Effectiveness of Shock Wave Therapy versus Intra-Articular Corticosteroid Injection in Diabetic Frozen Shoulder Patients’ Management: Randomized Controlled Trial

Round 1

Reviewer 1 Report

Elerian et al. present a study about compare the effectiveness of shock wave therapy to intra-articular cortico-steroid injection in diabetic frozen shoulder patient. The study involved 50 individuals who were divided into 2 groups according to the mode of treatment. And these two groups were compared not only in terms of treatment effectiveness but also in terms of its effect on diabetes. The study found that shock wave therapy was more effective in reducing pain and increasing mobility compared to steroid treatment and did not show any adverse effects (for example increase in FPG or PPBG).

1. In the Introduction chapter, the Authors summarize the topic briefly and concisely. Mention is made of previous use of shock wave therapy (ref. 14 and 15), however, it would be worthwhile to substantiate this statement with more literature data (independent of the Authors’ work).
2. Alternative therapeutic options could be briefly described in the Introduction.
3. In Figure 1, it would be worthwhile to indicate the sample numbers. Furthermore, it is not clear from the manuscript how many people belonged in each group (A and B) after the exclusion. Why were 2 out of 50 people excluded?
4. For individuals who received a corticosteroid injection, were the physical and laboratory tests performed before or after the injection? How much time elapsed between taking the measurements and giving the injection?
5. For Group A, baseline FBG and PPBG values are the same as those measured at the end of the first month, not only in the mean but also in the SD. How is this possible?
6. What could be the reason why PPBG and HbA1C were higher in group B than in group A? Could this have any effect on the results?
7. How can it be explained that patients treated with shock wave therapy had a significant improvement in their diabetes indices (FPG and PPBG)?
8. In the manuscript, the Authors should indicate the results uniformly to 2 or 3 decimal places.
9. The results in Tables 3, 4, and 5 are shown in Tables 1 and 2. There is no need to repeat the results. The tables can be merged or described in text form.
10. It would be more obvious to graph the results graphically (box plot or line diagram) and to calculate p for trend to justify the change.
11. It is unreasonable to indicate the results in tables in the Discussion chapter, please move them to the Results chapter.
12. Were the therapies equally effective for men and women? Or can gender differences be detected?
13. The conclusion is short and concise. It would be worth making some suggestions based on the results.
14. Despite linguistic proofreading, there are several spelling mistakes and repetitive sentences in the manuscript. Please correct these.

• Line 32: “as well as well as”
• Line 81: Abril 2019
• Line 138: 00 University hospital…
• Line 175 - 178 and line 182 - 184 are the same
• Line 317 - 327 and line 330 - 339 are the same

Overall, the manuscript is interesting, but the many formal errors that occur in it spoil the overall picture. A thorough overhaul is needed.

Author Response

Letter to the editor

Response to the reviewers' suggestions

 

Thank you for the comments that improved our manuscript. The following are the responses to all comments made by the reviewer: 1

Any changes in the manuscript were done in yellow highlight color. 

Reviewer: 1

 

1. In the Introduction chapter, the Authors summarize the topic briefly and concisely. Mention is made of previous use of shock wave therapy (ref. 14 and 15), however, it would be worthwhile to substantiate this statement with more literature data (independent of the Authors’ work).

Response: Done in the following manner:

Shock wave therapy (SWT) is a physical therapy modality that consists of very short energy wave; its speed is faster than the speed of sound and is considered a novel treatment in a wide variety of musculoskeletal dysfunction and illness [14,15]. Shock wave application has been reported to result in good clinical satisfaction in patients with many conditions that include pain and disability associated with ligament, muscle injuries, or joint arthritis, tendon entrapment, or inflammation [16-19].

            Grecco MV, Brech GC, Greve JM. One-year treatment follow-up of plantar fasciitis: radial shockwaves vs. Conventional physiotherapy Clinics (Sao Paulo, Brazil) 2013; 68:1089-95.

Elerian, AE, Ewidea T M, Nour A. Effect of shock wave therapy versus corticosteroid injection in management of knee osteoarthritis. International Journal of Physiotherapy 2016: 246-251.‏

Moya, Daniel MD1,a; Ramón, Silvia MD, PhD2; Schaden, Wolfgang MD3; Wang, Ching-Jen MD4; Guiloff, Leonardo MD5; Cheng, Jai-Hong MD4 The Role of Extracorporeal Shockwave Treatment in Musculoskeletal Disorders, The Journal of Bone and Joint Surgery: February 7, 2018 - Volume 100 - Issue 3 - p 251-263 doi: 10.2106/JBJS.17.00661.

Saggini R, Di Stefano A, Saggini A, Bellomo RG. CLINICAL APPLICATION OF SHOCK WAVE THERAPY IN MUSCULOSKELETAL DISORDERS: PART I. J Biol Regul Homeost Agents. 2015 Jul-Sep;29(3):533-45. PMID: 26403392.

Elerian  A E. Effect of shockwaves versus traditional physiotherapy in treating de quervain tenosynovitis. International Journal of Recent Scientific Research 2016: 7(4); 9902-06.

Gönen Aydın C, Örsçelik A, Gök M, C, Akman Y, E: The Efficacy of Extracorporeal Shock Wave Therapy for Chronic Coccydynia. Med Princ Pract 2020;29:444-450. doi: 10.1159/000505835.

2. Alternative therapeutic options could be briefly described in the Introduction.

Response: it was described in second paragraph of introduction section (line 56 – 58) with adding more details and more recent references, in following manner:

several studies approved many physiotherapy modalities such as ultrasound therapy , stretching exercises , manual mobilization and strengthening exercises as well-established conservative management techniques [7, 8].

Niraj Kumar, Vichitra Baliwan, Siddhartha Sen, Navneet Badoni, Sumit Khatri (2020); PREVALENCE AND MANAGEMENT OF THE DIABETIC FROZEN SHOULDER Int. J. of Adv. Res. 8 (Oct). 944-954]

3. In Figure 1, it would be worthwhile to indicate the sample numbers. Furthermore, it is not clear from the manuscript how many people belonged in each group (A and B) after the exclusion. Why were 2 out of 50 people excluded?

Response: figure 1 was updated to indicate the enrolled sample number, and sample numbers after inclusion criteria, and after exclusion criteria. Also the number in each group after exclusion was illustrated in Sample size and Randomization section line 101 to 115 in the following manner:

Sample size in the present study was calculated using G*Power software (Dusseldorf, Germany) to measure a variation of 15° in shoulder range of motion between groups, measured using an electro goniometer with an estimated standard deviation of 15°, 80% power analysis, and 5% significance level. The number of patients needed in each group was calculated as 21; to account for patient attrition during the study, this number was increased to be 30 subjects. ten subjects did not meet the inclusion criteria, while 2 diabetic frozen shoulder patients were excluded from the study before allocation to each group, one of them had fasting blood sugar greater than 11.1 mmol/L, and the other one had a history of prior shoulder surgery, the remaining 48 diabetic frozen shoulder patients were assigned randomly to receive intra articular corticosteroid in-jection accompanied by traditional physical therapy sessions (Group A = 24) or re-ceived 12 sessions of a shock wave in addition to the traditional physiotherapy sessions (Group B = 24) as shown in figure 1. Participants were allocated using a random num-bers table generated by computer and sealed in opaque envelopes for concealed alloca-tion.
The patients and practitioners and the outcome assessors were blinded to the patient groupings.

 

 

 

 

 

4. For individuals who received a corticosteroid injection, were the physical and laboratory tests performed before or after the injection? How much time elapsed between taking the measurements and giving the injection?

 Response:  it was illustrated in outcomes measurement section that all outcome measures except Hemoglobin A1c (HbA1c) were evaluated for all patients four times, first before allocated in their group, then two times during the study with 1-month intervals, and again after the end of the study (3 months). Hemoglobin A1c (HbA1c) measurement was evaluated only twice: just before allocating in the study group and after 3 months,

and also in Intraarticular corticosteroid injection section.  Each patient in Group A received a mix of 2 mL of 2% lidocaine and 40 mg/mL of methylprednisolone (1 mL) shoulder intra-articular corticosteroid injection using 3-mL and 1- inch syringe, after detection and sterilization of injection area using a marker and alcohol swabs at next day after each time of physical and laboratory evaluations for all outcomes of the study.

