Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Castillo-Gonzalez (2016)

Type of study:

Randomized, controlled trial

Setting and country:

Patients treated in our sports medicine and rehabilitation centre (Centro Médico Deyre, Madrid. Spain) between January 2007 and

December 2013.

Funding and conflicts of interest:

Funding.—This work was partly funded by grant awarded by the Santander Group to the Foundation Alfonso X el Sabio University.

 Conflicts of interest.—The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.

Inclusion criteria:

-patients whom attended our medical center between January 2007 and december 2013, -had a clinical, radiological and

ultrasound diagnosis of rcct. -had a minimum calcification

of 5 mm diameter, -had a minimum visual analogue scale (VAS) pain score of 6 (where 0 represents no pain, and 10 maximum pain), -and have no allergies to the medications used.

Exclusion criteria:

- patients with any form of

tendon rupture, total or partial, were excluded.

N total at baseline: 201

Intervention: 121

Control: 80

Important prognostic factors²:

age ± SD:

I: not reported

C: not reported

Sex:

I: % M not reported

C: % M not reported

VAS score at baseline:

mean VAS pain score: 7.43±0.99. Further solely textually mentioned that there was no significant difference between the groups.

This was so high since solely people with VAS 6 or higher were included.

Groups comparable at baseline?

Not reported

Describe intervention (treatment/procedure/test):

Patients with rotator cuff calcific tendinopathy (RCCT) received ultrasound-guided percutaneous lavage (UGPL).

Patients were provided an anxiolytic (bromazepam 1.5 mg) 30 minutes before the procedure to reduce the possibility of the appearance of vagal syndrome. A prior ultrasound examination was used to determine the position of the shoulder that would leave the calcification most accessible from the cutaneous plane. The procedure was performed with the patient sat in a chair with armrests, facing the physician, with the shoulder rotated internally and the forearm placed on the back. This position increases the pressure within the tendon

and facilitates the movement of the calcium into the syringe. All patients were told to hold this position during the entire procedure, which lasts about 30 minutes. The needle insertion point was marked on the skin. asepsis

was guaranteed by swabbing with iodated povidone. Under aseptic conditions, a 10-mL syringe filled with 2% mepivacaine, a 5-ml syringe containing triamcino lone, several syringes containing sterile physiological saline, and 18-G and 20-G needles were laid out on a sterile gauze. The procedure was begun by injecting the mepivacaine into the skin using a syringe with a 20G needle, and placing the ultrasound probe over the trajectory to cover (from the entry point to the calcification). The needle was gradually pushed towards the calcification,

anesthetizing from the point of entry in the skin through to the subacromial bursa. the needle was then placed below the calcification, and the remaining anesthetic used to begin its fragmentation and lavage, working the

plunger with a forward pumping movement only, i.e., without aspiration (Figure 2). These impulses were kept up until the calcified material began to leave the calcification and enter the syringe. When the syringe body was full it was replaced by one containing physiological saline, but without removing the needle from its position. the same lavage and pumping action was then performed again. the procedure was repeated until no more calcified material could be withdrawn, until the calcification had been completely fragmented, or until the patient showed signs of discomfort. at this point the syringe body was switched (without withdrawing the needle) for that containing 2 mL triamcinolone. The needle was then gradually extracted as far as the bursa where the syringe contents were emptied, before being completely removed. the insertion point in the skin was then covered with a sterile gauze. in patients

with a hard calcification, or in which the needle became

blocked due to the entry of dense material, the latter was switched for an 18-G one.

Describe control (treatment/procedure/test):

Patients with rotator cuff calcific tendinopathy (RCCT) receiving extracorporeal shockwave therapy.

This was performed with the patient sat in a chair

with armrests and facing the physician. a conducting

gel was placed on the area where the waves were to be

transmitted. The calcification was localized by fluoroscopy, and the point on the skin where the shockwaves would be delivered identified (Figure 3). A total of 2000 impacts (two series of 1000 each) at a frequency of 8-10 hz and an energy density of 0.20 J/mm2 was then delivered with the shockwave emitter in direct contact with the skin. this was performed twice per week for four weeks. After each session the patient was monitored in the waiting room for a few minutes to make sure no complications had arisen before discharge. the procedure can be painful, especially at the start of therapy, but never requires local anesthetic.

Number of sessions: two sessions per week for four weeks was chosen.

Length of follow-up:

12 month

Loss-to-follow-up:

Intervention:

N (%): 1 patient:

Reasons (describe): did not attend appointments.

Control (ESWT):

N (%): 41

Reasons (describe): 38 patients did not complete treatment, and 3 patients did not attend appointments. Analysed: 80 patients

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

6 months

1. Pain

Mean VAS-score (0-10) presented visually in a diagram

I: 2.2

C: 4

(p<0.01) with the UGPL treatment being more effective in reducing pain.

2. PROMS for function:

2.1. CMS

Not reported

2.2. CASH

Not reported

2.3. WORC

Not reported

2.4. ASES

Not reported

2.5. OSS

Not reported

2.6. DSST

Not reported

3. Patient satisfaction

Not reported

4. Complications/adverse events

Not reported

12 months

1. Pain

Mean VAS-score (0-10) presented visually in a diagram

I: 1.3

C: 3.3

(p<0.01) with the UGPL treatment being more effective in reducing pain.

Complete relive of pain at 12 months

I: 108 (89.26%)

C: 52 (65.0%)

2. PROMS for function:

2.1. CMS

Not reported

2.2. CASH

Not reported

2.3. WORC

Not reported

2.4. ASES

Not reported

2.5. OSS

Not reported

2.6. DSST

Not reported

3. Patient satisfaction

Not reported

4. Complications/adverse events

Not reported

Conclusion:

-Both techniques are valid for the treatment of RCCT, although UGPL is associated with a greater reduction of calcification and greater reduction in pain.

-Clinical rehabilitation impact: the results obtained applying uGpl, the low cost and the lack of complications should therefore make the treatment of choice in centres that are appropriately equipped and staffed.

Pain measured using the visual analogue scale (VAS)

De Boer (2017)

Type of study:

A prospective, randomized trial

Setting and country:

All patients were seen on the outpatient clinic of the hospital (Hagaziekenhuis) between May 2010 and March 2011.

Funding and conflicts of interest:

Conflict of interest: none.

Funding: not reported

Inclusion criteria:

-shoulder pain persisting more than 6 months, calcification in the rotator cuff region type I or II according to Gartner on a standard shoulder radiograph. -Numeric Rating Scale (NRS) for pain had to be >= 4 at the time of inclusion, -previous conservative therapy (physio, NSAIDs, cortisone infiltration) should have failed.

Exclusion criteria:

-insufficient knowledge of Dutch language, -age under 18, -inability to receive informed consent, -participation in other study, -other pathology which could cause shoulder – or upper limb pain (eg. Rotator cuff tears, acromioclavicular arthropathy, frozen shoulder, cervical disc hernia), -patients suffering from inflammatory-, malignant, - or clotting disease, -pregnant woman.

N total at baseline: 25

Intervention: 11

Control: 14

Important prognostic factors²:

age ± SD:

I: not reported

C: not reported

Sex:

I: % M not reported

C: % M not reported

Mean VAS pain score at baseline

I: 7.5 (6.5 – 8.6)

C: 7.9 [6.9 – 8.8]

Groups comparable at baseline? Unknown

Describe intervention (treatment/procedure/test):

The UN protocol consisted of a single treatment procedure. Before the start , 1 ml (40 mg) of corticosteroid) was left inside the subacromial bursa without ultrasound guidance. Then a local anaesthetic (lidocaine 1%) was administered to the skin, bursa and tendon. The calcification was localized with ultrasound and pierced several times with 2 hollow 18 guage needles. A saline solution was flushed through both needle portals in order to wash out the calcium. Procedure was done by the senior author who is a shoulder surgeon experienced in ultrasonography.

Describe control (treatment/procedure/test):

Consisted of 4 sessions of RSWT therapy one week apart.

Each session was similar: 500 pulses of 1.5 bar (150 kPa) with a frequency of 4.5 Hz, followed by 2000 pulses of 2.5 bar (250 kPa) with a frequency of 10 Hz; EFD 0.10 mJ/mm. Duration of pulses was 2 ms. A Masterpuls MP 100 in combination with a standard ultrasound transfergel was used.

RSWT was performed by a specialist physical therapist.

Length of follow-up:

1 year

Loss-to-follow-up:

Intervention: 1

N (%)

Reasons (describe) changed treatment due to consistent pain

Control:

N (%) 5

Reasons (describe) changed treatment due to consistent pain

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

6 months

1. Pain

Not reported

2. PROMS for function:

2.1. CMS (95% CI)

Not reported

2.2. CASH

Not reported

2.3. WORC

Not reported

2.4. ASES

Not reported

2.5. OSS

Not reported

2.6. DSST

Not reported

3. Patient satisfaction

Not reported

4. Complications/adverse events

Subacromial debridement and decompression because of unacceptable persistent pain

I: 1 patient

C: 0

12 months

1. Pain

Using the numerical rating scale (NRS)

I: 1.9 [0.6-3.2]

C: 2.1 [0.3-3.9]

2. PROMS for function:

2.1. CMS (95% CI)

Not reported

2.2. CASH

Not reported

2.3. WORC

Not reported

2.4. ASES

Not reported

2.5. OSS

(Mean, range)

I: 53.2 [47.1-59.3]

C: 49.1 [39.2-59.0]

(p=0.32)

2.6. DSST

Not reported

3. Patient satisfaction

Not reported

4. Complications/adverse events

Free of complaints [95 % CI]

I: 40%

C: 44%

Conclusion:

Compared to RSWT, UN resulted in lower pain and faster resorption of

calcifications after 6 weeks.

No significant differences were found after 1 year.

Since the study was terminated prematurely because of high NRS in the RSWT group, it could not be advised to use of RSWT over UN.

Funding not reported.

5 patients in the RSWT group changed to the UN group due to pain in the period between 6 weeks and 1 years. However, During the trial, the Data Safety Monitoring Board decided to stop the inclusion prematurely due to the extremely high NRS score of the patients in the RSWT group. Originally, 40 patients were needed for inclusion (power calculation), however when the study terminated 25 patients were included.

Pain was measured using the NRS (ranging from 0-10) in which only absolute numbers can be used. Score 0 equals no pain. When the patient could not choose between two number (e.g. Between a score of 3 and 4), we used the higher (4) score).

Oxford Shoulder Score, a 12-items questionnaire to assess the patients functional ability: for each question: 1 = worst, 5 = best). Score of 12 was the worst score which patients could receive, and a score of 60 the best score.

The Constant Murley Score: is a combined score which measures the pain score, functional assessment, range of motion and strength. Maximum score is 100, minimum is 2.

Kim (2014)

Type of study:

Prospective, randomized trial.

Setting and country:

From November 2005 to

 March 2011 in this study. patients diagnosed with unilateral

 calcium deposition at the supraspinatus tendon, were included in the study.

Department of orthopaedics, south Korea, Seoul.

Funding and conflicts of interest:

The authors, their immediate families, and any research

 foundation with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.

Inclusion criteria:

-Patients diagnosed with unilateral calcium deposition at the supraspinatus tendon, -confirmed on

 radiologic examination, - and disease duration of more than 3 months were included in the study.

Exclusion criteria:

Patients with other shoulder

 disease, such as rotator cuff tear, adhesive capsulitis, arthritis,

 fracture, infection, and history of treatment for the affected

 shoulder, were excluded from this study with initial examination

 (physical examination, radiography, and US).

N total at baseline: 62

Intervention: 30

Control: 32

Important prognostic factors²:

For example

age ± SD:

I: 53.9 years (range, 45-76 years)

C: 57.4 years (47-78)

Sex:

I: 23 F, 2 M

C: 26 F, 3 M

VAS score at baseline:

I: 6.8

C: 6.3

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

The US needling group underwent US-guided needling and received a

 subacromial corticosteroid injection. The US needling group underwent US-guided needling and received a

 subacromial corticosteroid injection.

All US-guided needling procedures were performed by 1 orthopaedic surgeon (Y.S.K.) with a single needle without lavage. The

 procedure was performed by sterile technique and surgical gloves.

The skin was then cleaned with a 10% iodopovidone solution 3 times and antiseptically draped. After administration of local anesthesia (2% lidocaine), the patients in this group underwent multiple percutaneous punctures for each deposit with an 18-gauge needle under real-time monitoring with US.

The final step in the procedure was an injection of 1 mL (40 mg) of Depo-Medrol into the subacromial space under US guidance.

Describe control (treatment/procedure/test):

This procedure was also performed in the sitting position by 1 experienced technician. The procedure involved aiming at the maximum sore spot according to anatomic targeting. ESWT was administered for 3 sessions, 1 week apart (1000 impulses, 0.36 mJ/mm2).

The ESWT group received ESWT 3 times a week.

Length of follow-up:

The average follow-up period was 23.0 months (range, 12.1-28.5 months) after treatment.

Loss-to-follow-up:

Intervention:

N (%) 5

Reasons (describe) because of noncompliance with the follow-up protocol after the procedure.

Control:

N (%) 3

Reasons (describe)

because of noncompliance with the follow-up protocol after the procedure.

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

6 months

1. Pain

Using the Visual analogue Scale (VAS)

I: 1.8

C: 2.5

2. PROMS for function:

2.1. CMS

Not reported

2.2. CASH

Not reported

2.3. WORC

Not reported

2.4. ASES

I: 85.2

C: 76.4

(p>0.5)

2.5. OSS

Not reported

2.6. DSST

Simple Shoulder Test

I: 74.1

C: 70.8

3. Patient satisfaction

Not reported

4. Complications/adverse events

Not reported

12 months

1. Pain

Using the Visual analogue Scale (VAS)

I: 1.4

C: 3.3

2. PROMS for function:

2.1. CMS

Not reported

2.2. CASH

Not reported

2.3. WORC

Not reported

2.4. ASES

I: 90.3

C: 74.6

(p<.05)

2.5. OSS

Not reported

2.6. DSST

Not reported

3. Patient satisfaction

Not reported

4. Complications/adverse events

Not reported

Conclusion:

Both methods showed improved outcomes without serious side effects.

Both treatment modalities for calcific tendinitis improved clinical outcomes and eliminated calcium deposits. US-guided needling treatment, however, was more effective in function restoration and pain relief in the short term.

American Shoulder and Elbow Surgeons (ASES)

Scale numbering/scoring of outcome measures not reported.

Kuo (2022)

Type of study:

A single-blind, randomized, controlled study.

Setting and country:

Between January 2013 and December 2014, 75 patients with calcific tendinitis of the shoulder were recruited from the outpatient clinic at the Department of

 Physical Medicine and Rehabilitation of the authors’

 Institution (Taiwan).

Funding and conflicts of interest:

This study was financially supported by Shin Kong

 WuHo-Su Memorial Hospital of Taiwan (SKH-8302

102-DR-33).

Conflict of interest was reported: the authors declared no conflicts of interest.

Inclusion criteria:

-between 20 and 75 years of age; 2), -at least

 a 3-month history of unilateral shoulder discomfort, - and radiological evidence of both type I and type

 II calcification– as defined by Gartner– or US-based

 evidence of arc-shaped calcification– as defined by

 Chiou.

Exclusion criteria:

-pregnancy, -clotting disorders, anticoagulant or antiplatelet treatment, cardiac pacemaker, chronic inflammatory joint disease,

 infection or tumor of the shoulder, adhesive capsulitis,

 hyperalgesia of the shoulder due to resorption of a calcific deposit, Garner’s type III calcification, or Chiou’s

 nodular or cystic calcification.

N total at baseline: 61

Intervention: 21

Control: 20

Important prognostic factors²:

For example

age ± SD:

I: 58.2 ± 7.9

C: 57.6 ± 9.4

Sex: (M/F)

I: 8/13

C: 8/12

VAS pain score at T0

VAS Sleep

I: 6.76 ± 3.40

C: 5.75 ± 2.77

VAS Rest

I: 4.29 ± 3.95

C: 2.90 ± 2.95

VAS Activity

I: 7.38 ± 2.44

C: 5.50 ± 2.33

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

All needle punctures were guided by US and performed once. A 3.8 cm-long 22-gauge needle attached to a 5-mL syringe was used for puncturing. The puncture site was steril ized with iodine, and the transducer was covered with a sterilized plastic bag. After injecting 3 cc of lidocaine (1%) into the subcutaneous tissue, muscle layer, and subdeltoid bursa, multiple punctures (10–20, depending on plaque size) were performed without aspiration or barbotage. The needle tract was monitored with US to ensure that the needle penetrated through the calcific plaque but not the rotator cuff.

Describe control (treatment/procedure/test):

RSWT was delivered at 2 Hz (2000 shock waves; energy level, 0.26 mJ/mm2) once a week for 3 weeks. Instead of nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen was prescribed as a rescue medication to avoid negative effects on tissue healing.

Length of follow-up:

At baseline, 1.5 and 3 months after completion of the treatment.

Loss-to-follow-up:

Intervention:

N (%): 0 patients

Reasons (describe)

Control:

N (%): 1 patient

Reasons (describe): not reported.

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

6 months

1. Pain

Not reported

2. PROMS for function:

2.1. CMS

Not reported

2.2. CASH

Not reported

2.3. WORC

Not reported

2.4. ASES

Not reported

2.5. OSS

Not reported

2.6. DSST

Not reported

3. Patient satisfaction

Not reported

4. Complications/adverse events

Not reported

 12 months

1. Pain

Not reported

2. PROMS for function:

2.1. CMS

Not reported

2.2. CASH

Not reported

2.3. WORC

Not reported

2.4. ASES

Not reported

2.5. OSS

Not reported

2.6. DSST

Not reported

3. Patient satisfaction

Not reported

4. Complications/adverse events

Not reported

Comments:

Clinical registered trial: NCT02677103

Three groups were compared (USNP; RSWT; and the combination of USNP + RSWT).

Although no significant differences were observed among the groups in the treatment of calcific tendinitis of

 the shoulder, more satisfactory outcomes were noted in the USNP group and the combination group (USNP + RSWT) than in the RSWT group.

Pain was measured using the visual analogue scale (VAS). Pain was measured using three VASs (horizontal lines measuring 100 mm in

 length, with 0 on the left indicating no pain and 100 on the right indicating severe pain) pertaining to shoulder pain at rest, during movement, and during sleep.

The Constant score is a 100 point scoring system comprising 15 points for pain,

 20 points for activities of daily living, 40 points for shoulder motion, and 25 points for muscle power of the affected arm.

Active and passive ROMs were measured using a conventional goniometer; the measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.

Louwerens (2020)

Type of study:

A single-center, randomized controlled trial with parallel groups

Setting and country:

Patients were included between May 2014 and December 2017 at Spaarne Gasthuis (the Netherlands).

Funding and conflicts of interest:

The authors report the following potential conflict of interest or source of funding: J.K.G.L. reports grants from Spaarne General Hospital and nonfinancial support from Richard Wolf GmbH, during the conduct of the study. D.E. reports personal fees from Zimmer Biomet, grants from Zimmer Biomet,

 and grants from Stryker, outside the conduct of the study. M.P.J.v.d.B. reports grants from Wright Medical Group and grants from Smith & Nephew, outside

 the submitted work. A.V.N. reports personal fees from DePuy Synthes and personal fees from Link Lima, outside the submitted work.

Inclusion criteria:

-age >18 years, -clinical sign of subacromial pain syndrome, -standardized radiographs showing a calcific

 deposit with a diameter of at least 5 mm in size, - morphologic type I and type II deposits corresponding

 to the classification of Gärtner17 (type I, sharply out

lined and densely structured; type II, sharply outlined

 and inhomogeneous or homogenous with no defined

 border), -symptoms for more than 4 months, - a

 completed and unsuccessful nonsurgical treatment program including nonsteroidal anti-inflammatory

 drugs, physiotherapy (centric and eccentric rotator

 cuff strengthening exercises in combination with

 scapular stabilization), -and at least 1 SAI with a

 corticosteroid.

Exclusion criteria:

-ultrasonic signs of a partial or full rotator cuff tendon,- clinical or radiographic signs of a resorption phase as defined as a recent period of increased pain in combination with a morphologic type III deposit (cloudy and transparent in structure) on radiographs, -calcific deposits in multiple tendons of the rotator cuff, -osteoarthritis of the glenohumeral or acromioclavicular

 joint, - adhesive capsulitis, -previous shoulder surgery, -ESWT or UGN to the affected shoulder, -instability of

 the shoulder, - rheumatoid arthritis, -neurologic disorders or dysfunction of the upper limb, - and the inability

 to give informed consent.

N total at baseline: 82

Intervention: 41

Control: 41

Important prognostic factors²:

age ± SD:

I: 52.7 (8.7)

C: 51.6 (9.4)

Sex (Female)

I: 26 (63%)

C: 27 (66%)

Mean VAS score at baseline (Mean, SD)

I: 6.0 (1.5)

C: 5.8 (1.8)

Groups comparable at baseline? Yes ,except for the Gartner types.

Describe intervention (treatment/procedure/test):

Patients with calcific tendinitis of the rotator cuff. UGN: In UGN, ultrasound is used to allow a radiation free, 3-dimensional localization and assessment of the calcific deposit. Assisted by real-time ultrasonic guidance the deposit is then punctured and irrigated with a needle to break it down. In this study a double-needle technique was used with repeated perforation of the deposit and subsequent aspiration and lavage. Patients were treated with a

 single UGN procedure.

The patient was positioned in a supine position and the

 size and location of the calcific deposit was confirmed and marked by ultrasound imaging. After sterile preparation, patients received a local anesthetic injection of the skin and subcutaneous tissue with 5 cc of lidocaine HCL 10 mg/mL.

The ultrasound transducer was kept focused on the calcific deposit and the deposit was punctured multiple times with a 40-mm 17-gauge needle. A second 40-mm 17 gauge needle was introduced from a different angle and lavage and aspiration of the deposit with a saline solution was performed. After the UGN procedure, one of the needles was introduced in the subacromial bursa under ultrasonic guidance and a mixture of 4 cc of bupivacaine HCL 0.5% and

 1 cc Depo-Medrol 40 mg/mL was injected.

The sterile drapes were removed and the puncture site was sealed with an island dressing.

After treatment, both groups followed a standardized physical therapy program including active and passive exercise mobilization techniques. Oral analgesics were administered for a maximum of 7 days postintervention when necessary. The medication was only prescribed once.

Describe control (treatment/procedure/test):

Patients with calcific tendinitis of the rotator cuff. ESWT: High-energy shockwave therapy is a technique in which monophasic pressure pulses with high peak pressure are distributed to the calcific deposit and the surrounding soft tissues through, in this study, a piezoelectric mechanism. The shockwave group was treated with 4 sessions of high-energy ESWT with a 1 week interval. Each session consisted of 2000 piezo

electric pressure pulses, focused on the calcific deposit, at a frequency of 4 Hz with a total energy flux density of 0.351 mJ/mm2 resulting in a total energy amount of 2808 mJ. The

 calcific deposit was localized by ultrasound with the patient positioned in a supine position. Patients initially received a small amount of low-energy pulse to get used to the sensation after which the actual therapeutic dose was administered.

After treatment, when necessary the shoulder was cooled with ice packs.

After treatment, both groups followed a standardized physical therapy program including active and passive exercise mobilization techniques. Oral analgesics were administered for a maximum of 7 days postintervention when necessary. The medication was only prescribed once.

Length of follow-up:

Loss-to-follow-up:

Intervention: 3

N (%)

Reasons (describe) not reported

Control: 2

N (%)

Reasons (describe) not reported

Incomplete outcome data:

Intervention:

N (%)

Reasons (describe)

Control:

N (%)

Reasons (describe)

Outcome measures and effect size (include 95%CI and p-value if available):

6 months

1. Pain

Baseline score VAS (Mean, SD)

I: 6.0 (1.5)

C: 5.8 (1.8)

Vas pain (Change from Baseline) (Mean, 95% CI)

I: -2.9 (-3.6; -2.2)

C: -2.3 (-3.3; -1.3)

(p=.28)

VAS score at 6 months

I: 3.1

C: 3.5

2. PROMS for function:

2.1. CMS (change from baseline)

I: 12.4 (7.1; 17.6)

C: 13.3 (7.8; 18.8)

(p=.80)

2.2. DASH (change from baseline)

I: -13.6 (-18.5; -8.7)

C: -17.6 (-24.1; -11.1)

(p=.32)

2.3. WORC

Not reported

2.4. ASES

Not reported

2.5. OSS

Not reported

2.6. DSST

Not reported

3. Patient satisfaction

Not reported

4. Complications/adverse events

Not reported

12 months

1. Pain

Vas pain (Change from Baseline) (Mean, 95% CI)

I: -3.9 (-4.6; -3.1)

C: -2.6 (-3.7; -1.6)

(p=.05)

VAS score at 12 months

I: 2.1

C: 3.2

2. PROMS for function:

2.1. CMS (change from baseline)

I: 20.9 (16.9; 24.8)

C: 15.7 (10.1; 21.3)

(p=.13)

2.2. DASH (change from baseline)

I: -20.1 (-25.4; -14.8)

C: -20.7 (-27.2; -14.2)

(p=.87)

2.3. WORC

Not reported

2.4. ASES

Not reported

2.5. OSS

Not reported

2.6. DSST

Not reported

3. Patient satisfaction

VAS for satisfaction (mean satisfaction scores)

I: 7.0 ± 2.8

C: 7.6 ± 2.2

4. Complications/adverse events

Not reported

Comments:

Conclusion: 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.

Clinical trial registered: NL4304/NTR4448.

Pain: measured using VAS: VAS for average pain during the last week and VAS for satisfaction. At 6 months and 1 year, the patients’ reported change in symptoms were screened using a 7-point Likert scale.

CMS: 0-100 point scale.

 In total, 26 patients received an additional treatment due to persistent pain and symptoms: 9 patients (22%) in the UGN group and 17 (41%) in the ESWT group.

Study reference

(first author, publication year)

Was the allocation sequence adequately generated?

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

LOW

Some concerns

HIGH

Castillo-Gonzalez (2016)

Probably yes

Reason:

Using tables of randomized numbers (www. random

ized.org), a collaborator who took no further part in the study randomly assigned patients to undergo either ESWT or UGPL. The medical staff involved did not know to which arm the patients had been assigned before treatment began.

Probably no

Reason:

Not reported

Probably no

Reason:

Not reported. Solely stated that: all interventions in both groups were performed by

specialist medical staff, and that the extent of calcification was determined by a

specialist in radiodiagnosis (FCG) and it was always

measured by ultrasound imaging.

Definitely no

Reason:

It was frequent. In the UPGL group, 1 patient was loss to follow-up. In the ESWT group, 41 patients were loss to follow-up (did not complete treatment, or did not attend appointments).

Definitely yes

Reason:

All relevant outcomes measures were reported.

Probably yes

Reason:

Pain

Some concerns of bias

PROMs for function

Some concerns of bias

Patient satisfaction

Some concerns of bias

Complications/adverse events

Some concerns of bias

De Boer (2017)

Probably yes

Reason:

Randomization was done by allowing the patient to choose an unmarked envelope containing the treatment protocol for either UN or RSWT from a box.

The envelopes were randomized in blocks (6 envelopes, 3 of each treatment). When a block was finished the next block was started.

Probably no

Reason:

Concealment of allocation not reported (also not stated whether envelopes were transparent etc.)  

Probably no

Reason:

Not reported. It was stated that data was collected e.g. through self-reports (patients completed the oxford shoulder score and NRS at home before the start of the intervention and during the subsequent follow-up measurements), and e.g. NRS scoring was done by a nurse practitioner. However not stated whether this was blinded or not.

Probably no

Reason:

5 patients in the RSWT group were loss to follow-up, however due to change to UN group due to pain during the follow-up measurements.

In the UN group, one patients was loss to follow-up due to consistent pain.

Definitely yes

Reason:

All relevant outcomes measures were reported.

Probably no

Reason:

Baseline characteristics intervention and control group not reported: groups comparable at baseline? Unknown .

During the trial, the Data Safety Monitoring Board decided to stop the inclusion prematurely due to the extremely high NRS score of the patients in the RSWT group. Originally, 40 patients were needed for inclusion (power calculation), however when the study terminated 25 patients were included.

Pain

High concerns of bias

PROMs for function

High concerns of bias

Patient satisfaction

High concerns of bias

Complications/adverse events

High concerns of bias

Kim (2014)

Probably yes

Reason:

The randomization was conducted by an independent statistician who provided us

 with a computer-generated randomization list.

Probably no

Reason:

Not reported

Probably no

Reason:

Solely reported that of the radiological outcomes, the resorption of the calcific deposit was graded by another

 physician who was blinded to the treatment status and grouping.

However, this was not reported for the clinical outcome measures.

Probably yes

Reason:

Loss to follow-up during procedure and follow-up occurred, however the number and reasons for people lost to follow-up were comparable in both groups.

Definitely yes

Reason:

All relevant outcomes measures were reported.

Probably yes

Reason:

None

Pain

Some concerns of bias

PROMs for function

Some concerns of bias

Patient satisfaction

Some concerns of bias

Complications/adverse events

Some concerns of bias

Kuo (2022)

Probably yes

Reason: an assignment scheme was generated from a table of random numbers. Written informed consent was obtained from all patients, who were subsequently randomly divided into three treatment groups: USNP, RSWT, and RSWT plus USNP (COMB).

Definitely no

Reason:

Not reported

Probably no

Reason:

The article reported that all assessments were performed by a masked assessor who was a trained study assistant. The patients were instructed not to reveal any treatment details to the assessor.

Definitely yes

Reason:

Solely one patient was loss to follow-up during postop.

Definitely yes

Reason:

All relevant outcomes measures were reported.

Probably yes

Reason:

None

Pain

Some concerns of bias

PROMs for function

Some concerns of bias

Patient satisfaction

Some concerns of bias

Complications/adverse events

Some concerns of bias

Louwerens (2020)

Probably yes

Reason: A research nurse allocated the patients to 1 of 2 treatment groups using the computer-generated block randomization function (10 patients per block) in Research

 Manager.

Definitely no

Reason:

Not reported

Probably no

Reason: for the assessment of the radiological outcomes: the independent physician was blinded for the allocated treatment.

Patient and healthcare provider not blinded.

Probably yes

Reason:

Respectively 2 and 3 patients were lost to follow-up. Solely one patient was loss to follow-up during postop.

Study performed a per protocol analysis and an intention to treat analysis.

Definitely yes

Reason:

All relevant outcomes measures were reported.

Probably yes

Reason:

In total, 26 patients received an additional treatment due to persistent pain and symptoms: 9 patients (22%) in the UGN group and 17 (41%) in the ESWT group (additional treatment could be: subacromial infiltration, and when being in the ESWT group: US-guided needling or arthroscopic surgery).

Pain

Some concerns of bias

PROMs for function

Some concerns of bias

Patient satisfaction

Some concerns of bias

Complications/adverse events

Some concerns of bias