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Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis

Primary Purpose

Glenohumeral Arthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manuel Therapy plus Exercise Intervention
Exercise Intervention
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glenohumeral Arthritis focused on measuring Glenohumeral Arthritis, Pain, Mobilisation, Physiotherapy, Rehabilitation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 40 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

Exclusion Criteria:

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

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

''Manuel Therapy group''

''Exercise group''

Arm Description

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

This treatment group will be received only exercise interventions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Visual Analogue Scale (VAS)
The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS).Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Manual Muscle Test
Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.
Short Form 12 (SF-12)
SF-12 will be used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Global Rating of Change (GRC) Scale
Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients. Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.

Full Information

First Posted
April 11, 2019
Last Updated
December 30, 2019
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03958227
Brief Title
Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis
Official Title
Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients will randomly divide into two groups. A common exercise program was applied to both groups during 15 sessions. Manual therapy techniques will apply to the manual therapy group in addition to exercise practices. Patients will evaluate in terms of functional status, pain, range of motion, muscle strength and health-related quality before and after 5 weeks of treatment. Also, patient's satisfaction from treatment will evaluate at the 5th week of the treatment. DASH and ASES forms for functional status, VAS for pain, digital goniometer for range of motion, manual muscle test for muscle strength, SF-12 for health-related quality of life, and Global Rating of Change (GRC) Scale for patient satisfaction will be used as evaluation criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glenohumeral Arthritis
Keywords
Glenohumeral Arthritis, Pain, Mobilisation, Physiotherapy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
''Manuel Therapy group''
Arm Type
Experimental
Arm Description
This treatment group will be received Manuel Therapy techniques and exercise interventions.
Arm Title
''Exercise group''
Arm Type
Experimental
Arm Description
This treatment group will be received only exercise interventions.
Intervention Type
Other
Intervention Name(s)
Manuel Therapy plus Exercise Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
Primary Outcome Measure Information:
Title
Shoulder Range of Motion (ROM)
Description
The shoulder flexion, abduction, internal and external rotation ROM will be evaluated with digital goniometer while the patient will be in supine position.
Time Frame
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 Outcome Measure Information:
Title
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
Description
ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Time Frame
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Title
Visual Analogue Scale (VAS)
Description
The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS).Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Time Frame
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Title
Manual Muscle Test
Description
Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.
Time Frame
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Title
Short Form 12 (SF-12)
Description
SF-12 will be used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Time Frame
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
Title
Global Rating of Change (GRC) Scale
Description
Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients. Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Time Frame
Evaluation will be performed after 5 weeks rehabilitation program.
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Description
DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.
Time Frame
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 40 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Gayretli Atan
Organizational Affiliation
sssibel_38@hotmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Bakırköy
State/Province
Istanbul
ZIP/Postal Code
34180
Country
Turkey

12. IPD Sharing Statement

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Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis

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