Clinical trial NCT05098860: Efficacy of Exercise, Manual Therapy and Tele-rehabilitation-Assisted Treatment on Degenerative Cervical Diseases
Official title: Comparison of the Efficacy of Exercise, Manual Therapy and Tele-rehabilitation-Assisted Treatment on Pain, Anxiety and Quality of Life in Degenerative Cervical Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine Disease
Neck Pain
Keywords: Pain
Anxiety
Quality of Life
Neck disability
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Pain at 8 weeks, 12 weeks and 6 months
timeFrame: Baseline, 8 weeks, 12 weeks, 6 months
measure: Change from Baseline in Anxiety at 8 weeks, 12 weeks and 6 months
timeFrame: Baseline, 8 weeks, 12 weeks, 6 months
measure: Change from Baseline in Quality of Life at 8 weeks, 12 weeks and 6 months
timeFrame: Baseline, 8 weeks, 12 weeks, 6 months
measure: Change from Baseline in Neck Disability at 8 weeks, 12 weeks and 6 months
timeFrame: Baseline, 8 weeks, 12 weeks, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Malatya Education and Research Hospital
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PhD
role: STUDY_DIRECTOR
References: