Comparison of the Effectiveness of Different Exercise Types in Individuals with Chronic Neck Pain

NCT ID: NCT06697457

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2025-02-28

Brief Summary

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The aim of this study is to compare the effectiveness of craniocervical flexion, static and dynamic isometric exercise training applied with a conventional physiotherapy program in individuals with chronic neck pain.

Detailed Description

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Neck pain is a significant musculoskeletal problem that is frequently encountered in society. Pain that cannot be diagnosed with a specific pathology is called "nonspecific" and pain that continues for more than three months is called "chronic pain". Chronic nonspecific neck pain has negative effects on function and quality of life. The importance of the exercise approach in the treatment of neck pain is quite great. Craniocervical flexion and static isometric exercises are frequently used in individuals with chronic neck pain. However, there are very few studies that include dynamic isometric exercises. The aim of this study is to compare the effectiveness of craniocervical flexion, static and dynamic isometric exercise training applied with a conventional physiotherapy program in individuals with chronic neck pain. The intervention groups of the study are deep cervical flexion exercise training, dynamic isometric exercise training and static isometric exercise training and electrotherapy group. The craniocervical flexion exercise training group will receive deep cervical flexor muscle training with Pressure Biofeedback, the dynamic isometric exercise group will receive exercise training with Thera-band, and the static isometric exercise group will receive neck isometric exercises. The electrotherapy group will receive hotpack, tens, and ultrasound applications. At the beginning and end of the study, pain, disability, posture, muscle strength, endurance, range of motion, and body awareness will be assessed in all individuals.TENS (Transcutaneous Electrical Nerve Stimulation) will be applied to all groups for 20 minutes with a TENS device at a strength of 10-30 mA and a frequency of 80 Hz. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that they are not disturbed by a numbness sensation. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.

Conditions

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Chronic Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Four groups, parallel, randomized controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Assessors and patients were not informed about group allocation

Study Groups

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Conventional Treatment

Conventional treatment will include electrotherapy agents (TENS, ultrasound and hotpack) and chin tuck posture exercises.

Group Type ACTIVE_COMPARATOR

Conventional Treatment Group

Intervention Type OTHER

TENS will be applied with a TENS device at an intensity of 10-30 mA and a frequency of 80 Hz for 20 minutes. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that the patient is not disturbed by a numb feeling. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.Treatments will be performed 3 days a week for 8 weeks.

Craniocervical Flexion Exercise Training

Patients will receive exercise in addition to conventional treatment. The exercises will be performed with an air-filled pressure stabilizer placed in the sub-occipital region.

Group Type ACTIVE_COMPARATOR

Craniocervical Flexion Exercise Group

Intervention Type OTHER

The patient will first be taught to contract the deep cervical flexors. Patients will be placed in a supine position (without a pillow) to ensure a neutral neck position. Patients will be asked to perform slow, controlled head and upper cervical flexion by bringing the chin closer to the chest ("yes" movement). The stabilizer will be inflated to 20 mmHg. Gradual training will be given to increase the pressure value by 2 mmHg between 20 and 30 mmHg. Each pressure value (22, 24, 26, 28 mmHg) will be held for 10 seconds and repeated 10 times. The exercise will be performed with 10 repetitions, 10 seconds of contraction and 5 seconds of relaxation. Exercise training will begin with 20 mmHg and once the patient can hold it for 10 seconds with 10 repetitions, the next level on the pressure stabilizer will be moved on.Treatments will be performed 3 days a week for 8 weeks.

Conventional Treatment Group

Intervention Type OTHER

TENS will be applied with a TENS device at an intensity of 10-30 mA and a frequency of 80 Hz for 20 minutes. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that the patient is not disturbed by a numb feeling. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.Treatments will be performed 3 days a week for 8 weeks.

Dynamic Isometric Exercise Training

Patients will receive exercise in addition to conventional treatment. The exercises will be performed by the patient with an elastic band.

Group Type ACTIVE_COMPARATOR

Conventional Treatment Group

Intervention Type OTHER

TENS will be applied with a TENS device at an intensity of 10-30 mA and a frequency of 80 Hz for 20 minutes. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that the patient is not disturbed by a numb feeling. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.Treatments will be performed 3 days a week for 8 weeks.

Dynamic Isometric Exercise Group

Intervention Type OTHER

The exercises will be performed by the patient with an elastic band. The progression of the exercises will be performed using different colors of Thera-bands with different resistances. It will start with the red Thera-band with the lowest resistance and then move on to the green and then blue Thera-bands with increasing resistance. Cervical isometric exercises will be performed with elastic resistance bands, maintaining the chin tuck position, forward, backward, crosswise, right and left. There will be 10 repetitions for 10 seconds for each. Progression in Therabands will be according to the patient. When the patient does 10 repetitions for 10 seconds, the next Theraband will be used.Treatments will be performed 3 days a week for 8 weeks.

Static Isometric Exercise Training

Patients will receive exercise in addition to conventional treatment. The patient will perform isometric exercises with maximal effort against neck flexion, extension, lateral flexion and rotation with his/her hand in a sitting position.

Group Type ACTIVE_COMPARATOR

Conventional Treatment Group

Intervention Type OTHER

TENS will be applied with a TENS device at an intensity of 10-30 mA and a frequency of 80 Hz for 20 minutes. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that the patient is not disturbed by a numb feeling. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.Treatments will be performed 3 days a week for 8 weeks.

Static Isometric Exercise Group

Intervention Type OTHER

The patient will perform isometric exercises with maximal effort against neck flexion, extension, lateral flexion and rotation with his/her hand in a sitting position. Each exercise will be performed for 10 seconds, with 15-second breaks in between, for 10 repetitions. Each patient will start with submaximal resistance to help them adapt to isometric exercises, and then progress will be checked until the patient reaches the maximum resistance that can be tolerated by each session. It will consist of cervical flexion, cervical extension, right lateral flexion, left lateral flexion, right rotation, left rotation exercises. Progress in the exercises will be according to the Rating of Perceived Exertion Borg (RPE) Scale according to the weeks.Treatments will be performed 3 days a week for 8 weeks.

Interventions

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Craniocervical Flexion Exercise Group

The patient will first be taught to contract the deep cervical flexors. Patients will be placed in a supine position (without a pillow) to ensure a neutral neck position. Patients will be asked to perform slow, controlled head and upper cervical flexion by bringing the chin closer to the chest ("yes" movement). The stabilizer will be inflated to 20 mmHg. Gradual training will be given to increase the pressure value by 2 mmHg between 20 and 30 mmHg. Each pressure value (22, 24, 26, 28 mmHg) will be held for 10 seconds and repeated 10 times. The exercise will be performed with 10 repetitions, 10 seconds of contraction and 5 seconds of relaxation. Exercise training will begin with 20 mmHg and once the patient can hold it for 10 seconds with 10 repetitions, the next level on the pressure stabilizer will be moved on.Treatments will be performed 3 days a week for 8 weeks.

Intervention Type OTHER

Conventional Treatment Group

TENS will be applied with a TENS device at an intensity of 10-30 mA and a frequency of 80 Hz for 20 minutes. A pair of surface electrodes will be placed on the painful area of the neck. The intensity of TENS will be adjusted according to the patient's sensory thresholds so that the patient is not disturbed by a numb feeling. After TENS, continuous ultrasound will be applied to the cervical region to produce thermal effects. The intensity will be 1.5 W/cm² and the duration will be 5 minutes. Hotpack will be applied to the trapezius muscle for 10 minutes. Chin tuck exercise will be applied to the cervical region.Treatments will be performed 3 days a week for 8 weeks.

Intervention Type OTHER

Dynamic Isometric Exercise Group

The exercises will be performed by the patient with an elastic band. The progression of the exercises will be performed using different colors of Thera-bands with different resistances. It will start with the red Thera-band with the lowest resistance and then move on to the green and then blue Thera-bands with increasing resistance. Cervical isometric exercises will be performed with elastic resistance bands, maintaining the chin tuck position, forward, backward, crosswise, right and left. There will be 10 repetitions for 10 seconds for each. Progression in Therabands will be according to the patient. When the patient does 10 repetitions for 10 seconds, the next Theraband will be used.Treatments will be performed 3 days a week for 8 weeks.

Intervention Type OTHER

Static Isometric Exercise Group

The patient will perform isometric exercises with maximal effort against neck flexion, extension, lateral flexion and rotation with his/her hand in a sitting position. Each exercise will be performed for 10 seconds, with 15-second breaks in between, for 10 repetitions. Each patient will start with submaximal resistance to help them adapt to isometric exercises, and then progress will be checked until the patient reaches the maximum resistance that can be tolerated by each session. It will consist of cervical flexion, cervical extension, right lateral flexion, left lateral flexion, right rotation, left rotation exercises. Progress in the exercises will be according to the Rating of Perceived Exertion Borg (RPE) Scale according to the weeks.Treatments will be performed 3 days a week for 8 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being between the ages of 18 and 55,
* Scoring 15/50 or less on the Neck Disability Index,
* Having a history of chronic neck pain for at least 3 months,
* Having a pain level of 5/10 or more,
* Showing signs of cervical movement control dysfunction,
* Having cervical muscle tenderness during physical examination.

Exclusion Criteria

* Being diagnosed with a vascular disease,
* Being diagnosed with a vestibular disease,
* Being diagnosed with hypertension,
* Being diagnosed with fibromyalgia or rheumatoid arthritis,
* Having had spine surgery in the last 12 months,
* Having received an exercise program or standard physiotherapy program involving the cervical region in the last 12 months,
* Having congenital or acquired kyphosis, scoliosis, etc. having postural deformity,
* Having specific neck pain such as cancer,
* Having fractures, instability, inflammatory diseases, history of neck trauma, infections, neurological deficit, having spinal diseases such as radiculopathy, spondylosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Ayşen Canan

Physiotherapist Ayşen Canan Pakeloğlu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mugla Education and Research Hospital

Muğla, Menteşe, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşen Canan Pakeloğlu, Physiotherapist

Role: CONTACT

+905059102642

Facility Contacts

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Ayşen Canan Pakeloğlu, Physiotherapist

Role: primary

+905059102642

Ayşen Canan Pakeloğlu, Physiotherapist

Role: backup

Other Identifiers

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MSKU-FTR-ACP-01

Identifier Type: -

Identifier Source: org_study_id

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