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The Effects of CSE and ISE on Pain, Strength, Flexibility, Disability and QoL in Patients With CDH

Primary Purpose

Cervical Disc Herniation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
segmental cervical stabilization exercises
cervical isometric exercises
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Herniation focused on measuring Cervical Disc Herniation, stabilization exercises, isometric exercises, pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with Cervical Disc Herniation Complaints started at least 3 months ago Patients with cervical disc herniation between the ages of 18-60; Has not received physical therapy or rehabilitation in the last 3 months; Not taking any medication such as analgesics, anti-inflammatory drugs or muscle relaxants to treat the symptoms. Exclusion Criteria: major psychiatric illness, Patients with cervical spine surgery and rheumatological diseases; pacemaker users; Those who are injected with local corticosteroids; pregnant woman; Cancer patients. Patients who refuse to participate in the study will be excluded from the study.

Sites / Locations

  • NPIstanbul Brain Hospital
  • Uskudar University NPIstanbul Brain Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cervical Stabilization Exercise Group

Cervical Isometric Exercise Group

Arm Description

After applying traditional treatment for 40 minutes to the cases in Group A, additional segmental cervical stabilization exercises (20 minutes) will be applied.

After applying traditional treatment for 40 minutes to the cases in Group B, additional cervical isometric exercises (20 minutes) will be applied.

Outcomes

Primary Outcome Measures

Visual analog Scale (VAS)
A visual analog scale (VAS) will be used to evaluate the patient's pain intensity. Patients will be asked to describe their current pain by marking "no pain" and "worst possible pain" on a 100 mm horizontal line.

Secondary Outcome Measures

Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a 10-item questionnaire that measures self-reported disability related to neck pain. The NDI is the most widely used, translated, and oldest questionnaire for neck pain. It has been shown to have high "test-retest" reliability. The NDI has also been shown to be valid when compared to other measures of pain and disability.
Universal Goniometer
Cervical Joint range of motion will be measured using a Universal goniometer (UG). Universal goniometer is a reliable device to evaluate Cervical ROM (3). For measurement of cervical ROM, after the subjects are seated sideways on the physiotherapist, the pivot point will be placed on the lateral projection of the acromion, measurements will be made while the fixed arm of the goniometer is kept parallel to the ground and the movable arm of the goniometer follows the midline during movement.
Manual Muscle testing
Manual muscle testing (MMT) is scored using the 0-5 point Medical Research Council muscle strength rating scale and is a common method of assessing muscle strength in therapeutic trials. MMT is less time consuming and MMT's rating system is subjective.
SF 12 (Short Form 12)
SF-12, a measure of Health-Related Quality of Life, can be used in age, disease and treatment groups. It is a shortened version of the SF-36 and contains 12 questions, each with two to five answer options. The patient is told to choose the option that best suits him/her. The SF-12 covers eight dimensions: general health, physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. A physical and mental health score, each ranging from 0 to 100, can be calculated using scoring algorithms.

Full Information

First Posted
October 18, 2023
Last Updated
October 24, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06098365
Brief Title
The Effects of CSE and ISE on Pain, Strength, Flexibility, Disability and QoL in Patients With CDH
Official Title
The Effects of Cervical Stabilization Exercises and Isometric Cervical Exercises on Pain, Strength, Flexibility, Disability and Quality of Life in Patients With Cervical Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Cervical disc herniation is a common source of cervical radiculopathy, which can occur suddenly due to trauma and results from chemical and mechanical degenerative changes that occur over time, with an annual incidence of 1.6 per 100,000 and is more common in people in the third to fifth decades of life. The prevalence of cervical disc herniation increases with age in both men and women. It is more common in women and accounts for more than 60% of cases. Cervical disc herniation is a spine disease that seriously affects the quality of life of patients and imposes a heavy economic burden on individuals and society. In recent years, with the widespread use of mobile phones and computers and the increase in the life pressure of today's people, the incidence of cervical disc herniation has shown a younger trend. The role of surgical and non-surgical treatment of patients with cervical disc herniation has not been adequately investigated. While the majority of published data reflects surgical outcomes, there is little data on the outcomes of patients treated without surgery. The most commonly used non-surgical treatments are manipulation, mobilization, kinesiology taping and therapeutic exercises along with electrotherapy agents such as laser therapy, TENS, vacuum interferential and traction. Exercise is considered one of the evidence-based methods to reduce pain in cervical disc herniation, prevent further injury, increase muscle strength, endurance and flexibility, improve proprioception, and contribute to and maintain normal life activities. Exercises used in neck pain in the literature consist of various exercises such as cervical isometrics, cervical concentric/eccentric exercises using pulley systems or weights, upper extremity exercises using dumbbells or deep neck flexor/extensor rehabilitation. Isometric exercises are effective in treating neck pain, range of motion and disability.
Detailed Description
It has been reported in the literature that neck stabilization exercises should be included in the rehabilitation of patients with chronic neck pain, as they increase the strength, endurance and coordination of the spinal stabilizer muscles and therefore help in reducing neck pain and improving cervical functions. Cervical stabilization exercises are a method of exercise designed to improve the innate mechanisms that enable the cervical spine to maintain a stable, injury-free state, as in the lumbar spine. Despite the popularity of stabilization exercises, which are performed with a series of exercises that are relatively simple in terms of time and equipment, but physiologically complex, in the treatment of back and pelvic pain, no randomized controlled trial (RCT) has investigated its effectiveness on neck pain, disability, strength, flexibility and quality of life in cases with cervical disc herniation. There is a deficiency. Therefore, in this study, investigators aim to evaluate and compare the effectiveness of three-week cervical stabilization exercises and cervical isometric exercises on neck pain, disability, strength, flexibility and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Herniation
Keywords
Cervical Disc Herniation, stabilization exercises, isometric exercises, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical Stabilization Exercise Group
Arm Type
Experimental
Arm Description
After applying traditional treatment for 40 minutes to the cases in Group A, additional segmental cervical stabilization exercises (20 minutes) will be applied.
Arm Title
Cervical Isometric Exercise Group
Arm Type
Other
Arm Description
After applying traditional treatment for 40 minutes to the cases in Group B, additional cervical isometric exercises (20 minutes) will be applied.
Intervention Type
Other
Intervention Name(s)
segmental cervical stabilization exercises
Other Intervention Name(s)
Traditional physiotherapy treatment (40 minutes)
Intervention Description
Segmental spine stabilization exercises were composed of axial extension, cervical extension exercises, cervico-scapulothoracic strengthening and cranio-cervical flexion exercises.
Intervention Type
Other
Intervention Name(s)
cervical isometric exercises
Other Intervention Name(s)
Traditional physiotherapy treatment (40 minutes)
Intervention Description
Cervical isometric exercises consist of 6 sets in a sitting position, each movement lasting 10 seconds, each repeated 5 times, with a 5-second rest in between.
Primary Outcome Measure Information:
Title
Visual analog Scale (VAS)
Description
A visual analog scale (VAS) will be used to evaluate the patient's pain intensity. Patients will be asked to describe their current pain by marking "no pain" and "worst possible pain" on a 100 mm horizontal line.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
The Neck Disability Index (NDI) is a 10-item questionnaire that measures self-reported disability related to neck pain. The NDI is the most widely used, translated, and oldest questionnaire for neck pain. It has been shown to have high "test-retest" reliability. The NDI has also been shown to be valid when compared to other measures of pain and disability.
Time Frame
3 weeks
Title
Universal Goniometer
Description
Cervical Joint range of motion will be measured using a Universal goniometer (UG). Universal goniometer is a reliable device to evaluate Cervical ROM (3). For measurement of cervical ROM, after the subjects are seated sideways on the physiotherapist, the pivot point will be placed on the lateral projection of the acromion, measurements will be made while the fixed arm of the goniometer is kept parallel to the ground and the movable arm of the goniometer follows the midline during movement.
Time Frame
3 weeks
Title
Manual Muscle testing
Description
Manual muscle testing (MMT) is scored using the 0-5 point Medical Research Council muscle strength rating scale and is a common method of assessing muscle strength in therapeutic trials. MMT is less time consuming and MMT's rating system is subjective.
Time Frame
3 weeks
Title
SF 12 (Short Form 12)
Description
SF-12, a measure of Health-Related Quality of Life, can be used in age, disease and treatment groups. It is a shortened version of the SF-36 and contains 12 questions, each with two to five answer options. The patient is told to choose the option that best suits him/her. The SF-12 covers eight dimensions: general health, physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. A physical and mental health score, each ranging from 0 to 100, can be calculated using scoring algorithms.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Cervical Disc Herniation Complaints started at least 3 months ago Patients with cervical disc herniation between the ages of 18-60; Has not received physical therapy or rehabilitation in the last 3 months; Not taking any medication such as analgesics, anti-inflammatory drugs or muscle relaxants to treat the symptoms. Exclusion Criteria: major psychiatric illness, Patients with cervical spine surgery and rheumatological diseases; pacemaker users; Those who are injected with local corticosteroids; pregnant woman; Cancer patients. Patients who refuse to participate in the study will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
osman coban, phd
Phone
05337242919
Email
oscoban28@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
nihal ozaras, professor
Phone
02166330633
Email
nihal.ozaras@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nihal Ozaras, Professor
Organizational Affiliation
Uskudar University, Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
NPIstanbul Brain Hospital
City
Istanbul
ZIP/Postal Code
34144
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nihal Ozaras, Professor
Phone
05386358998
Email
nihal.ozaras@uskudar.edu.tr
First Name & Middle Initial & Last Name & Degree
osman coban, PhD
Phone
05337242919
Email
oscoban@gmail.com
First Name & Middle Initial & Last Name & Degree
osman coban, phd
Facility Name
Uskudar University NPIstanbul Brain Hospital
City
Istanbul
ZIP/Postal Code
34144
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osman Coban, PhD
Phone
00905337242919
Email
oscoban@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After I complete my study I will decide to share.
Citations:
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34267943
Citation
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Results Reference
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The Effects of CSE and ISE on Pain, Strength, Flexibility, Disability and QoL in Patients With CDH

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