Arthroscopic Pan-Capsular and Transverse Humeral Ligament Release with Biceps Tenodesis for Patients with Refractory Frozen Shoulder

Round 1

Reviewer 1 Report (Previous Reviewer 1)

Overall improved, still introduction section is too extensive, going to much into discussion.

 

Author Response

Reviewer 1

Overall improved, still introduction section is too extensive, going to much into discussion.

Reply: We shortened the introduction in the revised manuscript. Thanks for the comment.

Author Response File: Author Response.docx

Reviewer 2 Report (New Reviewer)

Reviewer comments

Title

Arthroscopic Pan-Capsular and Transverse Humeral Ligament Release with Biceps Tenodesis for Patients with Refractory Frozen Shoulder

The authors discussed a very interesting topic. The manuscript is well written; However, some points need to be addressed.

 

·       25

and LHBT tenodesis

What is meant by this, did you men that the patient befitted from LHBT tenodesis..is it right or the sentence is confusing ?

·       47

various studies. [2, 3]

the citing of references after punctuation marks is not appropriate

·       64

Hagiwara et al. published

The reference was not added

·       96

Did the authors obtain consent rom the participants

·       96

Did the authors explain the methods to the participants

·       98

The authors should include the approval number

·       122

The authors should determine the sonographer experience and how the us scans were obtained

·       129

The authors did not determine how the sample size was calculated

·       213

The authors did not determine the us technique and if it was done by the same sonographer or by different one and how the bicipital tendinosis was defined

·       241

The authors did not determine what is meant by the letter ^a

·       5.2 ± 2.1

Not appropriate description of non-parametric data

·       88

From Oct 2013 to Jun 2019

In this section, the author did not determine the type of the study and if it was retrospective or prospective

However, at the end of the study, the authors mentioned that it was retrospective

The authors did not mention how they obtained all these data and how they reported

 

 

 

 

 

 

 

Author Response

Reviewer 2 

1. Line 25, …and LHBT tenodesis

What is meant by this, did you men that the patient benefitted from LHBT tenodesis..is it right or the sentence is confusing ?

Reply: Thanks for the comment. The sentence is rewritten into “The LHBT tenodesis decreased the possibility of LHBT instability.” to decrease the possibility of confusing.

2. various studies. [2, 3], the citing of references after punctuation marks is not appropriate.

Reply: Thanks for the comment. This is corrected.

3. Hagiwara et al. published…The reference was not added

Reply: Thanks for the comment. This reference is added.

4. Did the authors obtain consent from the participants

Reply: Yes, the authors obtained consent from all participants enrolled in this study. Thanks for the comment.

5. Did the authors explain the methods to the participants

Reply: Yes, the authors explained the methods to all participants enrolled in this study. Thanks for the comment.

6. The authors should include the approval number.

Reply: IRB 201900352B0 is included in the revised manuscript. Thanks for the comment.

7. The authors should determine the sonographer experience and how the us scans were obtained.

Reply: The ultrasonography was performed in consensus by 2 independent observers: 1 musculoskeletal radiologist and 1 orthopedic surgeon different from the operating surgeon. This is added in the revised manuscript. Thanks for the comment.

8. The authors did not determine how the sample size was calculated

Reply: An a priori power analysis was conducted to find the minimum sample needed to detect a difference in the pre-operative and pos-operative PVAS, SSV, ROM, AHD, and CSA. With alpha = 0.05, power set at 80%, and a standard deviation of 10, a minimum of thirty-three patients in each group was needed[1]. Above details are added to the revised manuscript. Thanks for the comment.

9. The authors did not determine the us technique and if it was done by the same sonographer or by different one and how the bicipital tendinosis was defined.

