The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome

July 19, 2022 updated by: Bezmialem Vakif University

The Effectiveness of Telerehabilitation in Patients With Subacromial Pain Syndrome: a Randomized Controlled Trial

The main hypothesis of the study is that telerehabilitation is an effective treatment method and it is not inferior than standard physiotherapy.The aim of this study is to evaluate the effectiveness of telerehabilitation in patients with subacromial pain syndrome by comparing it with standard physiotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subacromial pain syndrome formerly known as subacromial impingement syndrome is the cause of approximately 44% to 65% of pain complaints related to the shoulder. Methods such as immobilization, drug therapy, injection techniques, physical therapy modalities and therapeutic exercises, manual therapy, acupuncture and surgery can be used in the treatment of the disease. Due to the Coronavirus disease 2019 (COVID-19) pandemic that started in Wuhan province of China in December 2019, 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. Although there are many studies on the effectiveness of telerehabilitation in the literature, there is no study on the superiority of telerehabilitation, physical therapy under supervision and home exercise program over each other.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Medipol Mega University Hospital
      • Istanbul, Turkey
        • Çam and Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having subacromial pain for at least 2 weeks
  • Positive result of Hawkins-Kennedy, painful arc or infraspinatus muscle strength tests .
  • To have internet access and equipment to participate in videoconference .
  • Being literate and not having cognitive dysfunction.

Exclusion Criteria:

  • Positive drop arm test
  • Signs of adhesive capsulitis (restriction in range of motion-especially in abduction and external rotation)
  • Grade 3 or full thickness rotator cuff tear
  • Labral tears and other intraarticular structural pathologies
  • History of shoulder surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Telerehabilitation
Telerehabilitation program will be applied 5 days a week for 3 weeks to patients in the telerehabilitation group. A physiatrist will meet with patients via videoconferencing over the internet and guide the program.
Other: Telerehabilitation
The Posterior Glenohumeral Capsule Stretching Exercise, Pectoral Stretching Exercise, Push-up Against Wall Exercise, Scapular Plan Exercise, 90 Degree Shoulder Flexion Exercise, Isometric External Rotation Exercise and Isometric Internal Rotation Exercise will be applied according to the severity of the disease and the size of the disability.
ACTIVE_COMPARATOR: Standard Physiotherapy
Patients in the standard physiotherapy group will receive one-to-one physiotherapy sessions in the hospital 5 days a week for 3 weeks. In these sessions, active-passive exercises accompanied by a physiotherapist and physical therapy methods (electrotherapy and thermotherapy) will be applied in accordance with the standard procedure according to the patient's needs.
Other: Standard Physiotherapy
Active-passive exercises accompanied by a physiotherapist and physical therapy methods (electrotherapy and thermotherapy) will be applied in accordance with the standard procedure according to the patient's needs.
ACTIVE_COMPARATOR: Home exercise group
The home exercise program was explained to the patients in the control group by the physiotherapist and the relevant brochures were delivered to the patients. Home exercise program will consist of telerehabilitation group exercises. However, patients will be not under any supervision and exercise themselves at home.
Other: Home Exercise Group
The same exercise program applied to telerehabilitation group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Pain Intensity at 1 and 3 months
Time Frame: Baseline, one and three month after the randomisation
Patients will be asked to mark their pain by giving a score between zero (no pain) and 10 (the most severe pain) on a 10 cm long visual analog scale (VAS) during each visits.
Baseline, one and three month after the randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline SPADI total score at 1 and 3 months
Time Frame: Baseline, one and three month after the randomisation
The Shoulder Pain and Disability Index (SPADI) is a questionnaire with a total of 13 questions developed to measure shoulder pain and associated disability. In the subgroup of the pain, the patient is asked to express the severity of him/her pain by giving a score between zero (no pain) and 10 (the most severe pain) during different activities in the last week. In the subgroup of disability, the patient is asked to score between zero (no difficulty) and 10 (receiving assistance) how hard they have experienced during different activities in the last week. Zero points indicate maximum well-being, 130 points indicate maximum disability.
Baseline, one and three month after the randomisation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline range of motion of shoulder at 1 and 3 months
Time Frame: Baseline, one and three month after the randomisation
Range of motion of the Shoulder will be evaluated with a standard goniometer.
Baseline, one and three month after the randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mustafa Huseyin Temel, MD, Üsküdar State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BI280121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing will be done on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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