Interventional procedure overview of extracorporeal shockwave therapy for calcific tendinopathy in the shoulder

Efficacy summary

Pain relief

In a systematic review of 2,281 patients with rotator cuff disease, with or without calcification, pain relief of 50% or greater was reported as an outcome in 1 of the included randomised controlled trials (RCTs). In this RCT, 41% (14/34) of patients who had ESWT reported pain relief of 50% or greater compared with 38% (15/40) of those in the placebo group (relative risk [RR] 1.10, 95% confidence interval [CI] 0.62 to 1.94) at 3‑month follow up. In the same systematic review, the mean pain score across 9 trials was 3.02 points in the placebo group and 0.78 points better with shockwave therapy (range 0.17 to 1.4 better; clinically important change was 1.5 points; n=608). Subgroup analyses indicated that there were no between-group differences in pain outcomes in patients who did or did not have calcific deposits in the rotator cuff (Surace 2020).

In an RCT of 45 patients with calcific shoulder tendinopathy who had focused ESWT, radial ESWT or both, the mean difference in visual analogue scale (VAS) pain scores at 3‑month follow up compared with baseline were 4.40, 4.47 and 6.58 respectively (p=0.014; Abo Al-khaira 2021).

In a non-randomised comparative study of 60 patients with calcific or non-calcific rotator cuff tendinosis, the VAS pain score at 1 year after ESWT improved from 5.5 to 2.9 (p=0.001) in patients with non-calcified tendinosis, from 5.4 to 1.5 (p<0.001) in patients with translucent calcified tendinosis and from 5.4 to 3.8 (p=0.02) in patients with dense calcified tendinosis (p=0.011 between groups; Wu 2019).

In an RCT of 82 patients with calcific tendonitis of the rotator cuff, the mean VAS pain score reduced by 2.6 in patients who had ESWT and 3.9 in patients who had ultrasound-guided needling (p=0.05) at 1‑year follow up compared with baseline (Louwerens 2020).

In a cohort study of 268 patients, the intensity of pain at 1 year after ESWT was lower in those patients who had complete resorption (mean score 1.0; n=134) compared with those who had incomplete resorption (mean score 3.8; n=107; p<0.001 between groups). In both groups, the reduction in pain intensity at 1 year compared with baseline was statistically significant (p<0.001; Chou 2017).

Function

In the systematic review of 2,281 patients, the mean function score was 66 points in the placebo group and 7.9 points better with shockwave therapy (range 1.6 to 14 points better; clinically important difference was 10 points; 9 trials, n=612). Subgroup analyses indicated that there were no between-group differences in function outcomes in patients who did or did not have calcific deposits in the rotator cuff (Surace 2020).

In the RCT of 45 patients with calcific shoulder tendinopathy, the mean decrease in shoulder disability questionnaire scores at 3‑month follow up compared with baseline was 51.7 in those who had focused ESWT, 55.7 in those who had radial ESWT and 70.4 in those who had both (p=0.034; Abo Al-khaira 2021).

SPADI score

In an RCT of 143 patients with subacromial pain, with or without calcification in the rotator cuff, 54% (37/64) of patients who had active radial ESWT and supervised exercises had a reduction in SPADI score that exceeded 19.7 points at 1 year compared with 51% (38/66) of patients who had sham radial ESWT and supervised exercises (odds ratio 0.96, 95% CI 0.47 to 1.9, p=0.89). The mean SPADI score at 1 year was 26.9 in the active radial ESWT group and 28.3 in the sham group (p=0.71; Kvalvaag 2018). Shorter term outcomes from this study were also included in the systematic review of 2,281 patients.

CMS

In the non-randomised comparative study of 60 patients with calcific or non‑calcific rotator cuff tendinosis, the overall CMS at 1 year after ESWT improved from 52.5 to 78.7 (p=0.001) in patients with non-calcified tendinosis, from 49.7 to 86.9 (p<0.001) in patients with translucent calcified tendinosis and from 53.8 to 71.1 (p=0.001) in patients with dense calcified tendinosis (p=0.007 between groups; Wu 2019).

In the RCT of 82 patients with calcific tendonitis of the rotator cuff, the mean CMS improved by 15.7 points in patients who had ESWT and 20.9 points in patients who had ultrasound-guided needling (p=0.13) at 1‑year follow up compared with baseline (Louwerens 2020).

In a non-randomised comparative study of 115 patients with symptomatic chronic calcific tendonitis of the shoulder, there was no statistically significant difference in CMS when comparing 1 session of ESWT with 2 sessions of ESWT. The mean CMS at baseline, 6 months and 4 years was 49, 67 and 88 in patients who had 1 session of ESWT (p<0.001) and 44, 69 and 85 in patients who had 2 sessions of ESWT (p<0.05; Daecke 2002).

In the cohort study of 268 patients, the Constant score 1 year after ESWT was higher in those patients who had complete resorption (mean score 90.0) compared with those who had incomplete resorption (mean score 68.1; p<0.001 between groups). In both groups, the improvement at 1 year compared with baseline was statistically significant (p<0.001; Chou 2017).

Patient-reported success

In the systematic review of 2,281 patients, 39% (58/150) of patients who had shockwave therapy and 26% (35/137) of patients in the placebo group reported a successful outcome at the end of the study (RR 1.59, 95% CI 0.87 to 2.91; 6 trials, n=287; Surace 2020).

In the non-randomised comparative study of 60 patients with calcific or non-calcific rotator cuff tendinosis, the proportion of patients who were complaint-free at 1 year after ESWT was 15% (3/20) for patients with non-calcified tendinosis, 70% (14/20) for patients with translucent calcified tendinosis and 25% (5/20) for patients with dense calcified tendinosis (p=0.006 between groups; Wu 2019).

In the RCT of 82 patients with calcific tendonitis of the rotator cuff, an improvement in symptoms was reported by 67% (26/41) of patients who had ESWT and 78% (31/41) of patients who had ultrasound-guided needling at 1‑year follow up (p=0.25). Mean patient satisfaction scores at 1 year were 7.6 for ESWT and 7.0 for ultrasound-guided needling (p=0.30; Louwerens 2020).

In the non-randomised comparative study of 115 patients with calcific tendonitis of the shoulder, the proportion of patients reporting subjective success at 4‑year follow up was 78% in those who had 1 session of ESWT and 87% in those who had 2 sessions (p=not significant between groups; Daecke 2002).

In the cohort study of 268 patients, 81% (109/134) of patients who had complete calcific resorption were complaint-free 1 year after ESWT compared with 23% (25/107) of patients who had incomplete resorption (p<0.001; Chou 2017).

Quality of life

In the RCT of 143 patients, the health-related quality of life score (EQ-5D) at baseline was 0.53 in the active radial ESWT group and 0.58 in the sham group. At 1 year, the scores had improved to 0.71 and 0.73 respectively (p=0.94; Kvalvaag 2018).

Calcification resorption

In the systematic review of 2,281 patients, shockwave therapy was associated with an increased rate of complete resolution of calcium deposits by the end of the trial, but this was of uncertain clinical significance (Surace 2020).

In the RCT of 45 patients, the mean calcification size decreased by 5.72 mm in the focused ESWT group, 5.58 mm in the radial ESWT group and 8.83 mm in the combined ESWT group at 3‑month follow up (p=0.025). Complete resorption of calcification was seen in 20% (3/15) of patients who had focused ESWT, 27% (4/15) of patients who had radial ESWT and 67% (10/15) of patients who had combined focused and radial ESWT (Abo Al-khaira 2021).

In the RCT of 82 patients with calcific tendonitis of the rotator cuff, full resorption of calcific deposits at 6 months was reported in 34% (14/41) of patients who had ESWT and 68% (27/41) of patients who had ultrasound-guided needling (p<0.001; Louwerens 2020).

In the non-randomised comparative study of 115 patients with calcific tendonitis of the shoulder, the proportion of patients with complete or partial resorption of calcification at 4‑year follow up was 93% both in patients who had 1 session of ESWT and in those who had 2 sessions (Daecke 2002).

In the cohort study of 268 patients, there was complete resorption of calcification in 56% (134/241) of patients. Mean duration of symptoms was 12.5 months (range 6 to 48) in the complete resorption group and 26.6 months (range 12 to 126) in the incomplete resorption group (p<0.001; Chou 2017).

Additional treatment

In the RCT of 143 patients, 27% (17/64) of patients in the active radial ESWT group had additional treatments during the 1-year follow up compared with 18% (12/66) of patients in the sham group (Kvalvaag 2018).

In the RCT of 82 patients with calcific tendonitis of the rotator cuff, additional interventions for persistent pain or symptoms were reported in 42% (17/41) of patients who had ESWT and 22% (9/41) of patients who had ultrasound-guided needling (p=0.058; Louwerens 2020).

In the non-randomised comparative study of 115 patients with calcific tendonitis of the shoulder, 23% of patients who had 1 session of ESWT and 37% of patients who had 2 sessions of ESWT had no further treatment between 6 months and 4 years after ESWT. The types of treatment in the remaining patients included physiotherapy and subacromial injections, singly or in combination, and surgery (Daecke 2002).