Subacromial Impingement SyndromeNCT05402709
Effectiveness of Posterior Capsule Stretching and Posterior Mobilization on Subacromial Impingement Syndrome
A study testing Posterior mobilisation technique and Posterior capsule stretching in people with Subacromial Impingement Syndrome, run by Yeditepe University.
Trial summary
Subacromial Impingement Syndrome is one of the most common shoulder pathologies causing shoulder pain, functional disability and reduced quality of life. This study was designed to investigate the effectiveness of posterior capsule stretching and posterior mobilization on shoulder joint functions in Subacromial… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Posterior mobilisation technique and Posterior capsule stretching
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2016to 25 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be between 30-60 years old
- Positive Neer, Hawkins-Kennedy impingement tests
- Painful arch and minimal limitation during active flexion and abduction movements in the glenohumeral joint area or proximal arm
- Symptoms lasting longer than 1 month
Who cannot join
- Adhesive capsulitis,
- Rotator cuff tears,
- Calcific tendinitis findings in radiology,
- Having a heart disease
- Presence of neurological diseases,
- Cognitive and mental problems that will affect understanding,
Show all 11Show fewer
- Cervical radiculopathies,
- Presence of inflammatory joint diseases,
- Surgical intervention on the same shoulder in the last 12 months,
- To have had physical therapy on the same shoulder in the last 3 months,
- Presence of instability or previous dislocation history.
About this study
Official title: Comparison of the Effectiveness of Posterior Capsule Stretching and Posterior Mobilization on Subacromial Impingement Syndrome
Subacromial Impingement Syndrome is one of the most common shoulder pathologies causing shoulder pain, functional disability and reduced quality of life. This study was designed to investigate the effectiveness of posterior capsule stretching and posterior mobilization on shoulder joint functions in Subacromial Impingement Syndrome.
Read the detailed description
Subacromial Impingement Syndrome is one of the most common shoulder pathologies causing shoulder pain, functional disability, and reduced quality of life. This study investigated the effectiveness of posterior capsule stretching and posterior mobilization on shoulder joint functions in Subacromial Impingement Syndrome.
74 patients with SIS were enrolled, 58 were included, but 50 completed the study. Also, 30 healthy individuals were included and completed the study. The introductory characteristics of cases with the sociodemographic survey, pain intensity with VAS, upper extremity function with American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form and Modified Constant Murley Score, upper extremity disability and health situation with Quick Disability Arm, Shoulder and Hand Score, the evaluation of musculoskeletal symptoms with Cornell Musculoskeletal Discomfort Questionnaire, range of motion with a goniometer, shoulder muscle strength with myometer, grip strength with dynamometer and pinch meter and posterior capsule tightness with a tapeline. Individuals were divided into three different groups posterior mobilisation, posterior capsule, and control group. While participants included in the mobilization group were given classical stretching and strengthening and home exercise programs in addition to posterior mobilization, for the capsule stretching group, classical stretching and strengthening and home exercise program were given in addition to posterior capsule stretching exercise, and no exercise program was given to the control group and only posterior capsule tightness evaluation was applied.
In this study, while there was found a statistically significant difference between both groups in the Constant score and involved part External Rotation range of motion (p<0,05), a statistically significant difference was not observed in the evaluation of muscle strength, grip strength and posterior capsule tightness (p>0,05). In the participants who applied mobilization, the functional capacity of the shoulder joint was increased more than those of the capsule stretching.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Posterior mobilisation technique, Posterior capsule stretching
- Keywords
- subacromial impingement syndrome, posterior capsule, mobilisation
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior mobilisation techniqueOther
Posterior mobilisation technique were applied
Posterior capsule stretchingOther
Posterior capsule stretching were applied
| Study group | Role | What they receive |
|---|---|---|
| Posterior mobilization group | Active comparator | Posterior mobilization, classical stretching, strengthening exercises were applied and home exercise program were given Receives: Other: Posterior mobilisation technique |
| Posterior capsule stretching | Active comparator | Posterior capsule stretching, classical stretching, strengthening exercises were applied and home exercise program were given Receives: Other: Posterior capsule stretching |
| Control group | No intervention | No treatment was given, only assessment of posterior capsule tightness was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Joint Range of Motion
Shoulder flexion, abduction, external and internal rotations were evaluated actively and passively using a classical goniometer (Santa Pharma 12 inch) while the patient was in the supine position. Measurements were made twice, before and at the end of the treatment (6th week), and the average value was taken bilaterally three times.
