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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098860
• Other study ID #: KAUMS
• Status: Completed
• Phase: N/A
• Start date: October 29, 2021
• Est. completion date: April 15, 2023

Study information

• Verified date: December 2021
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 15, 2023
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spine Disease
• Neck Pain
• Spinal Diseases
• Uterine Cervical Diseases

Intervention

Other:
• 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.
• Manual Therapy Combined with Home Exercise Program
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. Patients will apply active cervical and thoracic region mobilizations called self-mobilization.

Locations

Country	Name	City	State
Turkey	Malatya Education and Research Hospital	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Pain at 8 weeks, 12 weeks and 6 months	Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 8 weeks intervention, and at the end of 12 weeks, and 6 months from baseline.	Baseline, 8 weeks, 12 weeks, 6 months
Primary	Change from Baseline in Anxiety at 8 weeks, 12 weeks and 6 months	Anxiety Sensitivity Index-3 will be used to evaluate the anxiety sensitivity of individuals effectively and multidimensionally. The scale is rated in a five-point Likert type and consists of a total of 18 items and is rated as 0 = very little, 4 = very much, and the total scale score ranges from 0 to 72.	Baseline, 8 weeks, 12 weeks, 6 months
Primary	Change from Baseline in Quality of Life at 8 weeks, 12 weeks and 6 months	Nottingham Health Profile will be used to assess health-related quality of life. It is a general quality of life questionnaire that measures the individual's perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items and evaluates six dimensions related to health status: Energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items). matter). Questions are answered with yes or no. Each section is scored between 0-100. 0 indicates best health, 100 indicates worst health.	Baseline, 8 weeks, 12 weeks, 6 months
Primary	Change from Baseline in Neck Disability at 8 weeks, 12 weeks and 6 months	Neck Disability Index, consists of 10 items. Individuals included in the study will be asked to give a score between 0 (no disability) and 5 (complete disability) for each item. The total score varies between 0 (no disability) and 50 (complete disability).	Baseline, 8 weeks, 12 weeks, 6 months