Subacromial Pain SyndromeNCT06374004
The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome
A study testing Exercise Group and Thoracic Mobilization Group in people with Subacromial Pain Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Subacromial Pain Syndrome
- What is being tested?
- Exercise Group and Thoracic Mobilization Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 5 Jul 2024
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Thoracic kyphosis angle > 40°
- Full active shoulder abduction
Who cannot join
- Bilateral shoulder pain
- Rotator cuff tear
- Shoulder/cervical injury other than SAPS
- Surgery history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: The Effect of Thoracic Mobilization on Pain Intensity, Muscle Tone, Functional and Muscle Activity Level in Individuals With Subacromial Pain Syndrome
The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.
Read the detailed description
Subacromial pain syndrome (SAPS) is the most common shoulder problem and accounts for 44%-65% of all shoulder problems. Repetitive compression of the rotator cuff tendons as they pass through the subacromial space affects shoulder function along with pain.
Studies have shown that scapular kinematics are affected in individuals with subacromial pain syndrome. In addition to increased scapular internal rotation, scapular upward rotation and posterior tilt during elevation are decreased in these individuals. These kinematic changes have been associated with decreased activation of the middle and lower trapezius and serratus anterior muscles and excessive upper trapezius activation. This change in scapular kinematics causes narrowing of the subacromial space and repeated traumatization of the rotator cuff muscles passing through it. In addition, kyphotic posture in the thoracic region (insufficient extension of the thoracic vertebrae) negatively affects scapular kinematics. Kyphotic posture has been shown to be associated with subacromial pain syndrome by causing anterior tilt, downward rotation and protraction in the scapula.
Exercise and mobilization applications are frequently applied in subacromial pain syndrome. Strengthening the muscles around the shoulder and scapula, increasing glenohumeral and scapulothoracic joint mobility, and stretching the posterior capsule are frequently applied to reduce pain and increase function. Studies on increasing thoracic mobilization are limited in number. In these studies, the acute effects of thoracic manipulation applications on pain, normal joint motion and functional activity level were examined in individuals with subacromial pain syndrome. There is only one pilot study that examined the effect of mobilization applied to the thoracic region. The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.
- Conditions
- Subacromial Pain Syndrome
- Being tested
- Exercise Group, Thoracic Mobilization Group
- Keywords
- Rehabilitation, Electromyography, Acromiohumeral Distance, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise GroupOther
The exercises will be given as a home program and each exercise will be performed 2 times a day for a total of 12 weeks. Participants will perform the exercises 1 day a week under the supervision of a physiotherapist. The exercise program lasts approximately 30 minutes.
Thoracic Mobilization GroupOther
The exercises will be given as a home program and each exercise will be performed 2 times a day for a total of 12 weeks. Participants will perform the exercises 1 day a week under the supervision of a physiotherapist. The exercise program lasts approximately 30 minutes. Thoracic mobilization will be applied to segments where passive accessory movement is insufficient or painful. 30 repetitions/4 sets will be applied to each determined segment. Thoracic mobilization will be performed with the patient lying prone position.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | The exercise group will perform stretching and strengthening exercises involving the muscle groups around the shoulder and scapula for 12 weeks. Receives: Other: Exercise Group |
| Thoracic Mobilization Group | Active comparator | The exercise group will perform stretching and strengthening exercises involving the muscle groups around the shoulder and scapula for 12 weeks. In addition to the exercises, thoracic mobilization will be applied to the participants in this group 1 day a week for a total of 6 weeks. Receives: Other: Exercise Group; Other: Thoracic Mobilization Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG)
A surface EMG system with 8 channels will use to measure muscle activation levels. A synchronized video record will take at 50 frames per second to identify 3 phases of the exercises ascending phase of the abduction (from 0°-60°, 60°-120°, and 120°-180°). Measurements will make from the affected side. The same examiner will place bipolar Ag-Cl surface electrodes over the Upper Trapezius (UT), Middle Trapezius (MT), Lower Trapezius (LT), Infraspinatus (IS), Middle Deltoid (MD), and Serratus Anterior (SA) muscles of all participants. Investigators will measure maximal voluntary isometric contractions (MVICs) of the UT, MT, LT, IS, MD, and SA muscles in randomized order first.
