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Subacromial Impingement SyndromeNCT06324487

A New Application in Subacromial Impingement Syndrome

A study testing Progressive Exercises and Blood Flow Restriction Therapy in people with Subacromial Impingement Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Individuals diagnosed with Subacromial Impingement Syndrome by a physical therapist based on MRI results and examination findings will be included in the study. 40 people will be randomly divided into blood flow restrictive exercise (BFRT) and structured exercise program (SEP) groups, 20 people in each group. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Subacromial Impingement Syndrome
What is being tested?
Progressive Exercises and Blood Flow Restriction Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2023to 1 Jun 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 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individuals between the ages of 25-65
  • Being diagnosed with Stage 2 or 3 Subacromial Impingement Syndrome
  • Not having had a steroid injection in the last 6 months

Who cannot join

  • Having neuromuscular disease
  • History of upper extremity fracture
  • Cardiovascular diseases
  • Rheumatic diseases
  • Having had shoulder, neck, elbow or hand surgery
  • Presence of acute inflammation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Medipol University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Blood Flow Restrictive Exercise Application in the Treatment of Subacromial Impingement Syndrome

Individuals diagnosed with Subacromial Impingement Syndrome by a physical therapist based on MRI results and examination findings will be included in the study. 40 people will be randomly divided into blood flow restrictive exercise (BFRT) and structured exercise program (SEP) groups, 20 people in each group. Participants will receive two evaluations: before starting treatment and immediately after 4 weeks of treatment. Pain, shoulder ROM, shoulder functional level, quality of life, shoulder muscle strength, grip strength, and sleep quality evaluation will be performed. The treatment program will be 5 days a week for a total of 4 weeks. The treatment will be individualized by calculating the appropriate resistance loads for the exercise program. All participants will undergo progressive exercises in sessions conducted by a physiotherapist.

Read the detailed description

The study is planned to be carried out between September 2023 and June 2024. Individuals diagnosed with Subacromial Impingement Syndrome by a physical therapist based on MRI results and examination findings will be included in the study. The sample size of this study was calculated using G-Power 3.1.9.7. Assuming that effect sizes (ES) are 0.99, significance level (a) is 0.05, and statistical power (1-b) is 0.8, a minimum of 36 participants in total are required for this study. Considering the 10% dropout rate, it is planned to include 40 people in our study. The 40 people included will be randomly divided into blood flow restrictive exercise (BFRT) and structured exercise program (SEP) groups, with 20 people in each group. Randomization will be generated using the random number sequence www.random.org.

Criteria for Inclusion in the Study

  • Being Volunteer
  • Being between the ages of 25-65
  • Being diagnosed with Stage 2 or 3 Subacromial Impingement Syndrome
  • Not having had a steroid injection in the last 6 months

Exclusion Criteria from the Study

  • Having neuromuscular disease
  • History of upper extremity fracture
  • Cardiovascular diseases
  • Rheumatic diseases
  • Having had shoulder, neck, elbow or hand surgery
  • Presence of acute inflammation

Evaluation Methods Demographic Information Form: In order to collect demographic information, a form that questions age, gender, height, weight, occupation, education level, smoking, alcohol and substance use, city of residence and previous counseling or alternative treatment history has been created and is presented in the appendix.Participants will receive two evaluations: before starting treatment and immediately after 4 weeks of treatment.

Pain assessment: It will be made with Visual Analog Scale (VAS). VAS is a scale that provides patient-based measurement between the perception of "painless" and "most severe pain" in a vertical or horizontal plane with a length of 10 cm divided into equal intervals. Individuals will be asked to mark on the scale the degree of pain they feel at rest, during arm elevation and during sleep, on a 10 cm line.

Shoulder ROM Evaluation: It will be done with a universal goniometer. Individuals' shoulder flexion, abduction, internal and external range of motion will be evaluated actively and passively while in the supine position.

Shoulder Functional Level Evaluation: It will be done with the Quick Disability Scale of the Arm, Shoulder and Hand (Quick-DASH). The Arm, Shoulder and Hand Disability Scale (DASH) is a tool developed to assess the health status of patients with upper extremity disorders. Shorter surveys are preferred because they are easy to understand and can be completed quickly by patients. In this context, DASH is abbreviated as Quick DASH, the 11-item Quick Disability of the Arm, Shoulder and Hand questionnaire. It was developed to measure physical function and symptoms in patients with upper extremity disorders. The survey consists of 11 items. Answers are scored from 1 (no difficulty) to 5 (not able to do it at all). A total score of 100 was expressed as the highest disability, while a total score of 0 indicated no disability. Turkish validity and reliability were evaluated by Evcik et al. It was made by in 2011.

