Subacromial Pain SyndromeNCT05200130
Effectiveness of Telerehabilitation on Subacromial Pain Syndrome
A study testing Home Exercise Group, Manual Therapy Group and Telerehabilitation Group in people with Subacromial Pain Syndrome, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Subacromial Pain Syndrome
- What is being tested?
- Home Exercise Group, Manual Therapy Group and Telerehabilitation Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Telerehabilitation With Self Mobilization in Patients With Subacromial Pain Syndrome
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.
Read the 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.
- Conditions
- Subacromial Pain Syndrome
- Being tested
- Home Exercise Group, Manual Therapy Group, Telerehabilitation Group
- Keywords
- Pain, Functionality, Patient Satisfaction
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise GroupOther
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 GroupOther
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.
Telerehabilitation GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Telerehabilitation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Nov 2021
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erman Berk Celik, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PhD, Study director, Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200130
- Sponsor's protocol ID
- 2021/074
- Status last verified
- Nov 2023
- First submitted
- 7 Dec 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38891149
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Telerehabilitation With Self Mobilization in Patients With Subacromial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05200130
- Acronym / sponsor ID
- 2021/074
- Conditions
- Subacromial Pain Syndrome
- Keywords
- Pain, Functionality, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home exercise group | Active comparator | Other: Home Exercise GroupThe 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. |
| Manual Therapy Group | Active comparator | Other: Manual Therapy GroupPatients 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. |
| Telerehabilitation Supported Group | Experimental | Other: Telerehabilitation GroupTelerehabilitation 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Exercise GroupThe 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. | Other | Home exercise group |
| Manual Therapy GroupManual 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. | Other | Manual Therapy Group |
| Telerehabilitation GroupThe 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. | Other | Telerehabilitation Supported Group |
Primary outcome
Change from Baseline in Pain at 8 weeks and 12 weeks
Time frame: 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 Short-Form Mcgill Pain questionnaire (SF-MPQ) at 8 weeks and 12 weeks
Time frame: 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: 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.
Change from Baseline in Posture Analysis at 8 weeks and 12 weeks
Time frame: 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
Change from Baseline in range of motion of the shoulder at 8 weeks and 12 weeks
Time frame: Baseline, 8 weeks, and 12 weeks
Range of motion of the shoulder will be evaluated with a standard goniometer.
Kibler classification for changes in position and scapular movements at 8 weeks and 12 weeks
Time frame: 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.
Lateral Scapular Slide test at 8 weeks and 12 weeks
Time frame: 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.
Change from Baseline in Glenohumeral internal rotation deficit (GIRD) at 8 weeks and 12 weeks
Time frame: 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.
Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (QuickDASH) at 8 weeks and 12 weeks
Time frame: 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.
Change from Baseline in The Shoulder Pain and Disability Index (SPADI)at 8 weeks and 12 weeks
Time frame: 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.
Patient Satisfaction questionnaire at 8 weeks.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 38891149Celik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysenur Tuncer, PhD study director
Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise Group, Manual Therapy Group and Telerehabilitation Group in people with Subacromial Pain Syndrome, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain at 8 weeks and 12 weeks (time frame: Change from Baseline in Pain at 8 weeks and 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05200130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.