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Effectiveness of Supervised Exercise Program in Subacromial Impingement Syndrome

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Subacromial-subdeltoid bursa corticosteroid injection
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Subacromial Impingement Syndrome, Subacromial-subdeltoid bursa corticosteroid injection, Exercise Therapy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Symptoms lasting longer than 3 months
  2. Aged between 20-60 years
  3. The diagnosis is made by the clinician and detected by MRI

Exclusion Criteria:

  1. History of physical therapy or injection in the last 3 months
  2. Shoulder fracture history
  3. Presence of Type III (hooked) acromion
  4. Complete rupture of the rotator cuff muscles
  5. Presence of instability problem in shoulder
  6. History of shoulder surgery
  7. History of inflammatory rheumatoid disease
  8. Uncontrolled diabetes mellitus
  9. Allergy to steroids or local anesthetics (drug hypersensitivity)
  10. Known contraindications for interventional procedures (infection at the injection site, coagulopathy, etc.)

Sites / Locations

  • Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supervised Exercise Program

Home-based Exercise Program

Arm Description

The exercise program that applied at the hospital includes rotator cuff and scapular muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises.

The home-based exercise program given with a brochure that includes rotator cuff and scapular muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises.

Outcomes

Primary Outcome Measures

Pain and tightness sensation
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Pain and tightness sensation
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Pain and tightness sensation
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Pain and tightness sensation
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)

Secondary Outcome Measures

Pain and Disability - SPADI
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Pain and Disability - SPADI
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Pain and Disability - SPADI
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Quality of life- Short Form-36
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Quality of life- Short Form-36
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Quality of life- Short Form-36
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.

Full Information

First Posted
November 25, 2019
Last Updated
September 2, 2020
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04186624
Brief Title
Effectiveness of Supervised Exercise Program in Subacromial Impingement Syndrome
Official Title
Effectiveness of Supervised Exercise Program After Subacromial- Subdeltoid Bursitis Injection in Subacromial Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It is the most common cause of shoulder pain, with an incidence of 44-65%. Restriction of the range of motion, along with the pain in the anterior region of the shoulder, is the main reason for disability and decreased quality of life in patients with SIS. Physical exercises to improve the range of motion, strengthening, and flexibility is the main part of treatment. The subacromial-subdeltoid bursa corticosteroid injection is shown to decrease pain during the exercise program and increase participation in the treatment. This study aims to compare the effectiveness of a supervised exercise program and home-based exercise program after subacromial-subdeltoid bursa corticosteroid injection in patients with SIS.
Detailed Description
Subacromial Impingement Syndrome (SIS) is a pathology resulting from mechanical repetitive compression and inflammation of the supraspinatus tendon, subacromial bursa and biceps tendon under the acromion and the coracoacromial ligament. It was first described in 1972 by Neer. Neer described SIS as a progressive syndrome with three stages, beginning with chronic bursitis and proceeding to partial and complete tears of the supraspinatus tendon, which may extend to rupture of other parts of the rotator cuff and may also involve the long biceps tendon. SIS is one of the most common causes of shoulder pain and disability reasons in both primary and secondary care. It is characterized by functional impairment of shoulder resulted from the progressive limitation of both active and passive glenohumeral movements. Restriction of the range of motion (ROM) along with the pain in the anterior region of the shoulder that gets worse with arm elevation or overhead activities is the main reason for decreased quality of life in patients with SIS. Therapeutic exercise programs are commonly used treatment methods in relieving pain and improving ROM and muscle elasticity. It was shown that such programs are more effective in reducing pain and improving functional loss than placebo in both short- and long-term. However, the optimal exercise regimen with the variety, frequency, and intensity exercises is still unclear. It is also controversial if a supervised exercise program is superior to a prescribed home-based exercise program. An efficient exercise program should target all structures affected by subacromial impingement. Therefore, both supervised and home-based exercise programs must involve rotator cuff and scapular stabilizing muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises. Corticosteroid injection into the subacromial-subdeltoid bursa is shown to increase participation, decrease pain during the exercise program, and found to be effective for symptomatic impingement. The analgesic effect provides significant improvement of functions mainly in the short-term. Therefore, some physicians prefer corticosteroid injections alone in the treatment of SIS. However, it was found that the combination of corticosteroid injection and exercise program is significantly superior to corticosteroid injections alone. Ultrasound-guided subacromial-subdeltoid bursa injections are shown to have better outcome results than blind injections for both pain and overall shoulder function. This study aims to compare the effectiveness of supervised exercise and home-based exercise programs after ultrasound-guided subacromial-subdeltoid bursa corticosteroid injection in patients with SIS. Patients diagnosed with SIS will be included and randomized into two groups. Both groups will receive subacromial-subdeltoid bursa 1 ml (7 mg/ml) betamethasone and 4 ml of 0.5% bupivacaine injection. The injection will be performed ultrasound-guided while the patient is in a sitting position with the lateral approach. The first group will perform their exercises under the supervision of the physiotherapist in the hospital. The second group will be taken to the home-based exercise program in a brochure format. Thus, both groups will receive the same exercises every day. The pain will be assessed with the Visual Analogue Scale (VAS), active and passive ROM will be measured with a goniometer before injection, immediately, first hour, third week, and third month after the injection. The quality of life will be evaluated by Short Form 36, and disability will be questioned by Shoulder Pain and Disability Index before injection and third week and third month after injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
Subacromial Impingement Syndrome, Subacromial-subdeltoid bursa corticosteroid injection, Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This randomized controlled study is designed to have two groups with a single arm.
Masking
Investigator
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Exercise Program
Arm Type
Experimental
Arm Description
The exercise program that applied at the hospital includes rotator cuff and scapular muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises.
Arm Title
Home-based Exercise Program
Arm Type
Active Comparator
Arm Description
The home-based exercise program given with a brochure that includes rotator cuff and scapular muscle strengthening, stretching and active-assistive range of motion exercises and proprioceptive neuromuscular facilitation exercises.
Intervention Type
Drug
Intervention Name(s)
Subacromial-subdeltoid bursa corticosteroid injection
Other Intervention Name(s)
Subacromial-subdeltoid bursa injection
Intervention Description
1 ml (7 mg / ml) betamethasone and 4 ml of 0.5% bupivacaine will be given subacromial bursa-subdeltoid space. Injection will be performed ultrasound-guided while the patient is in sitting position with the lateral approach.
Primary Outcome Measure Information:
Title
Pain and tightness sensation
Description
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Time Frame
before treatment (T0)
Title
Pain and tightness sensation
Description
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Time Frame
1st hour after injection (T1)
Title
Pain and tightness sensation
Description
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Time Frame
3rd week of treatment (T2)
Title
Pain and tightness sensation
Description
Shoulder pain and sensations of tightness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Time Frame
3rd month of treatment (T3)
Secondary Outcome Measure Information:
Title
Pain and Disability - SPADI
Description
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Time Frame
before treatment (T0)
Title
Pain and Disability - SPADI
Description
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Time Frame
3rd week of treatment (T1)
Title
Pain and Disability - SPADI
Description
Shoulder Pain and Disability Index (SPADI) is a questionnaire developed to assess pain and disability related to shoulder problems. Pain dimension has 5 questions regarding the pain severity. Functional activities are assessed with 8 questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. Each question is scored between 0 and 10, and high scores indicate increased severity and high scores indicate increased severity (0 = no difficulty and 10 = so difficult it require help) .The validity and reliability of the questionnaire in Turkish were conducted by Bumin et al.
Time Frame
3rd month of treatment (T2)
Title
Quality of life- Short Form-36
Description
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Time Frame
before treatment (T0)
Title
Quality of life- Short Form-36
Description
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Time Frame
3rd week of treatment (T1)
Title
Quality of life- Short Form-36
Description
Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.
Time Frame
3rd month of treatment (T2)
Title
Shoulder range of motion (ROM) will be evaluated with a goniometer
Description
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Time Frame
before treatment (T0)
Title
Shoulder range of motion (ROM) will be evaluated with a goniometer
Description
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Time Frame
1st hour after injection (T1)
Title
Shoulder range of motion (ROM) will be evaluated with a goniometer
Description
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Time Frame
3rd week of treatment (T2)
Title
Shoulder range of motion (ROM) will be evaluated with a goniometer
Description
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.
Time Frame
3rd month of treatment (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms lasting longer than 3 months Aged between 20-60 years The diagnosis is made by the clinician and detected by MRI Exclusion Criteria: History of physical therapy or injection in the last 3 months Shoulder fracture history Presence of Type III (hooked) acromion Complete rupture of the rotator cuff muscles Presence of instability problem in shoulder History of shoulder surgery History of inflammatory rheumatoid disease Uncontrolled diabetes mellitus Allergy to steroids or local anesthetics (drug hypersensitivity) Known contraindications for interventional procedures (infection at the injection site, coagulopathy, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İlker Yağcı, Prof
Organizational Affiliation
Marmara University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ebru Kaplan, PT
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
City
İstanbul
ZIP/Postal Code
34899
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31726927
Citation
Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, Struyf F. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020 Mar;50(3):131-141. doi: 10.2519/jospt.2020.8498. Epub 2019 Nov 15.
Results Reference
background
PubMed Identifier
26093810
Citation
Granviken F, Vasseljen O. Home exercises and supervised exercises are similarly effective for people with subacromial impingement: a randomised trial. J Physiother. 2015 Jul;61(3):135-41. doi: 10.1016/j.jphys.2015.05.014. Epub 2015 Jun 18.
Results Reference
background
PubMed Identifier
28630217
Citation
Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
Results Reference
background
PubMed Identifier
30135893
Citation
Burger M, Africa C, Droomer K, Norman A, Pheiffe C, Gericke A, Samsodien A, Miszewski N. Effect of corticosteroid injections versus physiotherapy on pain, shoulder range of motion and shoulder function in patients with subacromial impingement syndrome: A systematic review and meta-analysis. S Afr J Physiother. 2016 Sep 27;72(1):318. doi: 10.4102/sajp.v72i1.318. eCollection 2016.
Results Reference
background
PubMed Identifier
25211291
Citation
Kromer TO, de Bie RA, Bastiaenen CH. Effectiveness of physiotherapy and costs in patients with clinical signs of shoulder impingement syndrome: One-year follow-up of a randomized controlled trial. J Rehabil Med. 2014 Nov;46(10):1029-36. doi: 10.2340/16501977-1867.
Results Reference
background

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Effectiveness of Supervised Exercise Program in Subacromial Impingement Syndrome

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