Musculoskelet Surg (2013) 97 (Suppl 1):S49–S56 Ultrasound-guided subacromial injections of sodium hyaluronatefor the management of rotator cuff tendinopathy: a prospectivecomparative study with rehabilitation therapy G. Merolla • P. Bianchi • G. Porcellini Received: 20 December 2012 / Accepted: 3 March 2013 / Published online: 21 April 2013Ó Istituto Ortopedico Rizzoli 2013 Reduction in overall pain in the HA group was Rotator cuff (RC) tendinopathy is a common statistically significant at week 2 (p 0.05) week 4 (p cause of pain and shoulder dysfunction. The literature evi- 0.05), week 12 comparing to baseline. Similarly, pain sub- dence suggests that a combination of overuse and extrinsic scores (at night and with activity) were significantly lower compression may induce chronic RC tendinopathy. Aim of at week 2 (p 0.05), week 4 (p 0.05), and week 12 the current study was to compare the results of subacromial (p 0.05), respectively. In the Physio group, pain decreased sodium hyaluronate injections with rehabilitation therapy.
significantly at week 2 (p 0.05) but not maintained at week Materials and methods We enrolled 48 patients (M/F: 4 (p [ 0.05), week 12 (p [ 0.05), and week 24 (p [ 0.05). CS 26/22; mean age: 50 years; shoulder right/left: 29/19) with and OSS in the HA group increased significantly at week 2 persistent shoulder pain for at least 4 months. Exclusion cri- (p 0.05), week 4 (p 0.05), and week 12 (p 0.05). A teria were as follows: RC tear, calcifying tendinitis, gleno- non-statistically significant increase in clinical scores was found at week 24 (p [ 0.05). A significant improvement of CS physical therapy and/or injection in the previous 4 months, and OSS we found in the Physio group at week 2 (p 0.05), shoulder surgery, anesthetic nerve block, trauma, and severe but not at weeks 4, 12, and 24 (p [ 0.05).
medical diseases. The included subjects received either two Subacromial HA injections could be an ultrasound-guided subacromial hyaluronic acid (HA) injec- effective and safe alternative treatment for patients suffering tions (25 patients, HA group) at baseline and 14 days, or from RC tendinopathy. We believe that the results of this study underwent rehabilitation therapy (23 patients, Physio group) are encouraging but not lasting and we might suppose that a including active shoulder mobilization, soft tissue stretching series of three to four subacromial sodium hyaluronate injec- and humeral head positioner and propeller muscles strength- tions could provide good mid- and long-term clinical benefits.
ening for 30 days (3 sessions every week). Clinical assess-ment of shoulder function was performed with visual analog Shoulder  Injection  Sodium hyaluronate  scale score for pain (0–100), Oxford Shoulder Score (OSS), Rotator cuff  Tendinopathy and Constant–Murley Score (CS). Overall, patients wereexamined at baseline, week 2, week 4, week 12, and week 24.
Statistical significance was set at 5 % (p 0.05).
Rotator cuff (RC) tendinopathy is a common source of pain G. Merolla (&)  G. Porcellini and shoulder dysfunction that affects both the young and Unit of Shoulder and Elbow Surgery, D. Cervesi Hospital, older population [] mainly in arduous overhead workers Via L. V. Beethowen 46, Cattolica, Italye-mail: [email protected]; The available research findings emphasize the multi- factorial origin of RC tendinopathy that begins as a failurein the tendon fibers due to the overuse and cyclic loading on their internal side Under these conditions, the Department of Orthopedics, Traumatology, Rehabilitationand Plastic Surgery, Second University of Naples, Naples, Italy subunits of the RC tendons undergo internal compressive Musculoskelet Surg (2013) 97 (Suppl 1):S49–S56 forces which induce the development of fibrocartilage in or complete RC tears, calcifying tendinitis, previous these regions particularly, fibrocartilage develops on arthroscopic or open shoulder surgery, shoulder instability, the articular side of the supraspinatus tendon close to its infections or neoplasm, symptomatic cervical spine dis- insertion, where the articular fibers are subjected to less ease, rheumatoid arthritis or immune diseases, gout and strain than the non-articular side [, Fibrocartilage is uric acid diseases, severe medical conditions, or were less capable of withstanding tension load, and joint-side pregnant. Patients were also assessed for their mental status fibers have half the force of the bursal-side fibers and excluded if they presented with cognitive limitations Furthermore, the supraspinatus and infraspinatus are that could prevent them expressing a valid consent, or inserted into a cable located 1.5 cm from the humeral undergo subjective and objective evaluations. We also insertion of the fibers and the ‘‘crescent'' region is excluded subjects with known allergic or adverse reactions located between the cable and the humerus insertion where to previous nonsteroid or hyaluronan injections. All eval- the tendon fibers are thinner and close to the hypovascu- uations were performed by two experienced shoulder sur- larized region and therefore are more susceptible to geons. The diagnosis of RC tendinopathy was performed degeneration This evidence suggests that a combina- by trained musculoskeletal radiologists who depicted a tion of overuse and extrinsic compression may induce high tendon signal intensity that was anatomically intact on chronic RC tendinopathy. Conservative therapies, includ- the MRI in T2-weighted images. During the screening, 10 ing rehabilitation, physical therapies analgesics, and non- patients were excluded because they refused the treatment steroid anti-inflammatory drugs (NSAIDs), are commonly or failed to comply with the inclusion criteria. We allowed recommended to restore shoulder function in chronic RC a rescue medication of oral paracetamol at a maximum tendinopathy. Physiotherapy is based on the correction of dosage of 4 g/day, and the amount taken by each patient the flexibility, motion, and strength that are the cause of was recorded at the four follow-up visits. Withdrawal of painful shoulder []. Subacromial supplementation with rescue medication (paracetamol) 24 h prior to each follow- sodium hyaluronate or hyaluronic acid (HA) has been up visit was recommended by the assessor and confirmed proposed to treat RC dysfunction [due to its action as a by the patients during the examination. There were no lubricant [and suppressor of the joint inflammatory statistically significant differences between the two groups process ]. To our knowledge, no studies in the literature of treatment with respect to demographic characteristics at have compared physiotherapy and subacromial HA injec- baseline (Table ).
tion; therefore, the purpose of the current research was toassess the efficacy and safety of sodium hyaluronate Table 1 Demographic and anthropometric data of the population injection versus physiotherapy in a population of patients enrolled in the study with painful chronic RC tendinopathy.
Materials and methods Mean age (years ± SD) Mean height (cm ± SD) The study was approved by the Hospital Institutional Mean weight (kg ± SD) review board (Prot. 4232/2011/I.5/186), and all patients gave informed consent prior to enrollment. This was a prospective non-randomized comparative study involving a study population of 60 patients with RC tendinopathy aged Interval from symptoms from 47 to 53 years old, seen in the outpatient office of our to treatment (months) Shoulder and Elbow Unit between June 2010 and March Injection approach 2011 (Table ).
Patients were considered eligible for subacromial ther- apy if they were 18 years or older, had persistent shoulder pain for at least 4 months, clinical diagnosis of RC ten- dinopathy detected with MRI, no previous treatment with articular or subacromial steroid injections within the last 4 months, availability for the duration of the study. Patients were excluded if they refused to consent to such a proce- dure, had a positive history of shoulder trauma, partial SD standard deviation

Musculoskelet Surg (2013) 97 (Suppl 1):S49–S56 Fig. 1 Anatomical landmark with the two sites of injections drawn Fig. 2 The preparation is injected under ultrasound assistance taking for the anterolateral approach to the subacromial space care to direct the needle medially and posteriorly, on the insertionarea of the supraspinatus tendon (GIRD) and the coracoid base muscles tightness was We recruited an intent-to-treat population to be assigned to treated using open stretch in the supine position and rota- two treatment groups with the objective of gaining an tion stretch exercises with the scapula stabilized. Scapula improvement in the pain score of 4 points and in the control was obtained performing exercises for lower tra- Constant–Murley scale of 10 points. According to these pezius and serratus anterior with the arm below 90° parameters and a power value of 0.8, we had enrolled 50 abduction. RC activation exercises were allowed after a patients consecutively: the first half in the hyaluronic acid stable scapular base was established and included hori- group (HA group, N = 25) and the second half in the zontal and vertical closed-chain exercises, horizontal open- physiotherapy group (Physio group, N = 25).
chain exercises, and diagonal closed-chain exercises. Thefinal sequence was completed with open-chain plyometric The study material was a specific preparation (SportVisTM, Outcome measurements MDT Int'l SA, Switzerland), whose main content is aSTABHATM (Soft Tissue Adapted Biocompatible Hyalu- Primary outcome measurements were the visual analog ronic Acid) of 1 million of daltons contained in a pre-filled scale (VAS) for pain.
syringe (12 mg/1.2 ml).
Secondary outcomes measurements were the Constant– The procedure was performed in a standardized way in Murley scale (CS) ] and the Oxford Shoulder Score the outpatients' office with the patient in the upright (OSS) , the Patient Global Assessment (PGA), the position using local disinfection, sterile drape, and marking tolerability and any adverse events after each injection.
the site of injection (Fig. ). A shoulder surgeon (MG) with Pain included overall pain, pain at night, pain with 10 years of experience injected all the shoulders using an activity, and pain without activity and was rated subjec- ultrasound-guided anterolateral approach and the same GE tively on a scale ranging from 1 (no pain) to 10 (severe Logiq 7 ultrasound machine (7.5–14 MHz). We first pain). Patients were invited to write their average pain rate checked the tendon thickness and its superior limitant.
for the previous 48 h. The CS included a subjective ques- Subsequently, a 22G needle was introduced beneath the tionnaire for pain, the ability to perform daily living anterolateral acromial edge above the tendon (Fig. activity (DLA), an objective evaluation of active range of taking care not to overcome the superior limitant. The motion (ROM) and strength. Pain was scored on a 15-point preparation was injected allowing it to spread over the scale (0 severe pain, 15 no pain), while DLA was scored on superior tendon surface (Fig. a 20-point scale, with lower scores associated with greaterimpairment on DLA. ROM was measured using a standard goniometer between the upper arm and the upper part ofthe thorax. Shoulder strength was assessed using the We set a standard protocol of physiotherapy [] for Lafayette handheld dynamometer (Lafayette Instruments, 30 days, following three sessions a week. The loss of Lafayette, Ind, USA) that has a microprocessor with a flexibility due to the glenohumeral internal rotation deficit resolution of 0.4 lb (0.2 kg) in the range 0–50 pounds

Musculoskelet Surg (2013) 97 (Suppl 1):S49–S56 Table 2 Overall pain scores in the HA and Physio groups Data refer to mean ± SD values p values refer to analysis versus baseline Fig. 3 Ultrasound image showing the needle (red arrow) placed in Statistical analysis the subacromial bursa, on the superior limitant of the supraspinatustendon. The blue arrows emphasize the preparation that expanded Statistical analysis was performed using the Kruskal– above the tendon surface (color figure online) Wallis test for the equality of populations and the ANOVAtest for the variables, setting the significance at 5 %.
Bravais–Pearson correlation coefficient was calculated to (0–22.6 kg), 0.03 % accuracy with two calibration points: analyze the variability of the two independent observations.
0.25 and 50 lbs (0.11 and 22.6 kg). Data were recorded andanalyzed using SPSS version 10 software (SPSS Inc,Chicago, IL, USA). We assigned 1 point for each 0.5 kg of The OSS is a 12-item patient-reported outcome measure All the 25 patients with persistent shoulder pain due to RC specifically used for assessing the impact of RC tendin- tendinopathy considered for subacromial injection treat- opathy on the patient's quality of life. Each question on the ment with hyaluronic acid (HA group) from June to July OSS is scored 0–4, with 4 representing the best; the twelve 2010 completed the follow-up evaluations (Table ).
items are summed to produce overall scores ranging from 0 Among the 25 patients who were assigned to the phys- to 48. Interpreting the OSS: a score 0–19 indicates a severe iotherapy group (Physio group) from August to October shoulder condition, a score 20–29 indicates a moderate to 2010, two cases were excluded: one case because he severe shoulder condition, a score 30–39 indicates a mild refused to consent to the use of his data for research pur- to moderate shoulder condition, a score 40–48 may indicate poses at the time of the enrollment and one case due to a satisfactory shoulder function.
incomplete evaluation (lost at last follow-up examination)(Table Pain score and subscores Overall, patients were assessed immediately before thetreatment (baseline), at the time of the second injection In the HA group, we registered a remarkable decrease in (week 2), and subsequently at week 4, week 12, and week overall pain score from baseline to the week 2 (p 0.05), 24. The value of the subjective pain score was recorded by week 4 (p 005), and week 12 (p 0.05), and it was each patient using a printed analogic scale. Data were then always statistically significant. The pain reduction was entered on an electronic worksheet (Microsoft Excel for recorded at week 24, but no statistically significant dif- Mac OS 2011) which calculated the average values for pain ference was found (p [ 0.05) (Table ). Similarly, pain overall and relative subscores. CS and OSS were obtained subscores (at night and with activity) were significantly as the numeric sum of the subjective and objective evalu- lower compared with baseline values, respectively, at week ations using a dedicated electronic version of both scales 2 (p 0.05), week 4 (p 0.05), and week 12 (p 0.05), (that gave the final score at while at week 24, such reduction was maintained but not the end of the questionnaire. Overall clinical scores were statistically significant (p [ 0.05) (Table collected by two independent observers who had not per- In the Physio group at follow-up evaluation, we found formed the injections.