Reply: All the ultrasonography scans were performed using a Medison ACCUVIX V20 machine with 7.5–13 MHz linear array transducer (Medison America, Inc., Cypress, CA, USA). Standard scanning techniques and positions were used as described in previous studies[2, 3]. The OMERACT US definitions for tenosynovitis, synovitis, synovial hypertrophy and effusion were applied[4]. The criteria for biceps tendinosis were defined as the presence of an increased Doppler signal plus one of the following features: (1) thickening of the biceps tendon; (2) evidence of synovial thickening of more than 3 mm; (3) evidence of fluid collection in the biceps tendon sheath of more than 3 mm; and (4) splitting and hypoechoic change of the biceps tendon  or a negative Doppler signal but with two of the above mentioned features as previously described[5]. Above details are added to the revised manuscript. Thanks for the comment.

10. The authors did not determine what is meant by the letter ^a

Reply: The letter” ^a” was a type. It is corrected in the revised manuscript. Thanks for the comment.

11. Not appropriate description of non-parametric data

Reply: 5.2 ± 2.1 meant the number of previous injections. Thanks for the comment.

12. From Oct 2013 to Jun 2019…In this section, the author did not determine the type of the study and if it was retrospective or prospective. However, at the end of the study, the authors mentioned that it was retrospective. The authors did not mention how they obtained all these data and how they reported

Reply: From Oct 2013 to Jun 2019, patients with refractory frozen shoulder were enrolled in this retrospective study. It is mentioned in the revised manuscript. The written informed consent was obtained from all participants enrolled in this study. The authors explained the methods to all participants enrolled in this study. Thanks for the comment.

References

[1] Cuff DJ, Pupello DR. Comparison of hemiarthroplasty and reverse shoulder arthroplasty for the treatment of proximal humeral fractures in elderly patients. JBJS. 2013;95:2050-5.

[2] American Institute of Ultrasound in Medicine. Official statement: training guidelines for the performance of musculoskeletal ultrasound examinations. 2009.

[3] Rutten MJ, Maresch BJ, Jager GJ, Blickman JG, van Holsbeeck MT. Ultrasound of the rotator cuff with MRI and anatomic correlation. European journal of radiology. 2007;62:427-36.

[4] Wakefield RJ, Balint PV, Szkudlarek M, Filippucci E, Backhaus M, D'Agostino M-A, et al. Musculoskeletal ultrasound including definitions for ultrasonographic pathology. The Journal of rheumatology. 2005;32:2485-7.

[5] Chen H-S, Lin S-H, Hsu Y-H, Chen S-C, Kang J-H. A comparison of physical examinations with musculoskeletal ultrasound in the diagnosis of biceps long head tendinitis. Ultrasound in medicine & biology. 2011;37:1392-8.

 

 

Author Response File: Author Response.docx

Round 2

Reviewer 2 Report (New Reviewer)

The manuscript has been improved to a great extent 

This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.

Round 1

Reviewer 1 Report

Congratulations to the authors for an extensive surgical experience on this pathology. 

After reading the manuscript I can give the following statements:

Overall it would have been much better to compare two homogenous groups of patients with frozen shoulder treated with capsular release with or without a LHBT tenodesis and release of THL.

For the introduction, there is too much literature review, should be moved to discussion. Also, authors use the past tense in the introduction and draw a conclusion like “The associated LHB tenodesis decreased the possibility of LHBT instability “ which is an assumption. Introduction should end with hypothesis and level of evidence.

Authors should define what is their definition of refractory frozen shoulder

 

At material and methods authors describe the inclusion criteria, but it is unclear. For example external rotation up to 50 is almost normal. Also for exclusion criteria , arthroscopic signs of fracture is ambiguous. A fracture is usually diagnosed before arthroscopy. 

Since the operating surgeon performed the examinations, some bias could be expected.

Of the 60 patients included 26 failed to attend the followup visit at 2 years, this is almost half, thus transfer bias is expected. Should have about 80% followup

Discussion has duplicate information with introduction. Authors repeat same santences

 

In order to answer a clinical question that the authors focus on, namely the importance of addressing the LHBT in this pathology, they should have done a comparison with patients treated only with capsular release. A randomized trial would have been much more adequate, or at least a comparative study between two groups.  

