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Completed

NCT Number: NCT05501184

SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION

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.

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Key information

Conditions

Cervical Disc Herniation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Numerical Pain Rating Scale (NPRS)

    Time frame: 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.

    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.

Secondary outcomes

  1. Neck Disability Index (NDI)

    Time frame: 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.

    The participants' level of disability related to neck pain was evaluated using NDI. The NDI consists of 10 questions scored between 0 to 5 to measure disability related to limitation or pain (12). Questions include neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and leisure activities. The scores range from 0 to 50 with higher scores indicating a more severe disability. The Turkish version of NDI has been shown to be valid and reliable in patients with neck pain

  2. Tampa Scale of Kinesiophobia (TSK)

    Time frame: 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.

    The TSK is a scale developed by Vlaeyen et al. consisting of 17 questions that assess kinesiophobia. For each question, a 4-point Likert scoring (1 = strongly disagree, 4 = completely agree) is used. After reversing items 4, 8, 12, and 16, a total score is calculated. The total score ranges from 17-68. A higher score indicates a higher level of kinesiophobia. The Turkish version of TSK has been shown to be valid and reliable.

  3. Cervical Mobility

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

    The range of neck extension, flexion, and right and left lateral flexion were measured using a universal goniometer. For flexion and extension measurement, the participant sat on the side of the physiotherapist. The pivot point of the goniometer was placed at the acromion. The fixed arm of the goniometer was parallel to the ground. The measuring arm followed the midline of the ear. While measuring flexion, the participant was asked to try to touch his/her chin to the chest and for extension, to move his/her face parallel to the ceiling. For lateral flexion, pivot point of the goniometer was placed on the spinal ridge of C7. The fixed arm of the goniometer was kept parallel to the ground. The measuring arm followed the spinal projections of the vertebrae. The participant was asked to move his/her ear towards the shoulder.

  4. Short Form-36 (SF-36)

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

    The quality of life was assessed using SF-36, which consists of 36 items. The Sf-36 has a total of 8 subscales including physical functioning, limitation due to physical problems (physical role), limitation due to emotional problems (emotional role), vitality, bodily pain, mental health, general health, and social functioning (19). The Turkish version of the SF-36 has been shown to have validity and reliability.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

COMPARISON OF SYNCHRONOUS AND ASYNCHRONOUS TELEREHABILITATION METHODS IN PATIENTS WITH CERVICAL DISC HERNIATION

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2022
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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