NCT04738461

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

January 31, 2021

Last Update Submit

July 19, 2022

Conditions

Subacromial Pain Syndrome

Keywords

Subacromial Pain SyndromeSubacromial ImpingementSyndrometelerehabilitationphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Pain Intensity at 1 and 3 months

    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 Outcomes (1)

  • Change from Baseline SPADI total score at 1 and 3 months

    Baseline, one and three month after the randomisation

Other Outcomes (1)

  • Change from baseline range of motion of shoulder at 1 and 3 months

    Baseline, one and three month after the randomisation

Study Arms (3)

Telerehabilitation

EXPERIMENTAL

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

Standard Physiotherapy

ACTIVE COMPARATOR

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

Home exercise group

ACTIVE COMPARATOR

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

Interventions

TelerehabilitationOTHER

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.

Telerehabilitation
Standard PhysiotherapyOTHER

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.

Standard Physiotherapy
Home Exercise GroupOTHER

The same exercise program applied to telerehabilitation group.

Home exercise group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Garving C, Jakob S, Bauer I, Nadjar R, Brunner UH. Impingement Syndrome of the Shoulder. Dtsch Arztebl Int. 2017 Nov 10;114(45):765-776. doi: 10.3238/arztebl.2017.0765.

    PMID: 29202926BACKGROUND

  • Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371.

    PMID: 30441330BACKGROUND

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Bugra Ince, MD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

  • Mustafa Huseyin Temel, MD

    Uskudar State Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will not be able to be blinded due the inherent of interventions. Staff members who are responsible for statistical analysis, investigators and outcome assessors will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, triple-blinding, randomized controlled and 3-arm parallel group design clinical study. 3 arms of the study were planned to consist of telerehabilitation group, standard physiotherapy group and home exercise group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 4, 2021

Study Start

February 1, 2022

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Data sharing will be done on request

Locations

TU(2)