 

 

 

Author Response

Reviewer 1

1. Authors use the past tense in the introduction and draw a conclusion like “The associated LHB tenodesis decreased the possibility of LHBT instability “ which is an assumption. Introduction should end with hypothesis and level of evidence.

Reply: The sentence is revised as “The purpose of this study is to report our result of arthroscopic pan-capsular and THL release with LHBT tenodesis for patients with refractory frozen shoulder. We hypothesized that patients with a painful refractory frozen shoulder could be benefited from pan-capsular release, THL release, and LHBT tenodesis. The associated LHB tenodesis could decrease the possibility of LHBT instability. Balance of the shoulder joint could be maintained even after such extensive release and LHBT tenodesis.” Thanks for the comment.

 

2. Authors should define what is their definition of refractory frozen shoulder

Reply: The definition of refractory frozen shoulder was ”moderate to severe shoulder pain around the bicipital groove with no improvement after conservative treatments such as local steroid injections or physiotherapies for at least six months; limited range of motion of the shoulder with anterior elevation being up to 130°, external rotation up to 50°, and internal rotation up to L5.” [1], [2] It was mentioned in the revised manuscript in the “Patient enrollment” part.

 

3. At material and methods authors describe the inclusion criteria, but it is unclear. For example external rotation up to 50 is almost normal. Also for exclusion criteria, arthroscopic signs of fracture is ambiguous. A fracture is usually diagnosed before arthroscopy. Since the operating surgeon performed the examinations, some bias could be expected.

Reply: Although the external rotation up to 50 is almost normal, we referenced the definition of the refractory frozen shoulder as published evidence.[1], [2] Yes, the arthroscopic signs of fracture is ambiguous. We removed the description in the revised manuscript. Thanks for the comment.

 

4. Of the 60 patients included 26 failed to attend the follow-up visit at 2 years, this is almost half, thus transfer bias is expected. Should have about 80% follow-up. Discussion has duplicate information with introduction. Authors repeat same sentences

Reply: Thanks for the comment. The low follow-up rate is the inherited limitation of this study. Due to the natural course of frozen shoulder, most of them had symptom relief after the though release. Therefore, it was difficult to fulfill the 2-year follow-up for the asymptomatic patients. We removed the repeated sentence in the “Introduction” area.

 

5. In order to answer a clinical question that the authors focus on, namely the importance of addressing the LHBT in this pathology, they should have done a comparison with patients treated only with capsular release. A randomized trial would have been much more adequate, or at least a comparative study between two groups.  

Reply: Thanks for the comment. It was a retrospective study reporting the outcome following pan-capsular release, THL release, and LHB tenodesis for refractory frozen shoulder. Further study will compare with patients treated only with capsular release, even with biceps tenotomy.

 

Author Response File: Author Response.docx

Reviewer 2 Report

The authors report that the preoperative  external rotation was  24 °± 13.3°. Normally during the refractory Frozen Shoulder the patients  have 0 degrees of external rotation and difficult exceed the 10-15 degrees. 

 

Why the authors measured the CSA and AHD in these patients.

Did they found any correlation between the pathology of the Frozen Shoulder and the CSA??

 

 

Discussion 

Lines 332-333: The authors reported “Also, patients with diabetes did not respond as well toward surgical release as patients without diabetes.[42] In such patients, the author prefers LHBT tenotomy to tenodesis” . How you reached to this statement?? There is nothing described about diabetes in your manuscript. 

 

MInor Revisions are necessary 

 

 

Author Response

Reviewer 2

1. The authors report that the preoperative external rotation was 24 °± 13.3°. Normally during the refractory frozen shoulder the patients have 0 degrees of external rotation and difficult exceed the 10-15 degrees. 

Reply: We agree most frozen shoulder had 0 degrees of external rotation and difficult exceed the 10-15 degrees. However, our inclusion criteria of refractory shoulder was anterior elevation being up to 130°, external rotation up to 50°, and internal rotation up to L5 according to the literature. [2]  

 

2. Why the authors measured the CSA and AHD in these patients.

Did they find any correlation between the pathology of the Frozen Shoulder and the CSA??

