| Literature DB >> 31191975 |
Dimitrios Challoumas1, Christopher Clifford1,2, Paul Kirwan3,4, Neal L Millar1.
Abstract
PURPOSE: To assess the effectiveness of surgery on all tendinopathies by comparing it to no treatment, sham surgery and exercise-based therapies for both mid-term (12 months) and long-term (> 12 months) outcomes.Entities:
Keywords: physiotherapy; sham surgery; surgery; tendinopathy; tendon
Year: 2019 PMID: 31191975 PMCID: PMC6539146 DOI: 10.1136/bmjsem-2019-000528
Source DB: PubMed Journal: BMJ Open Sport Exerc Med ISSN: 2055-7647
Figure 1PRISMA flow diagram of included studies. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
Methodological characteristics of included studies
| First author— tendinopathy | Study type | Randomisation method | Blinding method | Allocation concealment | Statistical power calculation | Baseline comparison | Inclusion criteria | Exclusion criteria | Follow-up completion |
| Brox | Randomised controlled trial | Random permuted blocks | Patients wearing t-shirts at follow-up to hide scar; patients asked not to talk to assessor about treatment | – | Yes, 90% | Less women in surgery group | Age 18–66 y, shoulder pain for >3 m, resistant to physio and drugs, dysfunction/pain on abduction, normal passive ROM, pain during two of the three isometric-eccentric tests, positive impingement tests | Acromioclavicular joint arthritis, cervical syndrome, rotator cuff rupture, glenohumeral instability, bilateral muscular pain with tenderness and severely decreased ability to relax the shoulder/neck/temporomandibular joint on examination, reluctant to accept one or more of the treatment regimens of the study | 99% |
| Rahme | Randomised controlled trial | Blocked randomisation | Independent assessor | – | No | No comparison | Isolated shoulder disease, working age, shoulder pain >1 y at rest accentuated by movements involving elevation, positive Hawkins (impingement) sign, positive impingement test (relief of symptoms within 15 min of injection of local anaesthetic) | Glenohumeral osteoarthritis, those requiring resection of the lateral end of the clavicle | 93% |
| Rompe | Randomised trial (non-controlled) | Based on whether reimbursement for ESWT was approved by insurance company | Not blinded | – | – | No differences | Calcareous deposit on standard AP radiographs of a diameter of at least 10 mm; the morphological features of the deposit had to be homogeneous in appearance and with well-defined borders, or inhomogeneous in structure with sharp outline or homogeneous in structure with no defined border, shoulder pain for more than 12 m, clinical signs of subacromial impingement, unsuccessful conservative therapy in the previous 6 m, no evidence of bone-related anatomic outlet impingement or functional outlet impingement as seen on radiographs or MRI | Cloudy and transparent appearance of deposit, radiological signs of spontaneous resorption, evidence of type III acromial morphological feature according to Bigliani | 75% |
| Haahr | Randomised controlled trial | Computer-generated random sequence generation | Not blinded | Sealed envelopes | Yes, 80% | More sick leave due to more severe shoulder pain in surgery group | Fulfilment of all diagnostic criteria (shoulder pain, pain on abduction with painful arc, Hawkins sign, positive impingement test (relief of symptoms within 15 min of injection of local anaesthetic), symptoms 6 m–-3 y, age 18–55 y, normal passive glenohumeeal movements | Impaired glenohumeral rotation, history of acute trauma, previous surgery of fracture near affected shoulder, known OA in glenohumeral or acromioclavicular joint, clacifications >2 cm in rotator cuff tendons, rupture of the cuff, cervical root syndromes | 93% |
