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

Not Applicable

Completed

• Conditions: Cervical Disc Herniation
• Interventions: Other: segmental cervical stabilization exercises; Other: cervical isometric exercises

• Registration Number: NCT06098365
• Lead Sponsor: Uskudar University

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.

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Study Start: 2023-12-01
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical Stabilization Exercise Group	segmental cervical stabilization exercises	After applying traditional treatment for 40 minutes to the cases in Group A, additional segmental cervical stabilization exercises (20 minutes) will be applied.
Cervical Isometric Exercise Group	cervical isometric exercises	After applying traditional treatment for 40 minutes to the cases in Group B, additional cervical isometric exercises (20 minutes) will be applied.

Primary Outcome Measures

Name	Time	Method
Visual analog Scale (VAS)	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.

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI)	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.
SF 12 (Short Form 12)	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.
Manual Muscle testing	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.
Universal Goniometer	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.

Trial Locations

Locations (2)

NPIstanbul Brain Hospital; 🇹🇷 Istanbul, Turkey

Uskudar University NPIstanbul Brain Hospital; 🇹🇷 Istanbul, Turkey