NCT06391567

Brief Summary

The aim of this study was to investigate the balance characteristics of patients with Frozen Shoulder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

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

October 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 18, 2024

Last Update Submit

April 25, 2024

Conditions

Keywords

Adhesive CapsulitisBalancePain

Outcome Measures

Primary Outcomes (4)

  • Sociodemographic Form

    Sociodemographic information of the patients included in the study, such as age, gender, height, weight, BMI, educational status, dominant side, comorbid status, and clinical information such as affected side, pain intensity, and pain duration were collected in a case report form by face-to-face interview

    8 week

  • Balance Function

    Balance function was measured with the Timed Up and Go Test (TUG). The TUG is a short, simple, and reliable test used to assess balance. It shows that people who complete the test in less than 20 seconds are independent in transfers, while people who complete the test in 30 seconds or more are more dependent in activities of daily living.

    8 week

  • Static and Dynamic Postural Balance

    Biodex Balance System was used for objective assessment of static and dynamic postural balance. A high balance score indicates poor balance performance.

    8 week

  • Pain Intensity

    The pain intensity of the patients was measured using the Visual Analogue Scale. The pain intensity score ranges from 0 to 10. An increase in the score indicates an increase in pain; a decrease in the score indicates a decrease in pain.

    8 week

Study Arms (2)

Control Group

The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.

Other: There was no intervention in this study.

Patient Group

Patients who were diagnosed with Frozen Shoulder by physical examination, met the inclusion criteria, and agreed to participate in the study were selected for the patient group.

Other: There was no intervention in this study.

Interventions

There was no intervention in this study.

Control GroupPatient Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the Physical Medicine and Rehabilitation Outpatient Clinic with complaints of shoulder pain were examined by a physiatrist. Patients who were diagnosed with Frozen Shoulder by physical examination, who met the inclusion criteria, and who agreed to participate in the study were included in the study. The control group consisted of hospital and university staff. The control group was also assessed by the same physiatrist and confirmed by the country's health database as having no chronic disease affecting balance.

You may qualify if:

  • Volunteers aged 40-65 years,
  • Diagnosed with unilateral Frozen Shoulder, Frozen Shoulder stage 2-3,
  • Pain lasting more than 3 months,
  • No mental or cognitive impairment
  • At least 25% movement limitation in at least 2 movement planes and
  • Able to cooperate.

You may not qualify if:

  • Who had a neurological, rheumatic, cardiac and active malignant diseases
  • Who had a history of surgery, trauma, and fracture
  • Who had comorbid conditions that would affect balance
  • The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atahan TURHAN

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lecturer

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 30, 2024

Study Start

October 10, 2023

Primary Completion

April 10, 2024

Study Completion

April 16, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations