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. 2020 Mar 4;2020(3):CD008962. doi: 10.1002/14651858.CD008962.pub2

Kvalvaag 2017.

Methods Study design: single‐centre, parallel‐group, two‐arm, double‐blind, randomised sham‐controlled trial
Setting: outpatient shoulder clinic, Department of Physical Medicine and Rehabilitation, Oslo University hospital, Norway
Trial time period: enrolment 1 January 2012 to 15 April 2014
Interventions: supervised exercises plus rESWT vs supervised exercises plus sham rESWT
Sample size calculation: study was designed to detect a clinically relevant difference of 10 points (SD 20 points) between the groups with significance level (a) of 0.05 and power (b) of 80%. The sample size was calculated as 50 in each group. We included 143 participants to account for dropouts.
Analysis: ITT
Participants Number of participants:

  • screened: 265 (62 not meeting inclusion criteria; 60 declined to participate)

  • enrolled: 143

  • randomised: 143 (69 in supervised exercises plus rESWT group; 74 in supervised exercises plus sham group)

  • included in analyses at 24 weeks: 143 (69 in supervised exercises plus rESWT group; 74 in supervised exercises plus sham group)


Inclusion criteria:

  • aged 25–70 years

  • subacromial pain lasting for 3 months

  • dysfunction or pain on abduction

  • pain on 1 of 2 isometric tests (abduction or external rotation)

  • positive Hawkins sign

  • normal passive glenohumeral ROM

  • people with bilateral shoulder pain were included if both shoulders fulfilled the inclusion criteria.


Exclusion criteria:

  • previous surgery on affected shoulder

  • instability

  • total rupture of the rotator cuff (evaluated clinically or by US)

  • clinical signs of a cervical syndrome

  • infection in area

  • considered unable to fill out questionnaires or to go through the treatment

  • use of anticoagulant drugs or bleeding disorder

  • pregnancy

  • previous experience of 1 of the study interventions

  • corticosteroid injection in past 6 weeks

  • SPADI < 20


Baseline characteristics:
Supervised exercises plus rESWT (69 participants)

  • mean (SD) age: 47.6 (9.9) years

  • number male/female: 32/37

  • number (%) taking daily analgesics: 11 (15.9)

  • number (%) of symptoms: at 3–6 months: 12 (17.4), at 6–12 months: 18 (26.1), at 12–24 months: 14 (20.3), at ≥ 24 months: 25 (36.2)

  • mean (SD) emotional distress (1–4): 1.6 (0.4)

  • mean (SD) EQ‐VAS 0–100: 63.8 (19.5)

  • number (%) US examination: bursal thickening or effusion: 23 (33.3), tendinopathy in rotator cuff: 53 (76.8)

  • calcification in rotator cuff: 23 (33.3), partial thickness tear of rotator cuff: 28 (40.6), full‐thickness tear of rotator cuff: 2 (2.9)

  • mean (SD) SPADI score: 51.8 (17.5)

  • mean (SD) pain at rest (0–10 score, 10 indicating worst pain): 4.4 (2.4)

  • mean (SD) pain during activity (0–10 score): 6.4 (2.1)

  • mean (SD) function: carrying bag 4.9 (3.2), taking an item down from a shelf: 6.6 (2.4)


Supervised exercises plus sham rESWT (74 participants)

  • mean (SD) age: 46 (10.9) years

  • number male/female: 33/41

  • number (%) on daily analgesics: 9 (12.2)

  • number (%) of symptoms: at 3–6 months: 17 (23), at 6–12 months: 19 (25.7), at 12–24 months: 13 (17.6); at ≥ 24 months: 25 (33.8)

  • mean (SD) emotional distress (1–4): 1.6 (0.5)

  • mean (SD) EQ‐VAS 0–100: 65.8 (20.0)

  • number (%) US examination: bursal thickening or effusion: 32 (43.8); tendinopathy in rotator cuff50 (67.6), tendinopathy in rotator cuff: 50 (67.6)

  • calcification in rotator cuff: 23 (31.1), partial thickness tear of rotator cuff: 35 (47.3), full‐thickness tear of rotator cuff: 4 (5.4)

  • mean (SD) SPADI score: 51.9 (16.7)

  • mean (SD) pain at rest (0–10 score, 10 indicating worst pain): 4.3 (2.3)

  • mean (SD) pain during activity (0–10 score): 6.7 (1.8)

  • mean (SD) function: carrying bag 5.5 (2.8), taking an item down from a shelf: 6.4 (2.9)


Pretreatment group differences: none.
Interventions Supervised exercises plus rESWT:
Supervised exercises:

  • method of administration: experienced physiotherapists supervised the exercise regimen which were conducted 1:1. The first session included gathering of medical history and bilateral inspection of alignment, including scapula and the glenohumeral joint. Movement pattern, the immediate cocontraction, and timing of the scapula and the arm were observed during elevation to obtain a functional diagnosis for individual guidance of treatment. The principal treatment focus was on relearning of normal movement patterns, which could then be transferred to daily activities. The initial aim was to unload the stress on the rotator cuff and subacromial structures. This phase entailed awareness of posture and the use of manual techniques for tense muscles, an elastic rubber band for relaxed repetitive movements, exercises for periscapular muscles and a vertically fixed sling. The focus in next phase was to increase the eccentric force when the participant was lowering the arm in standing position. This training incorporates scapular control and dynamic scapular stability. The participants received immediate feedback from and correction (supervision) by the physiotherapist. Subsequently, endurance exercises with gradually increasing resistance were performed. The participants also performed exercises at home, usually with a thin elastic cord.

  • dose: each exercise session lasted 40 minutes

  • frequency: once a week for 4 weeks followed by twice a week for the next 8 weeks

  • co‐interventions: none reported


rESWT:

  • description of modality used: EMS Swiss DolorClast/Enimed

  • method of administration: rESWT was applied on the muscle tendon(s) that were painful on isometric tests using a power handpiece, which gives a maximum energy of 0.35 mJ/mm². rESWT was performed by physiotherapists who underwent an application course and training before the study started.

  • dose: 2000 impulses on each painful tendon with pressure 1.5–3 bar, depending on participant tolerance.

  • frequency: once a week for 4 weeks

  • co‐interventions: none reported


Supervised exercises plus sham rESWT:
Supervised exercises:

  • as above


Sham rESWT:

  • method of administration: the EMS Swiss DolorClast/Enimed was used to deliver sham RSWT on the muscle tendon(s) that were painful on isometric tests; however, there was no information on how the therapy was delivered as a sham procedure. The sham handpiece was similar to the real handpiece in design, shape and sound, and vibrated exactly like the real handpiece, but no real shock waves were conducted

  • frequency: once a week for 4 weeks

  • co‐interventions: none reported
Outcomes Measured at baseline, 12 and 24 weeks
Outcomes included in review:

  • SPADI score 0–100, higher score indicating worse pain and disability

  • pain at rest measured on a 11‐point Likert type scale, 10 indicating worst possible pain/function)

  • adverse events

  • withdrawals due to adverse events, intolerance to treatment or other reasons


Outcomes excluded from review:

  • pain during activity measured on a 11‐point Likert‐type scale, 10 indicating worst possible pain/function)

  • function measured on a 11‐point Likert type scale
Source of funding Sophies Minde Ortopedi, Norway
Notes Trial registration: ClinicalTrials.gov identifier NCT01441830
Time points included in review: 12 and 24 weeks
Data analysis: function measured on SPADI and pain on the 11‐point Likert‐type scale were extracted at 12 and 24 weeks
Withdrawals: 4/69 in shock wave group (2 loss to follow‐up, 2 discontinued intervention (1 developed adhesive capsulitis and 1 developed synovial chondromatosis)) and 4/74 in sham group (1 loss to follow‐up, 3 discontinued intervention, (1 developed adhesive capsulitis, 1 developed increased pain, 1 developed other serious disorder))
Adverse events:
Supervised exercise plus rESWT:

  • serious adverse events: 0/69

  • other adverse events: 2/69


Supervised exercise plus sham rESWT:

  • serious adverse events: 0/74

  • other adverse events: 3/74
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation in blocks of 20 in a 1:1 ratio used.
Allocation concealment (selection bias) Low risk Allocation concealed using sealed opaque envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding of participants and study personnel was done.
Blinding of outcome assessment (detection bias) 
 Self‐reported outcomes Low risk Blinding of participants resulted in low risk of bias in self‐reported outcomes of pain, disability and function.
Blinding of outcome assessment (detection bias) 
 Assessor‐reported outcomes Low risk Blinding of outcome assessors was done; however, not applicable in the measurement of study outcomes which were all self‐reported.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 8 withdrawals from this study, 4/69 in supervised exercise plus rESWT group and 4/74 in supervised exercise plus sham group, however none were excluded from the analysis in both groups.
Selective reporting (reporting bias) Unclear risk Study protocol and trial registration accessible to review authors. All measured outcomes were reported; however, the protocol stated return to work and health‐related quality of life as secondary outcomes, which were not measured in study.
Other bias Low risk No other biases apparent.