A New Application in Subacromial Impingement Syndrome

NCT ID: NCT06324487

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-06-01

Brief 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.

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.

Conditions

Subacromial Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SEP Group

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.

Group Type: ACTIVE_COMPARATOR

Progressive Exercises

Intervention Type: OTHER

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

BFRT Group

People 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

Group Type: EXPERIMENTAL

Progressive Exercises

Intervention Type: OTHER

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

Blood Flow Restriction Therapy

Intervention Type: OTHER

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

Interventions

Progressive Exercises

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

Intervention Type: OTHER

Blood Flow Restriction Therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Nursena Cansabuncu

MSc candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medipol University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-772.02-7487

Identifier Type: -

Identifier Source: org_study_id