The Effect of Telerehabilitation in Patients With Chronic Neck Pain

NCT04752488 | Completed

• 1 other identifier: Mugla Training and Research
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Telerehabilitation offers more efficient follow-up of patients during their home exercise period as a cost-effective and effective treatment model. This study was planned to examine the effectiveness of telerehabilitation in patients with chronic neck pain. The aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.

Conditions

Chronic Neck Pain

Keywords

Telerehabilitation

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale (VAS)

  The patients will be asked to mark their pain feelings for rest and activity on a 10 cm numerical line (0: no pain, 10: unbearable pain). It is planned to use numerical VAS in our study. The cut-off values for chronic musculoskeletal pain will be classified as the severity of pain according to VAS as follows: \<3.4 centimeters: mild pain, 3.5-7.4 centimeters: moderate pain, \> 7.5 centimeters: severe pain.

  2 minutes

• Neck Disability Index (NDI)

  NDI consists of 10 titles: pain intensity, personal care, lifting, reading, headache, concentration, study, driving, sleeping, and recreation. For each item included in the study; 0 indicates "no disability" and 5 represents "complete disability" Participants will be asked to give points between these scores. The total score ranges between 0 (no disability) and 50 (complete disability).

  5 minutes

• Short Form-36 (SF-36)

  SF-36 consists of thirty-six items. These provide measurements of eight dimensions. Subscales evaluate health between 0-100 points; '0' indicates poor health, '100' indicates good health.

  5 minutes

• Tampa Scale for Kinesiophobia

  The scale is a 17-item. A 4-point Likert scoring (1= strongly disagree, 4= totally agree) is used in the scale. The participant gets a total score between 17-68. The high score obtained by the participant indicates that the kinesiophobia is also high.

  5 minutes

Secondary Outcomes (2)

• Exercise Adherence Rating Scale (EARS)

  5 minutes

• Telemedicine Patient Questionnaire

  5 minutes

Study Arms (2)

Telerehabilitation (TR) Group

EXPERIMENTAL

The TR group will be followed up through the video-based exercise software within the 8-week home exercise program.

Other: Telerehabilitation (TR)

Conventional Rehabilitation (CR) Group

ACTIVE COMPARATOR

The CR group will be trained face-to-face with conventional methods before the 8-week home exercise program, and an exercise program will be prescribed with a visual information form.

Other: Conventional Rehabilitation (CR)

Interventions

Telerehabilitation (TR) OTHER

The home exercise program will be educated to the patient on the first day. Exercises for isometric and isotonic strengthening, stretching, and stabilization of the neck muscles will be given. Exercises will be presented to the patients in audio-video format and detailed instructions with explanations. The exercise protocol will also be the same as in the conventional rehabilitation group. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.

Telerehabilitation (TR) Group

Conventional Rehabilitation (CR) OTHER

The home exercise program will be educated to the patient on the first day. Isometric and isotonic strengthening, stretching and stabilization exercises for the neck muscles will be given. Exercise information form including explanation and picture of the exercises will be given to the patients. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.

Conventional Rehabilitation (CR) 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:

• Patients between the ages of 18 - 65
• Patients who have suffered from neck pain for at least 3 months
• Signing the consent form

You may not qualify if:

• Situations that prevent the evaluation or communication with the individual
• Illiterate individuals
• Individuals who have undergone an operation due to neck pain problem, diagnosed with a tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome
• Conditions in which specific pathological condition is proven such as malignant condition, fracture, systemic rheumatoid disease
• Orthopedic and neurological problems that prevent evaluation and/or treatment
• Complaints of pain and numbness spreading to the upper extremities
• Individuals with a diagnosed psychiatric disease
• Individuals who have received physiotherapy in the last 6 months
• Individuals using another treatment method during the study
• Individuals with musculoskeletal pain in any other part of the body during work
• Pregnant participants

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Training and Research Hospital

Muğla, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Mehmet Özkeskin, PhD

  Ege University

  STUDY DIRECTOR

• İsmet Tümtürk, MSc

  Ege University

  PRINCIPAL INVESTIGATOR

• Cem Yalın Kılınç

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

• Fatih Özden

  Muğla Sıtkı Koçman University

  STUDY CHAIR

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: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 12, 2021
• Study Start: March 20, 2022
• Primary Completion: June 20, 2022
• Study Completion: July 29, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)