Surgery for rotator cuff tears.
This review is one in a series of Cochrane Reviews of interventions for shoulder disorders.
To synthesise the available evidence regarding the benefits and harms of rotator cuff repair with or without subacromial decompression in the treatment of rotator cuff tears of the shoulder.
We searched the CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICRTP registry unrestricted by date or language until 8 January 2019.
Randomised controlled trials (RCTs) including adults with full-thickness rotator cuff tears and assessing the effect of rotator cuff repair compared to placebo, no treatment, or any other treatment were included. As there were no trials comparing surgery with placebo, the primary comparison was rotator cuff repair with or without subacromial decompression versus non-operative treatment (exercises with or without glucocorticoid injection). Other comparisons were rotator cuff repair and acromioplasty versus rotator cuff repair alone, and rotator cuff repair and subacromial decompression versus subacromial decompression alone. Major outcomes were mean pain, shoulder function, quality of life, participant-rated global assessment of treatment success, adverse events and serious adverse events. The primary endpoint for this review was one year.
We used standard methodologic procedures expected by Cochrane.
We included nine trials with 1007 participants. Three trials compared rotator cuff repair with subacromial decompression followed by exercises with exercise alone. These trials included 339 participants with full-thickness rotator cuff tears diagnosed with magnetic resonance imaging (MRI) or ultrasound examination. One of the three trials also provided up to three glucocorticoid injections in the exercise group. All surgery groups received tendon repair with subacromial decompression and the postoperative exercises were similar to the exercises provided for the non-operative groups. Five trials (526 participants) compared repair with acromioplasty versus repair alone; and one trial (142 participants) compared repair with subacromial decompression versus subacromial decompression alone. The mean age of trial participants ranged between 56 and 68 years, and females comprised 29% to 56% of the participants. Symptom duration varied from a mean of 10 months up to 28 months. Two trials excluded tears with traumatic onset of symptoms. One trial defined a minimum duration of symptoms of six months and required a trial of conservative therapy before inclusion. The trials included mainly repairable full-thickness supraspinatus tears, six trials specifically excluded tears involving the subscapularis tendon. All trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding, but also for other reasons such as unclearly reported methods of random sequence generation or allocation concealment (six trials), incomplete outcome data (three trials), selective reporting (six trials), and other biases (six trials). Our main comparison was subacromial decompression versus non-operative treatment and results are reported for the 12 month follow up. At one year, moderate-certainty evidence (downgraded for bias) from 3 trials with 258 participants indicates that surgery probably provides little or no improvement in pain; mean pain (range 0 to 10, higher scores indicate more pain) was 1.6 points with non-operative treatment and 0.87 points better (0.43 better to 1.30 better) with surgery.. Mean function (zero to 100, higher score indicating better outcome) was 72 points with non-operative treatment and 6 points better (2.43 better to 9.54 better) with surgery (3 trials; 269 participants), low-certainty evidence (downgraded for bias and imprecision). Participant-rated global success rate was 873/1000 after non-operative treatment and 943/1000 after surgery corresponding to (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.96 to 1.22; low-certainty evidence (downgraded for bias and imprecision). Health-related quality of life was 57.5 points (SF-36 mental component score, 0 to 100, higher score indicating better quality of life) with non-operative treatment and 1.3 points worse (4.5 worse to 1.9 better) with surgery (1 trial; 103 participants), low-certainty evidence (downgraded for bias and imprecision). We were unable to estimate the risk of adverse events and serious adverse events as only one event was reported across the trials (very low-certainty evidence; downgraded once due to bias and twice due to very serious imprecision).
At the moment, we are uncertain whether rotator cuff repair surgery provides clinically meaningful benefits to people with symptomatic tears; it may provide little or no clinically important benefits with respect to pain, function, overall quality of life or participant-rated global assessment of treatment success when compared with non-operative treatment. Surgery may not improve shoulder pain or function compared with exercises, with or without glucocorticoid injections. The trials included have methodology concerns and none included a placebo control. They included participants with mostly small degenerative tears involving the supraspinatus tendon and the conclusions of this review may not be applicable to traumatic tears, large tears involving the subscapularis tendon or young people. Furthermore, the trials did not assess if surgery could prevent arthritic changes in long-term follow-up. Further well-designed trials in this area that include a placebo-surgery control group and long follow-up are needed to further increase certainty about the effects of surgery for rotator cuff tears.
