Neck PainNCT04455048
The Effectiveness of Manipulation Treatment in Cervical Region
A study testing Cervicothoracic thrust manipulation in people with Neck Pain, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial summary
Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cervicothoracic thrust manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Feb 2019to 15 Dec 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis Nonspecific neck pain (NSNP)
- Symptoms should last longer than 12 weeks
Who cannot join
- Any known cause such as radiculopathy or neurological diseases,
- History of neck surgery,
- History of vertebral fracture,
- Osteoporosis,
- Tumor or a mass in the vertebral column,
- Any spinal thrust manipulation contraindication,
- Medication usage such as antiinflammatory or analgesic which might effect outcome assessments,
- History of spinal manipulation
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Abant Izzet Baysal University
Bolu, Merkez, 14100
Health Sciences Faculty Bolu Abant Izzet Baysal University
Bolu, Merkez, 14100
About this study
Official title: The Effectiveness of Manipulation Treatment in Acute Cervical Region Pain
Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4).
Read the detailed description
Acute neck pain is often caused by mechanical causes and can be classified as rheumatic diseases, infectious and tumoral pathologies, metabolic bone diseases such as osteoporosis and osteomalacia, pain reflected the cervical region. A-V malformation and syringomyelia are the causes of chronic cervical pain (5). Mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. (6, 7). Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected in the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome (9, 10). Many authors have suggested that facet joints are associated with mechanical dysfunction as a common cause of cervical pain (8-10).
The pain in the head and neck region affects the quality of life, cognitive and functional status of the person. The most important difficulty and failure in the treatment of such pain arise from the inability to diagnose the disease correctly. Good anatomical and biomechanical properties of the region, comprehensive anamnesis, physical examination under static and dynamic conditions, laboratory and radiological examinations are the most important milestones of diagnosis (12). In most cases, medical treatment and physical therapy modalities (superficial and deep heat, electrotherapy, laser, traction, massage, spa) are sufficient for pain relief and recovery of function, but interventional procedures and surgical procedures are needed for the fewer patient. Recently, spinal mobilization and manipulation techniques can be used to relieve pain and restore function in the early stages. Although it is a safe method, in order to prevent the rare complications it is necessary to determine the indications of treatment correctly, to exclude contiguous cases and to apply the manipulation by experts (12).
- Conditions
- Neck Pain
- Being tested
- Cervicothoracic thrust manipulation, Cervicothoracic thrust manipulation sham
- Keywords
- Tape, Pain, Rehabilitation
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervicothoracic thrust manipulationOther
The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. Thrust manipulation will be applied at the end of exhale.
Cervicothoracic thrust manipulation shamOther
The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. A soft compression will be applied at the end of exhale without a thrust.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks. Receives: Other: Cervicothoracic thrust manipulation |
| Control Group | Sham comparator | A sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied. Receives: Other: Cervicothoracic thrust manipulation sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Pain pressure threshold (PPT). was assessed with an algometer (JTECH Medical, Salt Lake City, UT) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.
Measured: two weeks
Secondary outcomes (4)
Visual analog scale
The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).
Measured: two weeks
Cervical range of motion
Cervical Range of Motion (ROM) of flexion,extension, lateral flexion and rotation were measured with basic cervical ROM device (Performance Attainment, Associates, St Paul, MN, USA) in seated position without back support.
Measured: two weeks
Neck Disability Index
Perceived disability of patients was assessed with 10-item item Neck Disability Index (NDI),which a modified from Oswestry Low Back Pain Disability Index to assess with a score range of 0 to 50.
