NCT05200130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

December 7, 2021

Last Update Submit

November 24, 2023

Conditions

Keywords

PainFunctionalityPatient Satisfaction

Outcome Measures

Primary Outcomes (10)

  • 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.

    Change from Baseline in Pain at 8 weeks and 12 weeks

  • Change from Baseline in Short-Form Mcgill Pain questionnaire (SF-MPQ) at 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: 1. Sensory subscale with 11 words 2. 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.

    Baseline, 8 weeks, and 12 weeks

  • Change from Baseline in Posture Analysis at 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

    Baseline, 8 weeks, and 12 weeks

  • Change from Baseline in range of motion of the shoulder at 8 weeks and 12 weeks

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

    Baseline, 8 weeks, and 12 weeks

  • Kibler classification for changes in position and scapular movements at 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.

    Baseline, 8 weeks, and 12 weeks

  • Lateral Scapular Slide test 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.

    Change from Baseline in Lateral Scapulara Slide at 8 weeks and 12 weeks

  • Change from Baseline in Glenohumeral internal rotation deficit (GIRD) at 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.

    Baseline, 8 weeks, and 12 weeks

  • Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at 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.

    Baseline, 8 weeks, and 12 weeks

  • Change from Baseline in The Shoulder Pain and Disability Index (SPADI)at 8 weeks and 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.

    Baseline, 8 weeks, 12 weeks

  • Patient Satisfaction questionnaire at 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.

    8 weeks

Study Arms (3)

Home exercise group

ACTIVE COMPARATOR

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

Manual Therapy Group

ACTIVE COMPARATOR

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

Telerehabilitation Supported Group

EXPERIMENTAL

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

Interventions

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.

Home exercise 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.

Manual Therapy 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.

Telerehabilitation Supported Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erman Berk Celik

Mardin, Artuklu, 47100, Turkey (Türkiye)

Location

Related Publications (1)

  • Celik EB, Tuncer A. Comparing the Efficacy of Manual Therapy and Exercise to Synchronized Telerehabilitation with Self-Manual Therapy and Exercise in Treating Subacromial Pain Syndrome: A Randomized Controlled Trial. Healthcare (Basel). 2024 May 24;12(11):1074. doi: 10.3390/healthcare12111074.

MeSH Terms

Conditions

PainPatient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Aysenur Tuncer, PhD

    Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, Msc, Research Assistant

Study Record Dates

First Submitted

December 7, 2021

First Posted

January 20, 2022

Study Start

November 1, 2021

Primary Completion

August 8, 2023

Study Completion

August 8, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations