Effect of Maitland and Mulligan mobilization on pain, range of motion and disability in patients with rotator cuff syndrome: a randomized clinical trial protocol

Samiksha Vinod Sonone; Deepali Patil

doi:10.12688/f1000research.138167.1

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Study Protocol

Effect of Maitland and Mulligan mobilization on pain, range of motion and disability in patients with rotator cuff syndrome: a randomized clinical trial protocol

[version 1; peer review: 1 not approved]

Samiksha Vinod Sonone ¹, Deepali Patil¹

PUBLISHED 23 Aug 2023

Author details Author details

¹ Musculoskeletal physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Samiksha Vinod Sonone
Roles: Conceptualization, Writing – Original Draft Preparation

Deepali Patil
Roles: Supervision, Validation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: Rotator cuff syndrome (RCS) comprises partial or whole-thickness rotator cuff tears, rotator cuff tendonitis, subacromial impingement syndrome, and bursitis. Expansion of rotator cuff arthropathy and glenohumeral degenerative disease are both made more likely by chronic rotator cuff syndrome. The maximum well-supported nonsurgical treatment for individual with rotator cuff (RC) injury appears to be musculoskeletal physiotherapy, including manual treatments and exercises. Scapular stabilisation exercises, proprioceptive neuromuscular facilitation (PNF), range of motion (ROM), rotator cuff strengthening exercises, and stretching exercises are some of the therapeutic exercises that have been shown to be useful in recovering shoulder function. The passive, expert movements known as joint mobilisation and manipulation are used by clinicians to increase joint mobility and to reduce pain.
Methods: In this study we aim to find out the effect of Maitland and Mulligan mobilization on improving ROM, functional disability and pain in individuals with rotator cuff syndrome through a randomized clinical trial. 80 individuals in total will be allocated equally into two groups, and both groups will be receiving treatment for six weeks with five sessions per week. After six weeks of therapy the results will be assessed for follow-up. By mobilization there will be increased range of motion, reduction in pain and functional disability, this technique may be used to patient with rotator cuff syndrome if our study's premise is found to be significant.
Conclusions: In this study, we expect that the Maitland and Mulligan mobilization on pain, range of motion and disability in patients with rotator cuff syndrome will have significant effects.
CTRI Registration: CTRI/2023/05/052643.

Keywords

Rotator cuff syndrome, Maitland Mobilization, Mulligan Mobilization, Visual analogue scale, Disability of arm, shoulder and hand and Range of Motion

Corresponding author: Samiksha Vinod Sonone

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Sonone SV and Patil D. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Sonone SV and Patil D. Effect of Maitland and Mulligan mobilization on pain, range of motion and disability in patients with rotator cuff syndrome: a randomized clinical trial protocol [version 1; peer review: 1 not approved]. F1000Research 2023, 12:1027 (https://doi.org/10.12688/f1000research.138167.1) First published: 23 Aug 2023, 12:1027 (https://doi.org/10.12688/f1000research.138167.1) Latest published: 23 Aug 2023, 12:1027 (https://doi.org/10.12688/f1000research.138167.1)

Introduction

The teres minor, infraspinatus, subscapularis and supraspinatus are the muscular units that make up the rotator cuff (RC). Subscapularis is the powerful rotator cuff muscle. The teres minor and infraspinatus, which are located in the larger tuberosity on the inferior and middle faces respectively, are the other rotator cuff muscles.¹ The greater tuberosity’s superior and middle faces receive the supraspinatus tendon, which has a breadth of about 23 mm. In order to abduct the arm past 15 degrees, the deltoid and supraspinatus must work together. The supraspinatus is largely engaged in shoulder abduction from 0 to 15 degrees. Anterior-most fibres of the infraspinatus tendon interdigitate with the posterior supraspinatus tendon, which has a comparable breadth and its insertion is on the middle facet. The teres minor, which insertion is on the inferior facet, and the infraspinatus work together to externally rotate the shoulder. With a strong internal rotator and adductor, the subscapularis is made up of four to six tendon slips that attach directly to the inferior third of the lesser tuberosity. Some of the subscapularis fibres cross the bicipital groove to attach to the lesser tuberosity, forming the transverse humeral ligament.²

Among the various complications of the shoulder, a rotator cuff injury is one of the most common injuries.³ In patients older than 50, rotator cuff tears (RCT) are a frequent source of shoulder discomfort and dysfunction. The aetiology is still up for question, however the prevalence rises with age. According to a number of authors, aging-related degenerative changes are the primary cause of the majority of tendon tears. As a result, this topic has received a lot of attention in study, and during the past few decades, many intrinsic and extrinsic causes of tendon degeneration have been proposed.⁴ Rotator cuff pathology might include inflammation, fibrotic alterations, partial- and full-thickness tears, and more. Subacromial impingement/pain syndrome is characterised by biomechanical dysfunction of the glenohumeral complex and the RC, which plays a role in its pathogenesis and development. Repetitive overhead activity is the highest frequent risk factor for subacromial discomfort and rotator cuff tendinopathy. Rotator cuff disorders frequently present with a gradual start of pain, but they can also be brought on by an abrupt injury.⁵ Any injury or declining condition affecting the RC is referred to as RCS. This comprises partial or whole thickness RCT, RC tendonitis, subacromial impingement syndrome, and bursitis. The probability of rotator cuff arthropathy and glenohumeral degenerative disease developing is increased by chronic rotator cuff syndrome. This exercise describes the diagnosis and treatment of RCS and the function of the multidisciplinary team in the care of individuals who have this condition.⁶

Patients with full thickness RCT are frequently given conservative treatment, which includes exercise therapy, as their first line of defence. Surprisingly, clinical outcome scores and subjective satisfaction levels have been shown to be comparable between patients whose repairs fail following surgical repair and those with intact repairs. The authors of this study hypothesise that these results may be explained by the fact that the majority of the patients in these studies underwent some type of structured post-operative physical therapy, raising the possibility that post-operative rehabilitation is more responsible for the improvements in outcome. Reduced pain, improved function, and improved daily living activities are the main goals of non-operative therapy of a torn rotator cuff.⁷ Between the capsule of shoulder and coracoid process of scapula is where the subcoracoid bursa is situated. Anterior shoulder pain that snaps in a painful manner could be caused by subcoracoid bursitis.⁸

The most well-supported nonsurgical treatment for people with rotator cuff injuries appears to be musculoskeletal physiotherapy, which includes manual therapies. To restore shoulder kinematics the exercises are widely recommended as a therapy opportunity for patients who present with subacromial impingement syndrome and, in the worst cases, surgical decompression and acromioplasty are used to restore subacromial space. There is accumulating evidence in favour of these recommendations. It has been shown that therapeutic exercises, which combine scapular stabilisation, range of motion (ROM), RC strengthening, stretching exercises and proprioceptive neuromuscular facilitation (PNF) are useful in recovering shoulder function.⁹

The manual therapy technique of joint mobilisations, which involves realigning collagen, enhancing fibre slip, reducing adhesion, and re-establishing correct glenohumeral joint kinematics, can relieve pain by stimulating peripheral mechanical receptors, suppressing nociceptors, boosting synovial fluid nutrition, and reducing adhesion. Additionally, exercise training will establish shoulder proprioception, mobility, and stability. Exercise and manual treatment for corticosteroid injections and subacromial decompression techniques have the same outcomes, according to a recent Cochrane analysis.¹⁰ The passive, expert movements known as joint mobilisation and manipulation are used by clinicians to reduce pain and increase joint mobility. Furthermore, the management of tendon discomfort has been promoted for these methods. The use of joint mobilisation and manipulation close to or locally on the afflicted joint may lessen tendon pain, according to limited evidence, suggesting that these techniques could be used as analgesic interventions for the treatment of tendinopathy.¹¹ Joints in the shoulder complex (acromioclavicular joint, glenohumeral joint, scapulothoracic joint and sternoclavicular joint), as well as the cervical or thoracic spine, may be subjected to joint mobilisations. Grades I, II, III, IV, and V — the most popular grading system — are used to categorise passive joint mobilisations based on the joint resistance which is influenced by the movement’s amplitude and the view in its range where it occurs. Grade V mobilisation, also known as manipulation, is a thrust technique that uses high velocity and low amplitude forces.¹²

Mulligan mobilisation is one of the techniques utilised for joint mobilisation. The Mulligan idea is a joint mobilisation approach that involves continuous active movement and continuous gliding when the joint is in a weight-bearing posture. In movement with mobilisation (MWM), the force application direction is chosen in accordance with the forces produced in the joints. Then, the ROM will be improved using the most suitable and efficient force.¹³

Aim and objectives of the study

1. To evaluate the effect of Maitland mobilization for pain (visual analogue scale), for range of motion (goniometer) and for functional disability (disability of arm, shoulder and hand) in individuals with rotator cuff syndrome.
2. To evaluate the effect of Mulligan mobilization for pain (visual analogue scale), for range of motion (goniometer), and for functional disability (disability of arm, shoulder and hand) in individuals with rotator cuff syndrome.
3. To compare the effects of Maitland and Mulligan mobilization for pain (visual analogue scale), for range of motion (goniometer) and for functional disability (disability of arm, shoulder and hand) in patient with rotator cuff syndrome.

Protocol

Trial design

This will be a single centric, two arm parallel equivalence randomized clinical trial.

Methods

This is an interventional study, where participants will be recruited from the Physiotherapy OPD at Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha, Maharashtra, following approval from the institutional ethics committee of Datta Meghe Institute of Higher Education and Research. A total of 80 participants will be required. Participants who meet the inclusion and exclusion criteria will be made aware of the study’s objectives and procedures, and then they will be separated into Group A and Group B by means of simple random selection in a 1:1 allocation ratio; each group will consist of 40 participants. Group A will be the Maitland mobilization and conventional physiotherapy group, and Group B will be the Mulligan mobilization and conventional physiotherapy group. Randomization will be done using a computer-generated system. For sample distribution, we will use the sequentially numbered opaque sealed envelopes technique.

The outcome measures used in the study will be quantified at baseline and at the end of the six-week treatment by a postgraduate (PG) resident in musculoskeletal-physiotherapy with similar expertise who is aware of the study but blind to the intervention. The study will be monitored by the PG guide, head of department, and the principal and chief advisor of the research cell. Through routine treatment sessions, we will make sure that the patients follow the suggested treatment plan faithfully. If needed, individuals will receive counselling or telephone reminders about their therapy appointments.

Prior to and following the analysis, the outcome measures will be assessed. The Visual Analogue Scale (VAS), Range of Motion (ROM) by Goniometer, Disabilities of the Arm, Shoulder, and Hand (DASH) and Short Form Survey (SF-36) are among of the tools used to measure pain, ROM, functional ability and quality of life. Along with conventional treatment for pain, ROM, and functional ability and quality of life, Group A will also undergo a Maitland Mobilization programme. Along with conventional treatment for pain, ROM, and functional ability and quality of life, Group B will also undergo a Mulligan Mobilization program. Figure 1 depicts the study’s design in visual form.

Figure 1. Procedure of protocol.

Eligibility criteria

Criteria for inclusion of subjects

1. Both male and female
2. Subjects having limited ROM of shoulder joint
3. Between 30 and 70 years old
4. Having a partial tear
5. No surgery on the shoulder
6. Willing to participate in the study.

Criteria for exclusion of subjects.

1. History of any neurological impairment
2. Any orthopaedic injury and heart issues that make it impossible to use assessment methodologies
3. A recent myocardial infarction or significant shoulder injury
4. Patients with osteoporosis
5. Not willing to participate in the study
6. Infections/tumours allied with shoulder joint and upper limb implants.

Interventions

Group A (interventional group)

The participants in this group will receive Maitland mobilization along with conventional physiotherapy. The patient will be lying with the arm bent at a 30-degree angle, and the therapist will be standing and gripping the proximal end of the humerus and keeping a lateral humeral distraction in the middle of its range. Conventional therapy will include: wand exercises, Codman exercises, shoulder capsule stretching exercises, stretching exercises, strengthening exercises, finger stairs, and shoulder hand wheel. They will also undergo 1.5 MHz of ultrasound (US) for 6 minutes and 100 Hz of transcutaneous electrical nerve stimulator (TENS) for 20 minutes. These exercises will be performed for 10 repetitions and gradually the repetition will be progressed week wise.

Patients in this group will be given 60 minutes of overall treatment which will include 20 minutes of Maitland mobilization and 40 minutes of conventional physiotherapy (6 minutes of US, 20 minutes of TENS and 15 minutes of exercises). Glenohumeral caudal glide mobilisation will be administered for five consecutive weeks at a rate of 2-3 glides per second for 30 seconds.

Group B (conventional group)

The participants in this group will receive Mulligan mobilization along with conventional physiotherapy. The patient will be lying down, humeral head will be actively mobilised in the abduction, flexion, external and internal rotation directions on the individuals using the MWM technique. This control group will receive physical treatment using conventional techniques. Participants in this technique will be lying on a stretcher, and the position of the therapist will be across the patient’s upper limb. In order to treat the shoulder restrictions, the therapist will stabilise the shoulder girdle of the participants and with another hand, a glide of the humeral head over the thenar eminence will be given. The therapist will apply a gliding force to the head of the humerus. Throughout the full range of motion, the physical therapist will make an effort to keep the glide at a right angle to the plane of motion while urging participants to make an active movement. Conventional therapy will include the same activities as described above. These exercises will be performed for 10 repetitions and gradually the repetition will be progressed week wise.

Patients in group B will need 60 minutes of overall treatment which will include 20 minutes of Mulligan mobilization and 40 minutes of conventional physiotherapy (6 minutes US, 20 minutes TENS and 15 minutes exercises). With a 30-second break in between each series, the MWM method requires approximately twenty minutes to complete in three sequences of 10 repetitions.¹³

Criteria for discontinuing interventions for a given trial participant

The treatment will be discontinued if any patients in either of the assigned groups experience adverse effects such as shoulder subluxation. After that, the patients will get the necessary treatment and outpatient therapy. In order to collect follow-up data and avoid missing data, study participants will still be included in the experiment (unless they decide to withdraw their consent).

Adherence and concomitant care

Exercise adherence will be measured as a percentage of exercises completed during the first follow-up (after the six-week intervention) for both groups, and will be taken into account when performing the pre-protocol analysis. Exercise adherence will be noted during the first consultation, where it will be stressed how important it is to follow the study guidelines and stay in the designated group.

All enrolled participants are encouraged to get in touch with the primary investigator immediately if they have any issues with the group intervention they were assigned. At these calls, the primary investigator will then complete a standard form. When necessary, patients can use the dietary supplements and medications that their doctor has prescribed. Patients will be urged to follow the prescribed rehabilitation intervention and refrain from using any other forms of healthcare while the trial is ongoing in order to prevent study contamination. Patients will be instructed to get in touch with the primary investigator or their general physician as needed.

Outcome measures

Time frames at baseline and six weeks later.

1. Visual Analogue Scale (VAS)
This scale assesses intensity of pain and is used to follow a patient’s pain evolution or relate pain severity. The distance (mm) on a 10-cm line is marked by the patient which represents their pain. A greater score specifies a bigger degree of suffering. In order to score and interpret the VAS, four different pain thresholds are established no pain 0–4 mm; mild pain 5–44 mm; moderate pain 45–74 mm; and severe pain 75–100 mm. VAS has been determined to be patient-acceptable and requires little training to administer and score.¹⁴
2. Shoulder flexion range of motion on universal goniometer (ROM)
A goniometer is a device that assesses a joint’s available range of motion. A joint’s or bodily part’s range of motion is the amount of movement that can be made around it.
3. Functionality (DASH)
The 30-question disabilities of the arm, shoulder, and hand (DASH) questionnaire measures a person’s ability to do particular upper extremity tasks. This questionnaire allows patients to self-report their responses and includes a 5-point Likert scale for measuring the degree of difficulty and interference with daily living. DASH is a measurement of physical restrictions and function in upper extremity issues.¹⁵
4. Quality of life (SF-36)
For quality of life, commonly utilised outcome measuring tools include the 36-Item Short Form Survey (SF-36), a self-reported, well-researched, measure of healthiness. It is adapted from a study known as the Medical Outcomes Study for the objective assessment of life quality.¹⁶

Sample size calculation

Formula using mean difference

The desired sample size will be calculated using mean difference

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Primary variable (DASH – disability of arm shoulder & hand).

Mean ± SD (pre) result on DASH for Mulligan (control group) = 50.92 ± 11.56.

Mean ± SD (post) result on DASH for Mulligan (control group) = 17.87 ± 11.53.

Pooled standard deviation = (50.92 ± 17.87)/2 = 11.545.

Difference = 33.05 (as per ref article).

Clinically relevant superiority = 20 % = (33.05 * 20)/100 = 6.61.

As per reference articles.

N1 = 2^{*} [{(1.64 + 0.84)}^{2} {(11.545)}^{2}] / {(6.61)}^{2} = 37 .

Total samples required = 37 per group.

Considering 10% drop out = 3.

Total sample size required = 37 + 3 = 40 per group = 80 in total.