Measured: two weeks
Global Perceived Effect Scale
Change in the perception of the symptoms after the treatment was measured by a Global Perceived Effect Scale. Patients were asked to rate change between 1 completely recovered, 4 unchanged, 7 vastly worse on a horizontal likert scale.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start2 Feb 2019
- Primary completion16 Oct 2023
- Study completion15 Dec 2023
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 Abant Izzet Baysal 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
- Model description
- Two groups with a sham control. Assessments will be performed before manipulation, immediately after first session, in the second week, and two months after the last session.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Erdal Dilekçi, MD, Principal investigator, Bolu Abant Izzet Baylsa UniversityRamazan KURUL, Ph.D, Principal investigator, Bolu Abant Izzet Baylsa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455048
- Sponsor's protocol ID
- AIBU-FTR-RK-04
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2020
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after study publicaiton with online link.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Manipulation Treatment in Acute Cervical Region Pain
- ClinicalTrials.gov ID
- NCT04455048
- Acronym / sponsor ID
- AIBU-FTR-RK-04
- Conditions
- Neck Pain
- Keywords
- Tape, Pain, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 2 Jul 2020 (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 the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4).
Detailed description
Acute neck pain is often caused by mechanical causes and can be classified as rheumatic diseases, infectious and tumoral pathologies, metabolic bone diseases such as osteoporosis and osteomalacia, pain reflected the cervical region. A-V malformation and syringomyelia are the causes of chronic cervical pain (5). Mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. (6, 7). Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected in the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome (9, 10). Many authors have suggested that facet joints are associated with mechanical dysfunction as a common cause of cervical pain (8-10).
The pain in the head and neck region affects the quality of life, cognitive and functional status of the person. The most important difficulty and failure in the treatment of such pain arise from the inability to diagnose the disease correctly. Good anatomical and biomechanical properties of the region, comprehensive anamnesis, physical examination under static and dynamic conditions, laboratory and radiological examinations are the most important milestones of diagnosis (12). In most cases, medical treatment and physical therapy modalities (superficial and deep heat, electrotherapy, laser, traction, massage, spa) are sufficient for pain relief and recovery of function, but interventional procedures and surgical procedures are needed for the fewer patient. Recently, spinal mobilization and manipulation techniques can be used to relieve pain and restore function in the early stages. Although it is a safe method, in order to prevent the rare complications it is necessary to determine the indications of treatment correctly, to exclude contiguous cases and to apply the manipulation by experts (12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with a sham control. Assessments will be performed before manipulation, immediately after first session, in the second week, and two months after the last session.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Cervicothoracic thrust manipulationA single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks. |
| Control Group | Sham comparator | Other: Cervicothoracic thrust manipulation shamA sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis Nonspecific neck pain (NSNP)
- Symptoms should last longer than 12 weeks
Key exclusion criteria (8 listed)
- Any known cause such as radiculopathy or neurological diseases,
- History of neck surgery,
- History of vertebral fracture,
- Osteoporosis,
- Tumor or a mass in the vertebral column,
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 |
|---|---|---|
| Cervicothoracic thrust manipulationThe patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. Thrust manipulation will be applied at the end of exhale. | Other | Intervention Group |
| Cervicothoracic thrust manipulation shamThe patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. A soft compression will be applied at the end of exhale without a thrust. | Other | Control Group |
Primary outcome
Pain pressure threshold
Time frame: two weeks
Pain pressure threshold (PPT). was assessed with an algometer (JTECH Medical, Salt Lake City, UT) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.
4 secondary outcomes
Visual analog scale
Time frame: two weeks
Cervical range of motion
Time frame: two weeks
Neck Disability Index
Time frame: two weeks
Global Perceived Effect Scale
Time frame: two 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 6 Aug 2026.
- Individual participant dataSharing planned: Yes. Data will be shared after study publicaiton with online link.
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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.
Erdal Dilekçi, MD principal investigator
Bolu Abant Izzet Baylsa University
Ramazan KURUL, Ph.D principal investigator
Bolu Abant Izzet Baylsa University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervicothoracic thrust manipulation in people with Neck Pain, run by Abant Izzet Baysal 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 2 inclusion and 8 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 6 Aug 2026. 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. Some participants in this study may receive a placebo. 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 pressure threshold (time frame: two 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 6 Aug 2026.