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A randomized clinical study of the heated lidocaine/tetracaine patch versus subacromial corticosteroid injection for the treatment of pain associated with shoulder impingement syndrome.

ABSTRACT: BACKGROUND:Treatment for pain due to shoulder impingement syndrome (SIS) typically begins conservatively with nonsteroidal anti-inflammatory drugs and physical therapy and can include subacromial injection of corticosteroids, particularly in patients unresponsive to conservative measures. The heated lidocaine/tetracaine (HLT) patch has been reported to reduce SIS pain in a small case series. METHODS:This was a prospective, randomized, open-label clinical trial in which adult patients with SIS pain lasting at least 14 days, with an average intensity of ?4 on a 0-10 scale (0= no pain, 10= worst pain) were randomized to treatment with the HLT patch or a single subacromial injection of triamcinolone acetonide (10 mg). Patients in the HLT patch group applied a single HLT patch to the shoulder for 4 hours twice daily, with a 12-hour interval between treatments during the first 14 days, and could continue to use the patch on an as-needed basis (up to twice daily) during the second 14-day period. No treatment was allowed in the final 14-day period. At baseline and at days 14, 28, and 42, patients rated their pain and pain interference with specific activities (0-10 scale). RESULTS:Sixty patients enrolled in the study (average age =51 years, range 18-75, n=21 female). Average pain scores declined from 6.0±1.6 at baseline to 3.5±2.4 at day 42 in the HLT patch group (n=29, P<0.001) and from 5.6±1.2 to 3.2±2.6 in the injection group (n=31, P<0.001). Similar improvements were seen in each group for worst pain; pain interference with general activity, work, or sleep; and range of motion. No significant between-group differences were seen for any pain or pain interference scores at any time point. CONCLUSION:These results suggest that short-term, noninvasive treatment with the HLT patch has similar efficacy to subacromial corticosteroid injections for the treatment of pain associated with SIS.

SUBMITTER: Radnovich R

PROVIDER: S-EPMC4266383 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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A randomized clinical study of the heated lidocaine/tetracaine patch versus subacromial corticosteroid injection for the treatment of pain associated with shoulder impingement syndrome.

Radnovich Richard R Trudeau Jeremiah J Gammaitoni Arnold R AR

Journal of pain research 20141209

<h4>Background</h4>Treatment for pain due to shoulder impingement syndrome (SIS) typically begins conservatively with nonsteroidal anti-inflammatory drugs and physical therapy and can include subacromial injection of corticosteroids, particularly in patients unresponsive to conservative measures. The heated lidocaine/tetracaine (HLT) patch has been reported to reduce SIS pain in a small case series.<h4>Methods</h4>This was a prospective, randomized, open-label clinical trial in which adult patie ...[more]

PMID: 25525385

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Project description:BackgroundShoulder pain is a very common presentation in primary care. Evidence of benefit for subacromial corticosteroid injection is inconclusive and confined largely to studies with short follow-up. We plan a large, definitive, primary-care-based trial to determine efficacy and safety in patients with rotator cuff tendinopathy, and conducted a pilot trial to explore feasibility.MethodsSix general practitioners (GPs) from Oxfordshire, UK underwent update training in assessing painful shoulders and injecting the subacromial space. Each then recruited patients aged 35 to 74 years from primary care complaining of shoulder pain lasting no more than 6 months. Eligible participants were randomized to receive either methylprednisolone acetate 40 mg with lidocaine 1% (total volume 1 ml), or lidocaine 1% alone (total volume 1 ml), injected into the subacromial space. The participants were blinded to treatment allocation. Feasibility outcomes were rates of recruitment, withdrawal, adherence to the protocol, completeness of follow-up, and success of patient masking. Clinical outcomes were the Oxford Shoulder Score (OSS) at baseline and at 4 and 12 weeks, and responses to three satisfaction questions at 2, 4 and 12 weeks. Outcome data were collected by postal questionnaires.ResultsA total of 40 participants were randomized (80% of the target 50 participants) over 26 weeks giving an overall recruitment rate of 1.5 participants per week. Rates of follow-up were maintained to a high level for the full 12 weeks. Four participants requested a 'rescue' corticosteroid injection but no patients withdrew. The trial GPs gave high scores for their confidence that the patient had remained blinded to treatment allocation during the procedure. The OSS at 4 and 12 weeks and the responses to the satisfaction questions are reported.ConclusionsIt is feasible to recruit participants with shoulder pain in the primary care setting for a blinded, randomized trial of corticosteroid injection. Online randomization of participants from the practice is also feasible, and postal questionnaires provide an effective means of gathering outcome data in this area of study. The lessons learned from this pilot will usefully inform the design of a large, definitive efficacy trial in primary care.Trial registrationCurrent Clinical Trials ISRCTN82357435.

