Whiplash SyndromeNCT03838224
A Single Dry Needling Session of the Obliquus Capitis Inferior for the Altered Sensorimotor Function in People With Neck Pain
A study testing dry needling in people with Whiplash Syndrome and Neck Pain, run by University of Valencia at 1 site in Spain.
Trial summary
Neck pain is the 3rd cause of disability worldwide and represents an enormous socioeconomic burden. It has been reported that people with neck pain, with traumatic and non-traumatic onset, have an alteration of the sensorimotor function compared to pain-free people, such as deficits in the head and neck repositioning… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Whiplash Syndrome, Neck Pain
- What is being tested?
- dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2019to 30 Jun 2019
- 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
- Neck pain longer than 3 months (traumatic or non-traumatic)
- Neck disability index (NDI) ≥10
- Visual analogue scale (VAS) ≥3
- Joint position error (JPE) ≥4.5º determined in the physical examination prior to enrollment
Who cannot join
- Previous cervical spine surgery
- Spine fracture
- Any neurological signs
- Cervical stenosis
- Needle phobia/fear of needles
- Anticoagulant medication consumption
Show all 9Show fewer
- Pregnancy
- Known or suspected vestibular pathology
- Vertigo or dizziness from ear or brain disorders, sensory nerve pathways (e.g. BPPV).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Single Dry Needling Session of the Obliquus Capitis Inferior on the Altered Sensorimotor Function in People With Neck Pain: a Random Control Trial
Neck pain is the 3rd cause of disability worldwide and represents an enormous socioeconomic burden. It has been reported that people with neck pain, with traumatic and non-traumatic onset, have an alteration of the sensorimotor function compared to pain-free people, such as deficits in the head and neck repositioning or alteration of the body balance. It has been suggested that alterations on the proprioception of the suboccipital muscles may cause a decrease in head and neck repositioning accuracy and changes in head and neck positioning patterns. The suboccipital muscles, particularly the obliquus capitis inferior (OCI), has a greater density of muscular spindles compared to lower cervical segments, which is believed to play an important role in the proprioception. The alteration of the JPE is more often found in patients with a dysfunction in the upper cervical spine, but people with lower dysfunction can also exhibit it. However, no conclusive results on JPE have been reported with articular techniques targeting the upper cervical spine. On the contrary, positive results on this test have been observed after the retraining of the upper cervical muscles. As OCI is a deep muscle, dry needling seems to be the most appropriate passive modality of treatment to target that muscle and restore the abnormal cervical sensorimotor control. However, this hypothesis has never been tested.
Read the detailed description
The aim of the proposed study is to investigate if a single dry needling (DN) session modifies the altered sensorimotor function in people with neck pain. The secondary objectives will be to investigate the effects of a single DN session on muscle length (indirectly measured with FRT) and to investigate the effects of a single DN session on self-reported pain.
With this aim, a random control trial (RCT) design will be conducted with two groups; intervention group (dry needling of the OCI) and placebo group (sham needling). Sham needling has shown to be a valid control method in dry needling research.
The study will take two days. In the first day, the outcome measures will be measured before (baseline) and immediately after the intervention (immediate follow-up). In the second day (one-week follow-up), outcome measures will be measured again. Pain intensity, measured with the visual analogue scale, will be only measured at baseline and one-week follow-up.
The baseline and follow-up assessments will be performed by an independent assessor who will be blinded to the intervention allocation. The interventions will be provided by a therapist with dry needling training and 3-years of musculoskeletal experience who will be blinded to outcome measures.
- Conditions
- Whiplash Syndrome, Neck Pain
- Being tested
- dry needling, Sham needling
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
Participants allocated in this group will receive a single session of dry needling of the obliquus capitis inferior. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The needle was shown to the participant before the intervention. Participants will be requested to lie in prone on the plinth. Participants' skin will be sterilized with antiseptic spray for the skin. The therapist will clean his hands and use sterilized gloves. The needle will be moved up and down within the muscle, using a "fast-in and fast-out" technique. Needle insertions will be repeated 12 times.
