NCT06337916

Brief 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. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

November 7, 2022

Last Update Submit

March 30, 2024

Conditions

Keywords

Chronic Neck PainCervical Stabilization ExercisesCervical Proprioception

Outcome Measures

Primary Outcomes (1)

  • assessment of cervical joint position sense

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

    6 weeks

Secondary Outcomes (4)

  • assessment of cervical range of motion

    6 weeks

  • assessment of neck disability

    6 weeks

  • assessment of pain

    6 weeks

  • assessment of life quality

    6 weeks

Study Arms (2)

Cervical Stabilization Exercise Group

ACTIVE COMPARATOR

1. 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

Behavioral: Cervical Stabilization Exercise

Cervical Standard Exercise Group

ACTIVE COMPARATOR

1. 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

Behavioral: Cervical Standard Exercise Group

Interventions

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 Stabilization Exercise Group

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).

Cervical Standard Exercise Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, 67100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 7, 2022

First Posted

March 29, 2024

Study Start

October 7, 2022

Primary Completion

November 25, 2022

Study Completion

January 30, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations