Synchronous and Asynchronous Telerehabilitation Methods in Patients With Shoulder Tendinopathy

NCT05549817 | Unknown

• 1 other identifier: 2022/67
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial conducted to compare the effects of synchronous and asynchronous telerehabilitation programs on pain, disability, and quality of life parameters in patients with shoulder tendinopathy in the Marmara University Physiotherapy and Rehabilitation Department.

Conditions

Tendinopathy; Shoulder Pain

Outcome Measures

Primary Outcomes (4)

• Numerical Pain Rating Scale (NPRS)

  Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.

  The pain was measured at baseline.

• Numerical Pain Rating Scale (NPRS)

  Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.

  The pain was measured at mid-treatment in the 4th week.

• Numerical Pain Rating Scale (NPRS)

  Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.

  The pain was measured at the end of treatment in the 8th week.

• Numerical Pain Rating Scale (NPRS)

  Pain intensity was measured with a 0-10 cm scale. Participants were asked to rate their pain as "0: no pain and 10: excruciating pain" on the 0-10 cm scale (10). The pain reported by the patients was recorded in centimeters.

  The pain was measured at long-term follow-up assessment in the 16th week.

Secondary Outcomes (8)

• Disabilities of the Arm, Shoulder and Hand (DASH)

  The disability was measured at baseline.

• Disabilities of the Arm, Shoulder and Hand (DASH)

  The disability was measured at mid-treatment in the 4th week.

• Disabilities of the Arm, Shoulder and Hand (DASH)

  The disability was measured at the end of treatment in the 8th week.

• Disabilities of the Arm, Shoulder and Hand (DASH)

  The disability was measured at long-term follow-up assessment in the 16th week.

• Short Form-36 (SF-36)

  The quality of life was measured at baseline.

Study Arms (2)

Synchronous Telerehabilitation Group

EXPERIMENTAL

The exercise program was applied to groups that include three participants of the synchronous group 3 days per week by video conference method on an online platform (Zoom) with the supervision of a physiotherapist. The time of the group session was organized according to the availability of participants in that group and the physiotherapist using shared calendar availability (Doodle). The physiotherapist sent a reminder to participants one hour prior to each session including the video conference meeting link. Each exercise session lasted approximately 40 minutes. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist demonstrated the exercises as needed, supervised the group by giving real-time feedback, and progressed the exercise program according to the needs of each group.

Other: Synchronous Exercise Program

Asynchronous Telerehabilitation Group

ACTIVE COMPARATOR

The exercise program was prescribed and followed up 3 days per week via the mobile application (FizyoTr). A notification was sent to participants' phones via mobile application prior to each session and attendance to the exercise program was recorded. For 8 weeks, a total of 24 exercise sessions were performed. The physiotherapist progressed the exercise program according to the assessment at 4 weeks and the needs of each participant.

Other: Asynchronous Exercise Program

Interventions

Synchronous Exercise Program OTHER

The exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression.

Synchronous Telerehabilitation Group

Asynchronous Exercise Program OTHER

The exercise program consisted of exercises by recommended guidelines for shoulder tendinopathy patients which includes various strengthening, stretching, and proprioceptive exercises with progression.

Asynchronous Telerehabilitation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants between the ages of 18-65,
• Who had access to the internet and smartphone,
• Had the ability to conduct video calls included in the study.

You may not qualify if:

• Participants were excluded if they had COVID-19,
• Had surgery in the last 6 months,
• Had neurological and psychological disorders,
• Received physiotherapy treatment.
• Had surgery in the last 6 months,
• Had a condition that prevented them from exercising.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Faculty of Health Sciences

Istanbul, Maltepe, 1464185881, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tendinopathy; Shoulder Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Arthralgia; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eren Timurtaş, Ph.D.

CONTACT

+905384855543; selcukhalit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 22, 2022
• Study Start: June 1, 2022
• Primary Completion: November 10, 2022
• Study Completion: November 25, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)