Effectiveness of Telerehabilitation on Subacromial Pain Syndrome

Sponsor
Hasan Kalyoncu University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05200130
Collaborator
(none)
75
1
3
10
7.5

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effectiveness of supervised exercise therapy with active soft tissue and joint mobilization.

The effectiveness of telerehabilitation- active mobilization and exercises in the evaluation of pain and function in patients with subacromial pain syndrome will be examined and compared with face-to-face treatment, which is passive manual therapy.

Condition or Disease Intervention/Treatment Phase
  • Other: Home Exercise Group
  • Other: Manual Therapy Group
  • Other: Telerehabilitation Group
N/A

Detailed Description

Shoulder pain is common in the population. Various treatment modalities are used. Due to the Coronavirus disease (COVID-19), the problems in patients' access to hospitals and rehabilitation services caused telerehabilitation to be on the agenda. Telerehabilitation can be summarized as the delivery of rehabilitation services to those in need by using communication technologies. This method covers the steps of evaluation, monitoring, prevention, intervention, control, training, and consultation. In addition, as a new treatment application, its effectiveness will be measured in patients with shoulder pain.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Telerehabilitation With Self Mobilization in Patients With Subacromial Pain Syndrome
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Home exercise group

The home exercise program will be explained to the patients in the control group by the physiotherapist and the relevant brochures will be delivered to the patients. Home exercise program will take 30-45 min. İt will be applied 5 days a week for 8 weeks. Patients will receive a reminder message from the physiotherapist once a week.

Other: Home Exercise Group
The home exercise program includes an educational training program and posture correction exercises. The program includes stretching and strengthening exercises of the neck and shoulder complex.

Active Comparator: Manual Therapy Group

Patients in the Manual Therapy Group will receive one-to-one physiotherapy sessions in the hospital 2 days a week for 8 weeks. In these sessions, soft tissue and joint mobilizations and exercises will be applied by physiotherapist.

Other: Manual Therapy Group
Manual Therapy includes deep friction massage and myofascial relaxation techniques to shoulder and neck complex, active and resistant shoulder complex movements, shoulder complex mobilization, mobilization cervical joints. The home exercise program includes an educational training program and posture correction exercises. The program includes stretching and strengthening exercises of the neck and shoulder complex.

Experimental: Telerehabilitation Supported Group

Telerehabilitation program will be applied 2 days a week for 8 weeks to patients in the telerehabilitation group. İt will take 30-45 min. A physiotherapist will meet with patients via videoconferencing over the internet and guide the program.

Other: Telerehabilitation Group
The telerehabilitation program applied to the same home exercise group. In addition, to the home exercises, these patients will apply active mobilization called self-mobilization. Self-myofascial release, active glenohumeral joint mobilization, thoracic mobilization, and active cervical mobilization.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Pain at 8 weeks and 12 weeks [Change from Baseline in Pain at 8 weeks and 12 weeks]

    Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain.

  2. Change from Baseline in Short-Form Mcgill Pain questionnaire (SF-MPQ) at 8 weeks and 12 weeks [Baseline, 8 weeks, and 12 weeks]

    The McGill Pain questionnaire will be used to evaluate a person experiencing significant pain.. The pain rating index has 2 subscales: Sensory subscale with 11 words Affective subscale with 4 words from the original MPQ. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe.

  3. Change from Baseline in Posture Analysis at 8 weeks and 12 weeks [Baseline, 8 weeks, and 12 weeks]

    Corbin posture analysis will be used. This form include lateral and posterior analyzes. Physiotherapist marks between 0 = none 3= severe point to disorders. Total score will calculate excellent = 0-2 to Poor = 12 or more

  4. Change from Baseline in range of motion of the shoulder at 8 weeks and 12 weeks [Baseline, 8 weeks, and 12 weeks]

    Range of motion of the shoulder will be evaluated with a standard goniometer.

  5. Kibler classification for changes in position and scapular movements at 8 weeks and 12 weeks [Baseline, 8 weeks, and 12 weeks]

    Kibler classification will be use assessment of Scapular Dyskinesia. Identifying changes in position and scapular movements that predispose to shoulder injuries. Identifying the type of abnormal scapular movement: type I, type II and type III.

  6. Lateral Scapular Slide test at 8 weeks and 12 weeks [Change from Baseline in Lateral Scapulara Slide at 8 weeks and 12 weeks]

    Lateral Scapular Slide test will be use assessment of Scapular Dyskinesia. The Measurement should not vary more than 1 to 1.5 cm, more the 1.5 cm difference significant.

  7. Change from Baseline in Glenohumeral internal rotation deficit (GIRD) at 8 weeks and 12 weeks [Baseline, 8 weeks, and 12 weeks]

    GIRD is a condition resulting in the loss of internal rotation of the glenohumeral joint as compared to the contralateral side.

  8. Change from Baseline in Subacromial space at 8 weeks. [Baseline and 8 weeks]

    Subacromial space will be measured from radiographic results. Subacromial space is defined by the humeral head inferiorly, the anterior edge and under surface of the anterior third of the acromion, coracoacromial ligament and the acromioclavicular joint superiorly Interposed between these two osseous structures are the rotator cuff tendons.

  9. Change from Baseline in Critical Shoulder Angle (CSA) at 8 weeks. [Baseline and 8 weeks]

    CSA will be measured by MRI results. CSA is the angle between the plane of the glenoid fossa (the line from the inferior edge of the glenoid to the superior edge of the glenoid) and a line drawn from the inferior edge of the glenoid to the lateral edge of the acromion.

  10. Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at 8 weeks and 12 weeks [Baseline, 8 weeks, and 12 weeks]

    QuickDASH will be used for assessing functional ability of the patients. The QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.

  11. Change from Baseline in The Shoulder Pain and Disability Index (SPADI)at 8 weeks and 12 weeks [Baseline, 8 weeks, 12 weeks]

    The SPADI will be used to assess shoulder pain and dysfunction. It consists of 13 items that assess two different areas. The first five items measure the pain, and the next eight items assess patient's disability.

  12. Patient Satisfaction questionnaire at 8 weeks. [8 weeks]

    The Patient Satisfaction questionnaire will be used to assess the patient's satisfaction with the treatment received. Patient Satisfaction questionnaire (PSQ) contains 18 items tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-18.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Individuals between the ages of 18-50 who complain of shoulder pain

  • Individuals diagnosed with a partial tear of the rotator cuff smaller than 1 cm and As a result of the examination performed by the physician stage 1 or 2 subacromial impingement syndrome.

  • Two of the following tests are positive Hawkins-Kennedy, painful arc or infraspinatus muscle strength tests

  • Presence of shoulder pain lasting longer than 6 weeks that limits activity.

  • Being literate and not having cognitive dysfunction.

Exclusion Criteria:
  • Presence of other orthopedic, neurological and systemic problems affecting the neck, shoulder and back complex,

  • Patients with heart failure and using a pacemaker,

  • Labral tears and other intraarticular structural pathologies

  • Signs of adhesive capsulitis

  • Grade 3 or full thickness rotator cuff tear

  • BMİ > 30 kg/m

  • Having been included in a physical therapy program related to the same side shoulder joint in the last 1 year

  • Using non-steroidal anti-inflammatory drugs.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erman Berk Celik Mardin Artuklu Turkey 47100

Sponsors and Collaborators

  • Hasan Kalyoncu University

Investigators

  • Study Director: Aysenur Tuncer, PhD, Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erman Berk Celik, PT, Msc, Research Assistant, Hasan Kalyoncu University
ClinicalTrials.gov Identifier:
NCT05200130
Other Study ID Numbers:
  • 2021/074
First Posted:
Jan 20, 2022
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erman Berk Celik, PT, Msc, Research Assistant, Hasan Kalyoncu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2022