AzTrials
AzTrials

Adhesive CapsulitisNCT06079515

Comparison of the Treatment Efficacy of Suprascapular Nerve Block and Intraarticular Shoulder Injection Techniques in Patients Diagnosed With Adhesive Capsulitis

A study testing Suprascapular Nerve Block and Intraarticular Shoulder Injection in people with Adhesive Capsulitis and Shoulder Pain, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Adhesive Capsulitis, Shoulder Pain
What is being tested?
Suprascapular Nerve Block and Intraarticular Shoulder Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2022to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 15 to 75
  • Adhesive phase

Who cannot join

  • Patients with bilateral symptoms
  • Radicular or inflammatory pain
  • Uncontrolled DM
  • Superficial infection at the injection site
  • Bleeding disorder
  • Stroke
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Antalya Education and Research Hospital

    Antalya

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Materials and Methods

Calculation of the Sample Size

The sample size of our study was calculated based on assuming the power of the study to be 80% and a type 1 (α) error of 0.05 using the G-Power 3.1.9.4 program. The sample size was calculated as 24 patients for each group. Considering the possibility of being excluded from the study, it was planned to recruit 30 patients for each group.

Patient Selection and Randomization

Our study was conducted at the Physical Therapy and Rehabilitation outpatient clinic of Antalya Education and Research Hospital between March and October 2022. A total of 84 patients aged between 18 and 75 who were found to be in the adhesive phase of AC after a detailed physical examination by the clinician were screened.

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, and patients who had previously received shoulder physical therapy were excluded from the study.

As a result, 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.

Each patient was informed about the course of the disease, possible side effects of injections, and complications. Written informed consent was obtained from each patient. This study was approved by the Local Ethics Committee and was conducted by the principles of the Declaration of Helsinki.

Interventions

All injections were performed by a physiatrist with 15 years of experience 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.

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.

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.

In addition, both groups were given a home exercise program consisting of shoulder range of motion exercises in all directions, especially posterior capsule stretching, isometric strengthening exercises, and Codman exercises.

Clinical Evaluation

The primary outcome measure of the study was the Shoulder Pain and Disability Index (SPADI), and the secondary outcome measures were the Visual Analog Scale (VAS) and ROM measures. SPADI is a self-assessment scale with Turkish validity and reliability, consisting of two parts and a total of 13 questions; each question is given a score between 0 and 10. 21,22 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. VAS scores were marked between 0 and 100 mm by the patients. 23 ROM measurements, including active and passive shoulder flexion, abduction, extension, internal rotation, and external rotation, were measured with a goniometer.

All outcome measures were evaluated by an injection-blind clinician. Outcomes were evaluated four times: pre-injection, post-injection week 1, week 4, and week 12. Information such as age, gender, duration of symptoms, additional disease, affected side, and dominant extremity was recorded before the intervention.

Statistical Analysis

Descriptive statistics are presented with frequency, percentage, mean, standard deviation, median, minimum, and maximum values. In the analysis of categorical data, Fisher's Exact Test (Fisher's Exact Test) was used if the percentage of cells with the expected value less than 5 was greater than 20%, and the Pearson Chi-Square Test was used if it was small. The assumption of normality was checked with the Shapiro-Wilk Test. In the analysis of the difference between the numerical data of the two groups, the Independent Samples T-Test was used when the data conformed to the normal distribution, and the Mann-Whitney U-Test was used when they did not. Repeated measures ANOVA analysis was applied to compare the pre-injection, post-injection week 1, week 4, and week 12 measurements of the continuous numbers of variables according to the SSNB and IAI groups. Since the VAS score did not provide a normal distribution, the SSNB and IAI groups were evaluated within themselves with the Friedman test. Analyzes were made with the SPSS 23.0 program. A P value <0.05 was considered statistically significant.

Being tested
Suprascapular Nerve Block, Intraarticular Shoulder Injection
Keywords
adhesive capsulitis, suprascapular nerve blockade, intra-articular shoulder injection
Medical subject headings
Bursitis, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suprascapular Nerve BlockProcedure or surgery

    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.

  • Intraarticular Shoulder InjectionProcedure or surgery

    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

Study groups in NCT06079515
Study groupRoleWhat they receive
Ali AkdağActive comparatorAll 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.
Receives: Procedure: Suprascapular Nerve Block; Procedure: Intraarticular Shoulder Injection
Muhammet Hüseyin SarıExperimentalBlind observer to injections
Receives: Procedure: Suprascapular Nerve Block; Procedure: Intraarticular Shoulder Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)
  1. Visual Analog Scale

    VAS scores were marked between 0 and 100 mm by the patients

    Min score: 0 Max score: 100

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

  2. Shoulder Range of Motion

    ROM measurements, including active and passive shoulder flexion, abduction, extension, internal rotation, and external rotation, were measured with a goniometer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start1 Mar 2022
  3. Primary completion1 Oct 2022
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079515
Sponsor's protocol ID
000000000000
Status last verified
Sep 2023
First submitted
8 Sep 2023
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Suprascapular Nerve Block and Intraarticular Shoulder Injection in people with Adhesive Capsulitis and Shoulder Pain, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder Pain and Disability Index (time frame: pre-injection, post-injection week 1, week 4, and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in