Neck PainNCT02782585
Manual Therapy Techniques on Cervical Spine and Psychological Interaction
A study testing Cervical manipulation, Cervical lateral glide and Cervical mobilisation in people with Neck Pain, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Manual therapy (MT) techniques applied over cervical region have over both local (neck) and distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological mechanisms are hypothesized to explain the underlying effects, with effects originating from peripheral mechanisms, spinal cord and… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cervical manipulation, Cervical lateral glide and Cervical mobilisation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jun 2011
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Neck pain
Who cannot join
- myelopathy
- fracture
- infection
- dystonia
- tumor
- inflammatory disease
- fibromyalgia
- or osteoporosis
About this study
Official title: Hypoalgesic Effects of Three Different Manual Therapy Techniques on Cervical Spine and Psychological Interaction: Randomized Clinical Trial
Manual therapy (MT) techniques applied over cervical region have over both local (neck) and distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological mechanisms are hypothesized to explain the underlying effects, with effects originating from peripheral mechanisms, spinal cord and supraspinal mechanisms.
There is also an increasing interest in the study of the role of psychological variables in the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or kinesiophobia are related to poor prognosis in the development of pain outcomes and disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models in this field.
- Conditions
- Neck Pain
- Being tested
- Cervical manipulation, Cervical lateral glide, Cervical mobilisation
- Keywords
- neck pain, Manual therapy, psychological interaction
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical manipulationOther
The therapist cradled the subject´s head with the other hand. Gentle ipsilateral side flexion and contralateral rotation to the targeted side were introduced until slight tension was perceived in the tissues at the contact point. The High velocity, low amplitude (HVLA) manipulation was directed upward and medially in the direction of the subject´s contralateral eye. The therapist monitored for cavitation or 'popping sound' accompanying the manipulations. If an audible popping sound was not heard during the first manipulative attempt, the procedure was repeated in the second time.
Cervical lateral glideOther
The upper limb of the right side of subjects was maintained in rest, with the arm along the trunk and the hand over the abdominal wall. The right hand of the treating therapist was positioned over scapula region, to depress the scapula while left hand cradled the occiput and neck above C5-C6 and left hand produced a passive lateral movement of the occipital and neck region.
Cervical mobilisationOther
The patients received a passive cervical mobilization that involved a grade III oscillatory unilateral posteroanterior mobilization to the right articular pillar of C5/C6 segment as described Maitland at a frequency of 2Hz. All the subjects were positioned in prone position as the protocol described by Sterling et al. for 3 sets of 2 minutes with 1 minute rest between sets.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Cervical Manipulation Receives: Other: Cervical manipulation |
| Experimental group 2 | Experimental | Cervical lateral glide Receives: Other: Cervical lateral glide |
| Control group | Placebo comparator | Cervical Mobilisation Receives: Other: Cervical mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Pressure Pain Thresholds (PPT) at 24 hours
PPT will be assessed bilaterally over the C7 zygapophyseal joint, epicondyle region, and trapezious muscle by an assessor blinded to the subjects condition.
Measured: 24 hours, 5 minutes after the treatment
Change from State-Trait Anxiety Inventory subscale (STAI-E) at 24 hours
Will be used to measure anxiety status
Measured: 24 hours, 5 minutes after the treatment
Secondary outcomes (2)
Beck depression Inventory (BDI-II)
Will be used to measure depression status
Measured: 24 hours, 5 minutes after the treatment
Tampa Scale for Kinesiophobia
Will be used to measure Kinesiophobia status
Measured: 24 hours, 5 minutes after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionJun 2011
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.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi ETS
- Investigators
- JORGE H VILLAFAÑE, PhD, Principal investigator, Don Gnocchi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782585
- Sponsor's protocol ID
- Psychological interaction
- Status last verified
- May 2016
- First submitted
- 17 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alonso-Perez JL, Lopez-Lopez A, La Touche R, Lerma-Lara S, Suarez E, Rojas J, Bishop MD, Villafane JH, Fernandez-Carnero J. Hypoalgesic effects of three different manual therapy techniques on cervical spine and psychological interaction: A randomized clinical trial. J Bodyw Mov Ther. 2017 Oct;21(4):798-803. doi: 10.1016/j.jbmt.2016.12.005. Epub 2016 Dec 22.
