Pain SyndromeNCT06435364
Cervical Manual Therapy and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
A study testing Vagus nerve stimilation and Manual therapy in people with Pain Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
People with chronic neck pain are becoming more and more common in society every day. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pain Syndrome
- What is being tested?
- Vagus nerve stimilation and Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2024to 21 Aug 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Having undergone surgery for the cervical region
- Rehabilitation of the neck area at least three months prior to treatment
- Traumatic medulla spinalis injury
- Neurological deficit
- Rheumatological disease
- Structural spinal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Instrument Supported Cervical Manual Therapy Methods and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
People with chronic neck pain are becoming more and more common in society every day.
Read the detailed description
In chronic neck pain investigations, it is generally reported that all people experience neck pain once in my life and more than half of the developed societies experience this problem. It has been stated that 48% of these continue as chronic neck pain, which significantly affects the quality of life due to the postponement of treatment due to its cost.
- Conditions
- Pain Syndrome
- Being tested
- Vagus nerve stimilation, Manual therapy
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimilationOther
This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents through the external ear. Somatosensory innervation is provided by the auricular branch.
Manual therapyOther
Manual therapy is mostly defined by the tissue targeted by the practitioner; it can be joint biased, muscle and connective tissue biased and/or neurovascular system biased techniques.
| Study group | Role | What they receive |
|---|---|---|
| Vagus nerve | Experimental | This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents via the external ear. Receives: Other: Vagus nerve stimilation |
| Manual therapy | Active comparator | Manual therapy is effective in the treatment of musculoskeletal pain. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Heart rate variability (HRV) is an indicator of the effects of these two components on the heart, reflecting the variations in the time intervals between heartbeats. High HRV generally indicates good autonomic balance and a healthy cardiovascular system, while low HRV can be a sign of stress, fatigue, or underlying health issues. When sympathetic nervous system activity increases, heart rate accelerates and HRV decreases; conversely, when parasympathetic nervous system activity increases, heart rate slows and HRV increases. Therefore, HRV is an important biomarker for assessing overall health status and developing stress management strategies.
Measured: 4 weeks
Neck disability index:
The neck disability index is the most commonly used functional outcome tool for disabilities in the cervical region. This outcome assessment tool was created by modifying the Oswestry Disability Index and is highly reliable (Chad E. Cook, Amy E. Cook 2011).
Scoring is given for each question as A: 0 points, B: 1 point, C: 2 points, D: 3 points, E: 4 points, F: 5 points. The total score gives the test score. According to the test result 0-4=No disability 5-14= Mild disability 15-24= Moderate disability 25-34 = Severe disability
Measured: 4 weeks
Joint Range of Motion
Range of motion is the ability of a joint to go through the full range of motion. The range of motion of a joint can be passive or active. Passive ROM - The maximum range of motion through which the joint can move with the aid of external force. Active ROM - the range of motion achieved by contracting and relaxing opposing muscles
Measured: 4 weeks
The visual analogue scale (VAS)
The visual analogue scale (VAS) is a validated, subjective measure of acute and chronic pain. Scores are recorded by placing a handwritten mark on a 10 cm line representing the continuum between "no pain" and "worst pain"
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 posted30 May 2024
- Study start17 May 2024
- Primary completion15 Jun 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435364
- Sponsor's protocol ID
- E-10840098-202.3.02-2983
- Status last verified
- Oct 2024
- First submitted
- 24 May 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Instrument Supported Cervical Manual Therapy Methods and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
- ClinicalTrials.gov ID
- NCT06435364
- Acronym / sponsor ID
- E-10840098-202.3.02-2983
- Conditions
- Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 30 May 2024 (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.
People with chronic neck pain are becoming more and more common in society every day.
Detailed description
In chronic neck pain investigations, it is generally reported that all people experience neck pain once in my life and more than half of the developed societies experience this problem. It has been stated that 48% of these continue as chronic neck pain, which significantly affects the quality of life due to the postponement of treatment due to its cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus nerve | Experimental | Other: Vagus nerve stimilationThis non-invasive system is activated by the cutaneous distribution of vagus nerve afferents via the external ear. |
| Manual therapy | Active comparator | Other: Manual therapyManual therapy is effective in the treatment of musculoskeletal pain. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Having undergone surgery for the cervical region
- Rehabilitation of the neck area at least three months prior to treatment
- Traumatic medulla spinalis injury
- Neurological deficit
- Rheumatological disease
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 |
|---|---|---|
| Vagus nerve stimilationThis non-invasive system is activated by the cutaneous distribution of vagus nerve afferents through the external ear. Somatosensory innervation is provided by the auricular branch. | Other | Vagus nerve |
| Manual therapyManual therapy is mostly defined by the tissue targeted by the practitioner; it can be joint biased, muscle and connective tissue biased and/or neurovascular system biased techniques. | Other | Manual therapy |
Primary outcome
Heart rate variability
Time frame: 4 weeks
Heart rate variability (HRV) is an indicator of the effects of these two components on the heart, reflecting the variations in the time intervals between heartbeats. High HRV generally indicates good autonomic balance and a healthy cardiovascular system, while low HRV can be a sign of stress, fatigue, or underlying health issues. When sympathetic nervous system activity increases, heart rate accelerates and HRV decreases; conversely, when parasympathetic nervous system activity increases, heart rate slows and HRV increases. Therefore, HRV is an important biomarker for assessing overall health status and developing stress management strategies.
Neck disability index:
Time frame: 4 weeks
The neck disability index is the most commonly used functional outcome tool for disabilities in the cervical region. This outcome assessment tool was created by modifying the Oswestry Disability Index and is highly reliable (Chad E. Cook, Amy E. Cook 2011). Scoring is given for each question as A: 0 points, B: 1 point, C: 2 points, D: 3 points, E: 4 points, F: 5 points. The total score gives the test score. According to the test result 0-4=No disability 5-14= Mild disability 15-24= Moderate disability 25-34 = Severe disability
Joint Range of Motion
Time frame: 4 weeks
Range of motion is the ability of a joint to go through the full range of motion. The range of motion of a joint can be passive or active. Passive ROM - The maximum range of motion through which the joint can move with the aid of external force. Active ROM - the range of motion achieved by contracting and relaxing opposing muscles
The visual analogue scale (VAS)
Time frame: 4 weeks
The visual analogue scale (VAS) is a validated, subjective measure of acute and chronic pain. Scores are recorded by placing a handwritten mark on a 10 cm line representing the continuum between "no pain" and "worst pain"
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 28 Oct 2024.
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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 Vagus nerve stimilation and Manual therapy in people with Pain Syndrome, run by Istanbul Medipol University Hospital 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 0 inclusion and 6 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 28 Oct 2024. 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?
Heart rate variability (time frame: 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 28 Oct 2024.