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

November 18, 2024 updated by: Ayşen Canan, Muğla Sıtkı Koçman University

Comparison of the Effectiveness of Dynamic Isometric, Static Isometric and Craniocervical Flexor Exercise Training in Individuals with Chronic Neck Pain

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Menteşe
      • Mugla, Menteşe, Turkey, 48000
        • Recruiting
        • Mugla Education and Research Hospital
        • Contact:
        • Contact:
          • Ayşen Canan Pakeloğlu, Physiotherapist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional Treatment
Conventional treatment will include electrotherapy agents (TENS, ultrasound and hotpack) and chin tuck posture exercises.
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.
Active Comparator: 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.
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.
Other: 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.
Active Comparator: 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.
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.
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.
Active Comparator: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Assesment
Time Frame: 8 week
The assessment will be made with Visual Analogue Scale (VAS) and algometer. VAS is considered both valid and reliable in measuring the pain intensity of patients. Each participant will be asked to indicate the intensity of pain they have experienced in the previous 24 hours. This will be done by marking on a 10 cm line where "0" is "No Pain" and "10" is "Maximum Pain".
8 week
Pain Assesment
Time Frame: 8 week
An algometer with a 1 cm2 rounded surface area will be used for objective pain assessment. Measurements will be made on the spinous processes of C2 and c5 and the trapezius muscle. The assessor will gradually increase the pressure until pain or discomfort occurs and the patient says "yes". The average of the three measurements will be taken. A 30-second rest period will be given between each measurement.
8 week
Disability Assesment
Time Frame: 8 week

Neck Disability Index, designed to assess how neck pain affects daily living activities, will be used. The questionnaire includes 10 items that measure disability secondary to neck pain. Scores range from 0-50 and are interpreted as follows:

  • 0-4 represents no disability,
  • 5-14 represents mild disability,
  • 15-24 represents moderate disability,
  • 25-33 represents severe disability,
  • 34 and above represents complete disability.
8 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cervical Joint Range of Motion Assessment
Time Frame: 8 week
Goniometer will be used for active ROM (flexion, extension, left/right rotation, left/right lateral flexion) measurements. Maximum ROM will be measured in degrees for each test. Participants will be asked to sit against the back of the chair, look forward, and position their arms in a relaxed manner.
8 week
Cervical Postur Assesment
Time Frame: 8 week
Tragus Wall Distance Measurement will be performed with 2-3 practical trials to ensure that the participant has taken the correct posture. After the posture is appropriate, the tragus wall distance will be measured with a millimeter ruler while the participants stand naturally and perform cervical retraction
8 week
Cervical Postur Assesment
Time Frame: 8 week
The craniovertebral angle will be measured for forward head posture in the sagittal plane. The craniovertebral angle will be measured with the photograph method. The camera is fixed 1.5 meters away on a flat surface aligned with the humeral head of the participants. The participants are asked to perform head flexion-extension movements to find the neutral head position and the participants are told to stay in the most appropriate position. A cursor is placed on the c7 spinous process and tragus in the photograph. The participants' photographs are taken 3 times. Craniovertebral angle is measured with the photographs taken and noted in degrees. The angles are averaged. Image processing will be done with Image J software
8 week
Cervical Strength Assessment
Time Frame: 8 week
Hand Held dynamometer will be used for strength assessment. It will include 3 isometric contractions held for 3 seconds for flexion, extension, lateral flexion and rotation movements. The value greater than the maximal contractions will be recorded.
8 week
Cervical Endurance Assessment
Time Frame: 8 week
In the Craniocervical Flexion Test, participants will be in a supine position and the compressed air unit will be placed behind the cervical spine, just below the occiput. It will be inflated to 20 mmHg initially and participants will be instructed to perform the craniocervical flexion movement. Thus, the pressure will increase to 22 mmHg and they will be asked to maintain this position for 10 seconds. Then, a 30-second rest period will be given and the entire procedure will be repeated for 24, 26, 28 and 30 mmHg. The final reading will be taken when the participant cannot hold the specific pressure for 10 seconds. Before the test, participants will be given enough time to practice.
8 week
Cervical Endurance Assesment
Time Frame: 8 week
Cervical Flexion Endurance Test: Participants will be asked to lie in a crook-lying position. The physiotherapist will place their hand under the patient's head. They will be asked to lift their head approximately 2.5 cm off the bed and maintain this position for as long as possible. The test will end when the patient feels any pain or fatigue or when their head touches the therapist's hand. Endurance time was measured in seconds. The test will be performed twice with 3 minutes of rest between repetitions.
8 week
Cervical Endurance Assessment
Time Frame: 8 week
Cervical Extensor Endurance Test: For the test, patients will be asked to lie in a prone position with their head and upper body positioned on the edge of the bed and their arms next to their body. A 2 kg sandbag will be placed on the patient's cervical region. They will then be asked to lift their head to a neutral position and maintain this position. The test will end when the patient feels any pain or fatigue or when there is a 5° deterioration in head position (measured with an inclinometer). The test will be repeated twice with a 3-minute rest interval and the longest holding time in seconds will be recorded as the test result.
8 week
Neck Awareness Assesment
Time Frame: 8 week
It will be evaluated with the Fremantle Neck Awareness Questionnaire. It is a simple Likert-type questionnaire (0=Never/Never feel like this, 1= Rarely feel like this, 2= Sometimes or some of the time feel like this, 3= Often feel like this, 4= Always or most of the time feel like this) that evaluates the individual's altered perception. The questionnaire asks individuals 9 questions such as how they perceive their neck in relation to their body.
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muğla Sıtkı Koçman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MSKU-FTR-ACP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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