Quality of Life Assessment: It will be done with the short form (SF-36). SF-36 is a test consisting of 36 items that the person fills out and answers himself to obtain information about the person's health status. It consists of 8 sub-parameters: physical function, physical role difficulty, emotional role difficulty, pain, mental health, social functionality, energy/vitality/vitality, and general health perception. Turkish validity and reliability were determined by Koçyiğit et al. It was made by in 1999.

Shoulder Muscle Strength Assessment: A hand dynamometer will be used to evaluate the shoulder flexor, abductor, internal rotator and external rotator muscles. The patient and the muscle to be tested will be adjusted to the correct testing position. The dynamometer will be placed distal to the joint at a comfortable level and the patient will actively participate in the evaluation.

Grip Strength Evaluation: The maximum isometric contraction strength of the hand and forearm muscles will be tested. Grip strength is evaluated with the patient in a sitting position. Elbows are kept close to the body and 90 degrees flexed. The patient is asked to grasp the dynamometer and squeeze it as hard as he can. The result of the test is determined by calculating the average of three measurements.

Sleep Quality Assessment: Sleep quality will be evaluated with the Pittsburgh Sleep Quality Index (PSQI). PSQI is a self-report scale consisting of 19 items that evaluates sleep quality and disturbance over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components (Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills and daytime dysfunction). Each component is evaluated on a scale of 0-3 points. The total score of the 7 components gives the scale total score. Total score varies between 0-21. A total score greater than 5 indicates "poor sleep quality". Turkish validity and reliability were determined by Ağargün et al. It was made by in 1996.

Treatment Program The treatment program will be planned under the supervision of a physiotherapist, 5 days a week for a total of 4 weeks. The treatment will be individualized by calculating the appropriate resistance loads for the exercise program. All participants will undergo progressive exercises in sessions conducted by a physiotherapist.

In the sessions, before exercise, both groups were given: 80 Hz to the shoulder area for 20 minutes. Electrotherapy will be applied as Asymmetric Biphasic TENS + Hotpack and 1.0 watt/cm2 Ultrasound (US) for 7 minutes.

Exercises to be Performed in Week 1 Shoulder isometric exercises (10 repetitions) Wand exercises for shoulder ROM (Shoulder flexion, abduction, hyperextension, internal and external rotation 10 repetitions) Finger ladder for shoulder ROM (Shoulder flexion and abduction 5 repetitions) Codman exercises for shoulder ROM (10 repetitions) Posterior, anterior and inferior capsule stretches (10 repetitions)

Exercises to be Added in Week 2 Strengthening exercises with dumbbells for the muscles around the rotator cuff and scapula (Shoulder flexion, abduction, external and internal rotation, scapular retraction exercises) (10 repetitions)

Exercises to be Added in Week 3 Pectoral muscle stretching exercise (10 repetitions) Proprioception exercises with a ball on the wall (10 repetitions)

Exercises to be Added in Week 4 Push-up exercise on the wall (10 repetitions) Dynamic stabilization exercise on balance board (10 repetitions)

Strengthening exercises will be applied at different intensities to the BFRT and YEP groups, to which the participants are randomly divided. People in the BFRT group will apply the structured exercise program at approximately 20-30% resistance of 1-RM, and an occlusion cuff surrounding the upper arm will be used during strengthening exercises with dumbbells for the rotator cuff and scapula muscles.

An exercise program consisting of 75 repetitions will be applied throughout four exercise sets, with 30 repetitions in the first set and 15 repetitions in each subsequent set. Rest periods between sets are determined as 30 seconds and the cuff will not be deflated between sets.

Set 1: 30 reps, rest time: 30 seconds Set 2: 15 reps, rest time: 30 seconds Set 3: 15 reps, rest time: 30 seconds Set 4: 15 reps

Determination of Arterial Occlusion Pressure The study will use a personalized tourniquet pressure set at 50% of the limb occlusion pressure according to BFR standards. Patients will be asked to lie on their back while resting comfortably. A vascular Doppler probe (DV-600; Marted, São Paulo, Brazil) will be placed over the brachial artery to capture the auscultatory pulse. To determine the cuff pressure required for complete blood flow restriction, an air cuff will be placed on the patient's arm and then inflated to the point where the auscultatory pulse ceases. This pressure will be recorded as AOP.

