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

April 22, 2024 updated by: osman coban, Uskudar University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34144
        • NPIstanbul Brain Hospital
      • Istanbul, Turkey, 34144
        • Uskudar University NPIstanbul Brain Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosed with Cervical Disc Herniation
  2. Complaints started at least 3 months ago
  3. Patients with cervical disc herniation between the ages of 18-60;
  4. Has not received physical therapy or rehabilitation in the last 3 months;
  5. Not taking any medication such as analgesics, anti-inflammatory drugs or muscle relaxants to treat the symptoms.

Exclusion Criteria:

  1. major psychiatric illness,
  2. Patients with cervical spine surgery and rheumatological diseases;
  3. pacemaker users;
  4. Those who are injected with local corticosteroids;
  5. pregnant woman; Cancer patients.
  6. Patients who refuse to participate in the study will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervical Stabilization Exercise Group
After applying traditional treatment for 40 minutes to the cases in Group A, additional segmental cervical stabilization exercises (20 minutes) will be applied.
Other: segmental cervical stabilization exercises
Segmental spine stabilization exercises were composed of axial extension, cervical extension exercises, cervico-scapulothoracic strengthening and cranio-cervical flexion exercises.
Other Names:
  • Traditional physiotherapy treatment (40 minutes)
Other: Cervical Isometric Exercise Group
After applying traditional treatment for 40 minutes to the cases in Group B, additional cervical isometric exercises (20 minutes) will be applied.
Other: cervical isometric exercises
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.
Other Names:
  • Traditional physiotherapy treatment (40 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog Scale (VAS)
Time Frame: 3 weeks
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index (NDI)
Time Frame: 3 weeks
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.
3 weeks
Universal Goniometer
Time Frame: 3 weeks
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.
3 weeks
Manual Muscle testing
Time Frame: 3 weeks
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.
3 weeks
SF 12 (Short Form 12)
Time Frame: 3 weeks
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.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Study Chair: Nihal Ozaras, Professor, Uskudar University, Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UskudaruniversityU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After I complete my study I will decide to share.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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