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Neck PainNCT06337916

The Effect of Cervical Stabilization Exercises on the Cervical Proprioception in Patients With Chronic Neck Pain

A study testing Cervical Stabilization Exercise and Cervical Standard Exercise Group in people with Neck Pain and Chronic Neck Pain, run by Şenay Özdolap at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Neck Pain, Chronic Neck Pain
What is being tested?
Cervical Stabilization Exercise and Cervical Standard Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Oct 2022to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • The patients age is between the ages of 18-55
  • Being literate and with good cognitive function,
  • Having neck pain longer than 3 months
  • Not taking painkillers and nsaid in the last 1 week

Who cannot join

  • Cervical extruded or sequestered disc herniation, diagnosis of myelopathy
  • Having neck and shoulder surgery
  • Diagnosis of major trauma, infection, malignancy, inflammatory disease or peripheral nerve compression, spinal congenital anatomical deformity
  • Having severe cardiovascular disease, neurological or mental illness and inability to tolerate treatment
  • Kyphoscoliosis
  • Osteoporosis
Show all 13Show fewer
  • Stage 3-4 osteoarthritis
  • Diagnosis of diabetes mellitus, uncontrolled hypertension
  • Having a diagnosis of fibromyalgia
  • Spinal stenosis
  • Pregnancy
  • Receiving physical therapy in less than 3 months
  • Obesity (BMI>30)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Zonguldak Bülent Ecevit University

    Zonguldak, 67100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Cervical Stabilization Exercises on the Sense of Cervical Proprioception in Patients With Chronic Neck Pain

Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Neck pain is categorized by duration as acute, subacute and chronic neck pain (acute, <6 weeks; subacute, ≤3 months; chronic, >3 months). Chronic neck pain is more common in women and its incidence increases with age. Cervical disc herniation, cervical spondylosis, cervical stenosis, myofascial pain syndrome, cervical instability, whiplash injury, Klippel feil syndrome, thoracic outlet syndrome, cervical sprain, cervical strain, tumors, rheumatic diseases, torticollis, inflammatory neck pain are the main causes.

Anterior tilt of the head is a common posture in neck pain. In this posture, the upper cervical vertebrae are extension, the lower cervical vertebrae are flexion and the cervical lordosis is decreased. With neck pain, inhibition occurs in the deep neck flexor (longus coli and capitis) and extensor (multifidus, rotator, semispinalis) muscles, increased fat infiltration, deterioration in type 1 and 2 fiber ratios, and muscle atrophy. The risk of micro and macro trauma increases and muscle support decreases. Thus, there is an increase in the activation response and fatigue of the neck superficial muscle group (trapeze, scalene, sternocleidomastoid muscles), and a decrease in neck joint movement and proprioception sense. As a result, it was determined that there are deficiencies in the sense of proprioception in patients with neck pain.

Read more

Studies have shown that many receptors related to the sense of position are on deep cervical flexor muscles such as Musculus Longus Capitis and Musculus Longus Colli. In cases where there are changes such as atrophy and fat infiltration in these muscles, there is a decrease in proprioceptive sensation.Conservative treatment is the first choice in the treatment of neck pain. The important components of this treatment are stretching, strengthening, posture, stabilization, proprioception, relaxation, joint movement exercises and aerobic exercises. The purpose of stabilization exercises, which have been used in the treatment of chronic neck pain recently; to support the vertebral column by activating the stabilizing muscles and to improve posture by increasing kinesthetic awareness.

This study will examine the relationship between the sense of cervical proprioception and cervical stabilization exercises in patients with chronic neck pain.

In this study, between 15 June 2022 and 30 January 2023; 72 volunteers, aged between 18-55 years, with neck pain for more than 3 months, with good cognitive function, who applied to the our Physical Medicine and Rehabilitation Clinic will be included. The patients will be randomized to two groups as cervical stabilization exercise group and conventional cervical exercise treatment group. The patients in group 1 will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks, and the patients in group 2 will perform cervical stabilization exercises for 6 weeks, 3 days a week, 1 session a day. conventional cervical exercises will be given. Patients of both groups will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.

Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.

Demographic information (address, telephone, age, occupation, height, weight, marital status, etc.) of the patients to be included in the study will be recorded and general musculoskeletal examinations will be performed. The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form-36 (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM).

Being tested
Cervical Stabilization Exercise, Cervical Standard Exercise Group
Keywords
Chronic Neck Pain, Cervical Stabilization Exercises, Cervical Proprioception
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical Stabilization ExerciseBehavioural

    The cervical stabilization exercise group will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks. Patients will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information of the patients to be included in the study will be recorded . The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM).

  • Cervical Standard Exercise GroupBehavioural

    The patients in cervical standard exercise group will receive conventional cervical exercise for 6 weeks, 3 days a week, 1 session a day. Patients will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information of the patients to be included in the study will be recorded . The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM).

Study groups in NCT06337916
Study groupRoleWhat they receive
Cervical Stabilization Exercise GroupActive comparator1. The patients age is between the ages of 18-55 2. Being literate and with good cognitive function, 3. Having neck pain longer than 3 months 4. Not taking painkillers and nsaid in the last 1 week
Receives: Behavioral: Cervical Stabilization Exercise
Cervical Standard Exercise GroupActive comparator1. The patients age is between the ages of 18-55 2. Being literate and with good cognitive function, 3. Having neck pain longer than 3 months 4. Not taking painkillers and nsaid in the last 1 week
Receives: Behavioral: Cervical Standard Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assessment of cervical joint position sense

    Cervical joint position sense will be evaluated with the CROM (Cervical Range of Motion) Deluxe Device.

    Measured: 6 weeks

Secondary outcomes (4)
  1. assessment of cervical range of motion

    Cervical range of motion will be evaluated with the CROM (Cervical Range of Motion) Deluxe Device.

    Measured: 6 weeks

  2. assessment of neck disability

    The patients will be evaluate with the Neck Disability Index (NDI) for assessment of neck disability. The score ranges from 0 to 50. As the score increases, disability increases.

    Measured: 6 weeks

  3. assessment of pain

    The patients will be evaluate with the Visual Analogue Scale (VAS) for assessment of pain. They are numbered from 1 to 10. As the score increases, pain intensity increases.

    Measured: 6 weeks

  4. assessment of life quality

    The patients will be evaluate with the Short Form (SF-36) for life quality. The SF-36 consists of 36 items - that are grouped in 8 subscales or domains: Physical functioning (10 items); Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue (4 items); Emotional well-being (5 items); Social functioning (2 items); Pain (2 items); General health (5 items). Scoring is between 0-100, higher scores indicate good health status.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2024
  2. Study start7 Oct 2022
  3. Primary completion25 Nov 2022
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06337916
Sponsor's protocol ID
2021/16-01
Status last verified
Mar 2024
First submitted
7 Nov 2022
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cervical Stabilization Exercise and Cervical Standard Exercise Group in people with Neck Pain and Chronic Neck Pain, run by Şenay Özdolap at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assessment of cervical joint position sense (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

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