Being tested
Progressive Exercises, Blood Flow Restriction Therapy
Keywords
subacromial impingement syndrome, rehabilitation, exercise
Medical subject headings
Shoulder Impingement Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive ExercisesOther

    Electrotherapy, stretching of the capsules, strengthening, ROM exercises, proprioceptive exercises

  • Blood Flow Restriction TherapyOther

    Strengthening exercises performed by using cuff surrounding proximal part of the arm.

Study groups in NCT06324487
Study groupRoleWhat they receive
SEP GroupActive comparatorThe treatment will be individualized by calculating the appropriate resistance loads for the exercise program. All participants will undergo progressive exercises in sessions conducted by a physiotherapist.
Receives: Other: Progressive Exercises
BFRT GroupExperimentalPeople in the BFRT categories will perform the exercise program at approximately 20-30% resistance of 1-RM, and an upper arm reinforcement occlusion cuff will be used during strengthening exercises with dumbbells for the rotator cuff and scapula girdles
Receives: Other: Progressive Exercises; Other: Blood Flow Restriction Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain İntensity

    The severity shoulder pain was questioned with the Visual Anolog Scale (VAS). The assessment was based on a horizontal 10 cm scale from 1 (least pain) to 10 (the worst pain ever)

    Measured: 4 weeks

  2. Shoulder ROM

    Shoulder ROM was questioned with the Universal Goniometer. Shoulder flexion, abduction, internal and external range of motion of the individuals in the supine position will be evaluated as active and passive.

    Measured: 4 weeks

Secondary outcomes (5)
  1. Quality of Life Assessment

    Quality of life assessment was questioned with the Short form-36 (SF-36). SF-36 is a test consisting of 36 items that the person fills out and answers in order to obtain information about the person's health status. It consists of 8 subparameters: international function, physical role strength, emotional role strength, pain, mental health, social functionality, energy/vitality and general health perception.

    Measured: 4 weeks

  2. Sleep Quality Assessment

    Sleep Quality Assessment was questioned with the Pittsburgh Sleep Quality Index. PSQI is a self-report performance consisting of 19 items that evaluates sleep temperature and disturbance over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are answered by the spouse or roommate. The 18 scored items of the scale are presented with 7 (Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills and daytime dysfunction). Unites it on 0-3 points. The total score of the 7 components gives the total score. Total score varies between 0-21. A total score greater than 5 indicates "poor sleep standards".

    Measured: 4 weeks

  3. Shoulder Functional Level Assessment

    Shoulder Functional Level Assessment was questioned with the Quick Disabilities of Arm, Shoulder \& Hand. It was developed to measure physical function and symptoms in patients with upper extremity disorders. The survey consists of 11 items. Answers are scored from 1 (no difficulty) to 5 (not able to do it at all). A total score of 100 was expressed as the highest disability, while a total score of 0 indicated no disability.

    Measured: 4 weeks

  4. Shoulder Muscle Strength Assessment

    A hand dynamometer was used to evaluate the shoulder flexor, abductor, internal rotator and external rotator muscles. The patient and the muscle to be tested will be adjusted to the correct testing position. By adding a dynamometer, the distal part will be placed comfortably and the patient will actively participate in the evaluation.

    Measured: 4 weeks

  5. Grip Strength Assessment

    Maximum isometric contraction strength of hand and forearm muscles was tested. Grip strength is evaluated with the patient in a sitting position. Elbows are kept close to the body and 90 degrees flexed. The patient is asked to grasp the dynamometer and squeeze it as hard as he can. The result of the test is determined by calculating the average of three measurements.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start1 Sep 2023
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06324487
Sponsor's protocol ID
E-10840098-772.02-7487
Status last verified
Mar 2024
First submitted
26 Feb 2024
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Exercises and Blood Flow Restriction Therapy in people with Subacromial Impingement Syndrome, run by Medipol 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Mar 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?

Results are not available in the source record.

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?

Pain İntensity (time frame: 4 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 22 Mar 2024.

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