SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION

NCT05501184 | Completed

• 1 other identifier: 26.05.2022/67
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized controlled trial conducted to examine the changes in the pain, physical function, quality of life, and kinesiophobia of participants with non-specific neck pain in Marmara University Physiotherapy and Rehabilitation Department. This study was approved by the Clinical Studies Ethics Committee of Marmara University Faculty of Health Sciences in January 2022 and was carried out in accordance with the Declaration of Helsinki. The participants were informed about the study and their consent was obtained.

Conditions

Cervical Disc Herniation

Outcome Measures

Primary Outcomes (1)

• 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, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.

Secondary Outcomes (4)

• Neck Disability Index (NDI)

  The disability was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.

• Tampa Scale of Kinesiophobia (TSK)

  The kinesiophobia was measured at baseline, mid-treatment in the 4th week, at the end of treatment in the 8th week, and a long-term follow-up assessment in the 16th week.

• Cervical Mobility

  The cervical mobility was measured at baseline and at the end of treatment in the 8th week.

• Short Form-36 (SF-36)

  The quality of life was measured at baseline and at the end of treatment in the 8th week.

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 nonspecific neck pain 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 nonspecific neck pain 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 were included in the study.

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 15, 2022
• Study Start: February 1, 2022
• Primary Completion: July 15, 2022
• Study Completion: August 11, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)