Efficacy of Exercise, Manual Therapy and Tele-rehabilitation-Assisted Treatment on Degenerative Cervical Diseases

NCT ID: NCT05098860

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-29

Study Completion Date

2023-04-15

Brief Summary

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The study aims to compare the effectiveness of soft tissue, joint mobilization, and tele-rehabilitation within the scope of Manual Therapy to the exercise program.

Detailed Description

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60 subjects with cervical degenerative disease will be included in the study after a voluntary consent form is filled out. Subjects will randomly be divided into 3 groups according to the order.

Group 1:Home Exercise Program: After a general education is given to the patients, an exercise program will be taught. Patients will be asked to do home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks, and fill in follow-up charts. In addition, reminder messages will be sent to these patients once a week by the physiotherapist.

Group 2: Manual Therapy Group: After a general education is given to the patients, the same exercise program will be taught. Soft tissue and joint mobilizations will be applied to the patients in this group within the scope of Manual Therapy (MT). Mobilizations of the cervical vertebrae, scapula, and thoracic vertebrae will be included. MT will be applied to the patients 2 days a week for 8 weeks.

Group 3: Tele-Rehabilitation Group: After general education, treatment will be given in the zoom environment. During the 8 weeks, regularly planned exercises will be done via Zoom for 30-45 minutes 2 days a week, accompanied by a physiotherapist. Patients will apply active cervical and thoracic region mobilizations called self-mobilization. Patients will be taught active mobilization applications with the help of a towel for the cervical region, mobilization of the thoracic region with a foam roller. Patients will apply those self-mobilization at home in front of the physiotherapist in a visual environment. Patients in this group will regularly do the same home exercises on the other days without tele-rehabilitation.

Measurement and evaluation will be done four times, as pre-treatment, post-treatment (8th week), first follow-up (12 weeks), second follow-up (6th month).

Conditions

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Cervical Spine Disease Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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Study Groups

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Home Exercise Program

The home exercise program includes a general educational training program. The program includes active stretching, strengthening, and stabilization exercises of neck muscles, head and neck posture exercises as well as relaxation and diaphragmatic breathing exercises.

Patients will be asked to do home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks.

Group Type ACTIVE_COMPARATOR

Home Exercise Program

Intervention Type OTHER

Educational training program includes active stretching, strengthening, and stabilization exercises of head and neck muscles as well as relaxation and breathing exercises.

Manual Therapy Combined with Home Exercise Program

Manual Therapy includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae. MT will be applied to the patients 2 days a week for 8 weeks.

The home exercise program includes active stretching, strengthening, and stabilization exercises of neck muscles, head and neck posture exercises as well as relaxation and diaphragmatic breathing exercises.

Group Type ACTIVE_COMPARATOR

Manual Therapy Combined with Home Exercise Program

Intervention Type OTHER

Manual Therapy program includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae.

Tele-rehabilitation Assisted Program

Tele-rehabilitation assisted program will be given in the on-line environment. During 8 weeks, regularly planned exercises will be done via online applications for 30-45 minutes 2 days a week, accompanied by a physiotherapist. These patients will apply active cervical and thoracic region mobilizations called self-mobilization. Patients will be taught active mobilization applications with the help of a towel for the cervical region, with the assistance of a foam-roller for active mobilization of the thoracic region.

Group Type ACTIVE_COMPARATOR

Tele-rehabilitation Assisted Program

Intervention Type OTHER

Tele-rehabilitation assisted program will be given in the on-line environment. Patients will apply active cervical and thoracic region mobilizations called self-mobilization.

Interventions

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Home Exercise Program

Educational training program includes active stretching, strengthening, and stabilization exercises of head and neck muscles as well as relaxation and breathing exercises.

Intervention Type OTHER

Manual Therapy Combined with Home Exercise Program

Manual Therapy program includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae.

Intervention Type OTHER

Tele-rehabilitation Assisted Program

Tele-rehabilitation assisted program will be given in the on-line environment. Patients will apply active cervical and thoracic region mobilizations called self-mobilization.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 40-65
* Patients diagnosed with cervical degenerative disease
* Patients with neck pain who have had pain for at least three months
* Patients who can participate in the treatment program by following WhatsApp messages with tele-rehabilitation.

Exclusion Criteria

* Patients with an indication for surgery for the cervical region and or a previous history of cervical surgery,
* Currently receiving treatment from another region,
* Having severe neurological loss,
* Having a primary or spinal metastatic malignancy,
* Having a vascular problem in the upper extremity,
* To be diagnosed with advanced osteoporosis,
* Being pregnant,
* Diagnosis of Diabetes Mellitus,
* Having an Inflammatory Disease (such as rheumatoid arthritis),
* Having a history of trauma,
* Those who have received physical therapy and rehabilitation for the cervical region in the last 6 months will not be included.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasan Kalyoncu University

OTHER

Sponsor Role lead

Responsible Party

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Gokhan Aygul

PT,MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysenur Tuncer, PhD

Role: STUDY_DIRECTOR

Hasan Kalyoncu University

Locations

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Malatya Education and Research Hospital

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAUMS

Identifier Type: -

Identifier Source: org_study_id

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