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

NCT05098860 | Completed DMC

• 1 other identifier: KAUMS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spine Disease; Neck Pain

Keywords

Pain; Anxiety; Quality of Life; Neck disability

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Home Exercise Program

ACTIVE COMPARATOR

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.

Other: Home Exercise Program

Manual Therapy Combined with Home Exercise Program

ACTIVE COMPARATOR

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.

Other: Manual Therapy Combined with Home Exercise Program

Tele-rehabilitation Assisted Program

ACTIVE COMPARATOR

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.

Other: Tele-rehabilitation Assisted Program

Interventions

Home Exercise Program OTHER

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

Home Exercise Program

Manual Therapy Combined with Home Exercise Program OTHER

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

Manual Therapy Combined with Home Exercise Program

Tele-rehabilitation Assisted Program 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.

Tele-rehabilitation Assisted Program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Malatya Education and Research Hospital

Malatya, 44000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Aysenur Tuncer, PhD

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Evaluations are made by another person who does not know about the research topic and research groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT,MSc

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: October 28, 2021
• Study Start: October 29, 2021
• Primary Completion: July 15, 2022
• Study Completion: April 15, 2023
• Last Updated: August 15, 2023

Record last verified: 2021-12

Locations

TU (1)