 

5. For Group A, baseline FBG and PPBG values are the same as those measured at the end of the first month, not only in the mean but also in the SD. How is this possible?

Response:

First, I appreciate the very careful revision that help me to discover this editing mistake due to presence of many variables at many times, and according to comments of reviewer 2 and his recommendation to use Mixed 2 way ANOVA, so I treat the data statistically again , the statical analysis section  as well as results section were updated , so many statistical and editing error were overcome as shown in table 2.

Table 2.   Basal Characteristics of The Subjects of the study*.
Characteristics	Group A (n=24)	Group B (n=24)
Age(years)	51.33 ± 4.01	52.13 ± 3.06
BMI (Kg/m2)	37.65 ± 0.85	37.7±1.07
SPADI Score	0.78 ± 8.96	8.92±0.78
Shoulder Flexion ROM (deg.)	62.29 ± 14.82	64.38±13.28
Shoulder ABDUCTION ROM (deg.)	45.00 ± 8.47	48.13 ±13.97
FBG (mg/dL)	149.13± 23.93	151 ± 19.07
PPBG mg/dL	203.76± 24.5	228.54 ± 36.04
HbA1c %	6.53 ± 0.85	7.30± 0.83
BMI, Body Mass Index; SPADI, Shoulder pain and Disability index; ROM, Range of Motion; FBG, Fasting blood glucose, PPBG, Post prandial Blood Glucose; HbAIc, Hemoglobin A1c.* Data are mean± SD.

 

 

 

 

 

 

 

 

 

 

 

6. What could be the reason why PPBG and HbA1C were higher in group B than in group A? Could this have any effect on the results?

Response: there were no intended reason for group B to have higher PPBG and HbA1C, but it was due to allocation of participated patients randomly without considering the level of PPBG and HbA1C to avoid bias as it was acceptable to be within in the inclusive criteria range, and out of exclusive range only.

Could this have any effect on the results?

It could affect the result if the group B has higher level of PPBG and HbA1C at post treatment measurement, but the opposite was true*, as illustrated in line, in following manner.

 Between-groups Effect:

After 1 month of treatment, there was no significant statistically difference be-tween Group A and B regarding the SPADI, FBG, and PPBG (p = 0.29, 0.77, and 0.09, respectively), but flexion and abduction ROM of the shoulder was higher in group B than group A (113.8± 19.85 vs. 66.67± 15.23, p < 0.001; 67.5±13.19 vs 51.25±7.41, p < 0.001 respectively) (Table 1). After 2 and 3 months of treatment, Group A and Group B showed a significant difference in SPADI score, shoulder flexion ROM, shoulder ab-duction ROM, FBG, and PPBG (all p-values < 0.001), as well as also for HbA1c after 3 months of treatment (< 0.001). The negative mean difference scores (95% CI) on SPAD score, FBG, PPBG, and HbA1c outcome measures indicated more improvement. In comparison, positive mean difference scores (95% CI) regarding the shoulder flexion and abduction ROM outcome measures indicated more improvement, so Group B (Shock wave) had more superiority than group A (intraarticular corticosteroid injec-tion) regarding all outcome measures after 2 and 3 months of intervention and after 1 month of intervention for shoulder flexion and abduction ROM (p < 0.001) (Table 1).

*O’Neill, S., Kreif, N., Grieve, R. et al. Estimating causal effects: considering three alternatives to difference-in-differences estimation. Health Serv Outcomes Res Method 16, 1–21 (2016). https://doi.org/10.1007/s10742-016-0146-8

 

7. How can it be explained that patients treated with shock wave therapy had a significant improvement in their diabetes indices (FPG and PPBG)?

Response : the effect of shock wave therapy on diabetic indices not only a safe modality to treat the musculoskeletal disorders in a diabetic patient but also a treatment modality for  type 2 diabetes mellitus disease through its  effects by   enhancing pancreatic islets area, c-peptide, GLP-1, and insulin production in the rat model of DM. Moreover, low-energy SW therapy increased the beta cells number in DM rats. Also, the low-energy SW therapy reduced pancreatic tissue inflammation, apoptosis, and oxidative stress as well as increasing angiogenesis, cell proliferation, and tissue repair potency [ *,**]

*Hsiao, C.-C.; Lin, C.-C.; Hou, Y.-S.; Ko, J.-Y.; Wang, C.-J. Low-Energy Extracorporeal Shock Wave Ameliorates Streptozotocin Induced Diabetes and Promotes Pancreatic Beta Cells Regeneration in a Rat Model. Int. J. Mol. Sci. 2019: 20; 4934. https://doi.org/10.3390/ijms20194934.

**Hsiao, C.-C.; Huang, W.-H.; Cheng, K.-H.; Lee, C.-T. Low-energy extracorporeal shock wave therapy ameliorates kidney function in diabetic nephropathy. Oxidative Med. Cell Longev. 2019; 1–12.

This was illustrated in discussion section as following:

The results of the present study was supported by recent study that revealed that the ESWT not only safe noninvasive modality to treat the musculoskeletal disorders in a diabetic patient but also could be a treatment modality for type 2 diabetes mellitus disease itself through increasing the pancreatic islets area, c-peptide, GLP-1, and the production of insulin in the rat model of DM, also the ESWT enhanced the numbers of beta cells and reduced pancreatic tissue inflammation, apoptosis, and oxidative stress as well as increasing angiogenesis, cell proliferation, and tissue repair potency [43,44]

 

8. In the manuscript, the Authors should indicate the results uniformly to 2 or 3 decimal places

Response: done in all tables

 

9. The results in Tables 3, 4, and 5 are shown in Tables 1 and 2. There is no need to repeat the results. The tables can be merged or described in text form.

 

Response :

According to updating of statical analysis and results section, tables 5 was deleted , and table 3, 4 were modified :

 

10. It would be more obvious to graph the results graphically (box plot or line diagram) and to calculate p for trend to justify the change.

 

Response: the following 3 figures were added to illustrate the difference between both groups of the study but this difference were well illustrated in results section paragraph , and tables , so this figures will duplicate repeated information .

 

 Figure 2. Comparison of Primary and Secondary Outcomes Data at 1-month follow-Up between both group of the study

 

Figure 3. Comparison of Primary and Secondary Outcomes Data at 2-month follow-Up between both group of the study.

 

 

 

 

 

 

 

Figure 4. Comparison of Primary and Secondary Outcomes Data at 2-month follow-Up between both group of the study.

 

 

 

 

11. It is unreasonable to indicate the results in tables in the Discussion chapter, please move them to the Results chapter.

 

Response: Table 3, 4, were deleted from the discussion chapter.

 

 

12. Were the therapies equally effective for men and women? Or can gender differences be detected?

 

 

Response:  actually, we didn’t investigate the effect of different gender neither on primary nor secondary outcomes aiming to eliminate the variables of this study, but it should consider as a limitation of this this study that need future research.

  This was illustrated in participant of the study section and in limitations section.  

The study inclusion criteria were any adult with age between 45 and 64 years from both sex.

And in limitation section:

Furthermore, this study did not investigate the effect of different gender on the results of the study, so future research is recommended to examine the effect of gender on the result of the study.   

 

 

13. The conclusion is short and concise:

Response; the conclusion section was written in the following manner:

 

ESWT could make a safe, noninvasive treatment for diabetic frozen shoulder patients. The SWT group showed better improvement of shoulder pain and disability level, and in shoulder range of motion than intraarticular articular corticosteroid injection group after 3 months of intervention, this improvement was enhanced with more glycemic control in diabetic AC patients.

 

. It would be worth making some suggestions based on the results.

 

Response : based on our  results some suggestions were mentioned in limitation paragraph at the end of discussion section in following manner:  

 

This study had limitations that should be considered. First, this study measured the intermediate effects after 1, 2, and 3 months during the treatment protocol. Further studies are now needed to determine the long-term effect of adding shock wave and intra-articular injection to the traditional therapy program. Second, this study investigates the effectiveness of shock wave treatment versus the intra-articular corticosteroid injection when combined with traditional physiotherapy. Further studies are recommended to investigate their effects alone, also this study did not investigate the effect of different gender on the results of the study, so future research is recommended to examine the effect of gender on the result of the study. 

 

 

14. Despite linguistic proofreading, there are several spelling mistakes and repetitive sentences in the manuscript. Please correct these.

• Line 32: “as well as well as”

Response:

The level of pain and the disability, range of motion, as well as the glucose triad were evaluated before patient assignment to each group then during the study and at the end of the study.

• Line 81: Abril 2019

Response:

A randomized controlled trial, in which participants were recruited from the Faculty of Physical Therapy Outpatient Clinic, in Cairo University Egypt. The SWT, traditional physiotherapy protocol, and the physical assessment of participants were conducted at the same outpatient clinic between April 2019 and February 2020. The Ethical Committee approved the study for Human Research at the faculty of Physical Therapy, Cairo University, Egypt. The study was registered at Pan African Clinical Trials Regis-try (PACTR) with a registration number PACTR201811597207089. All participants signed the consent form before enrolling in the study, according to the principles of the Helsinki Declaration 1975.

 

• Line 138: 00 University hospital…

Response:

, a blood sample was withdrawn at the Cairo University hospital clinical lab.

 

• Line 175 - 178 and line 182 - 184 are the same

 

Response: lines from 182 to 184 were deleted

 

• Line 317 - 327 and line 330 - 339 are the same.

Response: the repeated section was deleted.

Author Response File: Author Response.docx

Reviewer 2 Report

Line 98: a reference should be inserted to justify the hypothesized variation

Line 139: how many therapists were involved in the study? The authors should clarify this point

Line 169: Data analys, authors should clarify how they evaluate the inference of the time factor and the group factor. It would not have been more suitable to use a mixed two-way anova?

Line 177: this difference can be a possible bias

Table 3: this table lacks the post hoc analysis.

Line 345: I don't think this is a limit

Author Response

Letter to the editor

Response to the reviewers' suggestions

 

Thank you for the comments that improved our manuscript. The following are the responses to all comments made by the reviewer: 2

Any changes in the manuscript were done in yellow highlight color. 

Reviewer: 2

 

1. Line 98: a reference should be inserted to justify the hypothesized variation.

 

Response: the following reference was used to justify the estimation of standard deviation of 15° in shoulder range of motion measurements,

 

 

Elhafez HM, Elhafez SM. Axillary Ultrasound and Laser Combined With Postisometric Facilitation in Treatment of Shoulder Adhesive Capsulitis: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2016 Jun;39(5):330-338.

 

1. Line 139: how many therapists were involved in the study? The authors should clarify this point.

 

Response: 4 therapists were involved in this study

 

First one performed the whole primary outcomes measurements either pretest or posttest measurement as illustrated in line 133 and 35, the second one who performed the Traditional physiotherapy protocol as illustrated in line 149, while the third one was especial orthopedist for intra articular injection process as illustrated in line 162, and the fourth one was a different physical therapist to perform the shock wave therapy sessions as illustrated in line 170.

 

1. Line 169: Data analysis, authors should clarify how they evaluate the inference of the time factor and the group factor. It would not have been more suitable to use a mixed two-way ANOVA.

Response: all data analysis, results section was corrected in the following manner:

2.6 Data analysis:

SPSS software for Windows, version 25.0 (Armonk, NY, USA) was used to conduct the statistical analysis. Descriptive statistics were performed at baseline, after 1month, 2 months, and 3 months of the study.  The normal distribution of data was checked us-ing Shapiro-wilk’s test. A mixed-design multivariate analyses of variance (MANOVA) were used to detect any differences between the mean change scores of the groups re-garding SPADI scores, shoulder flexion ROM, shoulder abduction ROM, FBG level, PPBG level, and HbA1c level.  Wilks’ lambda was used to detect F value. When the MANOVA revealed a significant effect (P < 0.05), a follow-up univariate mixed design ANOVAs were done with Bonferroni correction to avoid of type I error as the results of pairwise comparisons. A repeated measure ANOVAs, with a Bonferroni correction for multiple comparisons, was done to determine if there were differences in SPADI scores, shoulder flexion ROM, shoulder abduction ROM, FBG level, PPBG level, and HbA1c level in each group.

3. Results

Between-groups Effect:

After 1 month of treatment, there was no significant statistically difference between Group A and B regarding the SPADI, FBG, and PPBG (p = 0.29, 0.77, and 0.09, respectively), but flexion and abduction ROM of the shoulder was higher in group B than group A (113.8± 19.85 vs. 66.67± 15.23, p < 0.001; 67.5±13.19 vs 51.25±7.41, p < 0.001 respectively) (Table 1). After 2 and 3 months of treatment, Group A and Group B showed a significant difference in SPADI score, shoulder flexion ROM, shoulder abduction ROM, FBG, and PPBG (all p-values < 0.001), as well as also for HbA1c after 3 months of treatment (< 0.001). The negative mean difference scores (95% CI) on SPAD score, FBG, PPBG, and HbA1c outcome measures indicated more improvement. In comparison, positive mean difference scores (95% CI) regarding the shoulder flexion and abduction ROM outcome measures indicated more improvement, so Group B (Shock wave) had more superiority than group A (intraarticular corticosteroid injection) regarding all outcome measures after 2 and 3 months of intervention and after 1 month of intervention for shoulder flexion and abduction ROM (p < 0.001) (Table 1).

Within-Group Effect:

    Within-group comparison for SPADI score revealed that there was a significant decrease in post treatment measurements in both groups (p < 0.001), while for shoulder flexion and abduction ROM revealed that there was a significant increase in post treatment in both groups (p < 0.05) except flexion ROM in group A (p> 0.05) as shown in table 2.

The result of present study showed significant increase in FBG and PPBG at post treatment measurements in group A (p < 0.001), with a greater increase at 3-month post-treatment measurement, with mean values of 196.9±25.49, 286.7±33.74 for FBG, PPBG, respectively. Also as shown in table 2, there was a significant increase in HbA1c after 3 months, with mean values of 6.53 ± 0.85 vs 8.71±1.01, (p < 0.001), at baseline and after 3 months, respectively. Regarding FBG and PPBG in group Group B, result found that post -treatment measurements for FBG and PPBG decreased significantly only with p value p = 0.03 for FBG and p P< 0.001, respectively for PPBG as shown on table 3, while in Group B, this study   detected significant difference in HbA1c be-tween pretreatment pre-treatment and post -treatment measurements (p> 0.21) as shown in table 4.

 

4. Line 177: this difference can be a possible bias.

Response: the whole data was retreated and statistically analyzed in different tests for normality according to previous comments as illustrated in data analysis section in the following manner:

STATISICAL ANALYSIS

SPSS software for Windows, version 25.0 (Armonk, NY, USA) was used to conduct the statistical analysis. Descriptive statistics were performed at baseline, after 1month, 2 months, and 3 months of the study.  The normal distribution of data was checked using Shapiro-wilk’s test. A mixed-design multivariate analyses of variance (MANOVA) were used to detect any differences between the mean change scores of the groups regarding SPADI scores, shoulder flexion ROM, shoulder abduction ROM, FBG level, PPBG level, and HbA1c level.  Wilks’ lambda was used to detect F value. When the MANOVA revealed a significant effect (P < 0.05), a follow-up univariate mixed design ANOVAs were done with Bonferroni correction to avoid of type I error as the results of pairwise comparisons. A repeated measure ANOVAs, with a Bonferroni correction for multiple comparisons, was done to determine if there were differences in SPADI scores, shoulder flexion ROM, shoulder abduction ROM, FBG level, PPBG level, and HbA1c level in each group.