| Ketola | Randomised controlled trial | Computer-generated numbers | Independent physiotherapist conducted 5-year assessment; participants wearing t-shirts to cover scars and asked not to indicate treatment group | Randomisation by independent statistician; | Yes, 80% | No difference in outcome measures, no comparison of demographics | Clinical symptoms of shoulder impingement, positive Neer’s test, symptoms for at least 3 m, failed management with rest, NSAIDs, steroid injections and regular physiotherapy, age 18–60 y, no previous shoulder operations, willingness and capacity to comply with study protocol | OA, glenohumeral instability, penetrating rotator cuff rupture, cervical radiculopathy, adhesive capsulitis, shoulder neuropathy | 78% |
| Farfaras | Randomised controlled trial | Envelopes divided in boxes based on sex and age | Independent physiotherapist conducted assessment; participants encouraged to wear a t-shirt at follow-up to conceal their scar | – | Yes, sample size not enough for 80% power | No difference | Positive Neer and Hawkins tests, failed conservative management, subacromial pain for more than 6 m | Diabetes mellitus, neurological or spine disorders, radiographic OA, chronic joint disorders, full-thickness rotator cuff tear, subacromial impingement syndrome stage 3 | 63% |
| Beard | Randomised controlled trial | Automated computer-generated minimisation system | Double blinded except ‘no treatment’ group; | Centralised telephone randomisation centre used | Yes, 90% | No difference | Subacromial pain for at least 3 m, consultant’s clinical diagnosis, eligible for arthroscopic surgery, completion of conservative management programme including physiotherapy and at least one steroid injection | Full-thickness rotator cuff tear, other shoulder pathology identified on MRI or USS, previous shoulder surgery on affected side, RA or other inflammatory joint conditions, cervical spine pathology, previous septic arthritis in shoulder, radiotherapy in same side as affected shoulder, lacking consent, cognitive impairment or language issues, unable to perform clinical assessments, >75 y of age | 81% |
| Bahr | Randomised controlled trial | Randomisation sequence in blocks of four created by statistician; those who had failed eccentric strengthening were allocated to secondary surgery group | Not blinded | Sealed envelopes; | Yes, 90% | No differences | History of exercise-related pain in proximal patellar tendon or patellar insertion and tenderness to palpation, pain during and after activity and unable to participate in sports at same level as before onset of pain, thickening and increased signal intensity on MRI | History of knee/patellar tendon surgery, inflammatory or degenerative joint condition, less than 18 y of age, inability to understand oral and written Norwegian | 88% |
| Alfredson | Randomised trial (non-controlled) | Box with envelopes | Not blinded | Opaque envelopes | No | No comparison as information not provided | – | – | 95% |
| Radwan | Randomised trial (non-controlled) | Closed envelopes | Not blinded | Closed envelopes | Yes, 80% | Characteristics of two groups presented but comparison not performed | Established diagnosis of lateral epicondylitis with failure of conservative Tx for 6 m (NSAIDs, steroid injections, physical therapy, exercise programme, elbow brace) | Younger than 18 y, local infection, malignancy, elbow arthritis, generalised polyarthritis, ipsilateral shoulder dysfunction, neurological abnormalities, radial nerve entrapment, cardiac arrhythmia, pacemaker, steroid injection last 6 w, pregnancy | 89% |
| Kroslak | Randomised controlled trial | Computer-generated code | Double blinded | Sealed, unmarked envelopes | Yes, 90% but not enough participant recruited | >18 y of age, clinical diagnosis lateral epicondylitis (point tenderness over lateral epicondyle and worse pain with chair pick-up test and maximal hand grip), failed conservative therapy for 6 m (including injections) | Previous surgery or dislocation of affected elbow, steroid injection in last 3 m, inadequate skin coverage over elbow, sensory/motor changes distal to elbow, unwillingness/inability to attend follow-up or enter either treatment arm | 85% |
AP, antero-posterior;ESWT, extracorporeal shock wave therapy;m, months; MRI; magnetic resonance imaging; NSAIDs, non-steroidal anti-inflammatory drugs;OA, osteoarthritis;RA, rheumatoid arthritis;ROM, range of movement;USS, ultrasound scan;w, weeks;y, years.
Description of samples, interventions and outcome measures
| First author | Tendon affected | Min duration of symptoms | Sample, mean/median age (range), %F | Interventions | Supervision? (physio only) | Follow-up | Outcome measures |
| Brox | Rotator cuff | 3 m | N=125; mean 48 y (18–66 y); 47% | Arthroscopic surgery (n=45) or | Yes, 3–6 m | 3 m, 6 m, 2.5 y | (a) Neer shoulder score (pain during previous week 0–35, function tests (muscle tests, reaching ability, stability 0–30 and active ROM 0–25), anatomical/radiological evaluation 0–10), (b) pain at rest, at night, during activity during previous week (1–9), (c) emotional distress with Hopkins symptom checklist (0–25), (d) costs |
| Rahme | Rotator cuff | 12 m | N=42; mean 42 y (28–63 y); 55% | Open surgery (n=21) | Yes, not stated | 6 m, 12 m | (a) VAS for pain at rest plus VAS for pain during ‘pour out of pot’ manoeuvre (treatment success if >50% improvement compared with baseline) |
| Rompe | Rotator cuff | 12 m | N=79; mean 50.8 y (31–68 y); 61% | ESWT 3000 impulses, 0.6 mJ/mm2(n=50) or | 12 m, 24 m | (a) UCLA rating for pain and function of the shoulder (Kay and Amstutz): max score 35 points; pain 1–10, function 1–10, active range forward flexion 0–5, strength in forward flexion 0–5, patient satisfaction 0–5, (b) Outcomes score (>33 excellent, 29–33 good,<29 poor), (c) radiological evaluation: AP radiograph 1 day before surgery or ESWT and at 12 m; resorption graded as none, partial or complete | |
| Haahr | Rotator cuff | 6 m | N=90; mean 44.4 y(; 69% | Arthroscopic surgery (n=45) | Yes, 12 w | 3 m, 6 m, 12 m, >4 y | (a) Constant score (primary outcome; 0–100; includes VAS for pain, limitations in ADLs, active ROM of glenohumeral joint in four directions, isometric shoulder strength measurement), (b) Likert scale (0–9, numerical box complaint scale), (c) employment within last 3 m, (d) sick leave, (e) labour compensation claims |
| Ketola | Rotator cuff | 3 m | N=140; mean 47.1 y (23–60 y); 63% | Arthroscopic surgery +physiotherapy (n=70) | Yes, mean 6.5 visits | 3 m, 6 m, 12 m, 24 m, 60 m | (a) VAS for pain (0–10; primary measure), (b) VAS for disability (0–10), (c) VAS for working ability (0–10), (d) VAS for pain at night (0–10), (e) SDQ score, (f) number of painful days in previous 3 m, (g) proportion of pain-free patients (VAS for pain <4), (h) health-related QoL (15-day tool) at 5 y |
| Farfaras | Rotator cuff | 6 m | N=87; mean 49.3 y (41–78); 51% | Arthroscopic surgery +physiotherapy (n=29) | Yes, 3–6 m | 2.5 y, >10 y | (a) Constant score (0–100; includes VAS for pain, limitations in ADLs, active ROM of glenohumeral joint in four directions, isometric shoulder strength measurement), (b) SF-36 (general health), (c) Watson & Sonnabend score (0–3, 14 questions), (d) ROM active elevation and internal rotation, (e) abduction strength, (f) USS and X-ray both shoulders |
| Beard | Rotator cuff | 3 m | N=313; mean 53 y 50% | Arthroscopic surgery (n=106) | 6 m, 12 m | (a) OSS (primary outcome; 0–48), (b) modified Constant-Murley Shoulder Score (for function and ROM), (c) Pain DETECT (questionnaire for neuropathic pain), (d) Quantitative sensory testing, (e) adverse events, (f) QoL life (EQ-5D-3L), (g) EQ VAS, (h) treatment expectations, (i) patient perception or satisfaction, (j) anxiety and depression (HADS score). | |