that pain decreased significantly at week 2 (p 0.05) while Musculoskelet Surg (2013) 97 (Suppl 1):S49–S56 Table 3 Pain with activity and pain at night in the HA and Physio groups Pain with activity Pain with activity Data refer to mean ± SD values p values refer to analysis versus baseline higher values were registered at week 4 (p [ 0.05), week be similar at week 2 and 4 in both groups, and higher from 12 (p [ 0.05), and week 24 (p [ 0.05) (Table ). Pain at the week 12 to the week 24 in the Physio group.
night and pain with activity had similar trend with a sig-nificant decreasing at week 2 (p 0.05) and persistent higher values at week 4 (p [ 0.05), week 12 (p [ 0.05),and week 24 (p [ 0.05) (Table ).
The CS showed no significant difference at baseline andweek 2 between the groups (p [ 0.05). There was a persis- Constant–Murley Score and Oxford Shoulder Score tently statistically significant higher score at week 4 andweek 12 in the HA group versus physiotherapy group The average values of CS and OSS in the HA group (p 0.05), and maintained at week 24 follow-up but without increased significantly comparing to baseline at week 2 statistical significance (p [ 0.05). The OSS in the two (p 0.05), week 4 (p 0.05), and week 12 (p 0.05). A groups had the same values at baseline, but significantly non-statistically significant increase in clinical scores was higher scorers registered in the HA group at weeks 4 and 12 found at week 24 (p [ 0.05). In the Physio group, we (p 0.05) and such improvement difference maintained at recorded significantly higher values of CS and OSS at week 24 but with no significant difference (p [ 0.05). Inter- week 2 (p 0.05), but at week 4, 12, and 24, there was no observer agreement resulted in k values ranging from 0.81 to significant difference compared with baseline values 0.85 for CS and from 0.80 to 0.88 for OSS; good intra- (p [ 0.05) (Tables observer agreement was registered with k = 0.85–0.90.
Comparison between HA and Physio groups Patient global assessment and adverse events Overall pain and subscores The PGA showed good patient compliance with no seriousadverse events registered during the experimentation. The Overall pain and subscores were stratified to evaluate the anterolateral approach injections, with US assistance, difference in pain scores between the two groups of treat- proved to be safe and well tolerated by all the patients ment. There was no statistically significant difference in enrolled for the study.
overall pain scores between the groups at baseline and atweek 2 (p [ 0.05). We found an average difference of 2.22points at week 4 (p = 0.0149) and 2.16 points at week 12 (p = 0.0168), while the difference at week 24 was notstatistically significant (p [ 0.05) (Table ). Subscores for Sodium hyaluronate is effective in managing acute or pain at night were significantly different at week 4 chronic ligaments and tendon injuries, like ankle sprains (p = 0.0487), and remained at week 12, while the average and epicondylalgia [HA is believed to integrate difference found at week 24 was not significant (p [ 0.05).
into the extracellular fibrin matrix to help realignment of A similar trend was found for pain with activity which fibrils thanks to electrostatic interactions. Thus, stability of registered a significant difference at week 4 (p = 0.0318) form and function is then restored allowing healing to and maintained at week 12 and but not at week 24 occur in structures (ligaments and tendons) and shorten- (p [ 0.05). Rescue medication consumption was found to ing the rehabilitation process. Recent research findings Musculoskelet Surg (2013) 97 (Suppl 1):S49–S56 Table 4 Comparison of Constant–Murley Score in the HA and Physio groups p value within HA group p value within Physio group p value between HA and Physio groups Data refer to mean ± SD values p values refer to analysis versus baseline Table 5 Comparison of Oxford Shoulder Score in the HA and Physio groups p value within HA group p value within Physio group p value between HA and Physio groups Data refer to mean ± SD values p values refer to analysis versus baseline demonstrated that repeated periarticular injections of the and in the long-term placebo injections showed the best study materials were more effective in pain relief and joint results. In the current study, physiotherapy was selected for function improvement, compared to placebo or standard the comparator because it is proven to be effective in conservative treatment for ankle sprains and lateral shoulder tendinopathy management [and is recom- epicondylalgia. Long-term follow-up by investigators mended by the recent European guidelines (2008). A confirmed the therapeutic effects persist after 12 and standard program of physiotherapy is recommended to 24 months [, ].
