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

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ClinicalTrials.gov Identifier: NCT03958227
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sibel Gayretli Atan, Istanbul University

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.

Condition or disease Intervention/treatment Phase
Glenohumeral Arthritis Other: Manuel Therapy plus Exercise Intervention Other: Exercise Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : October 18, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Shoulder Range of Motion (ROM) [ 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. ]
    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 :
  1. ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form [ Time Frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program. ]
    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.

  2. Visual Analogue Scale (VAS) [ Time Frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program. ]
    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.

  3. Manual Muscle Test [ Time Frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program. ]
    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.

  4. Short Form 12 (SF-12) [ Time Frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program. ]
    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.

  5. Global Rating of Change (GRC) Scale [ Time Frame: Evaluation will be performed after 5 weeks rehabilitation program. ]
    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.

  6. The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire [ Time Frame: Evaluation will be performed before treatment and after 5 weeks rehabilitation program. ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958227


Contacts
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Contact: Sibel Gayretli Atan +905447185832 sssibel_38@hotmail.com

Locations
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Turkey
Istanbul University Recruiting
Bakırköy, Istanbul, Turkey, 34180
Contact: Sibel Gayretli Atan, PT    05447185832    sssibel_38@hotmail.com   
Sponsors and Collaborators
Istanbul University

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Responsible Party: Sibel Gayretli Atan, Physiotherapist, Istanbul University
ClinicalTrials.gov Identifier: NCT03958227     History of Changes
Other Study ID Numbers: ''IU''
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sibel Gayretli Atan, Istanbul University:
Glenohumeral Arthritis
Pain
Mobilisation
Physiotherapy
Rehabilitation
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases