Neck PainNCT04729881
Effects of Exercise and Electrotherapy in Individuals With Chronic Neck Pain
A study testing Conventional Rehabiliation Group and Spesific Exercise Group in people with Neck Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
In the treatment of neck pain, physiotherapy modalities such as ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), hot packs and personalized exercise approaches are frequently used. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Conventional Rehabiliation Group and Spesific Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2021to 1 Apr 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scoring over 4 points in the neck disability questionnaire,
- Having neck pain for at least 3 months,
- Agreeing to participate in the study voluntarily,
- 66 individuals between the ages of 18-65 will be included in the study.
Who cannot join
- Undergoing surgery in the cervical region,
- Having a history of acute trauma in the cervical region,
- Cervical vertebrae infection,
- Having a history of malignancy,
- Have inflammatory arthritis,
- Fracture, dislocation, tumor, infection,
Show all 11Show fewer
- Who are pregnant,
- Receiving physical therapy within the last 1 year,
- With neurological deficits,
- Having a cardiac pacemaker,
- Patients with severe degeneration on magnetic resonance imaging will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medamerikan medical center
Istanbul, Kadıköy, 34724
İoana Tomi Yılmaz, Physician, 05334250262 ext. 30513, itomiyilmaz@medamerikan.com
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise on Pain, Functionality, Kinesophobia and Walking Speed in Individuals With Chronic Neck Pain
In the treatment of neck pain, physiotherapy modalities such as ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), hot packs and personalized exercise approaches are frequently used. In this planned study, the effects of TENS, ultrasound and a program of stretching, posture and strengthening exercises on pain intensity, functionality, fear of movement and single-task and double-task walking speed in individuals with chronic neck pain will be investigated.
Participants will be evaluated initially and after four weeks.66 participants, who will be included in the study with more than 4 points from the neck disability questionnaire, will be randomly divided into 3 groups with 22 people in each group, regardless of the pain severity.Aches; With Visual Analogue Scale (VAS), their functionality; Kinesiophobia with Neck Disability Index; Single-task dual-task walking speeds with the Tampa Kinesiophobia Scale (TSK); It will be evaluated by the 10 Meter Walk Test.
Read the detailed description
Among the musculoskeletal complaints of the spine, chronic neck pain (CKP), which is the second most common after low back pain, is seen in the society at a rate of 22-31%, and as it becomes chronic, it leads to an increase in doctor visits. KBA, which often originates from the spine and its surrounding soft tissues, can also be reflected from extravertebral tissues. Common clinical problems that cause neck pain include pathologies such as discopathies of cervical origin, spondylosis, stenosis, myofascial pain syndrome, and mechanical trauma caused by factors such as overuse and improper posture.It is known that being physically inactive in musculoskeletal system pain causes the pain to become chronic. However, CBA may prefer to remain physically inactive due to pain avoidance behaviors in individuals. Kinesiophobia, known as movement aversion; It is defined as "excessive avoidance of movement due to pain, re-injury and sensitivity". In addition to pain and impairment in functionality, CBA can lead to movement avoidance behaviors, many neuromuscular system and biomechanical disorders in individuals.In the studies in the literature, there are no studies that determine the effectiveness of the treatment approaches applied in individuals with CBA on functional status and pain, as well as movement avoidance and double-duty walking, which are effective in daily life. In this context, the aim of the study is to reveal the effectiveness of neck-specific exercises consisting of TENS, US and stretching-posture-strengthening exercises on pain intensity, functionality, kinesophobia and double and single task walking speed in individuals with CBA.
- Conditions
- Neck Pain
- Being tested
- Conventional Rehabiliation Group, Spesific Exercise Group, Control group
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Rehabiliation GroupOther
Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise
Spesific Exercise GroupOther
Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise
Control groupOther
No intervention will be aplied
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabiliation Group | Experimental | Participants 5 days a week for 4 weeks; TENS, US and neck specific exercise program will be applied.
Conventional TENS will be applied to the participants with the CefarCompex rehab400 (New Chattanooga Compex Rehab, USA) muscle rehabilitation device. It will be applied with electrodes coated with a special adhesive material for each participant for 20 minutes at a frequency of 60-120 Hz. In the study; 4 channels and 8 electrodes will be used. Electrodes will be placed paravertebrally in the cervicothoracic space, covering the painful area. The dose of the current will be increased as the patients become accustomed to the current intensity.
Continuous Ultrasound will be applied to the participants due to chronic neck pain. It will be applied at a frequency of 1MHz and a dose of 1.5 W / cm2 for 5 minutes. Receives: Other: Conventional Rehabiliation Group |
| Spesific Exercise Group | Active comparator | Participants will be given a home exercise program consisting of exercises specifically applied to the neck. Participants will be asked to practice the exercises 5 days a week. The application status of the participants' home exercise program will be followed by the researcher over the phone. Participants who do not practice the home exercise program will be excluded from the study. The exercise program to be applied to the participants in the exercise group is listed below.Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise. Receives: Other: Spesific Exercise Group |
| Control Group | Other | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The scale used to determine the severity of pain is 100mm long, and its two ends are named differently on the vertical or horizontal line. The patient will be asked to mark a point on this line corresponding to the intensity of pain he / she feels.The distance between the marked point and the lowest end of the line (0 = no pain) will be measured in millimeters and the numerical value found will be recorded.
Measured: Change between baseline and 4 weeks
Neck Disability Index
The Neck Disability Index scale, developed by Dr. Howard Vernon in 1980, was validated and reliable in 2012 by Kesiktaş et al. The scale evaluating the effects of neck pain on individuals' daily life activities consists of 10 titles: pain intensity, personal care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study will be asked to score between 0 (no disability) and 5 (complete disability) for each title. The total score ranges from 0 (no disability) to 50 (complete disability). There is no 0-4 limitation in scoring the scale; 5-14: mild disability; 15-24: moderate disability; 25-34: Severe Disability; 35 and above are considered as Totally Disability.
Measured: Change between baseline and 4 weeks
Tampa Kinesiophobia Scale
Developed to measure the fear of motion / re-injury, this scale includes the injury / re-injury and fear-avoidance parameters in work-related activities. 4-point Likert scoring (1 = Strongly disagree, 4 = Strongly agree) is used on the scale consisting of 17 questions. The Turkish validity and reliability of the scale has been proven. The person gets a total score between 17-68. The high score the person gets on the scale indicates that her kinesiophobia is also high.
Measured: Change between baseline and 4 weeks
10 Meter Walk Test
It will be used to evaluate participants' single-task and double-task walking speed (Wa
. The only task is to assess walking speed. In the ten-meter walking test, the person will be asked to walk at his / her own normal pace without speaking anything in the previously measured ten-meter field. The time will be started when the person's foot is on the starting line and will be terminated when they cross the finish line. Measurements will be recorded with the stopwatch in meters / second. To assess dual-task walking speeds; individuals will be asked to walk 2 counts from 100 during spontaneous walking of 10 meters and the measurements will be recorded in meters / second with a stopwatch.
Measured: Change between baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start11 Feb 2021
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The individuals are randomly allocated into control, intervention and specific exercise groups.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Yıldız, Bahçeşehir University
- Investigators
- Leyla Ataş Balcı, Assist.Prof, Study director, Bahceşehir Unıversıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729881
- Sponsor's protocol ID
- 199400
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise on Pain, Functionality, Kinesophobia and Walking Speed in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04729881
- Acronym / sponsor ID
- 199400
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the treatment of neck pain, physiotherapy modalities such as ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), hot packs and personalized exercise approaches are frequently used. In this planned study, the effects of TENS, ultrasound and a program of stretching, posture and strengthening exercises on pain intensity, functionality, fear of movement and single-task and double-task walking speed in individuals with chronic neck pain will be investigated.
Participants will be evaluated initially and after four weeks.66 participants, who will be included in the study with more than 4 points from the neck disability questionnaire, will be randomly divided into 3 groups with 22 people in each group, regardless of the pain severity.Aches; With Visual Analogue Scale (VAS), their functionality; Kinesiophobia with Neck Disability Index; Single-task dual-task walking speeds with the Tampa Kinesiophobia Scale (TSK); It will be evaluated by the 10 Meter Walk Test.
Detailed description
Among the musculoskeletal complaints of the spine, chronic neck pain (CKP), which is the second most common after low back pain, is seen in the society at a rate of 22-31%, and as it becomes chronic, it leads to an increase in doctor visits. KBA, which often originates from the spine and its surrounding soft tissues, can also be reflected from extravertebral tissues. Common clinical problems that cause neck pain include pathologies such as discopathies of cervical origin, spondylosis, stenosis, myofascial pain syndrome, and mechanical trauma caused by factors such as overuse and improper posture.It is known that being physically inactive in musculoskeletal system pain causes the pain to become chronic. However, CBA may prefer to remain physically inactive due to pain avoidance behaviors in individuals. Kinesiophobia, known as movement aversion; It is defined as "excessive avoidance of movement due to pain, re-injury and sensitivity". In addition to pain and impairment in functionality, CBA can lead to movement avoidance behaviors, many neuromuscular system and biomechanical disorders in individuals.In the studies in the literature, there are no studies that determine the effectiveness of the treatment approaches applied in individuals with CBA on functional status and pain, as well as movement avoidance and double-duty walking, which are effective in daily life. In this context, the aim of the study is to reveal the effectiveness of neck-specific exercises consisting of TENS, US and stretching-posture-strengthening exercises on pain intensity, functionality, kinesophobia and double and single task walking speed in individuals with CBA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The individuals are randomly allocated into control, intervention and specific exercise groups.
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabiliation Group | Experimental | Other: Conventional Rehabiliation GroupParticipants 5 days a week for 4 weeks; TENS, US and neck specific exercise program will be applied. Conventional TENS will be applied to the participants with the CefarCompex rehab400 (New Chattanooga Compex Rehab, USA) muscle rehabilitation device. It will be applied with electrodes coated with a special adhesive material for each participant for 20 minutes at a frequency of 60-120 Hz. In the study; 4 channels and 8 electrodes will be used. Electrodes will be placed paravertebrally in the cervicothoracic space, covering the painful area. The dose of the current will be increased as the patients become accustomed to the current intensity. Continuous Ultrasound will be applied to the participants due to chronic neck pain. It will be applied at a frequency of 1MHz and a dose of 1.5 W / cm2 for 5 minutes. |
| Spesific Exercise Group | Active comparator | Other: Spesific Exercise GroupParticipants will be given a home exercise program consisting of exercises specifically applied to the neck. Participants will be asked to practice the exercises 5 days a week. The application status of the participants' home exercise program will be followed by the researcher over the phone. Participants who do not practice the home exercise program will be excluded from the study. The exercise program to be applied to the participants in the exercise group is listed below.Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise. |
| Control Group | Other | Other: Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scoring over 4 points in the neck disability questionnaire,
- Having neck pain for at least 3 months,
- Agreeing to participate in the study voluntarily,
- 66 individuals between the ages of 18-65 will be included in the study.
Key exclusion criteria (11 listed)
- Undergoing surgery in the cervical region,
- Having a history of acute trauma in the cervical region,
- Cervical vertebrae infection,
- Having a history of malignancy,
- Have inflammatory arthritis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Rehabiliation GroupTranscutaneous Electrical Nerve Stimulation, Ultrasound and Exercise | Other | Conventional Rehabiliation Group |
| Spesific Exercise GroupCervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise | Other | Spesific Exercise Group |
| Control groupNo intervention will be aplied | Other | Control Group |
Primary outcome
Visual Analogue Scale
Time frame: Change between baseline and 4 weeks
The scale used to determine the severity of pain is 100mm long, and its two ends are named differently on the vertical or horizontal line. The patient will be asked to mark a point on this line corresponding to the intensity of pain he / she feels.The distance between the marked point and the lowest end of the line (0 = no pain) will be measured in millimeters and the numerical value found will be recorded.
Neck Disability Index
Time frame: Change between baseline and 4 weeks
The Neck Disability Index scale, developed by Dr. Howard Vernon in 1980, was validated and reliable in 2012 by Kesiktaş et al. The scale evaluating the effects of neck pain on individuals' daily life activities consists of 10 titles: pain intensity, personal care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study will be asked to score between 0 (no disability) and 5 (complete disability) for each title. The total score ranges from 0 (no disability) to 50 (complete disability). There is no 0-4 limitation in scoring the scale; 5-14: mild disability; 15-24: moderate disability; 25-34: Severe Disability; 35 and above are considered as Totally Disability.
Tampa Kinesiophobia Scale
Time frame: Change between baseline and 4 weeks
Developed to measure the fear of motion / re-injury, this scale includes the injury / re-injury and fear-avoidance parameters in work-related activities. 4-point Likert scoring (1 = Strongly disagree, 4 = Strongly agree) is used on the scale consisting of 17 questions. The Turkish validity and reliability of the scale has been proven. The person gets a total score between 17-68. The high score the person gets on the scale indicates that her kinesiophobia is also high.
10 Meter Walk Test
Time frame: Change between baseline and 4 weeks
It will be used to evaluate participants' single-task and double-task walking speed (Wa . The only task is to assess walking speed. In the ten-meter walking test, the person will be asked to walk at his / her own normal pace without speaking anything in the previously measured ten-meter field. The time will be started when the person's foot is on the starting line and will be terminated when they cross the finish line. Measurements will be recorded with the stopwatch in meters / second. To assess dual-task walking speeds; individuals will be asked to walk 2 counts from 100 during spontaneous walking of 10 meters and the measurements will be recorded in meters / second with a stopwatch.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyla Ataş Balcı, Assist.Prof study director
Bahceşehir Unıversıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Rehabiliation Group and Spesific Exercise Group in people with Neck Pain, run by Bahçeşehir University 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 11 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sevda Yıldız, PT (+905467929046, fzt.sevdayildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Change between baseline and 4 weeks). The study lists 4 primary outcomes in all. 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 12 Feb 2021.