Neck PainNCT02645630
Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation
A study testing Right Cervical Manipulation and Left Cervical Manipulation in people with Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Right Cervical Manipulation and Left Cervical Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.
Who cannot join
- any contraindication to manipulation, e.g., positive extension-rotation test;
- whiplash injury;
- previous cervical surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
- having undergone spinal manipulative therapy in the previous 6 months;
- less than 18 or greater than 65 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pain, Disability, Widespread Pressure Pain Sensitivity, and Cervicokinesthesia After Cervical Manipulation in Patients With Mechanical Neck Pain
Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability, widespread pressure pain sensitivity, and cervicokinethesia in patients with mechanical neck pain.
Read the detailed description
Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability and cervicokinethesia in patients with mechanical neck pain. Patients will receive cervical spine manipulation in either right or left side of the neck and will be assessed on pain intensity, neck-related disability, widespread pressure pain sensitivity, and cervicokinethesia by an assessor blinded to the allocation group.
- Conditions
- Neck Pain
- Being tested
- Right Cervical Manipulation, Left Cervical Manipulation, Sham Cervical Manipulation
- Keywords
- Cervical spine, 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.
Right Cervical ManipulationOther
We will use a high-velocity, mid-range, left rotational force to the right articular pillar of C3, on the right articular pillar of C4 with the patient in supine, with left rotation and right side-bending.
Left Cervical ManipulationOther
We will use a high-velocity, mid-range, left rotational force to the left articular pillar of C3, on the left articular pillar of C4 with the patient in supine, with right rotation and left side-bending.
Sham Cervical ManipulationOther
The sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust
| Study group | Role | What they receive |
|---|---|---|
| Right Cervical Manipulation | Experimental | Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the right side. Receives: Other: Right Cervical Manipulation |
| Left Cervical Manipulation | Experimental | Patients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the left side. Receives: Other: Left Cervical Manipulation |
| Sham Cervical Manipulation | Active comparator | Patients assigned to this group will receive a sham cervical spine manipulation targeting the C3/C4 segment on both sides. No therapeuthic thrust will be applied. Receives: Other: Sham Cervical Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cervical kinesthetic sense before and after the intervention
The joint position sense error (JPSE) will be calculated to determine cervicokinethesia
Measured: Baseline and 15 minutes after the intervention
Secondary outcomes (3)
Changes in disability before and after the intervention
The Neck Disability Index (NDI) will be used to determine neck-related disability
Measured: Baseline and one week after the intervention
Changes in neck pain intensity before and after the intervention
An 11 points numerical pain rate scale (NPRS, 0-10) will be used to assess the intensity of neck pain
Measured: Baseline and one week after the intervention
Changes in widespread pressure pain sensitivity before and after the intervention
Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints and the tibialis anterior muscle
Measured: Baseline and 15 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionNov 2016
- Study completionDec 2016
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645630
- Sponsor's protocol ID
- URJC2015-161120155015
- Status last verified
- Dec 2016
- First submitted
- 30 Dec 2015
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain, Disability, Widespread Pressure Pain Sensitivity, and Cervicokinesthesia After Cervical Manipulation in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT02645630
- Acronym / sponsor ID
- URJC2015-161120155015
- Conditions
- Neck Pain
- Keywords
- Cervical spine, Spinal manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Jan 2016 (estimated)
- 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.
Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability, widespread pressure pain sensitivity, and cervicokinethesia in patients with mechanical neck pain.
Detailed description
Cervical spine manipulation has been found to be effective in patients with mechanical neck pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual intervention. In addition, some authors have proposed that spinal manipulation can alter proprioception of the cervical spine. The aim of this study will be to investigate the effects of cervical spine manipulation on pain, disability and cervicokinethesia in patients with mechanical neck pain. Patients will receive cervical spine manipulation in either right or left side of the neck and will be assessed on pain intensity, neck-related disability, widespread pressure pain sensitivity, and cervicokinethesia by an assessor blinded to the allocation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right Cervical Manipulation | Experimental | Other: Right Cervical ManipulationPatients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the right side. |
| Left Cervical Manipulation | Experimental | Other: Left Cervical ManipulationPatients assigned to this group will receive a cervical spine manipulation targeting the C3/C4 segment on the left side. |
| Sham Cervical Manipulation | Active comparator | Other: Sham Cervical ManipulationPatients assigned to this group will receive a sham cervical spine manipulation targeting the C3/C4 segment on both sides. No therapeuthic thrust will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.
Key exclusion criteria (7 listed)
- any contraindication to manipulation, e.g., positive extension-rotation test;
- whiplash injury;
- previous cervical surgery;
- cervical radiculopathy or myelopathy;
- diagnosis of fibromyalgia syndrome;
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 |
|---|---|---|
| Right Cervical ManipulationWe will use a high-velocity, mid-range, left rotational force to the right articular pillar of C3, on the right articular pillar of C4 with the patient in supine, with left rotation and right side-bending. | Other | Right Cervical Manipulation |
| Left Cervical ManipulationWe will use a high-velocity, mid-range, left rotational force to the left articular pillar of C3, on the left articular pillar of C4 with the patient in supine, with right rotation and left side-bending. | Other | Left Cervical Manipulation |
| Sham Cervical ManipulationThe sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust | Other | Sham Cervical Manipulation |
Primary outcome
Changes in cervical kinesthetic sense before and after the intervention
Time frame: Baseline and 15 minutes after the intervention
The joint position sense error (JPSE) will be calculated to determine cervicokinethesia
3 secondary outcomes
Changes in disability before and after the intervention
Time frame: Baseline and one week after the intervention
Changes in neck pain intensity before and after the intervention
Time frame: Baseline and one week after the intervention
Changes in widespread pressure pain sensitivity before and after the intervention
Time frame: Baseline and 15 minutes after the intervention
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 9 Dec 2016.
- 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.
CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Cervical Manipulation and Left Cervical Manipulation in people with Neck Pain, run by Universidad Rey Juan Carlos 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 1 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 9 Dec 2016. 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?
Changes in cervical kinesthetic sense before and after the intervention (time frame: Baseline and 15 minutes after the intervention). 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 9 Dec 2016.