The width of the wooden blocks will adjust according to the arm distance of the patients. Shoulder abduction angles of 60° and 120° will mark with tape on the wooden blocks.
Measured: twelve weeks
Acromiohumeral Distance (AHD)
Real-time ultrasonography (US) images of the subacromial space will obtain with a 4 to 13 Megahertz linear transducer. All US images will evaluate by the same researcher with 5 years of experience in US imaging of the shoulder. US images will obtain from the affected side shoulder.
The AHD will measure linearly (as a millimetres) between the highest point of the humeral head and the lowest point of the acromion using the on-screen calibrations of the US system. Measurements will do at 0°, 60° and 90° abduction of the shoulder.
Measured: twelve weeks
Secondary outcomes (3)
Muscle Tone
The participant's upper trapezius muscle tone will assess. Measurements will make by placing the tip of the muscle tone assessment device vertically at the midpoint of the individuals' upper trapezius muscle. The resulting changes in muscle tone and stiffness will record as results.
Measured: twelve weeks
Functional Activity Level
American Shoulder and Elbow Surgeons (ASES) will use to determine functional activity level. ASES is frequently use in the evaluation of shoulder functions in rotator cuff injuries. Participants can score between 0-100 points in the ASES assessment. A high score on the ASES assessment indicates high activity level and low disability level.The Turkish version of the questionnaire will use in our study.
Measured: twelve weeks
Pain Intensity
A pain intensity will evaluate with the Visual Analog Scale (VAS). Participants will ask to mark the intensity of pain participants feel during rest and night pain and daily life activity on a 0-10 cm straight line. The length between the point will mark by the patient and the starting point on the line will measure with a ruler and the pain intensity will record in cm.
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start10 Apr 2024
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Model description
- One group received exercise therapy and the other group received manual therapy (thoracic mobilization) in addition to exercise therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Çalık, Hacettepe University
- Investigators
- MAHMUT ÇALIK, PhD Student, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374004
- Sponsor's protocol ID
- HU-FTR-MC-01
- Status last verified
- Jul 2024
- First submitted
- 11 Apr 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thoracic Mobilization on Pain Intensity, Muscle Tone, Functional and Muscle Activity Level in Individuals With Subacromial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06374004
- Acronym / sponsor ID
- HU-FTR-MC-01
- Conditions
- Subacromial Pain Syndrome
- Keywords
- Rehabilitation, Electromyography, Acromiohumeral Distance, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 18 Apr 2024 (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.
The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.
Detailed description
Subacromial pain syndrome (SAPS) is the most common shoulder problem and accounts for 44%-65% of all shoulder problems. Repetitive compression of the rotator cuff tendons as they pass through the subacromial space affects shoulder function along with pain.
Studies have shown that scapular kinematics are affected in individuals with subacromial pain syndrome. In addition to increased scapular internal rotation, scapular upward rotation and posterior tilt during elevation are decreased in these individuals. These kinematic changes have been associated with decreased activation of the middle and lower trapezius and serratus anterior muscles and excessive upper trapezius activation. This change in scapular kinematics causes narrowing of the subacromial space and repeated traumatization of the rotator cuff muscles passing through it. In addition, kyphotic posture in the thoracic region (insufficient extension of the thoracic vertebrae) negatively affects scapular kinematics. Kyphotic posture has been shown to be associated with subacromial pain syndrome by causing anterior tilt, downward rotation and protraction in the scapula.
Exercise and mobilization applications are frequently applied in subacromial pain syndrome. Strengthening the muscles around the shoulder and scapula, increasing glenohumeral and scapulothoracic joint mobility, and stretching the posterior capsule are frequently applied to reduce pain and increase function. Studies on increasing thoracic mobilization are limited in number. In these studies, the acute effects of thoracic manipulation applications on pain, normal joint motion and functional activity level were examined in individuals with subacromial pain syndrome. There is only one pilot study that examined the effect of mobilization applied to the thoracic region. The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One group received exercise therapy and the other group received manual therapy (thoracic mobilization) in addition to exercise therapy
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Other: Exercise GroupThe exercise group will perform stretching and strengthening exercises involving the muscle groups around the shoulder and scapula for 12 weeks. |
| Thoracic Mobilization Group | Active comparator | Other: Exercise Group, Other: Thoracic Mobilization GroupThe exercise group will perform stretching and strengthening exercises involving the muscle groups around the shoulder and scapula for 12 weeks. In addition to the exercises, thoracic mobilization will be applied to the participants in this group 1 day a week for a total of 6 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Thoracic kyphosis angle > 40°
- Full active shoulder abduction
Key exclusion criteria (4 listed)
- Bilateral shoulder pain
- Rotator cuff tear
- Shoulder/cervical injury other than SAPS
- Surgery history
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 |
|---|---|---|
| Exercise GroupThe exercises will be given as a home program and each exercise will be performed 2 times a day for a total of 12 weeks. Participants will perform the exercises 1 day a week under the supervision of a physiotherapist. The exercise program lasts approximately 30 minutes. | Other | Exercise Group, Thoracic Mobilization Group |
| Thoracic Mobilization GroupThe exercises will be given as a home program and each exercise will be performed 2 times a day for a total of 12 weeks. Participants will perform the exercises 1 day a week under the supervision of a physiotherapist. The exercise program lasts approximately 30 minutes. Thoracic mobilization will be applied to segments where passive accessory movement is insufficient or painful. 30 repetitions/4 sets will be applied to each determined segment. Thoracic mobilization will be performed with the patient lying prone position. | Other | Thoracic Mobilization Group |
Primary outcome
Electromyography (EMG)
Time frame: twelve weeks
A surface EMG system with 8 channels will use to measure muscle activation levels. A synchronized video record will take at 50 frames per second to identify 3 phases of the exercises ascending phase of the abduction (from 0°-60°, 60°-120°, and 120°-180°). Measurements will make from the affected side. The same examiner will place bipolar Ag-Cl surface electrodes over the Upper Trapezius (UT), Middle Trapezius (MT), Lower Trapezius (LT), Infraspinatus (IS), Middle Deltoid (MD), and Serratus Anterior (SA) muscles of all participants. Investigators will measure maximal voluntary isometric contractions (MVICs) of the UT, MT, LT, IS, MD, and SA muscles in randomized order first. The width of the wooden blocks will adjust according to the arm distance of the patients. Shoulder abduction angles of 60° and 120° will mark with tape on the wooden blocks.
Acromiohumeral Distance (AHD)
Time frame: twelve weeks
Real-time ultrasonography (US) images of the subacromial space will obtain with a 4 to 13 Megahertz linear transducer. All US images will evaluate by the same researcher with 5 years of experience in US imaging of the shoulder. US images will obtain from the affected side shoulder. The AHD will measure linearly (as a millimetres) between the highest point of the humeral head and the lowest point of the acromion using the on-screen calibrations of the US system. Measurements will do at 0°, 60° and 90° abduction of the shoulder.
3 secondary outcomes
Muscle Tone
Time frame: twelve weeks
Functional Activity Level
Time frame: twelve weeks
Pain Intensity
Time frame: twelve weeks
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 26 Jul 2024.
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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.
MAHMUT ÇALIK, PhD Student principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Group and Thoracic Mobilization Group in people with Subacromial Pain Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 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 26 Jul 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 Turkey (Türkiye). 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?
Electromyography (EMG) (time frame: twelve weeks). The study lists 2 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 26 Jul 2024.