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The Effect of Mobilization With Movement in Individuals With Shoulder Impingement Syndrome (SIS)

Primary Purpose

Shoulder Impingement Syndrome, Subacromial Impingement, Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Mobilization with movement
Conventional physical therapy
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Shoulder impingement syndrome, Mobilization with movement, Conventional physical therapy, Pain intensity, Visual analogue scale, Range of motion, Inclinometer, Shoulder pain and disability index, Postural assessment software, Craniovertebral angle, Sagittal shoulder posture, Hand held dynamometer

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anterior and/or lateral shoulder pain (between the acromion and glenoid)
  • Score 4 - 7 cm on the 0 - 10 visual analog scale
  • Experienced shoulder pain at least 3 months
  • Positive combination 2 of 3 impingement test (painful arc, empty can, and external rotation test)
  • Negative at least one of rotator cuff test (isometric infraspinatus and subscapularis muscle test)

Exclusion Criteria:

  • History of shoulder, cervical, or thoracic surgery
  • History of neurological conditions (stroke, brachial plexus injury)
  • Postural deformity and musculoskeletal condition that affects the shoulder movement
  • History of shoulder major trauma on the affected side (fracture, dislocation, tendon rupture and/or lateral torn)
  • Having bilateral shoulder impingement syndrome
  • Recently using muscle relaxants, pain killer, or corticosteroid injection
  • Ligamentous laxity based on positive sulcus sign
  • Numbness or tingling in upper extremity
  • Systemic illness or widespread pain
  • Rheumatic disease
  • Having malfunction of the rotator cuff (e.g. cannot perform at all)
  • Having a passive limitation due to adhesive capsulitis
  • Positive of scapular retraction test

Sites / Locations

  • Esa Unggul physical therapy clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mobilization with movement

Conventional physical therapy

Arm Description

Mobilization with movement on the shoulder abduction and external rotation

Postural correction exercise and muscle strengthening of the rotator cuff muscle and surrounding muscle on the subacromial region

Outcomes

Primary Outcome Measures

Pain intensity change between time
Visual analogue scale, 0 mean no pain at all until 10 scale mean the worst pain
Shoulder function change between time
Shoulder pain and disability index, this index is consist of 13 items with 0 score mean no pain and 10 score mean the worst pain imaginable, the scoring calculation is that the total score / 130 x 100 = ___%

Secondary Outcome Measures

Range of motion change between time
Inclinometer, measure the joint range of motion with 0 degree mean no motion at all and 180 degree is the maximum range for the shoulder abduction motion
Muscle strength change between time
Hand held dynamometer, measure the peak isometric force with 0 score mean there is no contraction of the muscle, the maximum isometric force of each individual can be vary from 1 kgf to the limit
Postural assessment change between time
Craniovertebral angle and sagittal shoulder posture, measures using the postural assessment software (PAS) to see the degree of craniovertebral angle and sagittal shoulder posture angle. The degree varying on each individual, the smallest craniovertebral angle mean that the person is more forward head and the smallest sagittal shoulder posture mean that the person is more slouchy.

