Jan K G Louwerens1, Inger N Sierevelt2, Erik T Kramer3, Rob Boonstra4, Michel P J van den Bekerom5, Barend J van Royen6, Denise Eygendaal7, Arthur van Noort2. 1. Department of Orthopaedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands. Electronic address: jlouwerens@spaarnegasthuis.nl. 2. Department of Orthopaedic Surgery, Spaarne Gasthuis, Hoofddorp, the Netherlands. 3. Verheul & Weerman Physical Therapists, Nieuw-Vennep, the Netherlands. 4. Paramedical Shoulder Clinic, Haarlem, the Netherlands. 5. Department of Orthopaedic Surgery, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands. 6. Department of Orthopaedic Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands. 7. Department of Orthopaedic Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands; Department of Orthopaedic Surgery, Breda, the Netherlands.
Abstract
PURPOSE: To compare clinical and radiographic outcomes after treatment with standardized high-energy extracorporeal shock wave therapy (ESWT) and ultrasound-guided needling (UGN) in patients with symptomatic calcific tendinitis of the rotator cuff who were nonresponsive to conservative treatment. METHODS: The study was designed as a randomized controlled trial. The ESWT group received ESWT (2000 pulses, energy flux density 0.35 mJ/mm2) in 4 sessions with 1-week intervals. UGN was combined with a corticosteroid ultrasound-guided subacromial bursa injection. Shoulder function was assessed at standardized follow-up intervals (6 weeks and 3, 6, and 12 months) using the Constant Murley Score (CMS), the Disabilities of the Arm, Shoulder, and Hand questionnaire, and visual analog scale for pain and satisfaction. The size, location, and morphology of the deposits were evaluated on radiographs. The a priori sample size calculation computed that 44 participants randomized in each treatment group was required to achieve a power of 80%. RESULTS:Eighty-two patients were treated (56 female, 65%; mean age 52.1 ± 9 years) with a mean baseline CMS of 66.8 ± 12 and mean calcification size of 15.1 ± 4.7 mm. One patient was lost to follow-up. At 1-year follow-up, the UGN group showed similar results as the ESWT group with regard to the change from baseline CMS (20.9 vs 15.7; P = .23), Disabilities of the Arm, Shoulder, and Hand questionnaire (-20.1 vs -20.7; P = .78), and visual analog scale for pain (-3.9 and -2.6; P = .12). The mean calcification size decreased by 13 ± 3.9 mm in the UGN group and 6.7 ± 8.2 mm in the ESWT group (<P = .001). In total, 22% of the UGN and 41% of the ESWT patients received an additional treatment during follow-up because of persistent symptoms. CONCLUSIONS: This RCT compares the clinical and radiographic results of UGN and high-energy ESWT in the treatment of calcific tendinitis of the rotator cuff. Both techniques are successful in improving function and pain, with high satisfaction rates after 1-year follow-up. However, UGN is more effective in eliminating the calcific deposit, and the amount of additional treatments was greater in the ESWT group. LEVEL OF EVIDENCE: II, randomized controlled trial.
RCT Entities:
PURPOSE: To compare clinical and radiographic outcomes after treatment with standardized high-energy extracorporeal shock wave therapy (ESWT) and ultrasound-guided needling (UGN) in patients with symptomatic calcific tendinitis of the rotator cuff who were nonresponsive to conservative treatment. METHODS: The study was designed as a randomized controlled trial. The ESWT group received ESWT (2000 pulses, energy flux density 0.35 mJ/mm2) in 4 sessions with 1-week intervals. UGN was combined with a corticosteroid ultrasound-guided subacromial bursa injection. Shoulder function was assessed at standardized follow-up intervals (6 weeks and 3, 6, and 12 months) using the Constant Murley Score (CMS), the Disabilities of the Arm, Shoulder, and Hand questionnaire, and visual analog scale for pain and satisfaction. The size, location, and morphology of the deposits were evaluated on radiographs. The a priori sample size calculation computed that 44 participants randomized in each treatment group was required to achieve a power of 80%. RESULTS: Eighty-two patients were treated (56 female, 65%; mean age 52.1 ± 9 years) with a mean baseline CMS of 66.8 ± 12 and mean calcification size of 15.1 ± 4.7 mm. One patient was lost to follow-up. At 1-year follow-up, the UGN group showed similar results as the ESWT group with regard to the change from baseline CMS (20.9 vs 15.7; P = .23), Disabilities of the Arm, Shoulder, and Hand questionnaire (-20.1 vs -20.7; P = .78), and visual analog scale for pain (-3.9 and -2.6; P = .12). The mean calcification size decreased by 13 ± 3.9 mm in the UGN group and 6.7 ± 8.2 mm in the ESWT group (<P = .001). In total, 22% of the UGN and 41% of the ESWT patients received an additional treatment during follow-up because of persistent symptoms. CONCLUSIONS: This RCT compares the clinical and radiographic results of UGN and high-energy ESWT in the treatment of calcific tendinitis of the rotator cuff. Both techniques are successful in improving function and pain, with high satisfaction rates after 1-year follow-up. However, UGN is more effective in eliminating the calcific deposit, and the amount of additional treatments was greater in the ESWT group. LEVEL OF EVIDENCE: II, randomized controlled trial.
Authors: Jan K G Louwerens; P Paul F M Kuijer; Inger N Sierevelt; Michel P J van den Bekerom; Barend J van Royen; Denise Eygendaal; Arthur van Noort Journal: Arthrosc Sports Med Rehabil Date: 2020-10-05
Authors: Jan K G Louwerens; Michel P J van den Bekerom; Barend J van Royen; Denise Eygendaal; Arthur van Noort; Inger N Sierevelt Journal: JSES Int Date: 2020-06-06