|Ahead of print publication
Comparison of outcome of ultrasound-guided suprascapular nerve block versus intra-articular steroid injection in adhesive capsulitis of shoulder: A randomized control trial
Davinder Kumar Verma1, Osama Neyaz1, Srishti Nanda2, Gita Handa3
1 Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Rishikesh, Uttarakhand, India
2 Department of Physiology, All India Institute of Medical Sciences, New Delhi, India
3 Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, New Delhi, India
Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Virbhadra Road, Rishikesh - 249 203, Uttarakhand
Source of Support: None, Conflict of Interest: None
Background: Adhesive capsulitis (AC) is the most common cause of shoulder pain in India. There is little consensus regarding the optimal course of treatment for AC. The aim of the present study was to compare the effectiveness of ultrasound-guided suprascapular nerve block (USNB) with intra-articular steroid injection (IASI) in AC of shoulder in providing pain relief, functional improvement, and reduction of disabilities.
Settings and Design: A prospective randomized control trial at a tertiary care hospital compared a single dose of IASI with USNB in patients having shoulder pain and stiffness secondary to AC of ≥12 weeks' duration, visiting Outpatient Department of Physical Medicine and Rehabilitation.
Materials and Methods: Patients in the first group were given IASI (2 ml of 40 mg/ml triamcinolone) while in the other group received USNB (4 ml of 0.5% injection bupivacaine). Home-based therapeutic exercise program for AC was advised for both the groups. The outcome measures were the Shoulder Pain and Disability Index (SPADI) and passive range of motion (ROM) (flexion, abduction, and external rotation) of the affected shoulder. Follow-up was done at 1-week, 3-week, and 6-week time-points.
Results: Both domains of SPADI (pain score and disability score) and passive shoulder ROM significantly improved (P < 0.05) within both the groups at 1-week, 3-week, and 6-week follow-ups as compared to baseline. However, no statistically significant differences were found between the two groups at baseline or at follow-up (P > 0.05).
Conclusion: Suprascapular nerve block is comparable in efficacy to IASI in patient with AC.
Keywords: Adhesive capsulitis of the shoulder, intra-articular injection, nerve block, shoulder pain
|How to cite this URL:|
Verma DK, Neyaz O, Nanda S, Handa G. Comparison of outcome of ultrasound-guided suprascapular nerve block versus intra-articular steroid injection in adhesive capsulitis of shoulder: A randomized control trial. Indian J Rheumatol [Epub ahead of print] [cited 2019 Jun 26]. Available from: http://www.indianjrheumatol.com/preprintarticle.asp?id=259717
| Introduction|| |
Shoulder complaint is the third most common musculoskeletal problem with 6.7%–66.7% lifetime prevalence, whereas adhesive capsulitis (AC) of shoulder is the most common cause of shoulder pain in India. The American Shoulder and Elbow Surgeons defines AC as “a condition of uncertain etiology characterized by significant restriction of both active and passive shoulder motion that occurs in the absence of a known intrinsic shoulder disorder.” The most frequent systemic predisposing factor causing AC is diabetes mellitus with a prevalence of 20% in India. However, the underlying pathology and precipitating factors are largely unknown.
At present, there is no consensus regarding the best treatment for AC. Different treatments such as oral analgesics, physiotherapy, oral and intra-articular corticosteroid injections, hydrodilatation, manipulation of the shoulder joint under general anesthesia, and surgical capsular release have been described in the literature. Intra-articular steroid injections (IASIs) along with physiotherapy are an effective treatment option and provide faster pain relief and earlier improvement of shoulder function and range of motion (ROM) in patients with AC. Suprascapular nerve block (SSNB) is also a safe and well-tolerated treatment option for the treatment of AC. It is effective in reducing pain severity and functional disability and hence improves quality of life of the patients with AC., There is a paucity of studies to establish its efficacy in the treatment of AC of shoulder. Therefore, a randomized trial was designed to compare effectiveness of ultrasound-guided SSNB (USNB) versus IASI in AC of shoulder in providing pain relief, functional improvement, and reduction of disabilities.
SSNB is similar in efficacy to IASI in patient with AC.
| Materials and Methods|| |
The study was designed as prospective randomized control trial comparing single dose of 2 ml of 40 mg/ml triamcinolone acetonide intra-articular injection with USNB with 0.5% bupivacaine injection followed by home exercise program in both the groups.
Settings and participants
This study has been conducted at the Physical Medicine and Rehabilitation (PMR) department at a tertiary care hospital. Inclusion criteria: patients of either sex aged between 35 and 75 years who were attending outpatient at PMR department with the complaint of shoulder pain and stiffness persisting ≥12 weeks were recruited. Patients who had received conservative management of pain with no relief from symptoms for at least 2 weeks were screened for eligibility. Exclusion criteria: shoulder pain due to secondary causes, e.g., acute trauma, fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology, and rotator cuff disorder and patients with known contraindications for block interventions, e.g., bleeding disorder, acute and chronic infection, and also individual having comorbid conditions such as uncontrolled diabetes, chronic renal failure, thyroid diseases, coronary artery disease, stroke, and connective tissue disorders were excluded from the study.
The diagnosis was made by thorough history and clinical examination of each shoulder. Active and passive ROM were measured using a goniometer by a PMR specialist and the shoulder pain was assessed with a numerical visual analog scale (VAS) 0–100, in which 0 presents no pain and 100 represents the worst pain in each participant. Plain radiograph of shoulder anterior-posterior and lateral view, routine blood investigation (complete blood count, erythrocyte sedimentation rate, blood sugar fasting, and postprandial), and ultrasound of affected shoulder was obtained.
One group was given 2 ml intra-articular injection of 40 mg/ml triamcinolone through posterior approach, and the other group USNB with 4 ml of 0.5% injection bupivacaine was given. Patients in both the groups were advised local ice fomentation at the injection site and regular therapeutic exercises for AC. No analgesics were prescribed postinjection in both groups of patients. Both groups were provided with a home exercise program (pendulum exercise, crossover arm stretch, passive internal and external rotation, and sleeper stretch) postintervention.
Intra-articular steroid injection technique group
All the injections were performed by one PMR specialist with 15 years' experience in his field. Two milliliters of 40 mg/ml triamcinolone acetonide was injected intra-articular into shoulder through posterior approach, using traditional posterior arthroscopic portal landmarks using a 24G 1½ inch needle. When in the right direction, the needle faces slight resistance on entering the joint. If the physician felt that the needle is not in the accurate plane, he was allowed to withdraw and reposition the needle. After entering the joint, a negative aspiration was done and the plunger pushed slowly with consistent pressure. After intra-articular injection, patients were advised to perform ROM exercise of shoulder within the pain-free range.
Ultrasound-guided suprascapular nerve block technique group
Ultrasound-guided block was given by a radiologist having 13 years of experience in the field of interventional radiology. Under aseptic precaution, real-time ultrasonography was performed with a 6–13 MHz linear-array ultrasound transducer (MyLab One Esaote, Netherland). A 23G spinal needle was inserted in longitudinal axis of the ultrasound beam to localize the tip of needle at the notch. Once needle was positioned, SSNB was given using 4 ml of 0.5% bupivacaine [Figure 1] and [Figure 2]. Steroid was not added in this injection. The success of procedure was confirmed as an immediate improvement in active ROM of the affected shoulder due to pain relief (due to capsular analgesia).
|Figure 1: Transverse view of suprascapular fossa and scapular notch with ultrasound|
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|Figure 2: Image of needle tip for the ultrasound-guided suprascapular block|
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The primary outcome measures were the Shoulder Pain and Disability Index (SPADI) and passive ROM of affected shoulder.
SPADI contains 13 items that assess two domains – a five-item subscale that measures pain and an eight-item subscale that measures disability. Each subscale scored 100 ranging from 0 (best) to 100 (worst). It is a self-administered, valid questionnaire, and also available in common domain without any restriction, for patients with shoulder pain due to musculoskeletal pathology. It was translated into local (Hindi) language before use, by a linguist expert.
Passive shoulder flexion, abduction, and external rotation were measured using goniometer. The outcome measures were assessed at baseline and subsequently at the 1st week, 3rd week, and 6th week follow-up postintervention. Postintervention effects have been reported as differences in the outcome measures with respect to baseline.
Sample size calculation
An Apriori sample size calculation was done assuming 90% power of the study at 5% level of significance and the SPADI mean (standard deviation) percentage change in 6 weeks in SSNB as 21.2 (25) and in IASI as 56 (50), and the required sample size for measuring effect was 30 participants in each group. Considering 10% dropout, the final sample size was 35 each group. Total sample size was 70.
Randomization and blinding
Patients were allocated into two study groups by computer-generated block randomized sequence, with 35 samples each. The allocation was concealed using opaque, sealed envelopes. The recruitment, outcome measurement, and statistical analysis were done by investigators who were not aware of the allocated treatment.
An intention-to-treat analysis was conducted to describe patients with AC managed with SSNB in comparison to IASI. Data were checked for normal distribution using Shapiro–Wilcoxon test. Effect of therapy on continuous variables was analyzed between the two therapy arms using Mann–Whitney U-test and within therapy arms using Friedman test followed by Bonferroni test for post hoc comparisons. Categorical variables were analyzed using Chi-squared test. All analysis was done using Origin(Pro), Version 8.5 (OriginLab Corporations, Northampton, MA, USA) keeping the level of significance at 5%. Data have been presented as Median (25th quartile and 75th quartile).