Karjalainen TV
,Jain NB
,Heikkinen J
,Johnston RV
,Page CM
,Buchbinder R
... -
《Cochrane Database of Systematic Reviews》
Arthroscopic surgery for degenerative knee disease (osteoarthritis including degenerative meniscal tears).
Arthroscopic knee surgery remains a common treatment for symptomatic knee osteoarthritis, including for degenerative meniscal tears, despite guidelines strongly recommending against its use. This Cochrane Review is an update of a non-Cochrane systematic review published in 2017.
To assess the benefits and harms of arthroscopic surgery, including debridement, partial menisectomy or both, compared with placebo surgery or non-surgical treatment in people with degenerative knee disease (osteoarthritis, degenerative meniscal tears, or both).
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and two trials registers up to 16 April 2021, unrestricted by language.
We included randomised controlled trials (RCTs), or trials using quasi-randomised methods of participant allocation, comparing arthroscopic surgery with placebo surgery or non-surgical interventions (e.g. exercise, injections, non-arthroscopic lavage/irrigation, drug therapy, and supplements and complementary therapies) in people with symptomatic degenerative knee disease (osteoarthritis or degenerative meniscal tears or both). Major outcomes were pain, function, participant-reported treatment success, knee-specific quality of life, serious adverse events, total adverse events and knee surgery (replacement or osteotomy).
Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and the certainty of evidence using GRADE. The primary comparison was arthroscopic surgery compared to placebo surgery for outcomes that measured benefits of surgery, but we combined data from all control groups to assess harms and knee surgery (replacement or osteotomy).
Sixteen trials (2105 participants) met our inclusion criteria. The average age of participants ranged from 46 to 65 years, and 56% of participants were women. Four trials (380 participants) compared arthroscopic surgery to placebo surgery. For the remaining trials, arthroscopic surgery was compared to exercise (eight trials, 1371 participants), a single intra-articular glucocorticoid injection (one trial, 120 participants), non-arthroscopic lavage (one trial, 34 participants), non-steroidal anti-inflammatory drugs (one trial, 80 participants) and weekly hyaluronic acid injections for five weeks (one trial, 120 participants). The majority of trials without a placebo control were susceptible to bias: in particular, selection (56%), performance (75%), detection (75%), attrition (44%) and selective reporting (75%) biases. The placebo-controlled trials were less susceptible to bias and none were at risk of performance or detection bias. Here we limit reporting to the main comparison, arthroscopic surgery versus placebo surgery. High-certainty evidence indicates arthroscopic surgery leads to little or no difference in pain or function at three months after surgery, moderate-certainty evidence indicates there is probably little or no improvement in knee-specific quality of life three months after surgery, and low-certainty evidence indicates arthroscopic surgery may lead to little or no difference in participant-reported success at up to five years, compared with placebo surgery. Mean post-operative pain in the placebo group was 40.1 points on a 0 to 100 scale (where lower score indicates less pain) compared to 35.5 points in the arthroscopic surgery group, a difference of 4.6 points better (95% confidence interval (CI) 0.02 better to 9 better; I2 = 0%; 4 trials, 309 participants). Mean post-operative function in the placebo group was 75.9 points on a 0 to 100 rating scale (where higher score indicates better function) compared to 76 points in the arthroscopic surgery group, a difference of 0.1 points better (95% CI 3.2 worse to 3.4 better; I2 = 0%; 3 trials, 302 participants). Mean post-operative knee-specific health-related quality of life in the placebo group was 69.7 points on a 0 to 100 rating scale (where higher score indicates better quality of life) compared with 75.3 points in the arthroscopic surgery group, a difference of 5.6 points better (95% CI 0.36 better to 10.68 better; I2 = 0%; 2 trials, 188 participants). We downgraded this evidence to moderate certainty as the 95% confidence interval does not rule in or rule out a clinically important change. After surgery, 74 out of 100 people reported treatment success with placebo and 82 out of 100 people reported treatment success with arthroscopic surgery at up to five years (risk ratio (RR) 1.11, 95% CI 0.66 to 1.86; I2 = 53%; 3 trials, 189 participants). We downgraded this evidence to low certainty due to serious indirectness (diversity in definition and timing of outcome measurement) and serious imprecision (small number of events). We are less certain if the risk of serious or total adverse events increased with arthroscopic surgery compared to placebo or non-surgical interventions. Serious adverse events were reported in 6 out of 100 people in the control groups and 8 out of 100 people in the arthroscopy groups from eight trials (RR 1.35, 95% CI 0.64 to 2.83; I2 = 47%; 8 trials, 1206 participants). Fifteen out of 100 people reported adverse events with control interventions, and 17 out of 100 people with surgery at up to five years (RR 1.15, 95% CI 0.78 to 1.70; I2 = 48%; 9 trials, 1326 participants). The certainty of the evidence was low, downgraded twice due to serious imprecision (small number of events) and possible reporting bias (incomplete reporting of outcome across studies). Serious adverse events included death, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and deep infection. Subsequent knee surgery (replacement or high tibial osteotomy) was reported in 2 out of 100 people in the control groups and 4 out of 100 people in the arthroscopy surgery groups at up to five years in four trials (RR 2.63, 95% CI 0.94 to 7.34; I2 = 11%; 4 trials, 864 participants). The certainty of the evidence was low, downgraded twice due to the small number of events.
Arthroscopic surgery provides little or no clinically important benefit in pain or function, probably does not provide clinically important benefits in knee-specific quality of life, and may not improve treatment success compared with a placebo procedure. It may lead to little or no difference, or a slight increase, in serious and total adverse events compared to control, but the evidence is of low certainty. Whether or not arthroscopic surgery results in slightly more subsequent knee surgery (replacement or osteotomy) compared to control remains unresolved.
O'Connor D
,Johnston RV
,Brignardello-Petersen R
,Poolman RW
,Cyril S
,Vandvik PO
,Buchbinder R
... -
《Cochrane Database of Systematic Reviews》
Kinesio taping for rotator cuff disease.
Kinesio Taping (KT) is one of the conservative treatments proposed for rotator cuff disease. KT is an elastic, adhesive, latex-free taping made from cotton, without active pharmacological agents. Clinicians have adopted it in the rehabilitation treatment of painful conditions, however, there is no firm evidence on its benefits.
To determine the benefits and harms of KT in adults with rotator cuff disease.
We searched the Cochrane Library, MEDLINE, Embase, PEDro, CINAHL, Clinicaltrials.gov and WHO ICRTP registry to July 27 2020, unrestricted by date and language.
We included randomised and quasi-randomised controlled trials (RCTs) including adults with rotator cuff disease. Major outcomes were overall pain, function, pain on motion, active range of motion, global assessment of treatment success, quality of life, and adverse events.
We used standard methodologic procedures expected by Cochrane.
We included 23 trials with 1054 participants. Nine studies (312 participants) assessed the effectiveness of KT versus sham therapy and fourteen studies (742 participants) assessed the effectiveness of KT versus conservative treatment. Most participants were aged between 18 and 50 years. Females comprised 52% of the sample. For the meta-analysis, we considered the last available measurement within 30 days from the end of the intervention. All trials were at risk of performance, selection, reporting, attrition, and other biases. Comparison with sham taping Due to very low-certainty evidence, we are uncertain whether KT improves overall pain, function, pain on motion and active range of motion compared with sham taping. Mean overall pain (0 to 10 scale, 0 no pain) was 2.96 points with sham taping and 3.03 points with KT (3 RCTs,106 participants), with an absolute difference of 0.7% worse, (95% CI 7.7% better to 9% worse) and a relative difference of 2% worse (95% CI 21% better to 24% worse) at four weeks. Mean function (0 to 100 scale, 0 better function) was 47.1 points with sham taping and 39.05 points with KT (6 RCTs, 214 participants), with an absolute improvement of 8% (95% CI 21% better to 5% worse)and a relative improvement of 15% (95% CI 40% better to 9% worse) at four weeks. Mean pain on motion (0 to 10 scale, 0 no pain) was 4.39 points with sham taping and 2.91 points with KT even though not clinically important (4 RCTs, 153 participants), with an absolute improvement of 14.8% (95% CI 22.5% better to 7.1% better) and a relative improvement of 30% (95% CI 45% better to 14% better) at four weeks. Mean active range of motion (shoulder abduction) without pain was 174.2 degrees with sham taping and 184.43 degrees with KT (2 RCTs, 68 participants), with an absolute improvement of 5.7% (95% CI 8.9% worse to 20.3% better) and a relative improvement of 6% (95% CI 10% worse to 22% better) at two weeks. No studies reported global assessment of treatment success. Quality of life was reported by one study but data were disaggregated in subscales. No reliable estimates for adverse events (4 studies; very low-certainty) could be provided due to the heterogeneous description of events in the sample. Comparison with conservative treatments Due to very low-certainty evidence, we are uncertain if KT improves overall pain, function, pain on motion and active range of motion compared with conservative treatments. However, KT may improve quality of life (low certainty of evidence). Mean overall pain (0 to 10 scale, 0 no pain) was 0.9 points with conservative treatment and 0.46 points with KT (5 RCTs, 266 participants), with an absolute improvement of 4.4% (95% CI 13% better to 4.6% worse) and a relative improvement of 15% (95% CI 46% better to 16% worse) at six weeks. Mean function (0 to 100 scale, 0 better function) was 46.6 points with conservative treatment and 33.47 points with KT (14 RCTs, 499 participants), with an absolute improvement of 13% (95% CI 24% better to 2% better) and a relative improvement of 18% (95% CI 32% better to 3% better) at four weeks. Mean pain on motion (0 to 10 scale, 0 no pain) was 4 points with conservative treatment and 3.94 points with KT (6 RCTs, 225 participants), with an absolute improvement of 0.6% (95% CI 7% better to 8% worse) and a relative improvement of 1% (95% CI 12% better to 10% worse) at four weeks. Mean active range of motion (shoulder abduction) without pain was 156.6 degrees with conservative treatment and 159.64 degrees with KT (3 RCTs, 143 participants), with an absolute improvement of 3% (95% CI 11% worse to 17 % better) and a relative improvement of 3% (95% CI 9% worse to 14% better) at six weeks. Mean of quality of life (0 to 100, 100 better quality of life) was 37.94 points with conservative treatment and 56.64 points with KT (1 RCTs, 30 participants), with an absolute improvement of 18.7% (95% CI 14.48% better to 22.92% better) and a relative improvement of 53% (95% CI 41% better to 65% better) at four weeks. No studies were found for global assessment of treatment success. No reliable estimates for adverse events (7 studies, very low certainty of evidence) could be provided due to the heterogeneous description of events in the whole sample.
Kinesio taping for rotator cuff disease has uncertain effects in terms of self-reported pain, function, pain on motion and active range of motion when compared to sham taping or other conservative treatments as the certainty of evidence was very low. Low-certainty evidence shows that kinesio taping may improve quality of life when compared to conservative treatment. We downgraded the evidence for indirectness due to differences among co-interventions, imprecision due to small number of participants across trials as well as selection bias, performance and detection bias. Evidence on adverse events was scarce and uncertain. Based upon the data in this review, the evidence for the efficacy of KT seems to demonstrate little or no benefit.
Gianola S
,Iannicelli V
,Fascio E
,Andreano A
,Li LC
,Valsecchi MG
,Moja L
,Castellini G
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《Cochrane Database of Systematic Reviews》