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

30. desember 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia
    • Istanbul
      • Bakırköy, Istanbul, Tyrkia, 34180
        • Istanbul University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ''Manuel Therapy group''
This treatment group will be received Manuel Therapy techniques and exercise interventions.
Annen: 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.
Eksperimentell: ''Exercise group''
This treatment group will be received only exercise interventions.
Annen: Exercise Intervention
Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Istanbul University

Etterforskere

  • Hovedetterforsker: Sibel Gayretli Atan, sssibel_38@hotmail.com

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mai 2019

Primær fullføring (Faktiske)

29. november 2019

Studiet fullført (Faktiske)

30. desember 2019

Datoer for studieregistrering

Først innsendt

11. april 2019

Først innsendt som oppfylte QC-kriteriene

20. mai 2019

Først lagt ut (Faktiske)

21. mai 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. januar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. desember 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ''IU''

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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