NCT07131839

Brief Summary

Patients with adhesive capulitis longlasting more than 3 months were participated in the study. they were divided into two groups whether they have central sensitizaiton or not. Conventional physical therapy responses were measured and compared between two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

August 13, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

Adhesive Capsulitischronic pain

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    A 10 cm VAS, with known validity and reliability, was used as a self-reported measure for the severity of joint pain.

    at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

  • Shoulder Pain Disability Index (SPADI)

    This questionnaire was developed to assess shoulder joint pain and disability. The SPADI has two sections; first section contains 5 questions to evaluate pain, whereas second item contains 8 questions to evaluate disability. Scores vary 0-130 and higher scores indicates high disability rates and pain

    at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

  • Measurement of Shoulder range of motion

    The same physician performed the measurement for the joint ranges in each plane of the joint with a goniometer. The goniometer's pivot point was positioned on the lateral projection of the shoulder joint while subjects in supine position. The fixed arm aligned parallel to the axillary lateral midline , while the movable arm tracked the humerus' lateral midline movement towards the axilla. The joint was passively forced to the end of the direction of range and measured twice and the average was taken

    at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

Secondary Outcomes (3)

  • Tampa Kinesiophobia Scale (TKS)

    at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

  • Pain Catastrophizing Scale (PCS)

    at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).

  • Beck Depression Inventory (BDI)

    at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

Study Arms (2)

Group 1

Adhesive shoulder patients with central sensitization

Group 2

Adhesive capsulitis patients without central sensitization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adhesive capsulitis patients aged between 18-80 years, and symptoms ongoing more than 3 months were participated in the study

You may qualify if:

  • )patients with adhesive capsulitis between 18-80 years old 2) symptoms ongoing more than 3 months 3) willing to participated in the study

You may not qualify if:

  • \) patients with cervical radiculopathy 2) Patients with predisposing factors to adhesive capsulitis, such as diabetes mellitus, thyroid disease, coronary artery disease, lung pathologies or tuberculosis 3) any defined central sensitization syndrome such as fibromiyalgia before 4) presence of rheumatologic diseases 5) pregnancy 6) patients underwent bypass surgery or who have cardiac pacemaker 7) patients with septic arthritis or sepsis 8) malignancy 9) patients that underwent surgery through the shoulder region or had injection through the shoulder joint in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Bilika P, Nijs J, Fandridis E, Dimitriadis Z, Strimpakos N, Kapreli E. In the Shoulder or in the Brain? Behavioral, Psychosocial and Cognitive Characteristics of Unilateral Chronic Shoulder Pain with Symptoms of Central Sensitization. Healthcare (Basel). 2022 Aug 30;10(9):1658. doi: 10.3390/healthcare10091658.

    PMID: 36141270BACKGROUND
  • Brindisino F, Girardi G, Crestani M, Fiore A, Giovannico G, Garzonio F, Venturin D, Struyf F. Effectiveness of electrophysical agents in subjects with frozen shoulder: a systematic review and meta-analysis. Disabil Rehabil. 2024 Aug;46(16):3513-3534. doi: 10.1080/09638288.2023.2251880. Epub 2023 Sep 5.

    PMID: 37667875BACKGROUND
  • James-Belin E, Lasbleiz S, Haddad A, Morchoisne O, Ostertag A, Yelnik A, Laredo JD, Bardin T, Orcel P, Richette P, Beaudreuil J. Shoulder adhesive capsulitis: diagnostic value of active and passive range of motion with volume of gleno-humeral capsule as a reference. Eur J Phys Rehabil Med. 2020 Aug;56(4):438-443. doi: 10.23736/S1973-9087.19.05890-8. Epub 2019 Nov 18.

    PMID: 31742369BACKGROUND

MeSH Terms

Conditions

BursitisChronic Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 20, 2025

Study Start

January 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 20, 2025

Record last verified: 2025-08

Locations