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

NCT06098365 | Completed

• 1 other identifier: UskudaruniversityU
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Disc Herniation

Keywords

Cervical Disc Herniation; stabilization exercises; isometric exercises; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Neck Disability Index (NDI)

  3 weeks

• Universal Goniometer

  3 weeks

• Manual Muscle testing

  3 weeks

• SF 12 (Short Form 12)

  3 weeks

Study Arms (2)

Cervical Stabilization Exercise Group

EXPERIMENTAL

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

Cervical Isometric Exercise Group

OTHER

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

Interventions

segmental cervical stabilization exercises OTHER

Segmental spine stabilization exercises were composed of axial extension, cervical extension exercises, cervico-scapulothoracic strengthening and cranio-cervical flexion exercises.

Also known as: Traditional physiotherapy treatment (40 minutes)

Cervical Stabilization Exercise Group

cervical isometric exercises OTHER

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.

Also known as: Traditional physiotherapy treatment (40 minutes)

Cervical Isometric Exercise Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (2)

NPIstanbul Brain Hospital

Istanbul, 34144, Turkey (Türkiye)

Location

Uskudar University NPIstanbul Brain Hospital

Istanbul, 34144, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 34267943 BACKGROUND

• 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.

  PMID: 24614255 BACKGROUND

• 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.

  PMID: 35060512 BACKGROUND

• 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.

  PMID: 8875719 BACKGROUND

• 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.

  PMID: 32147037 BACKGROUND

• 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.

  PMID: 26211422 BACKGROUND

• 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.

  PMID: 32520970 BACKGROUND

• 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.

  PMID: 19565156 BACKGROUND

• 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.

  PMID: 32731521 BACKGROUND

• 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.

  PMID: 37727425 BACKGROUND

• 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.

  PMID: 35710510 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nihal Ozaras, Professor

  Uskudar University, Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: December 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)