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

Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Glenohumeral Arthritis
• Intervention / Treatment: Other: Manuel Therapy plus Exercise Intervention; Other: Exercise Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul
    • Bakırköy, Istanbul, Turkey, 34180
      • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ''Manuel Therapy group''; This treatment group will be received Manuel Therapy techniques and exercise interventions.	Other: Manuel Therapy plus Exercise Intervention; 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.
Experimental: ''Exercise group''; This treatment group will be received only exercise interventions.	Other: Exercise Intervention; Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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.	Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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.	Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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.	Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
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.	Evaluation will be performed after 5 weeks rehabilitation program.
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.	Evaluation will be performed before treatment and after 5 weeks rehabilitation program.

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Sibel Gayretli Atan, sssibel_38@hotmail.com

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): November 29, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Pain; Physiotherapy; Mobilisation; Glenohumeral Arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: ''IU''

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No