Neck PainNCT05488756
Comparison of the Different Exercises on Chronic Neck Pain
A study testing Group 1, Group 2 and Group 3 in people with Neck Pain and Pain, Neck, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Neck pain is a widespread problem in the general population and is second only to low back pain in musculoskeletal issues. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Neck Pain, Pain, Neck
- What is being tested?
- Group 1, Group 2 and Group 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2022to 16 Sep 2022
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic neck pain more than 3 months
- Medically stable
Who cannot join
- Patients with benign or tumors in the cervical region
- Patients with active, localized osseous and discal infection in the spine (spondylodiscitis)
- Patients with history of spinal fractures
- Patients with congenital anomaly
- Patients with neck surgery and spinal instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Three Different Exercise Training in Patients With Chronic Neck Pain: A Randomized Study
Neck pain is a widespread problem in the general population and is second only to low back pain in musculoskeletal issues.
Read the detailed description
The aim of this study is to compare the conventional therapy, cervical stabilization exercise approach, and core stabilization exercise in addiction to cervical stabilization in patients with chronic neck pain.
- Conditions
- Neck Pain, Pain, Neck
- Being tested
- Group 1, Group 2, Group 3
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
Physical therapy agents and isometric exercise training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and isometric training 3 times a week for 4 weeks by the physical therapist.
Group 2Other
Physical therapy agents and deep cervical flexor muscle training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and muscle training 3 times a week for 4 weeks by the physical therapist. Training of the craniocervical flexor muscles is going to be focused on the deep flexor muscles such as longus capitis and longus colli muscles, making neck flexion, not the head.
Group 3Other
Physical therapy agents and core stabilization training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and stabilization training 3 times a week for 4 weeks by the physical therapist. These exercises will be performed for 10 repetitions with 10 seconds of contraction and 5 seconds of relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Conventional training plus isometric neck exercises Receives: Other: Group 1 |
| Group 2 | Experimental | Conventional training plus deep cervical flexor exercises Receives: Other: Group 2 |
| Group 3 | Experimental | Conventional training plus stabilization exercises of the neck and core region Receives: Other: Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Assessment
The 11-point Verbal Numeric Pain Scale (VNPS; 0 means no pain; 10 means worst pain) will be use to assess pain intensity. The VNPS is a reliable and valid measure for subjective pain measurement. Participants will be asked to report the pain severity at that moment on a scale from 0 to 10.
Measured: 4 weeks
Secondary outcomes (5)
Demografic Characteristic of Participants
The general demographic information of participants such as gender, age, body mass index will be recorded in a form created by investigators. Body mass index (BMI) values will be calculated by dividing body weights by the square of the height and be expressed in kg/m2.
Measured: 1 week before the first treatment session
Posture Evaluation
Reedco's posture score will be used in posture evaluation. The score is a standard tool and it is administered by visual inspection of 10 postural traits viewed laterally (sagittal view including neck, upper back, trunk, abdomen, and lower back) or from behind (coronal view including head, shoulders, spine, hips, and ankles). The scores are marked as follows: a value of 0 equals poor posture or severe deviation, a value of 5 equals fair posture or minimal to moderate deviation, and a value of 10 equals good posture or normal alignment. The maximum score of 100 indicates good posture and a score of 59% or less is recorded as postural dysfunction.
Measured: 4 weeks
Evaluation of Cervical Range of Motion
Cervical ROM will be evaluated using a goniometer while the patient sitting on the chair with both feet on the ground. In the evaluation, after the goniometer is brought to the neutral position, the patient is asked to perform the desired movement with the head: flexion, extension, right and left lateral flexion, right and left rotation. A degree will be recorded for each neck motion and be used in the average analysis
Measured: 4 weeks
Disability Evaluation
Neck Disability Index will be used to evaluate daily activities and ability. The form contains of 10 questions related to pain intensity, lifting, concentration, reading, headache, self-management, driving, working, sleeping, and daily activities. The score of each question is 0-5 according to the options and the total score is recorded by adding the scores of all answers. The lower the total score of the test, the less the effect of pain on performance in daily activities. The higher the score, the greater the performance of daily activities is affected.
Measured: 4 weeks
Assessment of Quality of Life
The Short Form-36 is a test that includes a 36-item self-administered comprehensive health status questionnaire and will be used to assess the quality of life. This test includes questions evaluating physical function, social function, limitations due to physical health, limitations due to mental health, vitality, body pain, and general health. In this test, two scores are generally calculated, the combined physical and mental summary score. Higher scores indicate higher quality of life.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start8 Aug 2022
- Primary completion9 Sep 2022
- Study completion16 Sep 2022
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.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylül Pınar KISA, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488756
- Sponsor's protocol ID
- Neck Pain
- Status last verified
- Sep 2022
- First submitted
- 1 Aug 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Exercise Training in Patients With Chronic Neck Pain: A Randomized Study
- ClinicalTrials.gov ID
- NCT05488756
- Acronym / sponsor ID
- Neck Pain
- Conditions
- Neck Pain, Pain, Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 5 Aug 2022 (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.
Neck pain is a widespread problem in the general population and is second only to low back pain in musculoskeletal issues.
Detailed description
The aim of this study is to compare the conventional therapy, cervical stabilization exercise approach, and core stabilization exercise in addiction to cervical stabilization in patients with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Group 1Conventional training plus isometric neck exercises |
| Group 2 | Experimental | Other: Group 2Conventional training plus deep cervical flexor exercises |
| Group 3 | Experimental | Other: Group 3Conventional training plus stabilization exercises of the neck and core region |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic neck pain more than 3 months
- Medically stable
Key exclusion criteria (5 listed)
- Patients with benign or tumors in the cervical region
- Patients with active, localized osseous and discal infection in the spine (spondylodiscitis)
- Patients with history of spinal fractures
- Patients with congenital anomaly
- Patients with neck surgery and spinal instability
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 |
|---|---|---|
| Group 1Physical therapy agents and isometric exercise training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and isometric training 3 times a week for 4 weeks by the physical therapist. | Other | Group 1 |
| Group 2Physical therapy agents and deep cervical flexor muscle training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and muscle training 3 times a week for 4 weeks by the physical therapist. Training of the craniocervical flexor muscles is going to be focused on the deep flexor muscles such as longus capitis and longus colli muscles, making neck flexion, not the head. | Other | Group 2 |
| Group 3Physical therapy agents and core stabilization training will be applied to the patients. These will be administered a combination of transcutaneous electrical nerve stimulation, ultrasound, a hot pack, and stabilization training 3 times a week for 4 weeks by the physical therapist. These exercises will be performed for 10 repetitions with 10 seconds of contraction and 5 seconds of relaxation. | Other | Group 3 |
Primary outcome
Pain Intensity Assessment
Time frame: 4 weeks
The 11-point Verbal Numeric Pain Scale (VNPS; 0 means no pain; 10 means worst pain) will be use to assess pain intensity. The VNPS is a reliable and valid measure for subjective pain measurement. Participants will be asked to report the pain severity at that moment on a scale from 0 to 10.
5 secondary outcomes
Demografic Characteristic of Participants
Time frame: 1 week before the first treatment session
Posture Evaluation
Time frame: 4 weeks
Evaluation of Cervical Range of Motion
Time frame: 4 weeks
Disability Evaluation
Time frame: 4 weeks
Assessment of Quality of Life
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1, Group 2 and Group 3 in people with Neck Pain and Pain, Neck, run by Biruni 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 2 inclusion and 5 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 21 Sep 2022. 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?
Pain Intensity Assessment (time frame: 4 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 21 Sep 2022.