correct inflexibility, loss of strength and mobility in RC, Several trials using sodium hyaluronate in the treatment and associated structures, but it is common that these for chronic shoulder pain have been documented, on conditions persist despite a proper rehabilitation program shoulder osteoarthritis RC tears ], peri-arthritis which is phased into a maintenance program to reduce the [] adhesive capsulitis ], and chronic shoulder pain risk of reinjury The current study compared directly of different etiologies ].
the effects of HA injections and physiotherapy, and we The effectiveness of subacromial injections of HA alone found that both treatments produced good results in pain in patients with chronic RC tendinopathy is also reported in and clinical scores in the short term, with a significant pain the literature. In an open label multicenter study, Itokazu decrease at week 2 of 3.3 points in the HA group and 2.8 et al. [observed a significant pain and range of motion points in the Physio group. In midterm, the pain score improvement after subacromial high-molecular weight maintained a significant improvement at week 4 and week sodium hyaluronate injection for 5 weeks or more, and 12 only in the HA group, while the improvement found in they conclude that this treatment was effective in patients the Physio group was not significant at week 4 and week 12 with periarthritis of the shoulder. Kim et al. [in a compared to the baseline. Pain subscores at night and prospective randomized single-blind comparative study on during activity in the HA group showed a significant 105 patients with subacromial impingement, found that reduction from the start of the study throughout follow-up, hyaluronate injections produced more significant pain except for week 24, while in the Physio group, the reduc- reduction and similar functional improvement comparing tion in pain subscores was not significant from week 2 to to corticosteroid at 12 weeks. On the contrary, respect to week 24. CS and OSS showed a course similar to overall our results, Penning et al. ] reported a significant pain, with a significant improvement in both treatment reduction in pain at short- and long-term follow-up with groups at week 2, persistent pain relief in the HA group corticosteroid injections compared with hyaluronic acid only at week 4 and week 12, and a return to lower but Musculoskelet Surg (2013) 97 (Suppl 1):S49–S56 non-statistically significant scores with respect to baseline, injections could provide good mid- and long-term clinical at week 24 in both groups. The consumption of rescue medication was higher in the Physio group from week 12 toweek 24, but at the end of the study, such differencebecame not significant. These results suggest that suba- cromial HA injections are effective in inducing betterclinical outcomes and pain relief compared to physiother- Despite the limitations of the current research, such as no apy from the start of the study up to week 12, the thera- randomization and relatively small sample size, we may peutic effects became less important at 6 months when conclude that subacromial HA injections could be an symptoms gradually returned. Stratifying the results, we effective and safe alternative treatment for patients suf- found that five patients in the Physio group had worsening fering from RC tendinopathy. Our results are encouraging VAS scores at the end of study, whereas this was seen in but not lasting, and we might suppose that further only two patients in the HA group. The two patients in the investigation with a larger sample size into the optimal HA group were young in age and have relative high daily injection regime and possible combination with current activities on the shoulder in life, that is, regular fitness standard therapies, so as to provide long-term benefits, are training and therefore higher risk to develop overuse ten- dinopathy and subacromial bursitis. The procedure forshoulder injection was safe without any adverse events Conflict of interest registered in all the enrolled subjects.
We used the same anterolateral approach with ultra- sound assistance, to allow the injection on the superior limitant of the supraspinatus tendon as accurate as possible [Using this approach, we ensured that the HA prepa- impingement syndrome: is it time for a new method of assess- ration was injected on the thinner crescent supraspinatus ment? Br J Sports Med 43:259–264 fibers, [] located within the hypovascular region (critical 2. Herberts P, Kadefors R, Hogfors C, Sigholm G (1984) Shoulder zone) [] and more at risk of degeneration and tearing.
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O'Shaughnessy's • Winter 2015/16 —7— Cannabis in the Treatment of Pediatric Epilepsy By Bonni Goldstein, MD The author documents the progress of more than 100 patients using CBD-rich cannabis oil to treat seizure disorders. I have been a medical cannabis physician seeing adult tion they are going to give their child. They cannot give oil, the added expense of testing every bottle becomes pro-