NCT06079515

Brief Summary

Objective: We aim to compare the efficiency of the ultrasonography-guided suprascapular nerve block (SSNB) and ultrasonography-guided intra-articular shoulder injection (IAI) techniques in terms of pain and functional status in the treatment of adhesive capsulitis. Design: 60 patients with adhesive capsulitis were divided into two groups: SSNB and IAI. Both groups received an injection of 1 ml of 40 mg of triamcinolone acetonide and 9 ml of 0.5% bupivacaine hydrochloride. The patients' Shoulder Pain and Disability Index (SPADI) scores, shoulder active and passive range of motions (ROM), and visual analog scale (VAS) scores were evaluated before and after the injection in the 1st week, 4th week, and 12th week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 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

March 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
Last Updated

October 12, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 8, 2023

Last Update Submit

October 6, 2023

Conditions

Keywords

adhesive capsulitissuprascapular nerve blockadeintra-articular shoulder injection

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain and Disability Index

    SPADI is a self-assessment scale with Turkish validity and reliability, consisting of two parts and a total of 13 questions; each question is scored between 0 and 10. Pain, disability, and total scores between 0 and 100 are obtained by calculating the percentage of the score indicated by the patients. SPADI variables were recorded as pain (SPADI-P), disability (SPADI-D), and total (SPADI-T) scores. Min score: 0 Max score: 100

    pre-injection, post-injection week 1, week 4, and week 12

Secondary Outcomes (2)

  • Visual Analog Scale

    pre-injection, post-injection week 1, week 4, and week 12

  • Shoulder Range of Motion

    pre-injection, post-injection week 1, week 4, and week 12

Study Arms (2)

Ali Akdağ

ACTIVE COMPARATOR

All injections were performed by him under the guidance of a Clarius portable USG device (L7 HD Linear Ultrasound Scanner). A total of 10 ml of a mixture of 1 ml of 40 mg triamcinolone acetonide (Kenakort-A ampoule) and 9 ml of 0.5% bupivacaine hydrochloride (Marcaine) was used in each injection.

Procedure: Suprascapular Nerve BlockProcedure: Intraarticular Shoulder Injection

Muhammet Hüseyin Sarı

EXPERIMENTAL

Blind observer to injections

Procedure: Suprascapular Nerve BlockProcedure: Intraarticular Shoulder Injection

Interventions

SSNB group: The patients were asked to sit comfortably in the chair, and the transducer was placed on the spine of the scapula in the coronal plane and moved laterally to observe the supraspinatus notch and the suprascapular nerve. The injection mixture was applied in-plane with a 22-gauge, 90-mm needle on the suprascapular nerve, under the fascia of the supraspinatus muscle.

Ali AkdağMuhammet Hüseyin Sarı

IAI group: The patients were asked to sit on the chair with their hands facing the opposite shoulder, and the transducer was placed slightly below the spina scapula. The humeral head was observed by moving laterally. The injection mixture was applied in-plane with a 22-gauge, 90-mm needle entering the skin at a 45-degree angle and applied to the joint space

Ali AkdağMuhammet Hüseyin Sarı

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 15 to 75
  • Adhesive phase

You may not qualify if:

  • Patients with bilateral symptoms
  • Radicular or inflammatory pain
  • Uncontrolled DM
  • Superficial infection at the injection site
  • Bleeding disorder
  • Stroke
  • History of drug allergy
  • Shoulder trauma in the last month
  • Any steroid injection in the last 3 months
  • Pregnant or postpartum patients
  • Patients who had previously received shoulder physical therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Education and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BursitisShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
close envelope method
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 60 patients who met the criteria and agreed to participate in the trial were included in the study. The patients were randomized into two groups suprascapular nerve block (SSNB) and intra-articular injection (IAI) using the closed envelope method.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

October 12, 2023

Study Start

March 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

October 12, 2023

Record last verified: 2023-09

Locations