PubMed 29037630
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoalgesic Effects of Three Different Manual Therapy Techniques on Cervical Spine and Psychological Interaction: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02782585
- Acronym / sponsor ID
- Psychological interaction
- Conditions
- Neck Pain
- Keywords
- neck pain, Manual therapy, psychological interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 May 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.
Manual therapy (MT) techniques applied over cervical region have over both local (neck) and distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological mechanisms are hypothesized to explain the underlying effects, with effects originating from peripheral mechanisms, spinal cord and supraspinal mechanisms.
There is also an increasing interest in the study of the role of psychological variables in the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or kinesiophobia are related to poor prognosis in the development of pain outcomes and disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Other: Cervical manipulationCervical Manipulation |
| Experimental group 2 | Experimental | Other: Cervical lateral glideCervical lateral glide |
| Control group | Placebo comparator | Other: Cervical mobilisationCervical Mobilisation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Neck pain
Key exclusion criteria (8 listed)
- myelopathy
- fracture
- infection
- dystonia
- tumor
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 |
|---|---|---|
| Cervical manipulationThe therapist cradled the subject´s head with the other hand. Gentle ipsilateral side flexion and contralateral rotation to the targeted side were introduced until slight tension was perceived in the tissues at the contact point. The High velocity, low amplitude (HVLA) manipulation was directed upward and medially in the direction of the subject´s contralateral eye. The therapist monitored for cavitation or 'popping sound' accompanying the manipulations. If an audible popping sound was not heard during the first manipulative attempt, the procedure was repeated in the second time. | Other | Experimental group 1 |
| Cervical lateral glideThe upper limb of the right side of subjects was maintained in rest, with the arm along the trunk and the hand over the abdominal wall. The right hand of the treating therapist was positioned over scapula region, to depress the scapula while left hand cradled the occiput and neck above C5-C6 and left hand produced a passive lateral movement of the occipital and neck region. | Other | Experimental group 2 |
| Cervical mobilisationThe patients received a passive cervical mobilization that involved a grade III oscillatory unilateral posteroanterior mobilization to the right articular pillar of C5/C6 segment as described Maitland at a frequency of 2Hz. All the subjects were positioned in prone position as the protocol described by Sterling et al. for 3 sets of 2 minutes with 1 minute rest between sets. | Other | Control group |
Primary outcome
Change from Pressure Pain Thresholds (PPT) at 24 hours
Time frame: 24 hours, 5 minutes after the treatment
PPT will be assessed bilaterally over the C7 zygapophyseal joint, epicondyle region, and trapezious muscle by an assessor blinded to the subjects condition.
Change from State-Trait Anxiety Inventory subscale (STAI-E) at 24 hours
Time frame: 24 hours, 5 minutes after the treatment
Will be used to measure anxiety status
2 secondary outcomes
Beck depression Inventory (BDI-II)
Time frame: 24 hours, 5 minutes after the treatment
Tampa Scale for Kinesiophobia
Time frame: 24 hours, 5 minutes after the 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 25 May 2016.
- Derived from this study: PubMed 29037630Alonso-Perez JL, Lopez-Lopez A, La Touche R, Lerma-Lara S, Suarez E, Rojas J, Bishop MD, Villafane JH, Fernandez-Carnero J. Hypoalgesic effects of three different manual therapy techniques on cervical spine and psychological interaction: A randomized clinical trial. J Bodyw Mov Ther. 2017 Oct;21(4):798-803. doi: 10.1016/j.jbmt.2016.12.005. Epub 2016 Dec 22.
- 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.
JORGE H VILLAFAÑE, PhD principal investigator
Don Gnocchi Foundation
Questions about this trial
What is this clinical trial studying?
A study testing Cervical manipulation, Cervical lateral glide and Cervical mobilisation in people with Neck Pain, run by Fondazione Don Carlo Gnocchi ETS.
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 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 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Pressure Pain Thresholds (PPT) at 24 hours (time frame: 24 hours, 5 minutes after the 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?
On the ClinicalTrials.gov record for NCT02782585, 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 25 May 2016.