Effect of Ultrasound-guided Hypertonic Dextrose Prolotherapy on Functional Outcomes in Patients with Rotator Cuff Pathology

Chronic shoulder pain is one of the common upper extremity musculoskeletal disorders frequently seen in outpatient and orthopaedic clinics. Among the numerous causes of chronic shoulder pain, Rotator cuff pathology is the most common, particularly over the 30 years of age. Corticosteroid injections in shoulder area are conventionally used to decrease pain and improve functional outcome in rotator cuff lesions. They suppress inflammation and help reducing pain but these injections have adverse outcomes on tendon repair and natural healing. They have side effects such as tendon weakening or rupture, skin hypopigmentation, sub cutaneous fat atrophy, severe allergic reaction and systemic steroid exposure. In our study, we will be giving hypertonic dextrose injections, which promote natural healing of the tissues and is devoid of known side effects associated with corticosteroids. Dextrose prolotherapy involves injection of small volumes of an irritant solution , most commonly hypertonic dextrose , into painful or degenerated tendon and ligament insertions. We will give three sessions at 2 weeks intervals, to promotes natural healing during the course of time. In this study, we are evaluating the efficacy of hypertonic dextrose injections (12.5%) in improving functional outcomes in various rotator cuff pathologies, under the guidance of ultrasound for enhancing the precision of point of injection.

Aim

To observe the effectiveness of ultrasound guided hypertonic dextrose prolotherapy injections on functional outcomes in patients with rotator cuff pathology

Objectives

1. To observe the effectiveness of dextrose prolotherapy sessions on improvement of pain and reduction in disability in activities of daily living as measured by Shoulder pain and disability index (SPADI) score in patients with rotator cuff pathology.

2. To observe the improvement in active range of motion (AROM) as measured by goniometer after three dextrose prolotherapy sessions

3. To observe the  improvement in patient satisfaction outcomes achieved after three dextrose prolotherapy sessions using five point Likert scale.

4. To observe the analgesic efficacy of dextrose prolotherapy using visual analogue scale (VAS).

5. To observe the improvement in muscle strength after administering 3 dextrose prolotherapy sessions, using medical research council scale (MRC).

6. To record any adverse events peri and post intervention.

Methodology

In this study we will do screening and a pre intervention checkup will be done. Patient will be shifted to interventional pain room in the operation theatre complex , intravenous access will be secured for any emergency drugs, vital monitoring will be done according to the standard ASA guidelines. The procedure is guided via using the ultrasound imaging.Local anaesthesia will be given at the site of needle insertion and may require conscious sedation. The desired skin will be prepared aseptically with 10 percent povidone iodine solution .All ultrasound images and subsequent injection therapy will be performed by same experienced pain interventionist. A high frequency linear ultrasound probe (5-10 MHz) will be positioned to obtain the desired view of the affected shoulder joint as per ASAP protocol. Under ultrasound guidance , the hypoechoic (tendinosis, bursitis) and/or hypo echoic with anechoic focus/cleft (partial thickness tear) will be identified as the pathology. After obtaining the desired ultrasound image of the affected area, local infiltration with maximum of 2 ml of 2 percent preservative free lignocaine hydrochloride will be given at the entry site and the intended tract using 26-gauge needle (0.5 mm length) and 22-guage stimuplex A needle will be advanced in-plane under ultrasound to the target. At each affected site (hypo echoic/ anechoic site of the tendon) after obtaining the long/short axis view, dry needling of the area of tendinosis was performed with 22-guage stimuplex A needle prior to the peri- and/or intra-tendinous and corresponding bursa injection of the prolotherapy solution. Following dry needling, maximum of 2 ml of prolotherapy solution ( 1 ml 25 percent dextrose and 1 ml of 1 percent lignocaine will be injected following negative aspiration each site. multiple sites may be injected , with total volume ranging from 2-20 ml. After completion of procedure , the needle will be withdrawn and a sterile dressing will be applied. Following the procedure, patient will be kept supine in the recovery room for 30 minutes with continuous monitoring of vitals. Patients will be given post procedural written instructions about analgesia and home exercises to be done.Shoulder pain and disability index (SPADI), Active Range of motion (AROM), overall shoulder satisfaction by Likert scale, VAS-week and average number of rescue analgesia will be assessed 1, 2 and 3 months after third prolotherapy session. We will also assess muscle strength by MRC grading scale prior to first and then at 3 months, after third prolotherapy session. Any adverse events peri intervention and post- intervention will be recorded.