Investigation The Efficacy of Manual Therapy and Exercise in Patients With Glenohumeral Arthritis
30. december 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Istanbul
-
Bakırköy, Istanbul, Kalkun, 34180
- Istanbul University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ''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.
|
|
Eksperimentel: ''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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder Range of Motion (ROM)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Sibel Gayretli Atan, sssibel_38@hotmail.com
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. maj 2019
Primær færdiggørelse (Faktiske)
29. november 2019
Studieafslutning (Faktiske)
30. december 2019
Datoer for studieregistrering
Først indsendt
11. april 2019
Først indsendt, der opfyldte QC-kriterier
20. maj 2019
Først opslået (Faktiske)
21. maj 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. december 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ''IU''
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .