Neck PainNCT06649903
Cervical Spinal Manipulation and Visteral Osteopathy for Mechanical Neck Pain
A study testing Chiropractic and Osteopathy in people with Neck Pain, run by Atlas University at 2 sites in Turkey (Türkiye).
Trial summary
This study compares two treatment techniques, cervical spinal manipulation (CSM) and visceral osteopathy (VO), in patients with mechanical neck pain (MNP). The aim of the study was to evaluate the effects of these treatments on pain levels, neck mobility, and muscle strength in both the neck and upper extremities. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Chiropractic and Osteopathy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 25 Oct 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants is included if they had neck pain present for at least one week, reduced cervical ROM, a manual muscle test score of 4 or higher for the neck muscles, and no neurological pain in the neck.
Who cannot join
- Exclusion criteria included individuals with rheumatic diseases, a history of spinal surgery, neck fractures, tumors in the neck region, vertebrobasilar artery insufficiency, blood clotting disorders, or inadequate mental capacity.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Atlas University
Istanbul, Kagıthane, 34408, 34403
Atlas University
Istanbul, Kağıthane, 34413
About this study
Official title: Comparison of Cervical Spinal Manipulation and Visceral Osteopathy Techniques in People with Mechanical Neck Pain
This study compares two treatment techniques, cervical spinal manipulation (CSM) and visceral osteopathy (VO), in patients with mechanical neck pain (MNP). The aim of the study was to evaluate the effects of these treatments on pain levels, neck mobility, and muscle strength in both the neck and upper extremities.
Read the detailed description
The purpose of this study is to compare the acute effects of cervical spinal manipulation (CSM) treatment and visceral osteopathy (VO) techniques on pain, cervical range of motion (ROM), muscle strength, and grip strength in individuals with mechanical neck pain (MNP).
The study is going to include a total of 30 subjects aged 18-60 diagnosed with MNP. The subjects are randomly divided into two groups. The CSM group received high-velocity, low-amplitude (HVLA) spinal manipulation, while the other group underwent VO techniques. Each treatment technique is going to be applied in only one session. Pain intensity is assessed using the Visual Analog Scale (VAS). Cervical ROM and the craniovertebral angle (CVA) are evaluated using a goniometer. Neck and elbow muscle strength are measured with a hand-held dynamometer, and grip strength is assessed using a hand-grip dynamometer.
- Conditions
- Neck Pain
- Being tested
- Chiropractic, Osteopathy
- Keywords
- neck pain treatment, visceral osteopathy, servical spinal manupilation, osteopathy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiropracticBehavioural
high speed low amplitude neck manipulation
OsteopathyBehavioural
the stomach and liver technique was applied
| Study group | Role | What they receive |
|---|---|---|
| Cervical Spinal Manipulation (CSM) | Experimental | This arm includes participants who receive a single session of high-velocity, low-amplitude spinal manipulation aimed at reducing pain and improving cervical range of motion and muscle strength in individuals with mechanical neck pain. The intervention is administered by a qualified physiotherapist, following established protocols for cervical spinal manipulation. Receives: Behavioral: Chiropractic |
| Visceral Osteopathy | Experimental | Participants in this arm undergo a single session of visceral osteopathy techniques focused on improving pain and functional outcomes in individuals with mechanical neck pain. The VO techniques are designed to enhance mobility and alleviate discomfort through manipulation of the viscera and associated structures, performed by a trained osteopath. Receives: Behavioral: Osteopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scale
The Visual Analog Scale (VAS) for pain is a subjective measurement tool used to assess an individual\'s pain intensity. It consists of a straight line, typically 10 centimeters in length, with endpoints that represent the extremes of pain: one end signifies \"no pain\" (0) and the other indicates \"worst pain imaginable\" (10).
Participants mark a point on the line that corresponds to their pain level at the moment of assessment. The distance from the \"no pain\" end to the marked point is then measured in centimeters, providing a numerical value that quantifies the intensity of the pain experienced. This scale is commonly used in clinical settings for its simplicity and effectiveness in capturing the subjective experience of pain.
Measured: At baseline and immediately following the intervention session.
Microfet 2 Dynamometer
The Microfet 2 Dynamometer is a handheld device used to objectively measure muscle strength in clinical and research settings. It employs a digital force transducer that provides accurate and reliable assessments of isometric muscle strength across various muscle groups.
It is commonly used in physical therapy and rehabilitation to evaluate muscle function, track progress over time, and inform treatment decisions. Its compact size and versatility make it suitable for various assessments, including grip strength, limb strength, and specific muscle testing. The device is particularly valuable for ensuring standardized measurements in strength evaluation protocols.
Measured: At baseline and immediately following the intervention session.
Secondary outcomes (1)
Hand Dynamometer
A hand dynamometer is a electronic device used to measure grip strength, which is an important indicator of overall muscle strength and function.
The hand dynamometer is widely used in clinical, rehabilitation, and research settings to assess the strength of the hand and forearm muscles. This measurement can provide valuable information regarding a patient\'s recovery progress, functional capacity, and overall health status.
Consistent use of the hand dynamometer can help establish baselines, track changes in muscle strength over time, and guide treatment interventions for various conditions affecting hand function.