Project description:BackgroundImpingement syndrome was shown to be associated with shoulder pain in 44-70% of patients worldwide. It usually occurs due to imbalance and insufficient activation of the rotator cuff (RC) muscles.AimThis study explores the relative effects of handgrip-strengthening exercises on shoulder function, pain, strength, and active range of motion as part of the treatment program for the patients with primary subacromial impingement syndrome.Materials and methodsA total of 58 patients aged 18-50 years with primary subacromial impingement syndrome were randomly enrolled to participate in this single-blind randomized clinical trial. Out of them, only forty patients have eligibly matched the inclusion criteria and randomly assigned to one of two groups to undergo a standardized therapeutic program consisting of two sessions a week for 8 weeks. The control group prescribed ultrasound therapy, ice, and stretching exercises, while the experimental group followed the same program with the addition of handgrip-strengthening exercises (HGSE). Both patients of conventional therapy (control) and handgrip-strengthening exercises (experimental group) were advised to adhere also to stretching and HGSE exercises once a day at home for eight weeks. The outcomes were the shoulder function, pain intensity, muscle strength, and active range of motion of the shoulder joint.ResultsPatients treated with conventional interventions plus handgrip-strengthening exercises showed the significant improvement over time in shoulder pain and function, strength of rotator cuff muscles, and pain-free range of motion forward flexion, abduction, and external and internal rotation through eight weeks in the experimental group compared to control patient group treated with conventional interventions. In addition, patients of both control and experimental groups showed no significant difference in the adherence to respective home-based stretching and HGSE exercises once a day at home for eight weeks.ConclusionsAdding handgrip-strengthening exercises to conventional intervention increases the efficacy of treatment for patients with primary subacromial impingement syndrome in terms of shoulder function, pain, muscle strength, and active range of motion.

Project description:ObjectiveTo assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting.DesignMulticentre, three group, randomised, double blind, sham controlled trial.SettingOrthopaedic departments at three public hospitals in Finland.Participants210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.InterventionsASD, diagnostic arthroscopy (placebo control), and exercise therapy.Main outcome measuresShoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15.ResultsIn the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (-7.5, -14.0 to -1.0, points; P=0.023) and VAS on arm activity (-12.0, -20.9 to -3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group.ConclusionsIn this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.Trial registrationClinicaltrials.gov NCT00428870.

Project description:BackgroundRehabilitation is the key to management of patients with subacromial impingement syndrome to prevent disability and loss of function. While point-of-care musculoskeletal ultrasound aids clinical diagnosis of subacromial impingement syndrome, many patients do not demonstrate the classic findings of dynamic supraspinatus tendon impingement beneath the acromion on ultrasound. The objective of this study was to establish the most reliable shoulder ultrasound measurements for subacromial impingement, by evaluating the intra-rater and inter-rater reliability of measurements in asymptomatic participants.MethodsEighteen participants (9 women, 9 men, mean ± standard deviation: 34.6 ± 7.9 years of age) underwent bilateral shoulder ultrasound evaluations with measurements for subacromial impingement (acromiohumeral distance, acromion-greater tuberosity distance, supraspinatus tendon, subacromial-subdeltoid bursa, and subacromial-subdeltoid bursal fluid thickness) performed by two sports medicine physicians. Intra-class coefficients were calculated to determine the intra- and inter-rater reliability of shoulder ultrasound images and measurements.ResultsIntra-rater reliability for acromiohumeral distance (0.76-0.79), supraspinatus tendon (0.91-0.95), subacromial-subdeltoid bursa (0.76-0.84), and subacromial-subdeltoid bursal fluid thickness (0.75-0.81) was found to be good to excellent, whereas inter-rater reliability ranged from poor to moderate.ConclusionsAcromiohumeral distance in neutral position and short axis ultrasound measurements of supraspinatus tendon, subacromial-subdeltoid bursa, and subacromial-subdeltoid bursal fluid thickness in the modified Crass position were the most reliable for subacromial impingement in asymptomatic participants. We recommend validation of these measurements in a symptomatic population to aid diagnosis and direct rehabilitation of patients with suspected subacromial impingement, and to increase point-of-care ultrasound uptake, availability, and training among rehabilitation professionals across health systems.

Dataset Information

A randomized clinical study of the heated lidocaine/tetracaine patch versus subacromial corticosteroid injection for the treatment of pain associated with shoulder impingement syndrome.

Publications

A randomized clinical study of the heated lidocaine/tetracaine patch versus subacromial corticosteroid injection for the treatment of pain associated with shoulder impingement syndrome.

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