Effectiveness of Supervised Exercise Program in Subacromial Impingement Syndrome

NCT04186624 | Completed

• 1 other identifier: 09.2019.347
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome

Keywords

Subacromial Impingement Syndrome; Subacromial-subdeltoid bursa corticosteroid injection; Exercise Therapy

Outcome Measures

Primary Outcomes (4)

• 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)

  before treatment (T0)

• 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)

  1st hour after injection (T1)

• 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)

  3rd week of treatment (T2)

• 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)

  3rd month of treatment (T3)

Secondary Outcomes (10)

• Pain and Disability - SPADI

  before treatment (T0)

• Pain and Disability - SPADI

  3rd week of treatment (T1)

• Pain and Disability - SPADI

  3rd month of treatment (T2)

• Quality of life- Short Form-36

  before treatment (T0)

• Quality of life- Short Form-36

  3rd week of treatment (T1)

Study Arms (2)

Supervised Exercise Program

EXPERIMENTAL

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.

Drug: Subacromial-subdeltoid bursa corticosteroid injection

Home-based Exercise Program

ACTIVE COMPARATOR

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.

Drug: Subacromial-subdeltoid bursa corticosteroid injection

Interventions

Subacromial-subdeltoid bursa corticosteroid injection DRUG

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.

Also known as: Subacromial-subdeltoid bursa injection

Home-based Exercise Program; Supervised Exercise Program

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

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

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 31726927 BACKGROUND

• 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.

  PMID: 26093810 BACKGROUND

• 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.

  PMID: 28630217 BACKGROUND

• 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.

  PMID: 30135893 BACKGROUND

• 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.

  PMID: 25211291 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• İlker Yağcı, Prof

  Marmara University

  STUDY CHAIR

• Ebru Kaplan, PT

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This randomized controlled study is designed to have two groups with a single arm.

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 5, 2019
• Study Start: December 5, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)