Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.
Kanto K, Bäck M, Ibounig T, Björkenheim R, Malmivaara A, Czuba T, Inkinen J, Kalske J, Savolainen V, Sinisaari I, Toivonen P, Taimela S, Järvinen TLN, Paavola M, Finnish Shoulder Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators
- DOI
- 10.1136/bmj-2025-086201
- Record issued
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-20
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/4512cf4b-e234-4694-aeb2-c8126c768f41 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ClaimsOverstated claim−0.5★
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- Statistics were not checked: no recomputable values were found in this text — no test statistic reported with its degrees of freedom, no effect estimate printed with both a 95% CI and a p-value, and no percentage printed with both its count and its denominator.
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 24 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
- 01Efficacy rests on an unvalidated surrogate endpoint
The primary outcomes are patient-reported pain scores (VAS) at rest and on arm activity, which are subjective symptom measures rather than hard clinical outcomes. The paper does not demonstrate target engagement at the tested dose or cite validated evidence linking these surrogate measures to a hard clinical outcome. The minimal important difference (MID) of 15 points is defined, but the link to clinical meaningfulness is not validated.
“The primary outcomes were shoulder pain at rest and on arm activity, both assessed at 10 years using a visual analogue scale (VAS, ranging from 0 to 100, with 0 denoting no pain). The minimally important difference was defined as 15.”
- 02Treatment effect not shown to be clinically meaningful
The primary comparison (ASD vs placebo surgery) showed no significant difference, with mean differences of -1.5 points (95% CI -8.6 to 5.6) for pain at rest and -3.2 points (-13.0 to 6.5) for pain on arm activity. These differences are far below the predefined MID of 15 points, indicating no clinically meaningful effect. The paper concludes no benefit, but the effect sizes are not anchored to clinical meaningfulness beyond the MID.
“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest and −3.2 points (−13.0 to 6.5) in VAS pain score on arm activity.”
- 03Conclusion reaches beyond the evidence
ASD should not be offered outside clinical trials.
“Based on current evidence, ASD should not be offered outside rigorously designed clinical trials.”
ConclusionFind in source - 04Other integrity concern
Trial NCT00428870 was first submitted to ClinicalTrials.gov on 2007-01-29, after the registered study start date of 2005-02. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT00428870
reviewer’s wording
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This is a rigorously designed and transparently reported randomized placebo-surgery-controlled trial with 10-year follow-up. The paper demonstrates strong methodology across all eight dimensions, with minor reporting gaps (outlier handling, retrospective registration) and a small arithmetic inconsistency in the abstract.
Both reviewers independently scored all dimensions as pass, with only minor divergence on outlier handling (one rated it inadequate). The study type is interventional, agreed by both. Non-applicable criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification could not recompute any tests due to limited coverage, so statistical correctness is not fully confirmed.
Numerical inconsistencies
1 finding · worst lowValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
- Internal contradictions in the reported numbersAssessed
- lowinternal contradictionThe abstract states 168 participants (87%) completed follow-up, but 56+55+57=168, and 168/210=80%, not 87%. The percentage may be based on a different denominator (e.g., those not withdrawn).
“a total of 168 participants (87%) completed the 10 year follow-up.”
AbstractFind in source
Overstated conclusions
3 findings · worst highConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
- Efficacy rests on an unvalidated surrogate endpointAssessed
- Treatment effect not shown to be clinically meaningfulAssessed
- Conclusions overstated beyond the evidenceAssessed
3 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).
- overstatedReviewers 1, 2ASD should not be offered outside clinical trials.The conclusion that ASD should not be offered is a policy recommendation that goes beyond the trial's direct findings, though it is consistent with the evidence.Evidence: The trial shows no benefit, but the recommendation is an inference from the totality of evidence.
“Based on current evidence, ASD should not be offered outside rigorously designed clinical trials.”
ConclusionFind in source - supportedReviewers 1, 2ASD offers no benefit over placebo surgery at 10 years.The primary analysis shows no significant difference between ASD and placebo surgery for both primary outcomes, with CIs excluding the MID.Evidence: Primary outcomes: VAS at rest mean difference -1.5 (95% CI -8.6 to 5.6); VAS on activity -3.2 (-13.0 to 6.5).
“In patients with subacromial pain syndrome, ASD offered no benefit over placebo surgery or exercise therapy during 10 year follow-up.”
