NCT07088562

Brief Summary

Adhesive Capsulitis (AC) is a condition that restricts the passive and active range of motion of the shoulder joint, impairing quality of life and activities. AC, which can be progressive and last a long time, is also called "frozen shoulder." The incidence of AC is 2-4% in the normal patient population. This rate varies between 10-30% in diabetic patients. The limitation and pain in AC joint range of motion (ROM) can last up to 3 years. There is no clear data on its prevalence in elderly patients. Its etiopathogenesis has not been fully elucidated. Fibrotic contractures form in the joint capsule. Diabetes, female gender, autoimmune diseases, thyroid disorders, immobilization, cardiovascular and cerebrovascular diseases, and advanced age are among the risk factors . AC is often diagnosed by physical examination and exclusion of other joint pathologies. Magnetic resonance imaging (MRI) can be helpful in diagnosis . Physical therapy, medical, interventional methods, and surgery are used in the treatment of AC. In physical therapy, exercises and modalities aimed at increasing ROM are used, while medical treatment includes oral analgesics, myorelaxants, and topical analgesics. Effective treatment options include intra-articular steroid injections and radiofrequency applications for blocking the suprascapular nerve (SN). The SN originates from the ventral branches of the C5-C6 brachial plexus. It is responsible for 70% of the shoulder innervation, particularly to the shoulder joint and capsule, and the acromioclavicular joint (ACJ). It provides motor innervation to the supraspinatus and infraspinatus muscles. NS block or radiofrequency applications are frequently used in the treatment of pain in shoulder joint pathologies, impingement syndrome, and ACJ pathologies. Previously, conventional radiofrequency applied at high temperatures had destructive effects on the nerve. While conventional methods are currently used in some cases, pulsed radiofrequency is effectively applied at lower temperatures, particularly to prevent motor damage . In this study, we aimed to present the effectiveness of pulsed radiofrequency (SS-PRF) application to the suprascapular nerve in a difficult and challenging patient group (elderly patients) in AC, a difficult disease to treat.

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 Jun 2025

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

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

July 20, 2025

Last Update Submit

September 17, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • numerical rating scale (NRS-11)

    The NRS-11 is an 11-point numerical scale on which patients can rate their pain from 0 (no pain at all) to 10 (the most severe pain they have ever felt).

    12 weeks

  • shoulder pain and disability index (SPADI)

    The SPADI is a validated index consisting of 13 questions, 5 of which assess pain and 8 assess disability, and is scored from 0 to 100 to assess shoulder pain and functionality. As the score increases, pain and disability increase.

    12 weeks

Study Arms (1)

Evaluation of the Effectiveness of Ultrasonography-Guided Pulsed Radiofrequency to the Suprascapular

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over the age of 65 who met the AK diagnostic criteria through clinical, radiological (MRI) and physical examination between June 2022 and June 2023, and who received SS-PRF treatment and who could not achieve adequate pain palliation despite medical and physical therapy modalities within an appropriate period of time, will be retrospectively screened.

You may qualify if:

  • Patients over the age of 65 who were diagnosed with adhesive capsulitis through clinical physical examination and imaging and who underwent shoulder SS-PRF.
  • Patients with complete data to be scanned in their files.

You may not qualify if:

  • Patients with a history of shoulder surgery,
  • shoulder impingement syndrome, osteoarthritis, or other primary shoulder pathologies that could explain shoulder pain,
  • patients who received shoulder injections within the last 3 months,
  • patients with psychosis,
  • patients with pacemakers (ICDs), patients with decompensated chronic diseases,
  • patients with bleeding disorders,
  • patients with active malignancy or infection,
  • patients with advanced cervical disc herniation,
  • patients with allergies to the medications to be administered,
  • patients who could not be communicated with, and patients who did not accept the procedure were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İKanuni Sultan Süleyman Training and Research Hospital

Küçükçekmece, Istanbul, (507) 277-4773, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • halil ibrahim altun

    Kanuni Sultan Süleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pain specialist

Study Record Dates

First Submitted

July 20, 2025

First Posted

July 28, 2025

Study Start

June 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 15, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations