A New Application in Subacromial Impingement Syndrome

NCT06324487 | Active Not Recruiting

• 1 other identifier: E-10840098-772.02-7487
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome

Keywords

subacromial impingement syndrome; rehabilitation; exercise

Outcome Measures

Primary Outcomes (2)

• 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)

  4 weeks

• 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.

  4 weeks

Secondary Outcomes (5)

• Quality of Life Assessment

  4 weeks

• Sleep Quality Assessment

  4 weeks

• Shoulder Functional Level Assessment

  4 weeks

• Shoulder Muscle Strength Assessment

  4 weeks

• Grip Strength Assessment

  4 weeks

Study Arms (2)

SEP Group

ACTIVE COMPARATOR

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.

Other: Progressive Exercises

BFRT Group

EXPERIMENTAL

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

Other: Progressive Exercises; Other: Blood Flow Restriction Therapy

Interventions

Progressive Exercises OTHER

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

BFRT Group; SEP Group

Blood Flow Restriction Therapy OTHER

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

BFRT Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Motor Activity

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc candidate

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 22, 2024
• Study Start: September 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)