ConclusionFind in source - supportedReviewers 1, 2ASD offers no benefit over exercise therapy at 10 years.The pragmatic comparison shows no significant difference, with CIs including zero and not reaching the MID.Evidence: Mean difference −4.0 (95% CI −11.0 to 3.0) for VAS at rest and −9.4 (−19.0 to 0.3) for VAS on arm activity.
“No significant between group differences were observed for the secondary outcomes or adverse events.”
AbstractFind in source
Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.
- INADEQUATESurrogate endpointThe primary outcomes are patient-reported pain scores (VAS) at rest and on arm activity, which are subjective symptom measures rather than hard clinical outcomes. The paper does not demonstrate target engagement at the tested dose or cite validated evidence linking these surrogate measures to a hard clinical outcome. The minimal important difference (MID) of 15 points is defined, but the link to clinical meaningfulness is not validated.
“The primary outcomes were shoulder pain at rest and on arm activity, both assessed at 10 years using a visual analogue scale (VAS, ranging from 0 to 100, with 0 denoting no pain). The minimally important difference was defined as 15.”
- INADEQUATEEffect sizeThe primary comparison (ASD vs placebo surgery) showed no significant difference, with mean differences of -1.5 points (95% CI -8.6 to 5.6) for pain at rest and -3.2 points (-13.0 to 6.5) for pain on arm activity. These differences are far below the predefined MID of 15 points, indicating no clinically meaningful effect. The paper concludes no benefit, but the effect sizes are not anchored to clinical meaningfulness beyond the MID.
“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest and −3.2 points (−13.0 to 6.5) in VAS pain score on arm activity.”
Data authenticity concerns
1 finding · worst mediumAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
- Other integrity concernAssessed
2 integrity concerns flagged (0 high).
- mediumotherTrial NCT00428870 was first submitted to ClinicalTrials.gov on 2007-01-29, after the registered study start date of 2005-02. Retrospective registration means the protocol and outcomes were not on the public record before the study ran, which is what prospective registration exists to establish.
NCT00428870
reviewer’s wording
Reporting gaps
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The introduction cites eight RCTs and a Cochrane review, acknowledging the consistency of short-term null results and the lack of long-term data. The rationale for the trial is clearly linked to the gap in long-term evidence. Limitations of prior work (e.g., short follow-up, open-label designs) are implicitly addressed by the trial's design and placebo control.
“Yet eight randomised controlled trials have shown with notable consistency that ASD provides no short term (12 to 24 months) or medium term (≤5 years) advantage over placebo surgery or non-surgical management”
“We conducted a multicentre, randomised, placebo surgery controlled trial to evaluate the long term (10 year) efficacy of ASD compared with placebo surgery”
“Our efficacy design, with a placebo surgery comparator and high participant retention (87%), strengthens the reliability of the effect estimates”
“Yet eight randomised controlled trials have shown with notable consistency that ASD provides no short term (12 to 24 months) or medium term (≤5 years) advantage over placebo surgery or non-surgical management”
“We conducted a multicentre, randomised, placebo surgery controlled trial to evaluate the long term (10 year) efficacy of ASD compared with placebo surgery”
“Both CSAW and FIMPACT showed no meaningful benefit of ASD over placebo surgery for pain or functional outcomes in the short term (one year for CSAW, two and five years for FIMPACT ), a result now confirmed by FIMPACT’s 10 year follow-up as well.”
Randomization used sequentially numbered sealed opaque envelopes with varied block sizes, and participants and outcome assessors were blinded. A priori power analysis (n=204, 90% power) was reported. Inclusion/exclusion criteria were detailed. Outlier handling is addressed via the pre-specified analysis population (ITT, per-protocol, as-treated) and mixed model handling of missing data. Controls are inherent in the placebo surgery arm. Independent replication is not applicable for a single pivotal trial.
“Randomisation was carried out using sequentially numbered sealed opaque envelopes. A statistician with no involvement in the clinical care of trial participants prepared separate randomisation lists for each centre using varied block size.”
“The participants in the two primary study groups (ASD and placebo surgery) as well as individuals who collected the data were unaware of the study group assignments.”
