Shoulder Impingement SyndromeNCT05605730
Maitland Thoracic Mobilization Versus Mulligan Thoracic Mobilization in Kyphotic Patients With Shoulder Impingement Syndrome
A study testing Maitland mobilization for thoracic spine, Mulligan thoracic sustained natural apophyseal glide (SNAGS) and Traditional exercise management in people with Shoulder Impingement Syndrome and Kyphosis Thoracic, run by Cairo University at 1 site in Egypt.
Trial summary
In recent years the management of shoulder impingement syndrome (SIS) included the thoracic spine as it was proved that it's highly correlated to pathologies in shoulder joint. SIS is proved to be associated with kyphotic posture. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Shoulder Impingement Syndrome, Kyphosis Thoracic
- What is being tested?
- Maitland mobilization for thoracic spine, Mulligan thoracic sustained natural apophyseal glide (SNAGS) and Traditional exercise management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Nov 2022to 20 Dec 2023
- 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 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Shoulder impingement syndrome SIS clinically diagnosed by using Hawkins-Kennedy test, the painful arc test, and the infraspinatus muscle strength test; and for a rotator cuff tear, the infraspinatus and the drop-arm test and supraspinatus muscle strength tests.
- Subjects will be diagnosed of having postural kyphosis proved by a physician referral or modified Cobb's angle of more than 40 degrees (x-ray).
Who cannot join
- The participants with any musculoskeletal abnormalities eg. Glenohumeral instability.
- Neurological abnormalities.
- Surgical operation of the last 4 months will be excluded from the study.
- Shoulder corticosteroid injection at any time in the past.
- Engaging in any athletic physical activities.
Trial locations and contacts
1 site in 1 country.
About this study
In recent years the management of shoulder impingement syndrome (SIS) included the thoracic spine as it was proved that it's highly correlated to pathologies in shoulder joint. SIS is proved to be associated with kyphotic posture. Also, It was proved that changing sitting posture affects the measured ROM of shoulder joint and this implicates the influence of changing thoracic position on shoulder mechanics. Explanations were made regarding the role of thoracic spine in affecting the shoulder joint through two ways. Firstly, through affecting the mechanics of scapular movements and secondly through altering the length tension relationship of shoulder musculature. This study would aim at studying the most effective thoracic mobilization in the treatment of SIS.
- Conditions
- Shoulder Impingement Syndrome, Kyphosis Thoracic
- Being tested
- Maitland mobilization for thoracic spine, Mulligan thoracic sustained natural apophyseal glide (SNAGS), Traditional exercise management
- 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.
Maitland mobilization for thoracic spineOther
The thoracic spine mobilization will be consisting of oscillations to the thoracic vertebrae from the prone positions for repeated 30 times with 1 min interval between each 4 sets for 15 minutes. For central posterio-anterior mobilization, a grade III large amplitude rhythmic oscillation in the postero-anterior direction will be applied to the joint sign segment which is defined as the patient's most painful or hardest to move segment. It will be detected through a passive accessory intervertebral motion (PAIVM) test. T6,7 will be used as a site for application if the joint sign can't be detected. The frequency of treatment sessions will be 3 sessions per week for 4 weeks.
Mulligan thoracic sustained natural apophyseal glide (SNAGS)Other
Verbal instructions will be provided for the patient to move into thoracic extension and do over-pressure at the end of ROM while a transverse glide is maintained by the therapist for a set of 10 repetitions. The significance of performing a pain-free movement will be emphasized to the patient all the time. There will be 3 sets of 10 repetitions with one minute rest between each set.
Traditional exercise managementOther
Prone back extension. Shoulder external rotation starting in 45° of internal rotation, with the arm by the side and the elbow flexed to 90 °.
Shoulder internal rotation starting in 45 ° of external rotation, with the arm by the side and the elbow flexed to 90 °..
Shoulder abduction (scapular plane) through a 0- to 60-° with the elbow flexed 90 ° and the shoulder in neutral rotation.
Shoulder flexion (sagittal plane) through a 0- to 60-°starting with the elbow flexed 90 ° and the shoulder in neutral rotation and punching forward, simultaneously extending the elbow and flexing the shoulder.
Internal rotation towel stretch: Subjects will be instructed to sit or stand while holding a towel with the affected arm behind the back and to use the other arm to pull the affected arm up the back.
| Study group | Role | What they receive |
|---|---|---|
| Traditional exercise management | Active comparator | 1. Prone back extension.
2. Shoulder external rotation starting in 45° of internal rotation, with the arm by the side and the elbow flexed to 90 °.
3. Shoulder internal rotation starting in 45 ° of external rotation, with the arm by the side and the elbow flexed to 90 °..
4. Shoulder abduction (scapular plane) through a 0- to 60-° with the elbow flexed 90 ° and the shoulder in neutral rotation.
5. Shoulder flexion (sagittal plane) through a 0- to 60-°starting with the elbow flexed 90 ° and the shoulder in neutral rotation and punching forward, simultaneously extending the elbow and flexing the shoulder.
6. Internal rotation towel stretch: Subjects will be instructed to sit or stand while holding a towel with the affected arm behind the back and to use the other arm to pull the affected arm up the back. Receives: Other: Traditional exercise management |
| Maitland mobilization for thoracic spine | Experimental | This group will receive the previously mentioned exercises protocol targeting shoulder joint in addition to Maitland mobilization for thoracic spine. Receives: Other: Maitland mobilization for thoracic spine; Other: Traditional exercise management |
| Mulligan thoracic sustained natural apophyseal glide (SNAGS) | Experimental | Treatment would be administered at the vertebral level revealed during the evaluation of thoracic SNAG. Receives: Other: Mulligan thoracic sustained natural apophyseal glide (SNAGS); Other: Traditional exercise management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active ROM of shoulder joint would be measured utilizing goniometric method
The patient will move the affected shoulder with the thumb pointing upwards through the full available active range of shoulder flexion, abduction and external rotation. The flexion angle will be formed by aligning the goniometer with the lateral epicondyle of the humerus, a vertical line in the coronal plane and the axis with the middle of the glenoid fossa. The abduction angle will be formed by aligning the goniometer with the lateral epicondyle of the humerus, a vertical line in the sagittal plane , and the axis in the middle of the posterior glenohumeral joint line. The external rotation angle will be formed by aligning the goniometer with the ulna styloid process, a horizontal line in the transverse plane , and the axis at the olecranon process of the ulna.
Measured: 6 weeks
Kyphotic angle utilizing photographic method
A lateral view image of the patient will be analyzed after fitting lateral earlobe markers. The patient will stand sideways against a calibration plane with shoulders and elbows at flexed 90 degrees while looking at a fixed point on the opposite wall. The shooting will be repeated 3 times with a camera placed 1.5 meters away from the calibration plane and at a one-meter height from the ground on a tripod. In the software, a line parallel to the calibration plane from the ear lobe would be considered the plumb line. The farthest point from the plumb line will be considered the apex of the kyphosis angle. Then, two lines at the top and bottom running parallel to the curvature of the back are considered the two lines of the angle. These lines intersected at the apex of each other. The angle of intersection of the lines was measured by Kinovea and decreased from 180°.
Measured: 6 weeks
The Arabic version of the Disability of Arm, Shoulder and Hand (DASH-Arabic)
The DASH-Arabic contains 30 items relating to the level of difficulty the patient faces while performing different activities using the arm, shoulder and hand; items assessing the severity of pain symptoms; and items assessing problems that affect social activities, work and sleep, and psychological impact. In the DASH-Arabic, each item has five response choices that range from 1, ''without any difficulty or no symptoms exist'' to 5, ''unable to engage in activity or very severe symptoms''. A minimum of 27 of the 30 items must be completed for the questionnaire to be regarded. The higher the score, the greater the disability.
Measured: 6 weeks
Pain will be assessed using visual analogue scale.
Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
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 posted4 Nov 2022
- Study start4 Nov 2022
- Primary completion14 Sep 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Salah Yousef Aboraya, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605730
- Sponsor's protocol ID
- P.T.REC/012/003447
- Status last verified
- Jan 2024
- First submitted
- 30 Oct 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maitland Thoracic Mobilization Versus Mulligan Thoracic Mobilization in Kyphotic Patients With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05605730
- Acronym / sponsor ID
- P.T.REC/012/003447
- Conditions
- Shoulder Impingement Syndrome, Kyphosis Thoracic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 4 Nov 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.
In recent years the management of shoulder impingement syndrome (SIS) included the thoracic spine as it was proved that it's highly correlated to pathologies in shoulder joint. SIS is proved to be associated with kyphotic posture. Also, It was proved that changing sitting posture affects the measured ROM of shoulder joint and this implicates the influence of changing thoracic position on shoulder mechanics. Explanations were made regarding the role of thoracic spine in affecting the shoulder joint through two ways. Firstly, through affecting the mechanics of scapular movements and secondly through altering the length tension relationship of shoulder musculature. This study would aim at studying the most effective thoracic mobilization in the treatment of SIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional exercise management | Active comparator | Other: Traditional exercise management1. Prone back extension. 2. Shoulder external rotation starting in 45° of internal rotation, with the arm by the side and the elbow flexed to 90 °. 3. Shoulder internal rotation starting in 45 ° of external rotation, with the arm by the side and the elbow flexed to 90 °.. 4. Shoulder abduction (scapular plane) through a 0- to 60-° with the elbow flexed 90 ° and the shoulder in neutral rotation. 5. Shoulder flexion (sagittal plane) through a 0- to 60-°starting with the elbow flexed 90 ° and the shoulder in neutral rotation and punching forward, simultaneously extending the elbow and flexing the shoulder. 6. Internal rotation towel stretch: Subjects will be instructed to sit or stand while holding a towel with the affected arm behind the back and to use the other arm to pull the affected arm up the back. |
| Maitland mobilization for thoracic spine | Experimental | Other: Maitland mobilization for thoracic spine, Other: Traditional exercise managementThis group will receive the previously mentioned exercises protocol targeting shoulder joint in addition to Maitland mobilization for thoracic spine. |
| Mulligan thoracic sustained natural apophyseal glide (SNAGS) | Experimental | Other: Mulligan thoracic sustained natural apophyseal glide (SNAGS), Other: Traditional exercise managementTreatment would be administered at the vertebral level revealed during the evaluation of thoracic SNAG. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Shoulder impingement syndrome SIS clinically diagnosed by using Hawkins-Kennedy test, the painful arc test, and the infraspinatus muscle strength test; and for a rotator cuff tear, the infraspinatus and the drop-arm test and supraspinatus muscle strength tests.
- Subjects will be diagnosed of having postural kyphosis proved by a physician referral or modified Cobb's angle of more than 40 degrees (x-ray).
Key exclusion criteria (5 listed)
- The participants with any musculoskeletal abnormalities eg. Glenohumeral instability.
- Neurological abnormalities.
- Surgical operation of the last 4 months will be excluded from the study.
- Shoulder corticosteroid injection at any time in the past.
- Engaging in any athletic physical activities.
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 |
|---|---|---|
| Maitland mobilization for thoracic spineThe thoracic spine mobilization will be consisting of oscillations to the thoracic vertebrae from the prone positions for repeated 30 times with 1 min interval between each 4 sets for 15 minutes. For central posterio-anterior mobilization, a grade III large amplitude rhythmic oscillation in the postero-anterior direction will be applied to the joint sign segment which is defined as the patient's most painful or hardest to move segment. It will be detected through a passive accessory intervertebral motion (PAIVM) test. T6,7 will be used as a site for application if the joint sign can't be detected. The frequency of treatment sessions will be 3 sessions per week for 4 weeks. | Other | Maitland mobilization for thoracic spine |
| Mulligan thoracic sustained natural apophyseal glide (SNAGS)Verbal instructions will be provided for the patient to move into thoracic extension and do over-pressure at the end of ROM while a transverse glide is maintained by the therapist for a set of 10 repetitions. The significance of performing a pain-free movement will be emphasized to the patient all the time. There will be 3 sets of 10 repetitions with one minute rest between each set. | Other | Mulligan thoracic sustained natural apophyseal glide (SNAGS) |
| Traditional exercise managementProne back extension. Shoulder external rotation starting in 45° of internal rotation, with the arm by the side and the elbow flexed to 90 °. Shoulder internal rotation starting in 45 ° of external rotation, with the arm by the side and the elbow flexed to 90 °.. Shoulder abduction (scapular plane) through a 0- to 60-° with the elbow flexed 90 ° and the shoulder in neutral rotation. Shoulder flexion (sagittal plane) through a 0- to 60-°starting with the elbow flexed 90 ° and the shoulder in neutral rotation and punching forward, simultaneously extending the elbow and flexing the shoulder. Internal rotation towel stretch: Subjects will be instructed to sit or stand while holding a towel with the affected arm behind the back and to use the other arm to pull the affected arm up the back. | Other | Maitland mobilization for thoracic spine, Mulligan thoracic sustained natural apophyseal glide (SNAGS), Traditional exercise management |
Primary outcome
Active ROM of shoulder joint would be measured utilizing goniometric method
Time frame: 6 weeks
The patient will move the affected shoulder with the thumb pointing upwards through the full available active range of shoulder flexion, abduction and external rotation. The flexion angle will be formed by aligning the goniometer with the lateral epicondyle of the humerus, a vertical line in the coronal plane and the axis with the middle of the glenoid fossa. The abduction angle will be formed by aligning the goniometer with the lateral epicondyle of the humerus, a vertical line in the sagittal plane , and the axis in the middle of the posterior glenohumeral joint line. The external rotation angle will be formed by aligning the goniometer with the ulna styloid process, a horizontal line in the transverse plane , and the axis at the olecranon process of the ulna.
Kyphotic angle utilizing photographic method
Time frame: 6 weeks
A lateral view image of the patient will be analyzed after fitting lateral earlobe markers. The patient will stand sideways against a calibration plane with shoulders and elbows at flexed 90 degrees while looking at a fixed point on the opposite wall. The shooting will be repeated 3 times with a camera placed 1.5 meters away from the calibration plane and at a one-meter height from the ground on a tripod. In the software, a line parallel to the calibration plane from the ear lobe would be considered the plumb line. The farthest point from the plumb line will be considered the apex of the kyphosis angle. Then, two lines at the top and bottom running parallel to the curvature of the back are considered the two lines of the angle. These lines intersected at the apex of each other. The angle of intersection of the lines was measured by Kinovea and decreased from 180°.
The Arabic version of the Disability of Arm, Shoulder and Hand (DASH-Arabic)
Time frame: 6 weeks
The DASH-Arabic contains 30 items relating to the level of difficulty the patient faces while performing different activities using the arm, shoulder and hand; items assessing the severity of pain symptoms; and items assessing problems that affect social activities, work and sleep, and psychological impact. In the DASH-Arabic, each item has five response choices that range from 1, ''without any difficulty or no symptoms exist'' to 5, ''unable to engage in activity or very severe symptoms''. A minimum of 27 of the 30 items must be completed for the questionnaire to be regarded. The higher the score, the greater the disability.
Pain will be assessed using visual analogue scale.
Time frame: 6 weeks
Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
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 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maitland mobilization for thoracic spine, Mulligan thoracic sustained natural apophyseal glide (SNAGS) and Traditional exercise management in people with Shoulder Impingement Syndrome and Kyphosis Thoracic, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 5 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Active ROM of shoulder joint would be measured utilizing goniometric method (time frame: 6 weeks). The study lists 4 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 3 Jan 2024.