Comparative Study Between Ultrasound guided Shoulder Intraarticular Corticosteroid versus Suprascapular Nerve Block With 5 percent Dextrose versus Steroid with Physical Exercises in Grade II and III Adhesive Capsulitis

1 Proposed Topic of Research

Comparative Study between Ultrasound Guided Shoulder Intraarticular Corticosteroid versus Suprascapular Nerve Block with 5 percent Dextrose versus Steroid with Physical Exercises for Grade II & Grade III Adhesive Capsulitis

2 Objective of Research

General Objective

To evaluate and compare the effectiveness of intra-articular corticosteroid suprascapular nerve

block with corticosteroid and suprascapular nerve block with 5 percent dextrose in managing pain

and disability in patients with Grade II and III periarthritis of the shoulder

Specific Objectives

Primary Objective

To assess the change in shoulder pain intensity using the Visual Analogue Scale (VAS) following the interventions.

Secondary Objectives

1 To assess functional improvement using the Shoulder Pain and Disability Index SPADI.

2 To compare the duration of clinical improvement over a 12 week follow up.

To determine how long the intervention effects last.

3 To identify and evaluate any adverse effects resulting from the intervention.

Evaluate the outcomes of GRADE II and GRADE III ADHESIVE CAPSULITIS patients.

3 Research hypothesis

The null hypothesis H0 states that the novel interventions suprascapular nerve block with steroid and 5 percent dextrose injection—are not clinically equivalent to the standard intra articular steroid injection in terms of pain reduction measured by the Visual Analogue Scale VAS.

The alternative hypothesis H1 is that these novel interventions are clinically equivalent to intra-articular steroid injection. Equivalence will be defined as a between group difference in mean VAS score change that lies within the pre-specified equivalence margin of 1.37 units which is considered the minimum clinically important difference MCID for this population.

Methodology

Study Design

This is a prospective randomized single blind three arm equivalence trial a tertiary care academic hospital in India.

Place of Study NIL RATAN SIRCAR MEDICAL COLLEGE and HOSPITAL PMR Dept OPD and IPD

Period Of Study 18 months preparatory 2 months

Enrollment  12 months

Analysis    4 months

Post procedure assessment at  1 4 and 12 weeks

Study Population Patients with shoulder pain for at least 3 months attending OPD of the Department of PMR, NRS Medical College & Hospital willing to join the study after fulfil the eligibility criteria.

Sample Size

Participants will be allocated in a 1 1 1 ratio to one of three intervention groups

Group 1 Intra articular IA corticosteroid

Group 2 SSNB with 5percent dextrose

Group 3 Suprascapular nerve block SSNB with corticosteroid

The IA corticosteroid Group 1 is considered the reference intervention.

Total Sample Size 64 in each group

total sample size  192 participants

Eligibility Criteria

Inclusion Criteria

Those who can willing to give consent

Age between 18 and 65 years

Pain for at least 3 months

VAS at least 5

Clinical diagnosis of periadhesive capsulitis with restricted active and passive range of motion in external rotation.

Inadequate response to conventional treatment

Exclusion Criteria

Intra articular injection or surgery on the affected shoulder within past 6 months

Full thickness rotator cuff tear advanced AC GH arthritis

Hemiplegic shoulder pain

Rheumatoid or other systemic inflammatory arthritis

Diabetes mellitus

Hypothyroidism

Complex regional pain syndrome

Known bleeding disorders or use of anticoagulants

Allergy to steroid lidocaine or dextrose

Local systemic infection

Cervical radiculopathy myelopathy

Pregnancy lactation

Immunocompromised state

h Variables studied

Pain VAS

SPADI pain

SPADI disability

SPADI total

i Data Collection & Interpretation

Data collection by filling pro forma clinical interviews physical examinations and required investigations and data will be filled up as per clinical scales taken in this study pre and post intervention.

Data interpretation will be done by using proper data analysis method to analyse the data obtained after classification of data in parametric and non parametric. If parametric ANOVA test if non parametric Kruskal Wallis test will be done.