“We calculated that a sample size of 204 participants (68 per arm; two sided α=0.05, β=90%) would be needed to detect a difference of at least the MID (15 points)”
“Randomisation was carried out using sequentially numbered sealed opaque envelopes. A statistician with no involvement in the clinical care of trial participants prepared separate randomisation lists for each centre using varied block size.”
“Participants and outcome assessors were blinded to group allocation in the primary (ASD versus placebo surgery) comparison.”
“We calculated that a sample size of 204 participants (68 per arm; two sided α=0.05, β=90%) would be needed to detect a difference of at least the MID (15 points)”
Sex and age are reported in Table 1. Health status is addressed through inclusion/exclusion criteria (e.g., no full-thickness rotator cuff tear, no osteoarthritis). Demographics include age, sex, and some functional status. Species/strain and housing are not applicable for a human trial.
“Age (years) | 50.5 (7.3) | 50.8 (7.6) | 50.4 (6.6) | | No (%) women | 42 (71) | 46 (73) | 47 (66)”
“Participants were considered eligible for the study if they were men or women aged 35-65 years, had experienced subacromial pain for longer than three months”
“Age (years) | 50.5 (7.3) | 50.8 (7.6) | 50.4 (6.6) | | No (%) women | 42 (71) | 46 (73) | 47 (66)”
“VAS score at rest* | 41.3 (25.8) | 41.6 (25.5) | 41.7 (27.5)”
The study was approved by the institutional review board of the Pirkanmaa Hospital District (R04200). Written informed consent was obtained from all participants. The trial was conducted in accordance with the Declaration of Helsinki.
“All participants gave written informed consent.”
“The trial was conducted in accordance with the Declaration of Helsinki.”
“All participants gave written informed consent.”
“The trial was conducted in accordance with the Declaration of Helsinki.”
The surgical procedures (ASD and placebo) are described in detail, including the equipment (4 mm arthroscope) and technique. No antibodies, cell lines, or reagents are used. Statistical software (Stata 18) is identified. The trial is scored because the surgical intervention is the key resource.
“we continued the surgery by performing a standard ASD procedure—a subacromial bursectomy and resection of bony spurs and the projecting anterolateral undersurface of the acromion with a shaver, burr, or electrocoagulation, or combination.”
“Stata version 18 (StataCorp, TX) was used for all statistical analyses.”
“We carried out arthroscopic examination of the glenohumeral joint and subacromial space and assessed rotator cuff integrity using standard posterior and lateral portals and a 4 mm arthroscope”
“Stata version 18 (StataCorp, TX) was used for all statistical analyses.”
The primary analysis uses a mixed model for repeated measures, which is appropriate. Effect sizes are reported with 95% CIs, and p-values are not the primary focus (estimation-based reporting). Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks were not applicable due to continuous outcomes and model-based estimates.
“A mixed model for repeated measurements analysis of variance was used with participant as a random factor (time points: three, six, 12, and 24 months, and five and 10 years), the baseline value as a covariate, and identity covariance as the covariance structure.”
“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest”
“A mixed model for repeated measurements analysis of variance was used with participant as a random factor (time points: three, six, 12, and 24 months, and five and 10 years), the baseline value as a covariate, and identity covariance as the covariance structure.”
“the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest”
The data availability statement provides a DOI for the dataset and states that code is in supplemental files. This is a concrete access route, satisfying the criterion. Repository deposit and accession numbers are covered by the DOI. Code sharing is via supplemental files, which is acceptable.
“The data underlying the findings in this paper are openly and publicly available at https://doi.org/10.23729/fd-d323a34b-f698-3bc6-b38d-9c93aeadbe74”
“The code used to analyse the data in the paper can be found in the supplemental files.”
“The data underlying the findings in this paper are openly and publicly available at https://doi.org/10.23729/fd-d323a34b-f698-3bc6-b38d-9c93aeadbe74”
“The code used to analyse the data in the paper can be found in the supplemental files.”
Trial registration number is provided (NCT00428870). CONSORT guidelines are followed. All pre-specified outcomes are reported, including null results. Limitations are discussed in the discussion and supplementary table S8. Conclusions are proportional to the evidence. Funding sources and COI are declared.
“ClinicalTrials.gov NCT00428870”
“Reporting follows the consolidated standards of reporting trials (CONSORT) guidelines.”
“The FIMPACT trial was supported by the Sigrid Juselius Foundation, State Research Funding for university level health research (Tampere and Helsinki University Hospitals), Academy of Finland, and Jane and Aatos Erkko Foundation.”
