Neck PainNCT02982369
The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
A study testing Spinal Manipulation and Pain Education in people with Neck Pain, run by Santa Catarina Federal University at 1 site in Brazil.
Trial summary
This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group. 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?
- Spinal Manipulation and Pain Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2016to 18 Apr 2018
- 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
- Main complaint of Neck Pain for at least six (6) months;
- Score of at least 10 points in NDI (Neck Disability Index);
- Pain and / or restriction of cervical movements;
- Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);
- The definition of the term Neck Pain follows the classification of TFNP.
Who cannot join
- Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders;
- History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;
- Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb;
- Red flags contraindicating spinal manipulation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Catarina Federal University
Florianópolis, Santa Catarina, 88040-900
About this study
This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.
- Conditions
- Neck Pain
- Being tested
- Spinal Manipulation, Pain Education, Sham
- 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
Also called Vertebral Manipulation
High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region
Pain EducationOther
Also called Pain Neuroscience Education
Subjects will receive pain education based in biopsychosocial approach
ShamOther
A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manipulation | Experimental | High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education.
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. Receives: Other: Spinal Manipulation; Other: Pain Education |
| Pain Education | Sham comparator | Pain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. Receives: Other: Pain Education; Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Intensity of pain will be measured by the numeric pain rating scale (NPRS)
Measured: 4 weeks after randomization
Secondary outcomes (7)
Cytokines
Level of concentration of pro and anti-inflammatory cytokines
Measured: 4 weeks after randomization
Pressure Pain Threshold
Pressure pain Threshold will be measured with a digital algometer
Measured: 4 weeks and 3 months after randomization
Disability
Disability will be measured by the Neck Disability Index (NDI)
Measured: 4 weeks and 3 months after randomization
Fear Avoidance Beliefs
Fear Avoidance will be measured by the Fear Avoidance Beliefs Questionnaire (FABQ)
Measured: 4 weeks and 3 months after randomization
Health-related Quality of Life
Quality of Life will be measured by the 12-Item Health Survey (SF-12)
Measured: 4 weeks and 3 months after randomization
Kinesiophobia
Kinesiophobia will be measured byTampa Scale for Kinesiophobia
Measured: 4 weeks and 3 months after randomization
Pain Intensity
Intensity of pain will be measured by the numeric pain rating scale (NPRS)
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion1 Mar 2018
- Study completion18 Apr 2018
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Catarina Federal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Anderson Bracht, Santa Catarina Federal University
- Investigators
- Adair R Soares dos Santos, PhD, Study director, Santa Catarina Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982369
- Sponsor's protocol ID
- MBracht
- Other IDs
- U1111-1190-4280
- Status last verified
- Aug 2018
- First submitted
- 28 Nov 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vertebral Manipulation and Pain Education in Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT02982369
- Acronym / sponsor ID
- MBracht
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Santa Catarina Federal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 5 Dec 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.
This study aims to investigate the effects of vertebral manipulation and pain education on subjects with neck pain. For this purpose, 90 subjects who present chronic neck pain will be selected and allocated randomly into 2 groups: vertebral manipulation group and pain education group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Manipulation | Experimental | Other: Spinal Manipulation, Other: Pain EducationHigh-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region and pain education. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. |
| Pain Education | Sham comparator | Other: Pain Education, Other: ShamPain education and a simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes. The subjects will receive the treatment twice a week, for four weeks, totaling eight sessions, with an average duration of 30 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Main complaint of Neck Pain for at least six (6) months;
- Score of at least 10 points in NDI (Neck Disability Index);
- Pain and / or restriction of cervical movements;
- Pain reported at least 3 points on the NPRS (Numeric Pain Rating Scale);
- The definition of the term Neck Pain follows the classification of TFNP.
Key exclusion criteria (4 listed)
- Previous history of rheumatic disease, cervical myelopathy, tumors, vertebrobasilar insufficiency, central or peripheral neurological disorders;
- History of major trauma, fracture or surgery in the neck, shoulder and/or upper limb;
- Signs of nerve root compression as important muscle weakness affecting the upper limbs, reduction, loss or increase of biceps and triceps reflexes, decreased sensation in the dermatomes of the upper limb;
- Red flags contraindicating spinal manipulation.
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 ManipulationAlso: Vertebral ManipulationHigh-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region | Other | Spinal Manipulation |
| Pain EducationAlso: Pain Neuroscience EducationSubjects will receive pain education based in biopsychosocial approach | Other | Pain Education, Spinal Manipulation |
| ShamA simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes. | Other | Pain Education |
Primary outcome
Pain Intensity
Time frame: 4 weeks after randomization
Intensity of pain will be measured by the numeric pain rating scale (NPRS)
7 secondary outcomes
Cytokines
Time frame: 4 weeks after randomization
Pressure Pain Threshold
Time frame: 4 weeks and 3 months after randomization
Disability
Time frame: 4 weeks and 3 months after randomization
Fear Avoidance Beliefs
Time frame: 4 weeks and 3 months after randomization
Health-related Quality of Life
Time frame: 4 weeks and 3 months after randomization
Kinesiophobia
Time frame: 4 weeks and 3 months after randomization
Pain Intensity
Time frame: 3 months after randomization
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 Aug 2018.
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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.
Adair R Soares dos Santos, PhD study director
Santa Catarina Federal University
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 and Pain Education in people with Neck Pain, run by Santa Catarina Federal University at 1 site in Brazil.
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 5 inclusion and 4 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 Aug 2018. 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 Brazil. 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 Intensity (time frame: 4 weeks after randomization). 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 Aug 2018.