The protocol of this study was approved by the institutional ethics committee (IESC/T-88/25.02.2015, RT-11/22.07.2015, dated 22.07, 2017). Written informed consent was obtained from all the participants.
| Results|| |
Seventy patients with AC were recruited after screening 120 possible participants from August 2015 to July 2017. The mean age of the participants was 52.90 ± 8.65 with a range of 39–72 years. Thirty-four participants were females and 36 were males, in 37 (52%) the right-sided shoulder was affected while in 33 (47%) the left-sided shoulder was affected. Participants reported an average duration onset of symptoms 4.5 ± 1.6 months with a range of 3–12 months. Diabetes mellitus was associated with 31 (44%) patients.
At randomization, the baseline variables of both groups such as age, gender, marital status, duration of symptoms, laterality of symptoms, diabetes, and baseline shoulder pain intensity were comparable [Table 1] and [Table 2].
|Table 2: Comparison of pain intensity at baseline, 1-week, 3-week, and 6-week follow-up|
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Sixty-three (90%) patients received intervention and 60 (86%) patients completed follow-up. All patients tolerated the interventions well and described the pain as “pinprick” with a mild level of pain (average = 37.5 ± 7.8). Two participants in SSNB and one participant in IASI group reported a moderate level of pain (pain intensity of “50,” “55,” and “60”) continued to participate in the study. Standard care instructions and procedure were recommended for the pain. The tenderness at the site of injection resolved between 24 and 48 h postinjection.
Seven participants dropped-out without any specified reasons. A consort flow chart for the study participants is depicted in [Figure 3].
A univariate analysis of shoulder pain intensity showed significant improvement in VAS within the IASI group and the SSNB group at 1-week, 3-week, and 6-week follow-up as compare to baseline. However, no statistically significant difference in the improvement was observed between the IASI group and the SSNB group at 1-week, 3-week, and 6-week follow-up [Table 2].
Both domains of SPADI (pain score and disability score) significantly improved within the IASI group and the SSNB group at follow-ups as compared to baseline. However, intergroup difference in the improvement was not statistically significant at follow-ups [Table 3].
|Table 3: Comparison of the Shoulder Pain and Disability Index at baseline, 1-week, 3-week, and 6-week follow-up|
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All three shoulder ROM (flexion, abduction, and external rotation) showed significant improvement in range within the IASI group and the SSNB group at 1-week, 3-week, and 6-week follow-up as compared to baseline. However, no statistically significant difference in the improvement was observed between the IASI group and the SSNB group at 1-week, 3-week, and 6-week follow-up [Table 4].
|Table 4: Comparison of passive range of motion at baseline, 1-week, 3-week, and 6-week follow-up|
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No serious adverse event was observed in both groups. Three participants reported nonserious side effect mostly related to increased pain for initial few days.
| Discussion|| |
In this clinical trial, we found equal efficiency of IASI with the ultrasound-guided local anesthetic injection around suprascapular nerve in AC in terms of pain relief, improvement in function, and passive ROM of the affected shoulder. The effect was prolonged and sustained even at the 6th week of follow-up. Diabetes mellitus was the most commonly associated comorbidity.
Taskaynatan et al. compared the efficacy of single IASI injection with SSNB in cases of AC of the shoulder. Result showed improvement in shoulder pain, disability, and ROM in both the groups at 4-week follow-up, and no method was found superior to each other. In a similar prospective clinical study, Teja and Banshiwal injected local anesthetic agent to block suprascapular nerve and compared its effect with IASI in AC of shoulder and found significant improvement in pain, restriction of movement, and SPADI scores at 4-week follow-up. Ozkan et al. reported that SSNB with mixture of 40 mg methylprednisolone acetate and 5 mL 1% lidocaine in patients with frozen shoulder and diabetes mellitus unresponsive to IASIs provides significant reduction in pain and improvement in range of movements at 12 weeks. The results of the present study are in line with the existing literature.
SSNB is a safe and effective option for the management of AC and it can be easily performed at outpatient basis. SSNB is also preferred over other therapeutic options such as anti-inflammatory drugs and IASIs, especially in elderly population who have many comorbidities such as diabetes as SSNB has lesser side effects.
It may be noted that the pain relief from the regional anesthetic block extends beyond the pharmacological blocking effect. A possible explanation could be that reduced peripheral inputs could decrease in the central sensitization of postsynaptic dorsal horn nociceptive neurons of the spinal cord. A depletion of substancePand nerve growth factor in the synovium and afferent C fibers of the glenohumeral joint after the blockade may also contribute to the long-term relief. Further, a transient reduction in the local sensitization could enable participants to have a better compliance with the recommended exercises, which have a known therapeutic effect. However, the relations between motor function, pain-associated disability, and pain are multidirectional and complex in nature and require more investigations.
The limitations of the study were that the participants could not have been blinded to the allocated treatment. The strengths of the study were use of appropriate methodology and statistics, successful implementation of blinding and allocation, low number of dropouts, and loss to follow-up.
| Conclusion|| |
Both IASI and SSNB interventions are effective in the management of AC, and efficacy of both is more or less similar in relieving shoulder pain, functional disability, and improving ROM in the management of AC.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]