- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07704411
The Effect of Osteopathic Visceral Manipulation on Pain, Mobility and Functional Disability in Patients With Right Shoulder Adhesive Capsulitis
14. juli 2026 opdateret af: Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
The aim of this study was to evaluate the effects of adding osteopathic visceral manipulation (OVM) to a standard physical therapy program on pain, functional disability, and range of motion (ROM) in patients diagnosed with right shoulder adhesive capsulitis (AC).
A total of 49 patients aged between 40 and 65 years who were diagnosed with right shoulder AC were included in the study.
Randomized patients received a standard physical therapy program for three weeks, consisting of 15 sessions (5 days per week) in both treatment groups.
The standard program included hot pack application to the shoulder region for 20 min, conventional transcutaneous electrical nerve stimulation (TENS) for 20 min, and ultrasound therapy at 1.5 W/cm² for 10 min.
In addition to the standard physical therapy program, Group 1 (n=25) received OVM once weekly, while Group 2 (n=24) received sham OVM once weekly.
Pain was evaluated using the Visual Analog Scale (VAS), while functional disability was evaluated using the Shoulder Pain and Disability Index (SPDI).
The ROM values were also recorded.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
56
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Goztepe Suleyman Yalcin Sehir Hastanesi Fiziksel Tıp ve Rehabilitasyon Klinigi
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age between 18 and 65 years
- Presence of pain originating from the right shoulder region persisting for at least 6 weeks
- Availability of two-view shoulder radiographs obtained prior to the study to exclude causes of shoulder pain other than AC
- No local corticosteroid injection for shoulder pain within the previous 6 months
- No physical therapy administered for shoulder pain within the previous 6 months
- No use of non-steroidal anti-inflammatory drugs (NSAIDs) during the study period
Availability of laboratory assessments including:
- Complete blood count (CBC)
- Erythrocyte sedimentation rate (ESR)
- Liver function tests (AST, ALT)
- C-reactive protein (CRP)
- Pain intensity score of at least 4 cm on the Visual Analog Scale (VAS, 0-10 cm)
Exclusion Criteria:
- History of shoulder fracture on the affected side
- Prior shoulder surgery
- History of traumatic shoulder instability (subluxation or dislocation)
- History of shoulder or visceral organ surgery within the past 6 months
- History of systemic or inflammatory disease or malignancy
- Presence of metabolic or endocrine bone disease
- Pregnancy
- Neurological disorders affecting upper extremity function
- Psychiatric disorders that could interfere with treatment compliance or symptom evaluation
- Use of antiplatelet medication
- Previous osteopathic treatment
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group 1 (OVM group, n=28) received a standard physical therapy program
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In the OVM group, mobilization of the liver and diaphragm was performed.
Liver mobilization was applied in three planes (coronal, transverse, and sagittal) for 5 min each, totaling 15 min, while the diaphragm technique was applied for 2 min.
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Sham-komparator: Group 2 (Sham group, n=28) received the same standard physical therapy program
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In the sham OVM group, light pressure and touch were applied with the palm over the same points selected for OVM, without the intention of providing therapeutic effect.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Pain (VAS)
Tidsramme: From enrollment to the end of treatment at 4 weeks
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From enrollment to the end of treatment at 4 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Active shoulder ROM for abduction, flexion, internal rotation, and external rotation
Tidsramme: From enrollment to the end of treatment at 4 weeks
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From enrollment to the end of treatment at 4 weeks
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Shoulder Pain and Disability Index (SPADI)
Tidsramme: From enrollment to the end of treatment at 4 weeks
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From enrollment to the end of treatment at 4 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
10. januar 2023
Primær færdiggørelse (Faktiske)
15. maj 2024
Studieafslutning (Faktiske)
20. marts 2025
Datoer for studieregistrering
Først indsendt
6. juli 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2022/0670
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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