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

Primary Purpose

Cervical Spine Disease, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home Exercise Program
Manual Therapy Combined with Home Exercise Program
Tele-rehabilitation Assisted Program
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spine Disease focused on measuring Pain, Anxiety, Quality of Life, Neck disability

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Malatya Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Home Exercise Program

Manual Therapy Combined with Home Exercise Program

Tele-rehabilitation Assisted Program

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
October 9, 2021
Last Updated
August 14, 2023
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05098860
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spine Disease, Neck Pain
Keywords
Pain, Anxiety, Quality of Life, Neck disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Evaluations are made by another person who does not know about the research topic and research groups.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Exercise Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Manual Therapy Combined with Home Exercise Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tele-rehabilitation Assisted Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home Exercise Program
Intervention Description
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
Intervention Name(s)
Manual Therapy Combined with Home Exercise Program
Intervention Description
Manual Therapy program includes soft tissue and joint mobilizations of the cervical vertebrae, scapula and thoracic vertebrae.
Intervention Type
Other
Intervention Name(s)
Tele-rehabilitation Assisted Program
Intervention Description
Tele-rehabilitation assisted program will be given in the on-line environment. Patients will apply active cervical and thoracic region mobilizations called self-mobilization.
Primary Outcome Measure Information:
Title
Change from Baseline in Pain at 8 weeks, 12 weeks and 6 months
Description
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.
Time Frame
Baseline, 8 weeks, 12 weeks, 6 months
Title
Change from Baseline in Anxiety at 8 weeks, 12 weeks and 6 months
Description
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.
Time Frame
Baseline, 8 weeks, 12 weeks, 6 months
Title
Change from Baseline in Quality of Life at 8 weeks, 12 weeks and 6 months
Description
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.
Time Frame
Baseline, 8 weeks, 12 weeks, 6 months
Title
Change from Baseline in Neck Disability at 8 weeks, 12 weeks and 6 months
Description
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).
Time Frame
Baseline, 8 weeks, 12 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur Tuncer, PhD
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Malatya Education and Research Hospital
City
Malatya
ZIP/Postal Code
44000
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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