| Bahr | Patellar | 3 m | N=35 (40 tendons); mean 31 y (19–49 y); 14% | Open surgery +physiotherapy (n=20 tendons) or | Yes, 12 w | 3 m, 6 m, 12 m | (a) VISA score (0–100), (b) global evaluation score (−5 to +5), (c) treatment satisfaction (4-grade scale), (d) functional tests (standing jumps, counter-movement jumps and leg extension strength), (e) VAS score for pain after each functional test (0–10) |
| Alfredson | Achilles | 6 m | N=20; mean 46 y; 55% | Open surgery (n=10) or | 12 w, 6 m | (a) VAS for pain (0–100) during activity, (b) patient satisfaction (satisfied or not satisfied) | |
| Radwan | Wrist extensors | 6 m | N=56; mean 40 y (22–60 y); 41% | ESWT 1800 impulses, 0.22 mJ/mm2 (n=29) or | 3 w, 6 w, 12 w, 1 y | (a) Pain (at night, at rest) with VAS score (0–100), (b) residual pain at 12 m based on criteria by Roles & Maudsley (excellent, good, acceptable, poor), (c) tenderness with VAS score (0–100), (d) grip strength (scale 1–4), (e) treatment success: asymptomatic at 15 days | |
| Kroslak | Wrist extensors | 6 m | N=26 mean 51.5 y (41–77 y); 68% | Open surgery (n=13) | 2 w, 6 w, 12 w, 26 w, >1 y | (a) Pain (frequency and severity) with Likert-based verbal descriptor scale with activity, at rest and during sleep, (b) Self-rated function (picking up objects, twisting motions, elbow stiffness, overall elbow rating), (c) point tenderness (Likert verbal descriptor pain scale), (d) elbow stiffness and ROM, (e) Maximal force of wrist extension during chair pick-up test using ORI-TETS, (f) maximal grip strength |
ADLs, activities of daily living; AP, antero-posterior; EQ-5D-3L, EuroQoL 5 Dimensions 3 Level index; ESWT, extracorporeal shock wave therapy; HADS, Hospital Anxiety and Depression Score; ORI-TETS, Orthopaedic Research Institute Tennis Elbow Testing System; OSS, Oxford Shoulder Score; QoL, quality of life; ROM, range of movement; SDQ, Strengths and Difficulties Questionnaire; SF-36, Short Form Health Survey; UCLA, University of California Los Angeles score; USS, ultrasound scan; VAS, Visual Analogue Scale; VISA, Victorian Institute of Sport Assessment; m, months; w, weeks; y, years.
Quality assessment of included studies
| First author | Internal validity | External Validity | Precision | Overall quality | ||||||
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| Brox | Low | ? | High | Low | Low | High | Low | Low | Low | Moderate |
| Rahme | Low | ? | High | Low | High | High | High | High | Low | Poor |
| Rompe | High | ? | High | High | Low | Low | Low | Low | ? | Poor |
| Keizer | ? | ? | High | High | Low | High | High | Low | High | Poor |
| Haahr | Low | Low | High | High | Low | Low | Low | Low | Low | Moderate |
| Bahr | Low | Low | High | High | Low | Low | Low | Low | Low | Moderate |
| Alfredson | Low | Low | High | High | Low | High | High | High | High | Poor |
| Radwan | ? | Low | High | High | Low | Low | ? | Low | Low | Moderate |
| Ketola | Low | Low | High | Low | Low | High | ? | High | Low | Poor |
| Farfaras | Low | ? | High | Low | High | Low | Low | Low | High | Poor |
| Beard | Low | Low | Low | Low | Low | Low | Low | Low | Low | Good |
| Kroslak | Low | Low | Low | Low | Low | Low | Low | Low | High | Good |
Mid-term results (<1-year follow-up)
| Treatment modes | Tendon affected | First author (year) | Pain | Function | ROM | Strength | Satisfaction | Treatment Success | QoL | Complications |
| Surgery versus detuned laser or no treatment | Rotator cuff | Brox | ↓ | ↑ | ↑ | – | – | ↑ | – | ↔ |
| Rotator cuff | Beard | ↓ | ↑ | ↑ | – | ↑ | ↑ | ↑ | ↔ | |
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| – (4) | ↑ (3) |
| ↑ (3) |
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| Surgery versus sham surgery | Rotator cuff | Beard | ↔ | ↔ | ↔ | – | ↔ | ↔ | ↔ | ↔ |
| Wrist extensors | Kroslak | ↔ | ↔ | ↔ | ↔ | – | – | – | ↔ | |
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| ↔ (3) | ↔ (3) | ↔ (3) | ↔ (3) |
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| Surgery versus physiotherapy | Rotator cuff | Brox | ↔ | ↔ | ↔ | – | – | – | – | – |
| Rotator cuff | Rahme | ↔ | – | – | – | – | – | – | – | |
| Rotator cuff | Haahr | ↔ | ↔ | ↔ | ↔ | – | – | – | – | |
| Patellar | Bahr | ↔ | ↔ | – | ↔ | ↔ | ↔ | – | – | |
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| ↔ (3) | ↔ (3) | – (4) | – (4) | ||
| Surgery versus ESWT (evidence level) | Rotator cuff | Rompe | ↔ (3) | – (4) | – (4) | – (4) | – (4) | ↔ (3) | – (4) | – (4) |
| Surgery versus botox (evidence level) | Wrist extensors | Keizer | ↔ (3) | – (4) | ↔ (3) | ↔ (3) | – (4) | ↔ (3) | – (4) | – (4) |
| Surgery versus polidocanol (evidence level) | Achilles | Alfredson | ↔ (3) | – (4) | – (4) | – (4) | ↔ (3) | – (4) | – (4) | – (4) |
up arrow = increased; down arrow = decreased; side arrow = no changes
ESWT, extracorporeal shock wave therapy; QoL, quality of life.
Long-term results (>1-year follow-up)
| Treatment modes | Tendon affected | First author (year) | Pain | Function | ROM | Force | Satisfaction | Treatment Success | QoL | Complications |
| Surgery versus detuned laser or no treatment (evidence level) | Rotator cuff | Brox | – (4) | – (4) | – (4) | – (4) | – (4) | ↑ (3) | – (4) | – (4) |
| Surgery versus sham surgery (evidence level) | Wrist extensors | Kroslak | ↔ (3) | ↔ (3) | ↔ (3) | ↔ (3) | – (4) | – (4) | – (4) | ↔ (3) |
| Surgery versus physiotherapy | Rotator cuff | Brox | – | – | – | – | – | ↔ | – | – |
| Rotator cuff | Ketola | ↔ | – | – | – | – | ↔ | ↔ | ||
| Rotator cuff | Haahr | ↔ | ↔ | – | – | – | ↔ | – | – | |
| Rotator cuff | Farfaras | – | ↑ | ↑ | ↔ | – | ↔ | ↔ | ↔ | |
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| | ↑ (3) | ↑ (3) | ↔ (3) | - (4) |
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| ↔ (3) | ||
| Surgery versus ESWT | Rotator cuff | Rompe | ↔ | – | – | – | – | ↑ | ||
| Wrist extensors | Radwan | ↔ | – | – | ↔ | – | ↔ | – | – | |
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| – (4) | – (4) | ↔ (3) | – (4) | ↑ (3) | – (4) | – (4) | ||
| Surgery versus botox (evidence level) | Wrist extensors | Keizer | ↔ (3) | – (4) | ↔ (3) | ↔ (3) | – (4) | ↔ (3) | – (4) | – (4) |
Significant results (strong or moderate evidence) are highlighted in bold. Strong evidence (Level 1) is provided by generally consistent findings in multiple high-quality RCTs. Moderate evidence (Level 2) is provided by generally consistent findings in one high-quality RCT and one or more low-quality RCTs, or by generally consistent findings in multiple low-quality or moderate-quality RCTs. Limited or conflicting evidence (Level 3) is provided by only one RCT (either high or low quality), or by inconsistent findings in multiple RCTs. No evidence (Level 4) is defined by the absence of RCTs (van Tulder et al26, 2003).
ESWT, extracorporeal shock wave therapy; RCTs, randomised controlled trials.