Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06324487 |
| Other study ID # |
E-10840098-772.02-7487 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Medipol University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
