Protocol / Summary

Title: Efficacy of Ultrasound guided intra articular steroid injection with and without capsular hydro distension in cases of adhesive capsulitis of shoulder joint – A randomized control study.

Introduction:

             Frozen shoulder is a painful condition with gradual onset and loss of range of motion in the glenohumeral joint. Intra-articular injections are commonly used for diagnostic and therapeutic purposes in orthopedics. Injections of local anesthetics into the joint are used in the ambulatory setting to determine and distinguish sources of pain. Combinations of local anesthetic and corticosteroid are often used to treat symptoms related to inflammatory and degenerative arthritis and have been reported to improve pain scores, range of motion and clinical outcome in cases of early adhesive capsulitis.

 Type of study: Randomized control study.

Aims & objectives :

Primary aim:

 To compare the efficacies of ultrasound-guided intra articular steroid injection with and without capsular hydro distension in cases of adhesive capsulitis of shoulder joint.

Secondary aims:

Correlation of the following radiological imaging factors with clinical outcome

-         Static parameters

1. Coraco humeral ligament thickness.

2. Vascularity at rotator interval.

3. Soft tissue thickening around the rotator interval

4. Fluid along the long head of biceps tendon.

-         Dynamic parameter : Sub-acromial gliding scale

5. Justification for study : Intra articular injections have been a time tested method of treatment in cases of adhesive capsulitis and have been routinely practiced as a standard of care in our hospital. Distension of capsule with fluid (hydro-distension) has proven to be of additional benefit in frozen shoulder to accelerate adhesiolysis . We intend to assess the efficacy of hydro-distension through this study.

In this study, we shall be providing the basic standard of care for all the patients (i.e. intra-articular steroid injection with bupivacaine as local anesthetic), with randomization being performed only with respect to the degree of capsular distension. There shall be no change in the dose of the steroid injected in both groups. The cost of the procedure in both groups shall remain the same as no additional drugs are being used.

 Departments involved: Department of Radio diagnosis and Imaging, Department of Orthopedics.

Study period: January 2017 to December 2018.

Sample size : 49 per group . 2 such groups - A total of 98.

Materials and methods:

 a) Ultrasonographic Equipment:   EPIQ 5 Philips (Philips Healthcare)

            b) Inclusion criteria:

1.     Patients between 18 - 80 years old

2.     Clinically suspected cases of adhesive capsulitis of shoulder.

    Exclusion criteria:

1.     Suspected infection of the shoulder joint.

2.     Bleeding diathesis.

3.     Full-thickness tear of rotator cuff tendon

4.     Joint capsular defect

5.     Musculoskeletal trauma

6.     Superior shoulder impingement

7.     Patient refusal

            c) Biological materials required: Nil

            d) Statistical methods:

Detailed description of procedure:

Patients (N= 49 per group – 2 such groups – a total of 98) with adhesive capsulitis of shoulder.

Static and dynamic radiological parameters of adhesive capsulitis are recorded in both the shoulder joints initially.

Subjects will be assigned to 2 groups after block randomization.

Patients in group A will be treated with 2ml of 80mg Depo-Medrol (methylprednisolone acetate) with 2-4 ml of 0.25% Bupivacaine – without distension of the shoulder joint

Patients in group B were treated with 2ml of 80mg Depo-Medrol (methylprednisolone acetate) with 12-16 ml of 0.25% Bupivacaine with capsular distension.

Outcome measures: Treatment effects will be assessed using the Shoulder Pain and Disability Index (SPADI), before injection and at 6 weeks after the injection.

Treatment effects will be assessed using Shoulder Pain and Disability Index (SPADI), Static and dynamic radiological parameters, the passive range of motion (ROM) of the shoulder (flexion, abduction, external rotation)

 At 12 weeks after the injections.

Potential risks and benefits: Improvement in the range of movement of the affected shoulder with reduction in the pain.

Ethical considerations and methods to address issues : The patients of adhesive capsulitis undergoing a time-tested procedure of intra articular steroid and local anesthetic injection - with a known set of risks and benefits. Additional capsular distension for the study poses no added risk to the patient.

Randomization would be performed only for distension and non-distension of the shoulder joint capsule, whereas all patients would receive the standard treatment of care.

Review of literature:

                Ki Deok Park MD, Hee-Seung Nam MD et al conducted a study bearing title - Treatment Effects of Ultrasound-Guided Capsular Distension with Hyaluronic Acid in Adhesive Capsulitis of the Shoulder during June 1, 2010 to May 31, 2011.

Subjects were randomly assigned to 2 groups: 45 patients in group A were treated with 0.5% lidocaine plus triamcinolone 40mg IA injection and 45 patients in group B were treated with 0.5% lidocaine plus hyaluronic acid 20mg and capsular distension. All injections were performed every 2 weeks for a total of 3 times.

The statistical differences were not observed in SPADI and VNS between groups (P <.05), and shoulder passive external rotation was more improved in group B than in group A (P <.05).

Ahn JK  et al conducted a study with title Effects of Ultrasound-guided intra-articular ketorolac injection with capsular distension. Between January 2009 and December 2012 with 121 patients, found greater improvement in a matter of range of motion in patients receiving Intra-articular ketorolac injection with capsular distension than participants receiving US-guided Intra-articular steroid injection alone. More improvement was noted in passive abduction and external rotation than steroid injection alone.