 

 

 

5. Table 3: this table lacks the post hoc analysis.

Response: correction was done in table 3, 4

 

 

Table 3.   Pairwise Comparisons for Group A Pre, after 1month, 2 months and 3 months.*
	Baseline vs 1month		Baseline vs 2months		Baseline vs 3months
Outcomes	MD (95% CI)	P-Value	MD (95% CI)	P-Value	MD (95% CI)	P-Value
SPADI Score	1.63(1.13, 2.12)	0.0001	2.73(1.99, 3.46)	0.0001	4.19(3.47, 4.91)	0.0001
Flexion ROM (deg.)	28.96(-36.9, 94.81)	0.99	21.25 (-45.0, -87.47)	0.99	3.96(-61.8, 69.69)	0.99
Abduction ROM (deg.)	-6.25(-11.0, -1.46)	0.005	-11.67(-19.0, -4.29)	0.0004	-20.21(-29.1, -11.3)	0.0001
FBG (mg/dL)	0.01(-3.69,3.69)	0.99	-33.13(-41.3, -25.0)	0.0001	-48.75(-62.2, -35.3)	0.0001
PPBG mg/dL	0.01(-7.25,7.25)	0.99	-50.83(-64.3, -37.4)	0.0001	-85.0(-103.3, -66.7)	0.0001
HbA1c %	-	-	-	-	-2.18(-2.67, -1.68)	0.0001
SPADI, Shoulder pain and Disability index; ROM, Range of Motion; FBG , Fasting blood glucose , PPBG, Post prandial Blood Glucose; HbAIc, Hemoglobin A1c; MD, Mean difference; CI, confidence interval.* Data are mean± SD, P-Value < 0.05 indicate statistical significance. ** P-Value adjusted for multiple comparison: Bonferroni.

 

 

 

 

 

 

 

 

Table 4.   Pairwise Comparisons for Group B Pre, after 1month, 2 months and 3 months.*
	Baseline vs 1month		Baseline vs 2months		Baseline vs 3months
Outcomes	MD (95% CI)	P-Value	MD (95% CI)	P-Value	MD (95% CI)	P-Value
SPADI Score	1.88(1.38, 2.37)	0.0001	4.69(3.95, 5.42)	0.0001	6.94(6.22, 7.66)	0.0001
Flexion ROM (deg.)	-38.38(-104.0, 27.47)	0.69	-60.88 (-127.0, 5.35)	0.09	-76.29(-142.0, -10.6)	0.01
Abduction ROM (deg.)	-19.38(-24.2, -14.6)	0.0001	-34.38(-41.8, -27.0)	0.0001	-53.33(-62.2, -44.5)	0.0001
FBG (mg/dL)	4.79(1.11,8.48)	0.005	8.75(0.58, 16.92)	0.03	14.58(1.11, 28.06)	0.03
PPBG mg/dL	14.79(7.55,22.04)	0.0001	18.75(5.32, 32.18)	0.002	32.71(14.37, 51.05)	0.0001
HbA1c %	-	-	-	-	0.39(-0.11, 0.89)	0.21
SPADI, Shoulder pain and Disability index; ROM, Range of Motion; FBG , Fasting blood glucose , PPBG, Post prandial Blood Glucose; HbAIc, Hemoglobin A1c; MD, Mean difference; CI, confidence interval.* Data are mean± SD, P-Value < 0.05 indicate statistical significance. ** P-Value adjusted for multiple comparison: Bonferroni.

 

 

6. Line 345: I do not think this is a limit.

Response: this limitation was replaced by another one in the following manner:

Furthermore, this study did not investigate the effect of different gender on the results of the study, so future research is recommended to examine the effect of gender on the result of the study

 

Author Response File: Author Response.docx

Round 2

Reviewer 1 Report

The authors have addressed all of my comments/suggestions. I have no further recommendations or revisions. I believe the manuscript provides a significant contribution to the field.