Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079515
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-09-08
Brief Title:
Comparison of the Treatment Efficacy of Suprascapular Nerve Block and Intraarticular Shoulder Injection Techniques in Patients Diagnosed With Adhesive Capsulitis
Sponsor:
Antalya Training and Research Hospital
Organization:
Antalya Training and Research Hospital
Study Overview
Official Title:
Comparison of the Treatment Efficacy of Suprascapular Nerve Block and Intraarticular Shoulder Injection Techniques in Patients Diagnosed With Adhesive Capsulitis
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 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
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 05 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 005 using the G-Power 3194 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 05 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 2122 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 Fishers Exact Test Fishers 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 230 program A P value 005 was considered statistically significant
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 005 using the G-Power 3194 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 05 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 2122 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 Fishers Exact Test Fishers 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 230 program A P value 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None