Measured: At baseline and immediately following the intervention session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Nov 2023
- Primary completion22 Dec 2023
- Study completion25 Oct 2024
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
- It is a randomized controlled study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Denizoğlu Külli, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649903
- Sponsor's protocol ID
- Cihat Seyrek
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, we are undecided about sharing individual participant data (IPD) with other researchers. We will evaluate the feasibility and ethical considerations of data sharing upon study completion. Factors influencing this decision may include participant confidentiality, data integrity, and potential research collaborations. A final determination will be made based on these considerations to ensure compliance with ethical guidelines and the responsible use of participant data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cervical Spinal Manipulation and Visceral Osteopathy Techniques in People with Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT06649903
- Acronym / sponsor ID
- Cihat Seyrek
- Conditions
- Neck Pain
- Keywords
- neck pain treatment, visceral osteopathy, servical spinal manupilation, osteopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 21 Oct 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.
This study compares two treatment techniques, cervical spinal manipulation (CSM) and visceral osteopathy (VO), in patients with mechanical neck pain (MNP). The aim of the study was to evaluate the effects of these treatments on pain levels, neck mobility, and muscle strength in both the neck and upper extremities.
Detailed description
The purpose of this study is to compare the acute effects of cervical spinal manipulation (CSM) treatment and visceral osteopathy (VO) techniques on pain, cervical range of motion (ROM), muscle strength, and grip strength in individuals with mechanical neck pain (MNP).
The study is going to include a total of 30 subjects aged 18-60 diagnosed with MNP. The subjects are randomly divided into two groups. The CSM group received high-velocity, low-amplitude (HVLA) spinal manipulation, while the other group underwent VO techniques. Each treatment technique is going to be applied in only one session. Pain intensity is assessed using the Visual Analog Scale (VAS). Cervical ROM and the craniovertebral angle (CVA) are evaluated using a goniometer. Neck and elbow muscle strength are measured with a hand-held dynamometer, and grip strength is assessed using a hand-grip dynamometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It is a randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Cervical Spinal Manipulation (CSM) | Experimental | Behavioral: ChiropracticThis arm includes participants who receive a single session of high-velocity, low-amplitude spinal manipulation aimed at reducing pain and improving cervical range of motion and muscle strength in individuals with mechanical neck pain. The intervention is administered by a qualified physiotherapist, following established protocols for cervical spinal manipulation. |
| Visceral Osteopathy | Experimental | Behavioral: OsteopathyParticipants in this arm undergo a single session of visceral osteopathy techniques focused on improving pain and functional outcomes in individuals with mechanical neck pain. The VO techniques are designed to enhance mobility and alleviate discomfort through manipulation of the viscera and associated structures, performed by a trained osteopath. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants is included if they had neck pain present for at least one week, reduced cervical ROM, a manual muscle test score of 4 or higher for the neck muscles, and no neurological pain in the neck.
Key exclusion criteria (1 listed)
- Exclusion criteria included individuals with rheumatic diseases, a history of spinal surgery, neck fractures, tumors in the neck region, vertebrobasilar artery insufficiency, blood clotting disorders, or inadequate mental capacity.
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 |
|---|---|---|
| Chiropractichigh speed low amplitude neck manipulation | Behavioural | Cervical Spinal Manipulation (CSM) |
| Osteopathythe stomach and liver technique was applied | Behavioural | Visceral Osteopathy |
Primary outcome
VAS pain scale
Time frame: At baseline and immediately following the intervention session.
The Visual Analog Scale (VAS) for pain is a subjective measurement tool used to assess an individual\'s pain intensity. It consists of a straight line, typically 10 centimeters in length, with endpoints that represent the extremes of pain: one end signifies \"no pain\" (0) and the other indicates \"worst pain imaginable\" (10). Participants mark a point on the line that corresponds to their pain level at the moment of assessment. The distance from the \"no pain\" end to the marked point is then measured in centimeters, providing a numerical value that quantifies the intensity of the pain experienced. This scale is commonly used in clinical settings for its simplicity and effectiveness in capturing the subjective experience of pain.
Microfet 2 Dynamometer
Time frame: At baseline and immediately following the intervention session.
The Microfet 2 Dynamometer is a handheld device used to objectively measure muscle strength in clinical and research settings. It employs a digital force transducer that provides accurate and reliable assessments of isometric muscle strength across various muscle groups. It is commonly used in physical therapy and rehabilitation to evaluate muscle function, track progress over time, and inform treatment decisions. Its compact size and versatility make it suitable for various assessments, including grip strength, limb strength, and specific muscle testing. The device is particularly valuable for ensuring standardized measurements in strength evaluation protocols.
1 secondary outcome
Hand Dynamometer
Time frame: At baseline and immediately following the intervention session.
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 4 Nov 2024.
- Individual participant dataSharing planned: No. At this time, we are undecided about sharing individual participant data (IPD) with other researchers. We will evaluate the feasibility and ethical considerations of data sharing upon study completion. Factors influencing this decision may include participant confidentiality, data integrity, and potential research collaborations. A final determination will be made based on these considerations to ensure compliance with ethical guidelines and the responsible use of participant data.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic and Osteopathy in people with Neck Pain, run by Atlas University at 2 sites 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 1 inclusion and 1 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
VAS pain scale (time frame: At baseline and immediately following the intervention session.). The study lists 2 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 4 Nov 2024.