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

Glenohumeral Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958227
• Other study ID #: ''IU''
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Glenohumeral Arthritis

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University	Bakirköy	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.