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

Cervical Disc Herniation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098365
• Other study ID #: UskudaruniversityU
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Hernia
• Intervertebral Disc Displacement

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	NPIstanbul Brain Hospital	Istanbul
Turkey	Uskudar University NPIstanbul Brain Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

Avaghade RR, Shinde SB, Dhane SB. Effectiveness of McKenzie approach and segmental spinal stabilization exercises on neck pain in individuals with cervical postural syndrome: An experimental study. J Educ Health Promot. 2023 Jul 29;12:225. doi: 10.4103/jehp.jehp_239_23. eCollection 2023. — View Citation

Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15. — View Citation

Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392. — View Citation

Kuo YL, Lee TH, Tsai YJ. Evaluation of a Cervical Stabilization Exercise Program for Pain, Disability, and Physical Impairments in University Violinists with Nonspecific Neck Pain. Int J Environ Res Public Health. 2020 Jul 28;17(15):5430. doi: 10.3390/ijerph17155430. — View Citation

Price J, Rushton A, Tyros I, Tyros V, Heneghan NR. Effectiveness and optimal dosage of exercise training for chronic non-specific neck pain: A systematic review with a narrative synthesis. PLoS One. 2020 Jun 10;15(6):e0234511. doi: 10.1371/journal.pone.0234511. eCollection 2020. — View Citation

Saal JS, Saal JA, Yurth EF. Nonoperative management of herniated cervical intervertebral disc with radiculopathy. Spine (Phila Pa 1976). 1996 Aug 15;21(16):1877-83. doi: 10.1097/00007632-199608150-00008. — View Citation

Sadeghi A, Rostami M, Ameri S, Karimi Moghaddam A, Karimi Moghaddam Z, Zeraatchi A. Effectiveness of isometric exercises on disability and pain of cervical spondylosis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Jun 16;14(1):108. doi: 10.1186/s13102-022-00500-7. — View Citation

Wong JJ, Cote P, Quesnele JJ, Stern PJ, Mior SA. The course and prognostic factors of symptomatic cervical disc herniation with radiculopathy: a systematic review of the literature. Spine J. 2014 Aug 1;14(8):1781-9. doi: 10.1016/j.spinee.2014.02.032. Epub 2014 Mar 12. — View Citation

Xu Q, Tian X, Bao X, Liu D, Zeng F, Sun Q. Nonsurgical spinal decompression system traction combined with electroacupuncture in the treatment of multi-segmental cervical disc herniation: A case report. Medicine (Baltimore). 2022 Jan 21;101(3):e28540. doi: 10.1097/MD.0000000000028540. — View Citation

Yilmaz M, Tarakci D, Tarakci E. Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation on cervical pain associated with cervical disc herniation: A randomized trial. Complement Ther Med. 2020 Mar;49:102295. doi: 10.1016/j.ctim.2019.102295. Epub 2020 Jan 3. — View Citation

Yoon WW, Koch J. Herniated discs: when is surgery necessary? EFORT Open Rev. 2021 Jun 28;6(6):526-530. doi: 10.1302/2058-5241.6.210020. eCollection 2021 Jun. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks
Secondary	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.	3 weeks
Secondary	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.	3 weeks
Secondary	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.	3 weeks
Secondary	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.	3 weeks