| CTRI Number |
CTRI/2022/01/039823 [Registered on: 28/01/2022] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nerve Block] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study on Nerve Blocks in Frozen Shoulder |
|
Scientific Title of Study
|
Ultrasound-guided Suprascapular Nerve Block with Subacromial Injection versus Suprascapular Nerve Block alone in Adhesive Capsulitis of Shoulder: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Mishra |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of PMR
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
09871925596 |
| Fax |
|
| Email |
drm.shalini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Mishra |
| Designation |
Student |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of PMR
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
09871925596 |
| Fax |
|
| Email |
drm.shalini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raj Kumar Yadav |
| Designation |
Associate Professor and Head |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of PMR
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
08800264547 |
| Fax |
|
| Email |
rajky4u@yahoo.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
AIIMS |
| Address |
Rishikesh
Uttarakhand |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalini Mishra |
AIIMS Rishikesh |
Room No 22,
Department of PMR,
AIIMS Rishikesh
Dehradun
UTTARANCHAL |
9871925596
drm.shalini@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Rishikesh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Suprascapular nerve block alone |
Ultrasound guided SSNB will be given under real time ultrasonography with a 5–14 MHz linear array ultrasound transducer system (MyLab Six esaote) With the patient in the sitting position the ultrasound probe is placed horizontal to the scapular spine and the supraspinous fossa is checked by moving the probe anteriorly. The suprascapular notch will be found by slowly locating the probe laterally. The pulsating suprascapular artery is found on color doppler ultrasound and is a good indicator for the location of suprascapular nerve. After disinfecting the superior cutaneous area of the probe with betadine, a 23G spinal needle will be inserted in longitudinal axis of the ultrasound beam to localize the tip of needle at the suprascapular notch. Once needle will be positioned, SSNB will be given using 4 ml of 0.5% bupivacaine. Steroid will not be added in this injection. After administration of the injection, we will examine for intactness of the motor and sensory activities of the ipsilateral arm The success of procedure will be confirmed as an immediate improvement in active ROM of the affected shoulder due to pain relief. |
| Intervention |
Suprascapular nerve block with subacromial injection |
Ultrasound guided SSNB will be given in same way as in group one i.e. 4ml of 0.5% bupivacaine by 23 G spinal needle. SA injection will be achieved as follows: The patient will be kept in a sitting position with the arm behind the back [Crass position]. A high-frequency linear ultrasound transducer (5-14MHz linear probe, MyLab Six esaote system) will be applied anterior to the acromion, and beside the coracoid process. The supraspinatus under the deltoid muscle will be identified in the longitudinal sagittal plane. After disinfecting the superior cutaneous area of the probe with betadine, a 2 ml mixture containing 1 ml triamcinolone and 1% lidocaine (1 ml) will be injected from superior to inferior using the in-plane technique. The target point of the injection will be the bursal space between the supraspinatus and the deltoid muscle. During the injection, we continuously monitored the successful spread of the injected fluid just above the supraspinatus, and not within the tendon. After administration of the injection, we will examine for intactness of the motor and sensory activities of the ipsilateral arm. The success of procedure will be confirmed as an immediate improvement in active ROM of the affected shoulder due to pain relief. |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Pain in the shoulder joint with stiffness more than 3 months duration
2. Had taken at least 2 weeks of conservative management for pain with no relief from symptoms
3. Patients who are willing to come for follow up |
|
| ExclusionCriteria |
| Details |
1. Shoulder pain due to acute trauma fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder etc
2. Bleeding disorder, acute and chronic infection, or any other contraindication for injection
3. Patients who are sensitive to bupivacaine
4. Having co-morbid conditions like uncontrolled diabetes, chronic renal failure, thyroid diseases, coronary artery disease, stroke, connective tissue disorders etc
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Shoulder pain in terms of SPADI (Shoulder Pain and Disability Index) and NPRS (Numerical Pain Rating Scale) measurements |
Baseline, 0, 1, 3 and, 6 weeks after intervention |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Passive range of motion of affected shoulder |
Baseline, 0, 1, 3 and, 6 weeks after intervention |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
• Introduction: Adhesive capsulitis of Shoulder (ACS) is characterized by painful, gradual loss of motion due to capsular fibrosis and contracture. The prevalence is 2–5% and managed with many modalities like Supra-scapular nerve block (SSNB), Sub-acromial injection (SAI),Intra-articular injection (IAI) & Hydro-dissection (HD) etcPurpose: is adding SAI with SSNB is beneficial or not? • Problem: There is a scanty evidence to support or refute the superiority of one modality of treatment over the other • Null Hypothesis: In treatment of ACS, The SSNB with SAI is equally effective with SSNB alone Aim •To compare the outcome of ultrasound-guided SSNB with SAI and SSNB alone in ACS Objectives -Primary objectives: • pain relief (Numeric Pain Rating Scale-NPRS) • functional improvement (Shoulder Pain and Disability Index –SPADI) -Secondary objective: •Passive ROM ( Range of Motion) of affected shoulder Study population: The recently diagnosed patients of ACS at AIIMS, Rishikesh Inclusion Criteria •Patients (male or female) between 35 to 75 years of age •Conservative management of at least 2 weeks with no improvement Exclusion Criteria •Shoulder pain due to acute trauma fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder etc •Having comorbid conditions like uncontrolled diabetes, chronic renal failure, thyroid diseases, coronary artery disease, stroke, connective tissue disorders etc Study duration: Two years Study design: Randomized Control study Sample Size: Using G power 3.1,an Apriori sample size calculation was done assuming 95% power of the study at 5% level of significance and the SPADI mean (standard deviation) percentage change in 6 weeks in SSNB 3.84(1.15) and in IASI 6.15 (2.69) with effect size of 1.116 and the required sample size for calculated effect sizeis22 participants in each group. Considering 10% dropout, the final sample size is 25 in each group. Total sample size is 50. Data will be checked for normal distribution using Shapiro– Wilcoxon test. Effect of therapy on continuous variables will be 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 will be analyzed using Chi�’squared test. The level of significance will be kept at 5% |