Neck PainNCT02816060
Neural Tensioner Exercise on Conditioned Pain Modulation
A study testing manual therapy in people with Neck Pain and Diffuse Noxious Inhibitory Control, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Neck Pain, Diffuse Noxious Inhibitory Control
- What is being tested?
- manual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to Nov 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-65 years.
- neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head, trunk, and/or the upper limbs.
- the ability to understand, write, and speak Spanish fluently
Who cannot join
- development of systemic or degenerative diseases;
- symptoms of depression according to Beck's questionnaire.
- pain in any area between the lower back and the head in the last 9 months.
- neck pain associated with whiplash injuries.
- medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). - neck pain with cervical radiculopathy.
- neck pain associated with externalized cervical disc herniation.
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- fibromyalgia syndrome.
- previous neck surgery.
- neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches due to a traumatic event in the past 12 months.
- and history of neck or face pain in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Neural Tensioner Exercise on Conditioned Pain Modulation, Disability and Range of Motion in Patients With Chronic Neck Pain: A Randomized Clinical Trial
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain there is no activation of CPM.
Objectives: The purpose of this study is to measure the CPM response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion.
Read more
Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the sham technique (ST) group.
Individuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. Neck pain intensity with a visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion will be measured pre and port intervention.
- Conditions
- Neck Pain, Diffuse Noxious Inhibitory Control
- Being tested
- manual therapy
- Keywords
- pain measurement
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapyProcedure or surgery
manual therapy with neural exercise will be applied on patients with neck pain
| Study group | Role | What they receive |
|---|---|---|
| neural tensionner exercise | Experimental | This group will receive a specific tensionner nerve exercise to provide mechanical stress across the median nerve. This technique have two positions, start and end. It consists on going from one to the other position constantly, controlling the speed of the technique to be constant. In the start position, the subject will be supine lying on a couch with the following parameters: contralateral cervical side bending, shoulder depression, shoulder abduction and external rotation to 90°, elbow flexion to 90º, and forearm supination. In the final position, the therapist will perform full elbow extension while maintaining all the joints previously situated as described above until the patients feel tension, then return to the start position. Receives: Procedure: manual therapy |
| sham neural tensionner exercise | Placebo comparator | The control group will receive a sham technique (ST) with minimal mechanical stress across the median nerve. Patients will be placed in neutral cervical spine position with no shoulder depression, shoulder abduction and external rotation to 45°, 45° of elbow extension, and forearm pronation.. This technique will be passively repeated from elbow flexion to extension in the same way than the NTE group Receives: Procedure: manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological parameter
Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test
Measured: 5 minutes
Secondary outcomes (2)
Visual analogue scale
Neck pain intensity measured by visual analogue scale (VAS)
Measured: 5 minutes
physiological movement
Cervical range of motion measured with cervical range of motion device
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Josué Fernández-Carnero, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816060
- Sponsor's protocol ID
- 14/2013
- Status last verified
- Mar 2017
- First submitted
- 9 Jun 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fernandez-Carnero J, Sierra-Silvestre E, Beltran-Alacreu H, Gil-Martinez A, La Touche R. Neural Tension Technique Improves Immediate Conditioned Pain Modulation in Patients with Chronic Neck Pain: A Randomized Clinical Trial. Pain Med. 2019 Jun 1;20(6):1227-1235. doi: 10.1093/pm/pny115.
PubMed 29945245
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neural Tensioner Exercise on Conditioned Pain Modulation, Disability and Range of Motion in Patients With Chronic Neck Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02816060
- Acronym / sponsor ID
- 14/2013
- Conditions
- Neck Pain, Diffuse Noxious Inhibitory Control
- Keywords
- pain measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Jun 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.
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain there is no activation of CPM.
Objectives: The purpose of this study is to measure the CPM response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion.
Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the sham technique (ST) group.
Individuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. Neck pain intensity with a visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion will be measured pre and port intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neural tensionner exercise | Experimental | Procedure: manual therapyThis group will receive a specific tensionner nerve exercise to provide mechanical stress across the median nerve. This technique have two positions, start and end. It consists on going from one to the other position constantly, controlling the speed of the technique to be constant. In the start position, the subject will be supine lying on a couch with the following parameters: contralateral cervical side bending, shoulder depression, shoulder abduction and external rotation to 90°, elbow flexion to 90º, and forearm supination. In the final position, the therapist will perform full elbow extension while maintaining all the joints previously situated as described above until the patients feel tension, then return to the start position. |
| sham neural tensionner exercise | Placebo comparator | Procedure: manual therapyThe control group will receive a sham technique (ST) with minimal mechanical stress across the median nerve. Patients will be placed in neutral cervical spine position with no shoulder depression, shoulder abduction and external rotation to 45°, 45° of elbow extension, and forearm pronation.. This technique will be passively repeated from elbow flexion to extension in the same way than the NTE group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18-65 years.
- neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head, trunk, and/or the upper limbs.
- the ability to understand, write, and speak Spanish fluently
Key exclusion criteria (10 listed)
- development of systemic or degenerative diseases;
- symptoms of depression according to Beck's questionnaire.
- pain in any area between the lower back and the head in the last 9 months.
- neck pain associated with whiplash injuries.
- medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). - neck pain with cervical radiculopathy.
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 |
|---|---|---|
| manual therapymanual therapy with neural exercise will be applied on patients with neck pain | Procedure or surgery | neural tensionner exercise, sham neural tensionner exercise |
Primary outcome
Physiological parameter
Time frame: 5 minutes
Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test
2 secondary outcomes
Visual analogue scale
Time frame: 5 minutes
physiological movement
Time frame: 5 minutes
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 Mar 2017.
- Derived from this study: PubMed 29945245Fernandez-Carnero J, Sierra-Silvestre E, Beltran-Alacreu H, Gil-Martinez A, La Touche R. Neural Tension Technique Improves Immediate Conditioned Pain Modulation in Patients with Chronic Neck Pain: A Randomized Clinical Trial. Pain Med. 2019 Jun 1;20(6):1227-1235. doi: 10.1093/pm/pny115.
- Related InfoLink provided by the sponsor.
- 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.
Josué Fernández-Carnero, 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 manual therapy in people with Neck Pain and Diffuse Noxious Inhibitory Control, 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 3 inclusion and 10 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 Mar 2017. 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. 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?
Physiological parameter (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816060, which also lists 1 linked publication.
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 Mar 2017.