Clinical trial NCT06098365: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Herniation
Keywords: Cervical Disc Herniation
stabilization exercises
isometric exercises
pain
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analog Scale (VAS)
timeFrame: 3 weeks
Secondary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 3 weeks
measure: Universal Goniometer
timeFrame: 3 weeks
measure: Manual Muscle testing
timeFrame: 3 weeks
measure: SF 12 (Short Form 12)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: NPIstanbul Brain Hospital
city: Istanbul
country: Turkey
facility: Uskudar University NPIstanbul Brain Hospital
Study officials:
affiliation: Uskudar University, Faculty of Medicine
name: Nihal Ozaras, Professor
role: STUDY_CHAIR
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