Full Information

First Posted
May 10, 2020
Last Updated
October 21, 2020
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04599127
Brief Title
The Effect of Mobilization With Movement in Individuals With Shoulder Impingement Syndrome
Acronym
SIS
Official Title
Mobilization With Movement as an Additional Treatment to Conventional Physical Therapy in Individuals With Shoulder Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study conducted to see the effect of adding mobilization with movement to conventional physical therapy to the subject with shoulder impingement syndrome. The shoulder impingement syndrome is often described as anterior lateral shoulder pain that provoked during shoulder elevation. The pain occurs during shoulder elevation and causes limited range of motion. Moreover, the patients with shoulder impingement syndrome commonly had a forward head posture and slouching shoulder. There is a theory that illustrates the mechanical factors lead to the injury of the bursa or rotator cuff tendons below the subacromial space which is highly related to the posture and scapular movement. Various treatments for shoulder impingement syndrome including medical treatments such as anti-inflammatory drugs, subacromial decompression, and acromion resection surgery. Conventional physical therapy treatments for shoulder impingement syndrome included modalities, exercises and manual therapy. Exercise has been showed to give a significant effect to decrease the pain intensity, increasing the range of motion and shoulder function. There is evidence that supports the use of manual therapy on shoulder impingement, the recent technique introduced by Brian Mulligan is mobilization with movement. Mobilization with movement is a manual therapy technique that uses the active movement while the physical therapist applies an accessory force to align the positional fault of the joint. A previous study investigated the effect of mobilization with movement that uses the mobilization with movement in shoulder impingement syndrome showed different outcomes in the measurement of pain intensity and shoulder range of motion. As the posture may be related to shoulder impingement syndrome, this research will measure the cervical posture, shoulder posture, and muscle strength. Therefore, the purposes of this study will be to compare the effects of conventional physical therapy treatments and the conventional therapy treatments plus the mobilization with movement on pain intensity, shoulder range of motion, cervical and shoulder posture, shoulder muscle strength and shoulder function. The study hypothesis was that mobilization with movement is more effective in improving the investigated outcomes in individuals with shoulder impingement syndrome than the conventional physical therapy.
Detailed Description
Shoulder impingement syndrome causes positional fault of the subacromial and soft tissues below the subacromial space. This condition leads to the wrong biomechanics of precise ball and socket kinematics creating maximum concavity compression for shoulder stability. This wrong biomechanics is resulting in the injury of tissue below the subacromial space, such as rotator cuff tendinitis, tears of rotator cuff tendons, and subacromial bursitis. The space between the acromion and humeral was small varying between nine to 14 mm. However, the subacromial space will be decreased during the arm elevation or in the abduction and external rotation position. Some of the researchers defined the shoulder impingement syndrome as the mechanical entrapment of the rotator cuff or the subacromial bursa in the subacromial space. The highest compression of the structures below the subacromial space occurs when people elevate the arm, especially during the shoulder flexion, abduction, and rotation. The etiology of shoulder impingement syndrome is multifactorial, although a few common causes of the shoulder impingement syndrome were narrowing of the subacromial space and enlargement of the subacromial bursa or rotator cuff tendons. The mechanical factor is believed as the main cause of shoulder impingement syndrome. The postural misalignment and the movement control that makes the improper muscle activation and cause false movement times between acromion and glenoid were shown to associated with the etiology of shoulder impingement syndrome. Individu with the protracted shoulder is frequently associated with the anteriorly tilted and internally rotated of the scapula. The protracted shoulder or forward displacement of the acromion can be measured by the shoulder angle to the seventh cervical spinous process. The humeral head position depends on the soft tissues surrounding the subacromial region. During arm elevation, the humeral head position should be at the center and adjust anterior translation along with the acromion movement to anterior and lateral. When the humeral head position is faulty or not in the center, because of the anterior inferior glenohumeral ligament cannot restrain the abnormal humeral head translation. This condition leads to decreased subacromial space and irritation to the soft tissue below the acromion which causes the impingement syndrome. Study protocol This study will recruit shoulder patients around Jakarta city, the age between 20 and 60 years. The patients with shoulder impingement syndrome will be recruited by online brochures and leaflets. All eligible participants will receive a clear explanation of the purposes, procedures, advantages, and possible risks of this study. Each participant will be asked to sign an informed consent after they understand and accept to participate in this study. Based on the assessment form, the participant will be assessed by the examiner and researcher. The participants' age will be used to grouping the participants into the conventional or mobilization with the movement group. The participant will be asked to rate their pain intensity using the visual analog scale during the maximum shoulder abduction. Shoulder range of motion will be assessed using the bubble inclinometer during shoulder abduction in the standing position, internal and external rotation in the supine position with 90° shoulder abduction and 90° elbow flexion. Cervical and shoulder with the instruction to the participants to stand in their relaxed posture will be recorded by photogrammetry. Muscle strength of shoulder abductors, external rotators, and internal rotators will be assessed using the handheld dynamometer. The shoulder function will be recorded by the shoulder pain and disability index. Conventional physical therapy For the conventional group, PT (E), who has had certified level 1 sports physical therapy from the Australian Physiotherapy Association and has had 5 years of working experience, will treat the participants with the conventional and postural correction exercise. This therapist will be blinded by unknowing the group allocation. The participants will receive the conventional intervention, the postural correction exercise, and 10 minutes rest. Then the outcome measures will be reassessed thereafter. The participants in the conventional group will receive conventional physical therapy including stretching, modality, ice, therapeutic exercise, passive mobilization, and postural correction exercise. The conventional physical therapy is adjustable or tailor-made depending on the patient's specific conditions. Therapeutic exercise has a wide variety of types and modes of exercise. The postural correction exercises consist of rotator cuff muscle strengthening with eccentric-concentric, scapular stabilization exercise, and postural awareness. In addition, these exercises include motor control therapeutic exercise for the relearn process and motor control of the correct posture to change the participant's behavior. Mobilization with movement For the mobilization with movement group, PT (S) will know the code to treat the participants using the conventional or mobilization with movement protocol. Moreover, this therapist will apply the mobilization with movement technique. The participants will receive the conventional intervention, the postural correction exercise, and the mobilization with movement. Then the outcome measures will be reassessed thereafter. The directions of mobilization with movement are a posterolateral glide when the participants raise their arm to perform shoulder abduction until the overhead movement. The therapist will place one hand on the participant's scapula to stabilize movement while placing the thenar eminence of the other hand on the medial of the humeral head. The treatment belt will be placed on the participant's shoulder on top of the PT (S)'s hand. The therapist will provide sustained posterolateral and inferior glide while the participants will be asked to move the shoulder freely in the pain-free angle. PT (S)'s hands will move along with the movement to sustain the glide along the treatment plane with upward rotation of the scapula. The mobilization with movement dose will be 3 sets of 10 repetitions with rest interval 30 seconds between sets, twice a week for 4 weeks. Sample size calculation will be performed using the formula for the test of the difference between 2 independent means. According to the G*power 3.1.9.2 program calculation, the total of this study equals 20 subjects. Based on the previous study using the shoulder pain and disability index to measure the shoulder function, in the study of comparing the immediate effects of mobilization with movement and sham techniques. The mean (standard deviation) between group post-intervention for the mobilization with movement group was 4.6 (5.0) and that for the sham group was 0.4 (1.1). In this proposed study, the investigators need an equal number of participants per group; therefore, the drop out the calculation of 20% of the total participants (n = 1/1-20%). Therefore, after the ethical approval, the researcher will collect data from 24 shoulder impingement syndrome patients (12 subjects on the conventional group and 12 subjects on the mobilization with movement group). Statistical Analysis Data will be analyzed using SPSS version 23. The statistical significance level is set at a p-value < 0.05. Shapiro-Wilk will be used to examine the distribution of the data Descriptive statistics for demographic data, mean and standard deviation for continuous, cumulative frequency for categorical, and median for ordinal variables, will be calculated. Two-way mixed-design ANOVA (two group x four-time) for parametric data. If the data are significant the post hoc analysis will be performed using Bonferroni. Friedman tests if the data are not normally distributed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome, Subacromial Impingement, Subacromial Impingement Syndrome, Subacromial Pain Syndrome, Impingement Syndrome, Shoulder
Keywords
Shoulder impingement syndrome, Mobilization with movement, Conventional physical therapy, Pain intensity, Visual analogue scale, Range of motion, Inclinometer, Shoulder pain and disability index, Postural assessment software, Craniovertebral angle, Sagittal shoulder posture, Hand held dynamometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All of the eligible participants will be divided into two groups; conventional physical therapy and conventional physical therapy plus mobilization with movement
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The participant will be blinded by unknowing the randomization of the group allocation using a sealed envelope. The physical therapy (S) who treats the participants using mobilization with movement will be blinded by unknowing the group allocation of the participants. The physical therapy (E) who treats the participants using conventional physical therapy will be blinded by unknowing the group allocation because all of the participants will be treated using conventional physical therapy. The examiner (AH) and (FN) will be blinded by unknowing the participant group and the sequence of assessments will be randomized.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobilization with movement
Arm Type
Experimental
Arm Description
Mobilization with movement on the shoulder abduction and external rotation
Arm Title
Conventional physical therapy
Arm Type
Placebo Comparator
Arm Description
Postural correction exercise and muscle strengthening of the rotator cuff muscle and surrounding muscle on the subacromial region
Intervention Type
Other
Intervention Name(s)
Mobilization with movement
Other Intervention Name(s)
Mulligan techniques
Intervention Description
The physical therapist will adjust the active movement of the shoulder joint during the arm elevation or abduction and shoulder external rotation
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Other Intervention Name(s)
Postural correction exercise
Intervention Description
The exercise is tailor-made and each participant will be performing some of the exercises based on the list that physical therapist prescription
Primary Outcome Measure Information:
Title
Pain intensity change between time
Description
Visual analogue scale, 0 mean no pain at all until 10 scale mean the worst pain
Time Frame
Baseline, at the week 1, week 2, week 3, and week 4
Title
Shoulder function change between time
Description
Shoulder pain and disability index, this index is consist of 13 items with 0 score mean no pain and 10 score mean the worst pain imaginable, the scoring calculation is that the total score / 130 x 100 = ___%
Time Frame
Baseline, at the week 2, and week 4
Secondary Outcome Measure Information:
Title
Range of motion change between time
Description
Inclinometer, measure the joint range of motion with 0 degree mean no motion at all and 180 degree is the maximum range for the shoulder abduction motion
Time Frame
Baseline, at week 1, week 2, week 3, and week 4
Title
Muscle strength change between time
Description
Hand held dynamometer, measure the peak isometric force with 0 score mean there is no contraction of the muscle, the maximum isometric force of each individual can be vary from 1 kgf to the limit
Time Frame
Baseline, at week 2 and week 4
Title
Postural assessment change between time
Description
Craniovertebral angle and sagittal shoulder posture, measures using the postural assessment software (PAS) to see the degree of craniovertebral angle and sagittal shoulder posture angle. The degree varying on each individual, the smallest craniovertebral angle mean that the person is more forward head and the smallest sagittal shoulder posture mean that the person is more slouchy.
Time Frame
Baseline, at week 2 and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anterior and/or lateral shoulder pain (between the acromion and glenoid) Score 4 - 7 cm on the 0 - 10 visual analog scale Experienced shoulder pain at least 3 months Positive combination 2 of 3 impingement test (painful arc, empty can, and external rotation test) Negative at least one of rotator cuff test (isometric infraspinatus and subscapularis muscle test) Exclusion Criteria: History of shoulder, cervical, or thoracic surgery History of neurological conditions (stroke, brachial plexus injury) Postural deformity and musculoskeletal condition that affects the shoulder movement History of shoulder major trauma on the affected side (fracture, dislocation, tendon rupture and/or lateral torn) Having bilateral shoulder impingement syndrome Recently using muscle relaxants, pain killer, or corticosteroid injection Ligamentous laxity based on positive sulcus sign Numbness or tingling in upper extremity Systemic illness or widespread pain Rheumatic disease Having malfunction of the rotator cuff (e.g. cannot perform at all) Having a passive limitation due to adhesive capsulitis Positive of scapular retraction test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wunpen Chansirinukor, Dr.
Organizational Affiliation
Mahidol University
Official's Role
Study Director
Facility Information:
Facility Name
Esa Unggul physical therapy clinic
City
Jakarta
State/Province
Jakarta Barat
ZIP/Postal Code
11510
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocols and the participant's data record with only initial or code
IPD Sharing Time Frame
The data will be available in May 2020 and will be held until two years after the data collection is done
IPD Sharing Access Criteria
The access for the data will be shared using the Mahidol University Physical therapy e-library and anyone can get access by contacting the administrator
IPD Sharing URL
https://www.li.mahidol.ac.th/e-databases/
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Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://sp.mahidol.ac.th/eng/contact-mucirb.html
Available IPD/Information Identifier
MU-CIRB 2019/206.06.08
Available IPD/Information Comments
The data can be accessed by using the ethics committee of Mahidol University Central Institutional Review Board to see the ethics approval protocols with the code: MU-CIRB 2019/206.06.08 or using the email to feypqbd@yahoo.com

Learn more about this trial

The Effect of Mobilization With Movement in Individuals With Shoulder Impingement Syndrome

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