOA by specialist physician via MRI, US or radiography and physical examination
  • Unilateral shoulder pain lasting more than 2 months seen during daily living activities and at rest

You may not qualify if:

  • Patients with:
  • Severe arthrosis
  • Tumor
  • Cervical radiculopathy
  • Emotional or cognitive problems
  • A neurological disease that causes muscle weakness on the shoulder
  • A skin disease that may affect upper extremity assessment.
  • Frozen shoulder
  • Thoracic outlet syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Bakırköy, Istanbul, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sibel Gayretli Atan

    sssibel_38@hotmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

April 11, 2019

First Posted

May 21, 2019

Study Start

May 20, 2019

Primary Completion

November 29, 2019

Study Completion

December 30, 2019

Last Updated

January 2, 2020

Record last verified: 2019-11

Locations

TU(1)