Reply: Thanks for the comment. The authors did not find any correlation between the pathology of the frozen shoulder and the CSA. The reason why the authors applied CSA as a post-operative radiological parameter is that we wonder if the extensive soft tissue release creates further rotator cuff tears, leading to shoulder inbalance and CSA changes, indicating rotator cuff tears.[3]

 

Discussion 

3. Lines 332-333: The authors reported “Also, patients with diabetes did not respond as well toward surgical release as patients without diabetes. In such patients, the author prefers LHBT tenotomy to tenodesis”. How you reached to this statement?? There is nothing described about diabetes in your manuscript. 

Reply: According to Hagiwara et al.,[4] intra-articular steroid injection improves the ROM in forward flexion and the UCLA scores of pain at the final follow-up only in those without diabetes mellitus, which implied the patient with diabetes responded poorly to the surgical release than those who didn’t. Therefore, we only enrolled 5 patients with diabetes in our patient group. For those patients with diabetes, we prefer LHBT tenotomy to tenodesis. The objective of this study is to report the clinical and radiological results of patients with refractory frozen shoulders who underwent pan-capsular and THL release. Therefore, we try to simplify our patient group.

 

References

[1] Boonstra AM, Preuper HRS, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain®. 2014;155:2545-50.

[2] Fernandes MR. Arthroscopic treatment of refractory adhesive capsulitis of the shoulder. Rev Col Bras Cir. 2014;41:30-5.

[3] Moor BK, Bouaicha S, Rothenfluh DA, Sukthankar A, Gerber C. Is there an association between the individual anatomy of the scapula and the development of rotator cuff tears or osteoarthritis of the glenohumeral joint?: A radiological study of the critical shoulder angle. Bone Joint J. 2013;95-B:935-41.

[4] Hagiwara Y, Sugaya H, Takahashi N, Kawai N, Ando A, Hamada J, et al. Effects of intra-articular steroid injection before pan-capsular release in patients with refractory frozen shoulder. Knee Surgery, Sports Traumatology, Arthroscopy. 2015;23:1536-41.

 

Author Response File: Author Response.docx

Reviewer 3 Report

What is the best management of frozen shoulder is a controversial topic. Certainly the presence of pain that is resistant to conservative treatment leads the surgeon to offer a surgical option. In any case, it is now widely accepted that the natural history of this condition leads to resolution of stiffness and symptoms in the most cases. For these reasons, I find that a study evaluating the results after 2 years of follow-up of arthroscopic release cannot fail to highlight that after 2 years there would probably have been an improvement in the clinical setting regardless of the choice of treatment. I think the study proposed by the authors is well conducted and the article is well written, but the absence of a control group (although correctly cited by the authors among the limitations of the study) cannot be ignored in this specific case (considering the evolution of the pathology). I also have concerns about the statistical methodology: the authors stated that they used a parametric test, but with a population of 35 patients it seems unlikely to me that the criteria for using a parametric test could have been met (e.g., how was the Gaussian distribution attested?). I think the study cannot be published in this form unfortunately, although I congratulate the authors on an interesting discussion and mastery of the topic. I recommend that the authors resubmit the study by including a control study cohort, comparing not only the final outcomes, but also the intermediate outcomes in order to show different functional recovery curves depending on time elapsed. Thank you.

Author Response

Reviewer 3

I recommend that the authors resubmit the study by including a control study cohort, comparing not only the final outcomes, but also the intermediate outcomes in order to show different functional recovery curves depending on time elapsed. Thank you.

Reply: Thanks for the comment. Indeed, most frozen shoulders are resolved spontaneously or by conservative treatment such as stretching and steroid injections. Surgery is not the first-line treatment in our institute. Therefore, we only enrolled refractory shoulders who failed conservative treatment for at least six months. For most patients with “regular” frozen shoulders, their symptoms improved within three times of steroid injection and physiotherapies. The study aims to report the clinical and radiological results of patients with “refractory” frozen shoulders who underwent pan-capsular and THL release.

 

 

Author Response File: Author Response.docx