Notations:

Z_{α} = 1.64

α = Type I error at 5% at both the sides total 10%

Z_{β} = 0.84 (1 - β) = Power at 80%

σ = std . dev

Reference article: The effect of Mulligan mobilization on pain and life quality of patients with Rotator cuff syndrome: A randomized controlled trial.¹⁷

Data collection methods

The participants will be screened in accordance with the inclusion and exclusion criteria prior to group assignment. The indicated outcome measures’ baseline evaluation will come next. All participants will be randomly assigned to either Group A or Group B after the randomization process. Five sessions each week for six weeks, each 60 minutes, will be devoted to the intervention. After the final day of the intervention session, the post-intervention data for the outcomes will be recorded. The information will be gathered and examined in order to study the outcomes. Throughout the course of the study, the guide will supervise the principal investigator as they administer the study interventions. In order to ensure that the patients’ adhere to the study, messages will be sent to their mobile phones informing and reminding them of the sessions in advance. Additionally, the standby days from the week will be used if the patient misses their appointments for any reason, ensuring that they receive a total of 30 intervention sessions over the course of the six-week period.

As per in the sample size calculation we have accounted for a 10% drop-out rate so that it does not interfere with the results of our study.

The data collection forms can be found in extended data.

Data management

The evaluation information will come from a pre-made spreadsheet with a variety of baseline characteristics. A secure database will be used to store the research data. The study environment will safely store paper copies of evaluation forms, signed informed consent forms, and other non-electronic paperwork. A full backup of the data entries will be made once per month till the trial is ended. The mechanisms for acquiring data and reporting will be under the direction of the lead investigators. The study papers’ accuracy has to be thoroughly examined. The Excel spreadsheet will published and sent to the statistician at the end of the study for the required analysis. Data loss caused by inefficient staff procedures can be prevented by using a checklist. The extensive follow-up assessment of this experiment indicates that participant retention and follow-up assessment completion will be relatively high. After six weeks, the participants in this trial will be invited to follow-up examinations.

Statistical analysis

The overall results will be calculated using R studio software 4.3 version. Descriptive statistics will be calculated for the quantitative assessment over the parameters mean SD, medium, maximal, and minimum for the demographic variables (age). For the qualitative assessment, frequency and percentage will be calculated over the variables (gender and hand dominance). All the results for inferential statistics will be tabulated and tested for the significance at 5% level of significance p ≤ 0.05. The outcome variables (primary) Visual Analogue Scale for Pain, Goniometer for measuring range of motion, disability of shoulder, arm and hand for physical limitations and function in upper extremity problems and (secondary) SF-36 for the measurement of quality of life will be evaluated pre and post-test using a paired-t test. Data for the outcome measure will initially be tested for normality using the Kolmogorov-Smirnov Test.

If the data fails to achieve normality, it will be attempted to transform into normal distribution by using a mathematical algorithm like log function, inverse mention, exponential function or boxcox transformation. If data persist with non-normal distribution then an alternative non-parametric test will be used for the parametric test result. For paired-t test, the alternative will be the Wilcoxon sign test. Unpaired t-test will be used to find the significance difference over the mean for both primary and secondary variables between control and experimental groups. Alternatively, the Mann Whitney test will be used in place of the unpaired t-test. Association analysis for finding significance of cofounding parameters will be appraised by using Chi-squared test or Fisher’s exact test, or a multi-variant analysis will be used to analyze association in order to determine the significance of confounding parameters.

Monitoring

Data monitoring

We will have a data monitoring committee led by the PI for maintaining and integrating the data.

Harms

The entire procedure will be managed by a departmental committee and clinical staff. Any injuries or adverse events will be immediately reported to the committee during the trial. The completed dataset will be published on the institutional research website and made available to the appropriate authorities.

Auditing

Every month, auditing of the trial is going to be conducted. Any deviation from the protocol will be documented and will be addressed.

Ethics and dissemination

Ethical considerations

Ethical approval was obtained from Datta Meghe Institute of Higher Education and Research (IEC no. DMIHER (DU)/IEC/2023/806; IEC approval date 21/03/2023). This protocol has been registered on CTRI (trial registration number CTRI/2023/05/052643, registration date 15/05/2023).

Protocol amendments

The study has been approved by the Scrutiny Committee at the college level on 01/03/2023 and by the IEC at the university level on 21/03/2023, following which, the CTRI registration was completed. As per the suggestions through these committees the study has already been modified and approved. So further changes could not be carried out.

Consent

Patients will be given a translation of the study protocol into their local language. All study participants will provide their written consent after being fully informed.

Confidentiality

The principal investigator will gather personal data as part of the procedure after explaining the study plan to the participant and a member of their family. The principal investigator, the subject, and two witnesses will all sign a confidentiality statement on the permission form. Consent from the patient will always be sought with full assurances of confidentiality whenever it is required to release information for the study.

Access to data

The Principal Investigator will have access to the final trial datasheet.