Baseline 1 weeks 4 weeks and 12 weeks post-intervention

Data entered using Excel

l Laboratory investigation parameters and procedure Routine examinations X ray of shoulder joint AP view &lateral view .

Blood investigations FBS PPBS TSH FT4 CBC ESR CRP  BT CT PT INR HBSAg HCV HIV 1 and 2.

Randomization and blinding

Participants will be randomized using a computer-generated block randomization schedule block size  6 into one of the 3 treatment arms. Allocation concealment will be maintained through sequentially numbered opaque sealed envelopes prepared by personnel independent of the research team.

The trial will follow a double blind design participants clinical evaluators and data analysts will remain blinded to group allocation. Syringes will be masked with opaque covering to conceal the physical differences between injectates.

Intervention Procedures

Blinding

Ensuring that patients assessors and data analysts are unaware of group assignment

All injections will be performed under strict aseptic conditions and real-time ultrasound guidance by a qualified interventional physiatrist.

Group 1  1mL triamcinolone acetonide 40 mg per mL mixed with 2 mL of 1 percent lignocaine injection in glenohumeral joint

Group 2 5percent Dextrose Prolotherapy Participants will receive an ultrasound guided suprascapular nerve block with  using 10 mL of  dextrose solution.

Group 3 Steroid Injection Participants will receive an ultrasound guided SSNB using 1 mL triamcinolone acetonide 40 mg per mL mixed with 9 mL of 1 percent lignocaine totaling 10 mL.

Study Tools

Ultrasonography machine SAMSUNG SONOACER7 with 5 to 12 MHz Linear probe.

Position The patient will be in lateral decubitus position with the symptomatic side up and the patient facing the clinician. Spinoglenoid notch will be identified by scanning the inferior aspect of the spine of scapula from medial to lateral side. Glenohumeral joint intraarticular approach  by posterior approach . The posterior glenohumeral joint will be identified by sliding the tranducer laterally from the position of spinoglenoid notch

Probe linear 5 to 12 hz

Needle 23 G

Injection Technique

A high frequency linear ultrasound probe 5 to 12 MHz will be used to identify the suprascapular notch in the transverse oblique plane. The suprascapular nerve and artery will be visualized, and a 22-gauge spinal needle will be advanced using an in-plane, lateral to medial approach. Correct placement will be confirmed by visualizing spread of injectate around the nerve avoiding intraneural infiltration.

Post-procedure Care

Steroid Group Participants will be advised to apply cold compresses three times daily and to use paracetamol 500 mg as needed up to a maximum of 2000 mg per day for pain relief. They will be informed of common steroid related adverse effects and instructed to report any new or worsening symptoms. Use of other analgesics including NSAIDs will be restricted.

Dextrose Group Participants will be informed that mild post injection pain may be expected due to the inflammatory mechanism of prolotherapy. They will be advised to avoid ice packs and NSAIDs. Use of paracetamol 500 mg as needed maximum 2000 mg day will be permitted along with heat therapy and cold compress. Participants will be advised to avoid strenuous shoulder activity for 48 hours post injection and to record any medication or side effects in diary. Adverse effect to be monitored and managed .

For intraarticular corticosteroid injection posterior approach under ultrasound guidance taken targetting glenohumeral joint space

Parameter

Outcome Measures

Primary Outcome

Change in pain intensity as measured by the Visual Analogue Scale VAS 0 to 10 at rest and during activity at baseline 1 week 4 weeks and 12 weeks post intervention. A reduction of more than 1.8 points in VAS will be considered clinically meaningful.

Secondary Outcome

Functional improvement will be assessed using the Shoulder Pain and Disability Index SPADI total score including pain and disability domains at the same time points.

Statistical Analysis

All data will be analyzed using R. The primary outcome VAS score and secondary outcomes SPADI domains will be assessed for normality using the Shapiro Wilk test. Based on the distribution of the data appropriate parametric or non parametric equivalence analyses will be applied.