Measured: 6 weeks
Assessment of Muscle Strength
"JTech Commander Power Track IITM" Myometer device was used for muscle strength evaluation. In the evaluation, shoulder flexion, extension, abduction, internal and external rotation movements were held with resistance for 3-5 seconds for each movement (according to the manual muscle test rules). Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times, and the average values were taken and tested by the physiotherapist.
Measured: 6 weeks
Assessment of Grip Strength
The grip strength of the hand was evaluated using the "JTech Commander Grip Track Hand Dynamometer". The patient was evaluated by the physiotherapist in a sitting position in a chair, with the shoulder to be tested in adduction and neutral rotation, the elbow in 90 degree flexion, and the forearm and wrist in neutral position. The patients were asked to squeeze the dynamometer as hard as possible. After a 30-second rest break between measurements, the next measurement was started. Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times and evaluated by taking the average values.
Measured: 6 weeks
Assessment of Pain
The pain intensity of the patients was evaluated with the Visual Analogue Scale (VAS) by the physiotherapist. The Visual Analogue Scale is a scale in which evaluation is made on a 10 cm line drawn on the horizontal plane with a maximum of 10 and a minimum of 0 points. The patient was asked to mark the severity of the pain he felt in his shoulder on this line, and the pain before and after the treatment was evaluated with this method.
Measured: 6 weeks
American Shoulder and Elbow Surgeons Assessment Form
The American Shoulder and Elbow Surgeons Assessment Form (ASES) is a standard shoulder evaluation form that evaluates pain and function in the upper extremity, including objective and subjective parts, prepared by shoulder and elbow surgeons. The questionnaire consists of pain (VAS) and function (10 questions). The function section consists of a 4-point Likert scale for each question. The Turkish version of ASES was used in the study, the validity and reliability of which were made by Çelik et al. in 2012. The total score of the questionnaire completed by the patients before and after the treatment was evaluated out of 100.
Measured: 6 weeks
Quick-DASH
The Arm, Shoulder and Hand Problems Questionnaire (Quick-DASH) is a scale that evaluates the disability and health status of the upper extremity, which can be filled by the individual alone. The questionnaire consists of 11 questions, each of which evaluates problems such as whether the patient has limitations in activities that require upper extremity functions in daily life activities, the effect of the current problem on the person's social activities, pain, tingling sensation and difficulty in sleeping, and a business model with 4 questions each, and sports that require high performance. The questions do not only address the shoulder area, but also cover the hand and arm. Scoring takes a value between 0-100 and a high score reflects more disability. In our study, we made use of the website while performing the Quick-DASH scoring. People with Subacromial Impingement Syndrome completed this questionnaire at the beginning and end of treatment.
Measured: 6 weeks
Modified Constant-Murley Score (CMS)
Constant Murley Score (CMS), the first shoulder scoring system developed, was put into effect in 1987 by Constant and Murley. This questionnaire, which is used to evaluate various diseases of the shoulder; pain, activities of daily living, strength and range of motion are evaluated qualitatively and quantitatively. The CMS consists of pain (15 points), activities of daily living (20 points), movement (40 points), and strength (25 points) subscales. The difference of the modified CMS from the original CMS; While the VAS was used for the pain scale in the modified CMS, the pain was rated as "severe", "moderate", "mild", and "absent" in the original. Modified CMS is scored over 100 points. A higher score indicates higher quality of functionality. We also used the Turkish version of Modified Constant-Murley Score at the beginning and end of the treatment in our study.
Measured: 6 weeks
Cornell Musculoskeletal Discomfort Questionnaire
The Cornell Musculoskeletal Discomfort Questionnaire is a data collection tool developed at the Human Factors and Ergonomics Laboratory at Cornell University and used to evaluate musculoskeletal problems. The Cornell Musculoskeletal Disorders Questionnaire includes questions such as the frequency and severity of musculoskeletal disorders and whether these disorders interfere with work, over 10 upper extremity body regions on 3 separated scales. In our study, the Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire was used, and it was filled in by the patients at the beginning and end of the treatment.
Measured: 6 weeks
Assessment of Posterior Capsule Tightness
The medial epicondyle of the tested arm is marked with a pencil and aligned with the subject's acromion perpendicular to the treatment table with the spine in a neutral position. By stabilizing the lateral border of the scapula while the shoulder is in the retracted position, scapular movement is restricted and the subject's humerus is positioned at 90° horizontal abduction, 0° rotation at the start of the test.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start26 Dec 2016
- Primary completion8 Feb 2017
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals were randomly divided into 3 different groups as posterior mobilisation, posterior capsule stretching and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Akbuğa Koç, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402709
- Sponsor's protocol ID
- 2016-11/03
- Status last verified
- Nov 2022
- First submitted
- 28 May 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Posterior Capsule Stretching and Posterior Mobilization on Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05402709
- Acronym / sponsor ID
- 2016-11/03
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- subacromial impingement syndrome, posterior capsule, mobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 26 Dec 2016 (actual)
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subacromial Impingement Syndrome is one of the most common shoulder pathologies causing shoulder pain, functional disability and reduced quality of life. This study was designed to investigate the effectiveness of posterior capsule stretching and posterior mobilization on shoulder joint functions in Subacromial Impingement Syndrome.
Detailed description
Subacromial Impingement Syndrome is one of the most common shoulder pathologies causing shoulder pain, functional disability, and reduced quality of life. This study investigated the effectiveness of posterior capsule stretching and posterior mobilization on shoulder joint functions in Subacromial Impingement Syndrome.
74 patients with SIS were enrolled, 58 were included, but 50 completed the study. Also, 30 healthy individuals were included and completed the study. The introductory characteristics of cases with the sociodemographic survey, pain intensity with VAS, upper extremity function with American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form and Modified Constant Murley Score, upper extremity disability and health situation with Quick Disability Arm, Shoulder and Hand Score, the evaluation of musculoskeletal symptoms with Cornell Musculoskeletal Discomfort Questionnaire, range of motion with a goniometer, shoulder muscle strength with myometer, grip strength with dynamometer and pinch meter and posterior capsule tightness with a tapeline. Individuals were divided into three different groups posterior mobilisation, posterior capsule, and control group. While participants included in the mobilization group were given classical stretching and strengthening and home exercise programs in addition to posterior mobilization, for the capsule stretching group, classical stretching and strengthening and home exercise program were given in addition to posterior capsule stretching exercise, and no exercise program was given to the control group and only posterior capsule tightness evaluation was applied.
In this study, while there was found a statistically significant difference between both groups in the Constant score and involved part External Rotation range of motion (p<0,05), a statistically significant difference was not observed in the evaluation of muscle strength, grip strength and posterior capsule tightness (p>0,05). In the participants who applied mobilization, the functional capacity of the shoulder joint was increased more than those of the capsule stretching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Individuals were randomly divided into 3 different groups as posterior mobilisation, posterior capsule stretching and control group
| Arm | Type | Receives |
|---|---|---|
| Posterior mobilization group | Active comparator | Other: Posterior mobilisation techniquePosterior mobilization, classical stretching, strengthening exercises were applied and home exercise program were given |
| Posterior capsule stretching | Active comparator | Other: Posterior capsule stretchingPosterior capsule stretching, classical stretching, strengthening exercises were applied and home exercise program were given |
| Control group | No intervention | –No treatment was given, only assessment of posterior capsule tightness was applied. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- To be between 30-60 years old
- Positive Neer, Hawkins-Kennedy impingement tests
- Painful arch and minimal limitation during active flexion and abduction movements in the glenohumeral joint area or proximal arm
- Symptoms lasting longer than 1 month
Key exclusion criteria (11 listed)
- Adhesive capsulitis,
- Rotator cuff tears,
- Calcific tendinitis findings in radiology,
- Having a heart disease
- Presence of neurological diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior mobilisation techniquePosterior mobilisation technique were applied | Other | Posterior mobilization group |
| Posterior capsule stretchingPosterior capsule stretching were applied | Other | Posterior capsule stretching |
Primary outcome
Assessment of Joint Range of Motion
Time frame: 6 weeks
Shoulder flexion, abduction, external and internal rotations were evaluated actively and passively using a classical goniometer (Santa Pharma 12 inch) while the patient was in the supine position. Measurements were made twice, before and at the end of the treatment (6th week), and the average value was taken bilaterally three times.
Assessment of Muscle Strength
Time frame: 6 weeks
"JTech Commander Power Track IITM" Myometer device was used for muscle strength evaluation. In the evaluation, shoulder flexion, extension, abduction, internal and external rotation movements were held with resistance for 3-5 seconds for each movement (according to the manual muscle test rules). Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times, and the average values were taken and tested by the physiotherapist.
Assessment of Grip Strength
Time frame: 6 weeks
The grip strength of the hand was evaluated using the "JTech Commander Grip Track Hand Dynamometer". The patient was evaluated by the physiotherapist in a sitting position in a chair, with the shoulder to be tested in adduction and neutral rotation, the elbow in 90 degree flexion, and the forearm and wrist in neutral position. The patients were asked to squeeze the dynamometer as hard as possible. After a 30-second rest break between measurements, the next measurement was started. Measurements were made twice, before and after the treatment. Each measurement was repeated bilaterally and three times and evaluated by taking the average values.
Assessment of Pain
Time frame: 6 weeks
The pain intensity of the patients was evaluated with the Visual Analogue Scale (VAS) by the physiotherapist. The Visual Analogue Scale is a scale in which evaluation is made on a 10 cm line drawn on the horizontal plane with a maximum of 10 and a minimum of 0 points. The patient was asked to mark the severity of the pain he felt in his shoulder on this line, and the pain before and after the treatment was evaluated with this method.
American Shoulder and Elbow Surgeons Assessment Form
Time frame: 6 weeks
The American Shoulder and Elbow Surgeons Assessment Form (ASES) is a standard shoulder evaluation form that evaluates pain and function in the upper extremity, including objective and subjective parts, prepared by shoulder and elbow surgeons. The questionnaire consists of pain (VAS) and function (10 questions). The function section consists of a 4-point Likert scale for each question. The Turkish version of ASES was used in the study, the validity and reliability of which were made by Çelik et al. in 2012. The total score of the questionnaire completed by the patients before and after the treatment was evaluated out of 100.
Quick-DASH
Time frame: 6 weeks
The Arm, Shoulder and Hand Problems Questionnaire (Quick-DASH) is a scale that evaluates the disability and health status of the upper extremity, which can be filled by the individual alone. The questionnaire consists of 11 questions, each of which evaluates problems such as whether the patient has limitations in activities that require upper extremity functions in daily life activities, the effect of the current problem on the person's social activities, pain, tingling sensation and difficulty in sleeping, and a business model with 4 questions each, and sports that require high performance. The questions do not only address the shoulder area, but also cover the hand and arm. Scoring takes a value between 0-100 and a high score reflects more disability. In our study, we made use of the website while performing the Quick-DASH scoring. People with Subacromial Impingement Syndrome completed this questionnaire at the beginning and end of treatment.
Modified Constant-Murley Score (CMS)
Time frame: 6 weeks
Constant Murley Score (CMS), the first shoulder scoring system developed, was put into effect in 1987 by Constant and Murley. This questionnaire, which is used to evaluate various diseases of the shoulder; pain, activities of daily living, strength and range of motion are evaluated qualitatively and quantitatively. The CMS consists of pain (15 points), activities of daily living (20 points), movement (40 points), and strength (25 points) subscales. The difference of the modified CMS from the original CMS; While the VAS was used for the pain scale in the modified CMS, the pain was rated as "severe", "moderate", "mild", and "absent" in the original. Modified CMS is scored over 100 points. A higher score indicates higher quality of functionality. We also used the Turkish version of Modified Constant-Murley Score at the beginning and end of the treatment in our study.
Cornell Musculoskeletal Discomfort Questionnaire
Time frame: 6 weeks
The Cornell Musculoskeletal Discomfort Questionnaire is a data collection tool developed at the Human Factors and Ergonomics Laboratory at Cornell University and used to evaluate musculoskeletal problems. The Cornell Musculoskeletal Disorders Questionnaire includes questions such as the frequency and severity of musculoskeletal disorders and whether these disorders interfere with work, over 10 upper extremity body regions on 3 separated scales. In our study, the Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire was used, and it was filled in by the patients at the beginning and end of the treatment.
Assessment of Posterior Capsule Tightness
Time frame: 6 weeks
The medial epicondyle of the tested arm is marked with a pencil and aligned with the subject's acromion perpendicular to the treatment table with the spine in a neutral position. By stabilizing the lateral border of the scapula while the shoulder is in the retracted position, scapular movement is restricted and the subject's humerus is positioned at 90° horizontal abduction, 0° rotation at the start of the test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior mobilisation technique and Posterior capsule stretching in people with Subacromial Impingement Syndrome, run by Yeditepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Joint Range of Motion (time frame: 6 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.