Comparison of the Treatment Efficacy of Suprascapular Nerve Block and Intraarticular Shoulder Injection Techniques in Patients Diagnosed With Adhesive Capsulitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Shoulder Pain and Disability Index
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
close envelope method
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 15 to 75
- •Adhesive phase
Exclusion Criteria
- •Patients with bilateral symptoms
- •Radicular or inflammatory pain
- •Uncontrolled DM
- •Superficial infection at the injection site
- •Bleeding disorder
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)