Neck PainNCT04268667
Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain
A study testing Spinal manipulation in people with Neck Pain, run by Clínica Ciudad de Almería at 1 site in Spain.
Trial summary
There is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Spinal manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteSpain
- Study dates
- 6 Feb 2023to 15 Mar 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptom persistence for more than 12 weeks.
- Age from 18 to 55 years.
- Localized pain in the cervical spine.
- Symptoms are caused by cervical movement or sustained postures.
Who cannot join
- Stage acute of symptoms.
- Any contraindication to cervical spinal manipulation (fracture, osteoporosis, joint infections or vertebrobasilar insufficiency).
- Patients with previous neck trauma or cervical spine surgery.
- Patients diagnosed with cervical radiculopathy.
- Patients diagnosed with fibromyalgia.
- Have been treated with manual therapy in the last 3 months.
- Receiving other treatment during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Cervicothoracic and Upper Cervical Spine Manipulation in Patients With Chronic Mechanical Neck Pain: a Randomized Controlled Trial
There is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation with the application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain, disability and cervical range of motion in individuals with chronic mechanical neck pain.
- Conditions
- Neck Pain
- Being tested
- Spinal manipulation
- Keywords
- disability evaluation, musculoskeletal manipulations, neck pain, spinal manipulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulationOther
Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Upper cervical spine manipulation group | Experimental | Spinal thrust joint manipulation on the atlantoaxial joint Receives: Other: Spinal manipulation |
| Cervicothoracic spine manipulations group | Active comparator | Different spinal thrust joint manipulations on the thoracic spine (T6), mid-cervical spine (C3-C4) and cervicothoracic junction (C7-T1). Receives: Other: Spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neck pain at rest: Numeric Pain Rating Scale (0-10)
Neck pain at rest. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).
Measured: Baseline and 7 days post-treatment
Change in neck disability: Neck Disability Index (0-50)
Neck disability is measured with Neck Disability Index (10 items). A higher score indicates greater disability.
Measured: Baseline and 7 days post-treatment
Secondary outcomes (6)
Change in flexion movement: Cervical Range of Motion device
Range of cervical motion in flexion. Measured with a Cervical Range of Motion (CROM) device
Measured: Baseline and 7 days post-treatment
Change in extension movement: Cervical Range of Motion device
Range of cervical motion in extension. Measured with a Cervical Range of Motion (CROM) device
Measured: Baseline and 7 days post-treatment
Change in rigth lateral flexion movement: Cervical Range of Motion device
Range of cervical motion in right lateral flexion. Measured with a Cervical Range of Motion (CROM) device
Measured: Baseline and 7 days post-treatment
Change in left lateral flexion movement: Cervical Range of Motion device
Range of cervical motion in left lateral flexion. Measured with a Cervical Range of Motion (CROM) device
Measured: Baseline and 7 days post-treatment
Change in right rotation movement: Cervical Range of Motion device
Range of cervical motion in right rotation. Measured with a Cervical Range of Motion (CROM) device
Measured: Baseline and 7 days post-treatment
Change in left rotation movement: Cervical Range of Motion device
Range of cervical motion in left rotation. Measured with a Cervical Range of Motion (CROM) device
Measured: Baseline and 7 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start6 Feb 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica Ciudad de Almería
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raúl Romero del Rey, Universidad de Almeria
- Investigators
- Raúl Romero del Rey, Mr, Principal investigator, Clinica Ciudad de Almería
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268667
- Sponsor's protocol ID
- spinal manipulation
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2020
- Last updated
- 26 Mar 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 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Cervicothoracic and Upper Cervical Spine Manipulation in Patients With Chronic Mechanical Neck Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04268667
- Acronym / sponsor ID
- spinal manipulation
- Conditions
- Neck Pain
- Keywords
- disability evaluation, musculoskeletal manipulations, neck pain, spinal manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Clínica Ciudad de AlmeríaUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 13 Feb 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.
There is enough evidence to suggest that the spinal manipulation of the upper cervical spine and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of this randomized controlled trial is to compare the effects of an isolated application of upper cervical spine thrust joint manipulation with the application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain, disability and cervical range of motion in individuals with chronic mechanical neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper cervical spine manipulation group | Experimental | Other: Spinal manipulationSpinal thrust joint manipulation on the atlantoaxial joint |
| Cervicothoracic spine manipulations group | Active comparator | Other: Spinal manipulationDifferent spinal thrust joint manipulations on the thoracic spine (T6), mid-cervical spine (C3-C4) and cervicothoracic junction (C7-T1). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptom persistence for more than 12 weeks.
- Age from 18 to 55 years.
- Localized pain in the cervical spine.
- Symptoms are caused by cervical movement or sustained postures.
Key exclusion criteria (7 listed)
- Stage acute of symptoms.
- Any contraindication to cervical spinal manipulation (fracture, osteoporosis, joint infections or vertebrobasilar insufficiency).
- Patients with previous neck trauma or cervical spine surgery.
- Patients diagnosed with cervical radiculopathy.
- Patients diagnosed with fibromyalgia.
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 |
|---|---|---|
| Spinal manipulationApplication of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation. | Other | Cervicothoracic spine manipulations group, Upper cervical spine manipulation group |
Primary outcome
Change in neck pain at rest: Numeric Pain Rating Scale (0-10)
Time frame: Baseline and 7 days post-treatment
Neck pain at rest. Measured with the Numeric Pain Rating Scale (0 = ''no pain'' and 10 = ''worst imaginable pain).
Change in neck disability: Neck Disability Index (0-50)
Time frame: Baseline and 7 days post-treatment
Neck disability is measured with Neck Disability Index (10 items). A higher score indicates greater disability.
6 secondary outcomes
Change in flexion movement: Cervical Range of Motion device
Time frame: Baseline and 7 days post-treatment
Change in extension movement: Cervical Range of Motion device
Time frame: Baseline and 7 days post-treatment
Change in rigth lateral flexion movement: Cervical Range of Motion device
Time frame: Baseline and 7 days post-treatment
Change in left lateral flexion movement: Cervical Range of Motion device
Time frame: Baseline and 7 days post-treatment
Change in right rotation movement: Cervical Range of Motion device
Time frame: Baseline and 7 days post-treatment
Change in left rotation movement: Cervical Range of Motion device
Time frame: Baseline and 7 days post-treatment
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 26 Mar 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.
Raúl Romero del Rey, Mr principal investigator
Clinica Ciudad de Almería
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal manipulation in people with Neck Pain, run by Clínica Ciudad de Almería at 1 site in Spain.
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 7 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 26 Mar 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 Spain. 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?
Change in neck pain at rest: Numeric Pain Rating Scale (0-10) (time frame: Baseline and 7 days post-treatment). 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 26 Mar 2024.