NCT07704411

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 6, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Adhesive capsulitisosteopathic visceral manipulationphysical therapyvisceral dysfunction

Outcome Measures

Primary Outcomes (1)

  • Pain (VAS)

    From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (2)

  • Active shoulder ROM for abduction, flexion, internal rotation, and external rotation

    From enrollment to the end of treatment at 4 weeks

  • Shoulder Pain and Disability Index (SPADI)

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Group 1 (OVM group, n=28) received a standard physical therapy program

EXPERIMENTAL
Other: physical therapy program

Group 2 (Sham group, n=28) received the same standard physical therapy program

SHAM COMPARATOR
Other: Sham (No Treatment)

Interventions

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.

Group 1 (OVM group, n=28) received a standard physical therapy program

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.

Group 2 (Sham group, n=28) received the same standard physical therapy program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goztepe Suleyman Yalcin Sehir Hastanesi Fiziksel Tıp ve Rehabilitasyon Klinigi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-center, single-blind, randomized-controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 15, 2026

Study Start

January 10, 2023

Primary Completion

May 15, 2024

Study Completion

March 20, 2025

Last Updated

July 15, 2026

Record last verified: 2026-07

Locations