Rotator Cuff TearsNCT04319250
The Effectiveness Of Ischemic Compression And IASTM In Trigger Point Treatment In Patients With Rotator Cuff Tear
A study testing ischemic compression, IASTM and Rehabilitation Program in people with Rotator Cuff Tears and Shoulder Pain, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Rotator Cuff Tears, Shoulder Pain, Myofascial Trigger Point Pain
- What is being tested?
- ischemic compression, IASTM and Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 30 Aug 2019
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 40-65 years old
- Having been diagnosed with partial RM rupture
- RM rupture in MRI image
- At least 3 ATNs in the shoulder complex
- Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months
Who cannot join
- Sensory problems in the back and shoulders,
- Shoulder instability
- Osteoarthritis in the shoulder joint area
- Glenoid or bone fracture
- Frozen shoulder pathology
- Massive RM rupture
- Rheumatological joint problems
- Shoulder surgery history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness Of Ischemic Compression And Instrument Assisted Soft Tissue Mobilization In Trigger Point Treatment In Patients With Rotator Cuff Tear
The aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were aimed to compare and to reveal which application would be more useful.
Read the detailed description
In this study participants were randomly divided into two groups. While ischemic compression was applied to one group for the determined active trigger points, instrument assisted soft tissue mobilization (IASTM) was applied to the other group for active trigger points. In addition to the treatment, both groups were subjected to a joint rehabilitation program.
- Being tested
- ischemic compression, IASTM, Rehabilitation Program
- Keywords
- ischemic compression, instrument assisted soft tissue mobilization, trigger point
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic compressionOther
ATNs detected in a total of 13 muscles around the shoulder were applied constant pressure at the level of pain tolerated with the thumb (discomfort severity level 7 to 8 out of 10) and for 90 seconds. This method was applied twice a week for 6 weeks.
IASTMOther
In order to apply EDYDM in the treatment of ATN, titanium plated stainless steel was divided into two parts, front and back, with two tools. The sweep was applied to the anterior muscle fibers at an angle of 45 ° for 40 seconds.
For each TN, continuous pressure was applied with swivel movement at tolerable pain level (discomfort severity level 7 to 8 out of 10) for 1 minute. The back group muscles were applied in the same way.
Rehabilitation ProgramOther
A rehabilitation program consisting of exercises and manual therapy used in the conservative treatment of rotator cuff tear for both groups was applied twice a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Ischemic compression and rehabilitation program applied to the group 1 Receives: Other: ischemic compression; Other: Rehabilitation Program |
| Group 2 | Active comparator | IASTM and rehabilitation program applied to the group 2 Receives: Other: IASTM; Other: Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
This is a questionnaire that identifies both functionality and symptoms that can be used in arm, elbow and hand problems. High scores of individuals mean that functional dysfunction is high. Ratings are made between 0 and 100.
Measured: Change from Baseline at 6 weeks
Secondary outcomes (7)
Visual Analogue Scale (VAS)
The levels of pain felt at rest / activity / night were measured using Visual Analogue Scale (VAS).
Measured: Change from Baseline at 6 weeks
Shoulder Range of Motion (ROM)
EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the universal goniometer.
Measured: Change from Baseline at 6 weeks
Active trigger points
Active trigger points were evaluated by palpation method according to Travell and Simons criteria. Scalene, upper trapezius, levator scapula, supraspinatus, infraspinatus, subskapularis, teres minor, teres major, deltoid anterior and posterior group fibers, pectoralis major, pectoralis minor, biceps brachii muscles were evaluated with palpation method in terms of trigger point presence.
Measured: Change from Baseline at 6 weeks
Pain Pressure Threshold (PPT)
Wagner Force One ™ FDIX" digital algometer was used to evaluate the pain threshold. Measurements were recorded in kg / cm².
Measured: Change from Baseline at 6 weeks
The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES)
This score consists of 1 questioning pain and 10 questions questioning daily life activities.The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Measured: Change from Baseline at 6 weeks
Emotional state
The emotional states of the cases were evaluated using the Hospital Anxiety and Depression Scale (HAD), which consists of 14 questions. (HAD). This scale has a 7-question anxiety (HAD-A) subscale that evaluates the anxiety state, and a 7-question depression (HAD-D) subscale that evaluates the state of depression, and a four-point likert scale is used to answer the questions. For the total score of each sub-score, 0-7 points are normal, 8-10 points are at the border, and 11 points are defined as abnormal
Measured: Change from Baseline at 6 weeks
Global Rating of Change (GRC) scale
Patient Satisfaction was assessed Global Rating of Change (GRC) scale. The scale used included 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).
Measured: After 6 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Aksan Sadıkoğlu, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319250
- Sponsor's protocol ID
- Büşra Aksan Sadıkoğlu
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Of Ischemic Compression And Instrument Assisted Soft Tissue Mobilization In Trigger Point Treatment In Patients With Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT04319250
- Acronym / sponsor ID
- Büşra Aksan Sadıkoğlu
- Keywords
- ischemic compression, instrument assisted soft tissue mobilization, trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 24 Mar 2020 (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 aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were aimed to compare and to reveal which application would be more useful.
Detailed description
In this study participants were randomly divided into two groups. While ischemic compression was applied to one group for the determined active trigger points, instrument assisted soft tissue mobilization (IASTM) was applied to the other group for active trigger points. In addition to the treatment, both groups were subjected to a joint rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: ischemic compression, Other: Rehabilitation ProgramIschemic compression and rehabilitation program applied to the group 1 |
| Group 2 | Active comparator | Other: IASTM, Other: Rehabilitation ProgramIASTM and rehabilitation program applied to the group 2 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between 40-65 years old
- Having been diagnosed with partial RM rupture
- RM rupture in MRI image
- At least 3 ATNs in the shoulder complex
- Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months
Key exclusion criteria (8 listed)
- Sensory problems in the back and shoulders,
- Shoulder instability
- Osteoarthritis in the shoulder joint area
- Glenoid or bone fracture
- Frozen shoulder pathology
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 |
|---|---|---|
| ischemic compressionATNs detected in a total of 13 muscles around the shoulder were applied constant pressure at the level of pain tolerated with the thumb (discomfort severity level 7 to 8 out of 10) and for 90 seconds. This method was applied twice a week for 6 weeks. | Other | Group 1 |
| IASTMIn order to apply EDYDM in the treatment of ATN, titanium plated stainless steel was divided into two parts, front and back, with two tools. The sweep was applied to the anterior muscle fibers at an angle of 45 ° for 40 seconds. For each TN, continuous pressure was applied with swivel movement at tolerable pain level (discomfort severity level 7 to 8 out of 10) for 1 minute. The back group muscles were applied in the same way. | Other | Group 2 |
| Rehabilitation ProgramA rehabilitation program consisting of exercises and manual therapy used in the conservative treatment of rotator cuff tear for both groups was applied twice a week for 6 weeks. | Other | Group 1, Group 2 |
Primary outcome
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
Time frame: Change from Baseline at 6 weeks
This is a questionnaire that identifies both functionality and symptoms that can be used in arm, elbow and hand problems. High scores of individuals mean that functional dysfunction is high. Ratings are made between 0 and 100.
7 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Change from Baseline at 6 weeks
Shoulder Range of Motion (ROM)
Time frame: Change from Baseline at 6 weeks
Active trigger points
Time frame: Change from Baseline at 6 weeks
Pain Pressure Threshold (PPT)
Time frame: Change from Baseline at 6 weeks
The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES)
Time frame: Change from Baseline at 6 weeks
Emotional state
Time frame: Change from Baseline at 6 weeks
Global Rating of Change (GRC) scale
Time frame: After 6 weeks treatment
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 1 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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 ischemic compression, IASTM and Rehabilitation Program in people with Rotator Cuff Tears and Shoulder Pain, run by Istanbul Aydın 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 5 inclusion and 8 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 1 Mar 2021. 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?
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) (time frame: Change from Baseline at 6 weeks). 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 1 Mar 2021.