Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis
30. Dezember 2019 aktualisiert von: Sibel Gayretli Atan, Istanbul University
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
30
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Istanbul
-
Bakırköy, Istanbul, Truthahn, 34180
- Istanbul University
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: ''Manuel Therapy group''
This treatment group will be received Manuel Therapy techniques and exercise interventions.
|
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.
|
Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Shoulder Range of Motion (ROM)
Zeitfenster: 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.
|
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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
Zeitfenster: 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.
|
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
|
|
Visual Analogue Scale (VAS)
Zeitfenster: 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.
|
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
|
|
Manual Muscle Test
Zeitfenster: 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.
|
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
|
|
Short Form 12 (SF-12)
Zeitfenster: 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.
|
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
|
|
Global Rating of Change (GRC) Scale
Zeitfenster: 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.
|
Evaluation will be performed after 5 weeks rehabilitation program.
|
|
The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Zeitfenster: 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.
|
Evaluation will be performed before treatment and after 5 weeks rehabilitation program.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Sibel Gayretli Atan, sssibel_38@hotmail.com
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
20. Mai 2019
Primärer Abschluss (Tatsächlich)
29. November 2019
Studienabschluss (Tatsächlich)
30. Dezember 2019
Studienanmeldedaten
Zuerst eingereicht
11. April 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Mai 2019
Zuerst gepostet (Tatsächlich)
21. Mai 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. Januar 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. Dezember 2019
Zuletzt verifiziert
1. November 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ''IU''
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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