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).
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Adhesive Capsulitis, Shoulder Pain
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Suprascapular Nerve Block; Procedure: Intraarticular Shoulder Injection |
| Muhammet Hüseyin Sarı | Experimental | Blind 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.
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)
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
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.
- First posted12 Oct 2023
- Study start1 Mar 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Treatment Efficacy of Suprascapular Nerve Block and Intraarticular Shoulder Injection Techniques in Patients Diagnosed With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06079515
- Acronym / sponsor ID
- 000000000000
- Conditions
- Adhesive Capsulitis, Shoulder Pain
- Keywords
- adhesive capsulitis, suprascapular nerve blockade, intra-articular shoulder injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ali Akdağ | Active comparator | Procedure: Suprascapular Nerve Block, Procedure: Intraarticular Shoulder InjectionAll 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. |
| Muhammet Hüseyin Sarı | Experimental | Procedure: Suprascapular Nerve Block, Procedure: Intraarticular Shoulder InjectionBlind observer to injections |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 15 to 75
- Adhesive phase
Key exclusion criteria (11 listed)
- Patients with bilateral symptoms
- Radicular or inflammatory pain
- Uncontrolled DM
- Superficial infection at the injection site
- Bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprascapular Nerve BlockSSNB 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. | Procedure or surgery | Ali Akdağ, Muhammet Hüseyin Sarı |
| Intraarticular Shoulder InjectionIAI 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 | Procedure or surgery | Ali Akdağ, Muhammet Hüseyin Sarı |
Primary outcome
Shoulder Pain and Disability Index
Time frame: pre-injection, post-injection week 1, week 4, and week 12
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
2 secondary outcomes
Visual Analog Scale
Time frame: pre-injection, post-injection week 1, week 4, and week 12
Shoulder Range of Motion
Time frame: pre-injection, post-injection week 1, week 4, and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.