“ClinicalTrials.gov NCT00428870”
“Reporting follows the consolidated standards of reporting trials (CONSORT) guidelines.”
“The FIMPACT trial was supported by the Sigrid Juselius Foundation, State Research Funding for university level health research (Tampere and Helsinki University Hospitals), Academy of Finland, and Jane and Aatos Erkko Foundation.”
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Checked — nothing surfaced.
Checked 27 references by DOI: 25 verified — 2 no DOI (shown, not verified).
- NO DOIMinimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff diseaseNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIThe minimal detectable change of the Constant score in impingement, full-thickness tears, and massive rotator cuff tearsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 1 live.
- datahttps://doi.org/10.23729/fd-d323a34b-f698-3bc6-b38d-9c93aeadbe74LIVEHTTP 200Resolved page looks like data.
Copyediting
3 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 3 minor suggestions below.
3 copyedit issues flagged: mostly consistency, typo.
- MINORtypoMethods, Enrolment and randomisation“and a alcohol dependency”→ and an alcohol dependencyArticle error.
- MINORconsistencyAbstract, Results“a total of 168 participants (87%) completed the 10 year follow-up.”→ Verify that 168/210 = 80%, not 87%. The percentage may be based on a different denominator.Potential inconsistency in percentage calculation.
- MINORconsistencyAbstract, Results“a total of 168 participants (87%) completed the 10 year follow-up.”→ Verify that 168/210 = 80%, not 87%. The percentage appears inconsistent with the numbers.Potential arithmetic inconsistency in the abstract.
The published work is methodologically robust and transparent, with minor reporting gaps that an informed reader should weigh: the abstract's 87% completion figure appears inconsistent with the numbers (168/210=80%), and trial registration was retrospective. These do not undermine the core findings but warrant clarification or an erratum.
- 1.HIGHcopyeditIn the Abstract (Results), correct the percentage for participants completing 10-year follow-up: 168/210 = 80%, not 87%. Verify the denominator and adjust the text or provide the correct denominator.The stated 87% is arithmetically inconsistent with the reported numbers (168/210), which could mislead readers and reviewers.
- 2.HIGHreportingIn the Methods (Enrolment and randomisation), add a statement on how outliers were handled, e.g., whether any were identified and whether sensitivity analyses excluding them were performed.One reviewer flagged outlier handling as inadequate; explicit reporting would fully address the criterion.
- 3.HIGHreportingIn the Discussion or a footnote, acknowledge that trial registration (NCT00428870) was retrospective (first submitted 2007-01-29, after the study start date of 2005-02) and discuss any implications for transparency.Retrospective registration is a transparency concern that readers should be aware of; acknowledging it strengthens the paper's integrity.
- 4.MEDIUMcopyeditIn the Methods (Enrolment and randomisation), fix the article error: change 'and a alcohol dependency' to 'and an alcohol dependency'.Minor typo that should be corrected for professional presentation.
- 5.MEDIUMreportingIn the Discussion, temper the claim that 'ASD should not be offered outside clinical trials' to reflect that this is a policy recommendation extending beyond the trial's direct findings, or add supporting evidence.The claim audit flagged this as overstated; aligning the conclusion with the evidence avoids over-claiming.
- 6.MEDIUMdata codeConsider depositing the statistical analysis code in a public repository (e.g., GitHub) with a versioned DOI, in addition to supplemental files.Enhances reproducibility and discoverability beyond supplemental files.
- 7.MEDIUMreportingAdd a statement in the Methods or supplement on whether any post-hoc analyses were performed and how they were flagged.Transparency about post-hoc analyses helps readers interpret exploratory findings.
- 8.MEDIUMreportingAdd a note in the Methods on the handling of multiple comparisons for secondary outcomes, even if exploratory.Clarifies the risk of type I errors in secondary analyses.
- 9.LOWreportingConsider reporting exact p-values for secondary outcomes in supplementary tables to facilitate meta-analyses.While estimation-based reporting is acceptable, exact p-values aid future syntheses.
- 10.LOWreportingAdd a statement on the generalizability of findings to other healthcare settings, given the single-country setting.Helps readers assess external validity.
- 11.LOWreportingAdd a patient and public involvement statement in the main text, if not already present.Enhances transparency about patient engagement.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
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