Ancillary and post-trial care

The whole procedure is going to be held under the supervision of clinicians and the departmental committee i.e., Guide, Head of the department, Principal and member of Research Guidance Cell.

After the trial session, the participations are going to be under supervision for about four weeks so that if there will be any harm, the Principal Investigator will take care of the participants.

Dissemination policy

We will present the work in International Conference Proceedings and publish in an indexed journal.

Study status

The study has not yet started.

Discussion

Rotator cuff syndrome refers to degeneration or other injury to the rotator cuff. This includes rotator cuff tendonitis, bursitis, rotator cuff tears, full- or partial-thickness subacromial impingement syndrome, and bursitis. The goal of the study is to determine whether Maitland mobilisation and Mulligan mobilisation have any impact on range ROM, pain, and functional disability in people with RCS. The overall number of people with subacromial shoulder discomfort included in this study was 358 across 11 RCTs, they compared the efficiency of MWM combined with exercise for rotator cuff mobilisation, isometric, ROM, strengthening and sham techniques. There was a non-significant difference in SPADI but a significant difference in VAS when MWM was compared to exercise, according to a meta-analysis by Mohamed Abdellatif Hassan et al. (2021).¹⁷ In another study, joint mobilisation paired with supervised exercise were examined in people with subacromial impingement syndrome (SAIS), between June 2014 and June 2015, 40 participants with SAIS for longer than six weeks were enrolled in this randomized-controlled research. The participants were split into two groups at random: group one (n = 20) underwent joint mobilisation and electrical stimulation, whereas group two (n = 20) received a supervised exercise plan and electrical stimulation. Pain intensity, DASH questionnaire, the Short Form-36, ROM, the Global Rating of Change Questionnaire, and the American Shoulder and Elbow Surgeons Standardised Shoulder Assessment Form (patient self-report part) were all used as outcome measures. Using the VAS, pain was assessed. After therapy, the range of motion dramatically improved while the mean VAS values in both groups greatly decreased. Both groups’ patient satisfaction with the course of treatment was comparable (p = 0.28). According to the findings of the study, patients with SAIS respond to both supervised exercise and mobilisation in a similar way, Ferit Pekgöz et al.¹⁸

Data availability

Underlying data

No underlying data are associated with this article.

Extended data

figshare: Extended data - Samiksha.docx, https://doi.org/10.6084/m9.figshare.23909667.v1.¹⁹

This project contains the following extended data:

- Model consent form
- Data collection form
- Figure of study procedure

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Reporting guidelines

figshare: SPIRIT checklist for ‘Effect of Maitland and Mulligan mobilization on pain, range of motion and disability in patients with rotator cuff syndrome: a randomized clinical trial protocol’, https://doi.org/10.6084/m9.figshare.23909727.v1.²⁰

Acknowledgements

I would like to acknowledge Mr. Manoj Patil and Mr. Laxmikant Umate for their assistance in designing the data analysis and calculating the sample size.

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¹ Musculoskeletal physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Samiksha Vinod Sonone
Roles: Conceptualization, Writing – Original Draft Preparation

Deepali Patil
Roles: Supervision, Validation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

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version 1

Published: 23 Aug 2023, 12:1027

https://doi.org/10.12688/f1000research.138167.1

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© 2023 Sonone SV and Patil D. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Sonone SV and Patil D. Effect of Maitland and Mulligan mobilization on pain, range of motion and disability in patients with rotator cuff syndrome: a randomized clinical trial protocol [version 1; peer review: 1 not approved]. F1000Research 2023, 12:1027 (https://doi.org/10.12688/f1000research.138167.1)

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VERSION 1

PUBLISHED 23 Aug 2023

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Reviewer Report 13 Oct 2023

Annegret Mündermann, Biomedical Engineering, University of Basel, Basel,, Switzerland; Orthopaedics and Traumatology, University Hospital Basel, Basel, Switzerland

Not Approved

https://doi.org/10.5256/f1000research.151349.r212901

The goal of the clinical trial described in this protocol is to compare the effects of Maitland and Mulligan mobilization on pain, range of motion and functional disability in patients with rotator cuff syndrome. The authors intend to randomize patients ... Continue reading

The goal of the clinical trial described in this protocol is to compare the effects of Maitland and Mulligan mobilization on pain, range of motion and functional disability in patients with rotator cuff syndrome. The authors intend to randomize patients with rotator cuff syndrome to two different therapeutic interventions. While the topic of this manuscript is relevant, there are several aspects of the manuscript that require clarification:

The entire article requires copy-editing including, also for consistent use of US or OK spelling.
The authors start their introduction with a detailed description of shoulder anatomy which is basic knowledge and should be deleted from the article.
Many statements in the introduction section lack references. The authors should cite appropriate literature.
While the Mulligan mobilization is described in the introduction session, appropriate information should also be provided for the Maitland mobilization.
There are some open questions regarding the inclusion and exclusion criteria. One inclusion criterion is having a partial tear, and one exclusion criterion is osteoporosis. How will the authors confirm check these criteria? Will patients with glenohumeral or acromioclavicular osteoarthritis be excluded as these can affect the proposed outcome measures.
The authors state that shoulder subluxation is a reason for discontinuation. How often does this typically occur in standard intervention?
The authors should describe earlier in the manuscript how adherence will be recorded. In the current version it appears that this will be reported by the study participants. However, later in the manuscript it becomes clear that the therapists will know which sessions the participants will complete.
Shoulder flexion range of motion will be assessed using a goniometer. The authors describe what a goniometer is and what it can be used for. Please describe how and by whom the shoulder flexion range of motion assessment will be conducted.
The authors conducted a sample size estimation but should report the reference article earlier in the section. The calculation for the pooled standard deviation is incorrect. The pooled standard deviation is 16.3. With this value, 75 patients are needed for the study. The sample size estimation describes superiority, yet the statistical analyses aim at determining if both interventions have significant effects on the outcome parameters.
The authors assumed a drop-out rate of 10%. Is this realistic?
The authors should specify how missing data are handled and which intent to treat analysis is planned.
All participants will be expected to complete five sessions per week. Will these only be scheduled on weekdays? The authors state that missed appointments will be available on standby days. Are these on weekends? Please provide more details.
All data will be managed in excel. Excel spreadsheets are not appropriate for clinical trials for several reasons including that data can be lost. The authors are strongly encouraged to use a data management tool appropriate for clinical trials with a data log such as Redcap.
The authors state that data monitoring will be led by the PI. The data monitoring should be performed by an independent committee.
The discussion should address aspects related to the study design, expected results and implications of these results as well as the strengths and limitations of aspects of the study protocol

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Rotator cuff pathologies, movement science, shoulder biomechanics, patient reported outcomes, clinical trials

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Annegret Mündermann, University of Basel, Basel,, Switzerland; University Hospital Basel, Basel, Switzerland

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Reviewer Report

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13 Oct 2023 | for Version 1

Annegret Mündermann, Biomedical Engineering, University of Basel, Basel,, Switzerland; Orthopaedics and Traumatology, University Hospital Basel, Basel, Switzerland

7 Views Cite this report Responses(0)

Not Approved

The goal of the clinical trial described in this protocol is to compare the effects of Maitland and Mulligan mobilization on pain, range of motion and functional disability in patients with rotator cuff syndrome. The authors intend to randomize patients with rotator cuff syndrome to two different therapeutic interventions. While the topic of this manuscript is relevant, there are several aspects of the manuscript that require clarification:

The entire article requires copy-editing including, also for consistent use of US or OK spelling.
The authors start their introduction with a detailed description of shoulder anatomy which is basic knowledge and should be deleted from the article.
Many statements in the introduction section lack references. The authors should cite appropriate literature.
While the Mulligan mobilization is described in the introduction session, appropriate information should also be provided for the Maitland mobilization.
There are some open questions regarding the inclusion and exclusion criteria. One inclusion criterion is having a partial tear, and one exclusion criterion is osteoporosis. How will the authors confirm check these criteria? Will patients with glenohumeral or acromioclavicular osteoarthritis be excluded as these can affect the proposed outcome measures.
The authors state that shoulder subluxation is a reason for discontinuation. How often does this typically occur in standard intervention?
The authors should describe earlier in the manuscript how adherence will be recorded. In the current version it appears that this will be reported by the study participants. However, later in the manuscript it becomes clear that the therapists will know which sessions the participants will complete.
Shoulder flexion range of motion will be assessed using a goniometer. The authors describe what a goniometer is and what it can be used for. Please describe how and by whom the shoulder flexion range of motion assessment will be conducted.
The authors conducted a sample size estimation but should report the reference article earlier in the section. The calculation for the pooled standard deviation is incorrect. The pooled standard deviation is 16.3. With this value, 75 patients are needed for the study. The sample size estimation describes superiority, yet the statistical analyses aim at determining if both interventions have significant effects on the outcome parameters.
The authors assumed a drop-out rate of 10%. Is this realistic?
The authors should specify how missing data are handled and which intent to treat analysis is planned.
All participants will be expected to complete five sessions per week. Will these only be scheduled on weekdays? The authors state that missed appointments will be available on standby days. Are these on weekends? Please provide more details.
All data will be managed in excel. Excel spreadsheets are not appropriate for clinical trials for several reasons including that data can be lost. The authors are strongly encouraged to use a data management tool appropriate for clinical trials with a data log such as Redcap.
The authors state that data monitoring will be led by the PI. The data monitoring should be performed by an independent committee.
The discussion should address aspects related to the study design, expected results and implications of these results as well as the strengths and limitations of aspects of the study protocol

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Rotator cuff pathologies, movement science, shoulder biomechanics, patient reported outcomes, clinical trials

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

Respond to this report

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[7] 7. Edwards P, Ebert J, Joss B, et al.: EXERCISE REHABILITATION IN THE NON-OPERATIVE MANAGEMENT OF ROTATOR CUFF TEARS: A REVIEW OF THE LITERATURE. Int. J. Sports Phys. Ther. 2016 Apr [cited 2023 Mar 1]; 11(2): 279–301. PubMed Abstract Reference Source

[8] 8. Deshmukh MK, Fating TB, Phansopkar PA: Comprehensive Physiotherapy Rehabilitation on a Complex Case of Combination of Subcoracoid, Subacromial, Subdeltoid, and Supraspinatus Tendinitis. J. Evol. Med. Dent. Sci. 2020 Oct 12 [cited 2021 Feb 14]; 9(41): 3075–3078. Publisher Full Text Reference Source

[9] 9. Ravichandran H, Janakiraman B, Gelaw AY, et al.: Effect of scapular stabilization exercise program in patients with subacromial impingement syndrome: a systematic review. J. Exerc. Rehabil. 2020 Jun 30 [cited 2023 Mar 3]; 16(3): 216–226. Publisher Full Text Reference Source

[10] 10. Zhang C, Wang J, Wang L, et al.: The effect of physiotherapy in rotator cuff injury patients with platelet-rich plasma: study protocol of a non-randomized controlled trial. BMC Musculoskelet. Disord. 2021 Mar 20 [cited 2023 Mar 1]; 22(1): 292. PubMed Abstract | Publisher Full Text | Free Full Text

[11] 11. Savva C, Karagiannis C, Korakakis V, et al.: The analgesic effect of joint mobilization and manipulation in tendinopathy: a narrative review. J. Man. Manip. Ther. [cited 2023 Mar 1]; 29(5): 276–287. Publisher Full Text Reference Source

[12] 12. Wang S, Chapple CM, Quinn D, et al.: Dosage of joint mobilisation for the management of rotator cuff-related shoulder pain: protocol for a scoping review. BMJ Open. 2022 Jun 3 [cited 2023 Mar 1]; 12(6): e056771. PubMed Abstract | Publisher Full Text | Free Full Text

[13] 13. Menek B, Tarakci D, Algun ZC: The effect of Mulligan mobilization on pain and life quality of patients with Rotator cuff syndrome: A randomized controlled trial. J. Back Musculoskelet. Rehabil. 2019 Jan 1 [cited 2023 Mar 1]; 32(1): 171–178. PubMed Abstract | Publisher Full Text Reference Source

[14] 14. Hawker GA, Mian S, Kendzerska T, et al.: Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res. 2011 Nov; 63: S240–S252. Publisher Full Text

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[18] 18. Hassan MA, Elanni EF, Hassan KA, et al.: Effect of Mulligan Technique on Subacromial Impingement Syndrome: A Systematic Review. Egypt. J. Hosp. Med. 2021 Oct 1 [cited 2023 Mar 2]; 85(1): 3043–3053. Publisher Full Text Reference Source

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Effect of Maitland and Mulligan mobilization on pain, range of motion and disability in patients with rotator cuff syndrome: a randomized clinical trial protocol

Abstract

Keywords

Introduction

Aim and objectives of the study

Protocol

Trial design

Methods

Figure 1. Procedure of protocol.

Eligibility criteria

Interventions

Outcome measures

Sample size calculation

Data collection methods

Data management

Statistical analysis

Monitoring

Ethics and dissemination

Protocol amendments

Consent

Confidentiality

Access to data

Ancillary and post-trial care

Dissemination policy

Study status

Discussion

Data availability

Underlying data

Extended data

Reporting guidelines

Acknowledgements

References

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