Sham needlingOther
Sham needling has shown to be a valid control method in dry needling research. The procedure in the sham group will be the same as the experimental group to guarantee the participants' blinding. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The sham needle (same appearance/material as the true needle) was shown to the participant before the intervention to guarantee the blinding.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Participants allocated in this group will receive a single session of dry needling of the obliquus capitis inferior. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The needle was shown to the participant before the intervention. Participants will be requested to lie in prone on the plinth. Participants' skin will be sterilized with antiseptic spray for the skin. The therapist will clean his hands and use sterilized gloves. Receives: Other: dry needling |
| sham needling | Sham comparator | Sham needling has shown to be a valid control method in dry needling research. The procedure in the sham group will be the same as the experimental group to guarantee the participants' blinding. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The sham needle (same appearance/material as the true needle) was shown to the participant before the intervention to guarantee the blinding. Receives: Other: Sham needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Joint position error (JPE)
Cervical JPE will be measured using a laser-pointer attached to a lightweight headband. In sitting position, 90 cm away from a target and blindfolded, patients will be requested to rotate to the right and to the left. An absolute error between the starting and end points will be calculated in millimeters and then converted to degrees. Six repetitions will be performed each side according to recommendations and the mean will be calculated.
Measured: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Secondary outcomes (6)
Change in Cervical movement sense
Participants will trace with the laser-pointer in their heads a specific pattern (located at 100 cm distance) at two velocities (accurate; accurate and fast). This test will be recorded and later examined at slow motion by a video analysis programme. Time (total time taken to complete the pattern), error frequency (number of deviations) and error magnitude (sum of deviations multiplied by the distance from the central line) will be measured. This test has shown high intra and inter-rater reliability.
Measured: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Postural stability
Patients will be positioned on the force platform. The postural sway will be measured in 4 conditions as follows: (neutral) narrow stance (feet close together) on firm and soft surfaces with eyes open and eyes closed
Measured: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Active cervical range of motion (rotation)
Cervical ROM in rotation will be measured bilaterally with the patients in sitting position using a Cervical Range of Motion (CROM) instrument, which has been shown to be a reliable and valid tool.
Measured: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Cervical flexion-rotation test (CFRT)
Upper cervical ROM in rotation will be measured bilaterally with the CFRT using the CROM. Participants will be requested to lie in supine on the plitch and the examiner will perform rotation passively with the rest of the cervical spine blocked in full flexion position. This test has shown to be a valid and reliable tool to measure the range of motion of the upper cervical spine (C1-C2).
Measured: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Smooth pursuit neck torsion (SPNT)
This test is understood to assess eye movement disturbances due to altered cervical afferent input. Patients will be sat in a neutral position on a swivel chair and will be requested to follow a pen in the hand of the examiner (with their eyes) whilst keeping their head still. The pen will be moved at the participant's natural focal length across their field of vision horizontally in a visual range of 40 degrees several times. The speed of the movement will be 20 degrees per second. Pursuit of the eyes will be observed. The test will be repeated with the neck torsioned to the left and right by rotating the trunk and shoulders to the right 45 degrees, keeping the head still. This is done so that input to the vestibular system is avoided.
Increased catch up saccades in the torsion position especially as they cross the midline and/or reproduction of symptoms in the torsion position compared to the neutral position is a positive test.
Measured: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Neck pain intensity
Neck pain intensity will be measured using a visual analogue scale (VAS). Patients will be requested to grade their pain intensity of neck pain experienced on a 0-100 mm horizontal line (0 mm= no pain and 100 mm= worst pain imaginable).
Measured: Baseline and one-week post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start12 Mar 2019
- Primary completion15 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Whiplash SyndromeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Lluch Girbés, University of Valencia
- Investigators
- Enrique Lluch, PhD, Study director, Physiotherapy Department University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838224
- Sponsor's protocol ID
- H1542206264486
- Status last verified
- Aug 2019
- First submitted
- 29 Jan 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.
PubMed 17143898Kulkarni V, Chandy MJ, Babu KS. Quantitative study of muscle spindles in suboccipital muscles of human foetuses. Neurol India. 2001 Dec;49(4):355-9.
PubMed 11799407Mitchell UH, Stoneman P, Larson RE, Page GL. The Construction of Sham Dry Needles and Their Validity. Evid Based Complement Alternat Med. 2018 Jun 14;2018:9567061. doi: 10.1155/2018/9567061. eCollection 2018.
PubMed 30013605Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.
PubMed 24792139Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91.
PubMed 2009044Treleaven J, Clamaron-Cheers C, Jull G. Does the region of pain influence the presence of sensorimotor disturbances in neck pain disorders? Man Ther. 2011 Dec;16(6):636-40. doi: 10.1016/j.math.2011.07.008. Epub 2011 Sep 3.
PubMed 21890397Hallgren RC, Andary MT, Wyman AJ, Rowan JJ. A standardized protocol for needle placement in suboccipital muscles. Clin Anat. 2008 Sep;21(6):501-8. doi: 10.1002/ca.20660.
PubMed 18627103Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
PubMed 20436238Hall T, Robinson K. The flexion-rotation test and active cervical mobility--a comparative measurement study in cervicogenic headache. Man Ther. 2004 Nov;9(4):197-202. doi: 10.1016/j.math.2004.04.004.
PubMed 15522644Hall TM, Robinson KW, Fujinawa O, Akasaka K, Pyne EA. Intertester reliability and diagnostic validity of the cervical flexion-rotation test. J Manipulative Physiol Ther. 2008 May;31(4):293-300. doi: 10.1016/j.jmpt.2008.03.012.
PubMed 18486750Kamper SJ, Grootjans SJ, Michaleff ZA, Maher CG, McAuley JH, Sterling M. Measuring pain intensity in patients with neck pain: does it matter how you do it? Pain Pract. 2015 Feb;15(2):159-67. doi: 10.1111/papr.12169. Epub 2014 Jan 17.
PubMed 24433369Silva AG, Cruz AL. Standing balance in patients with whiplash-associated neck pain and idiopathic neck pain when compared with asymptomatic participants: A systematic review. Physiother Theory Pract. 2013 Jan;29(1):1-18. doi: 10.3109/09593985.2012.677111. Epub 2012 Apr 20.
PubMed 22515180Swait G, Rushton AB, Miall RC, Newell D. Evaluation of cervical proprioceptive function: optimizing protocols and comparison between tests in normal subjects. Spine (Phila Pa 1976). 2007 Nov 15;32(24):E692-701. doi: 10.1097/BRS.0b013e31815a5a1b.
PubMed 18007229Takasaki H, Hall T, Oshiro S, Kaneko S, Ikemoto Y, Jull G. Normal kinematics of the upper cervical spine during the Flexion-Rotation Test - In vivo measurements using magnetic resonance imaging. Man Ther. 2011 Apr;16(2):167-71. doi: 10.1016/j.math.2010.10.002. Epub 2010 Nov 4.
PubMed 21055995Werner IM, Ernst MJ, Treleaven J, Crawford RJ. Intra and interrater reliability and clinical feasibility of a simple measure of cervical movement sense in patients with neck pain. BMC Musculoskelet Disord. 2018 Oct 5;19(1):358. doi: 10.1186/s12891-018-2287-0.
PubMed 30290759
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Dry Needling Session of the Obliquus Capitis Inferior on the Altered Sensorimotor Function in People With Neck Pain: a Random Control Trial
- ClinicalTrials.gov ID
- NCT03838224
- Acronym / sponsor ID
- H1542206264486
- Conditions
- Whiplash Syndrome, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 12 Feb 2019 (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.
Neck pain is the 3rd cause of disability worldwide and represents an enormous socioeconomic burden. It has been reported that people with neck pain, with traumatic and non-traumatic onset, have an alteration of the sensorimotor function compared to pain-free people, such as deficits in the head and neck repositioning or alteration of the body balance. It has been suggested that alterations on the proprioception of the suboccipital muscles may cause a decrease in head and neck repositioning accuracy and changes in head and neck positioning patterns. The suboccipital muscles, particularly the obliquus capitis inferior (OCI), has a greater density of muscular spindles compared to lower cervical segments, which is believed to play an important role in the proprioception. The alteration of the JPE is more often found in patients with a dysfunction in the upper cervical spine, but people with lower dysfunction can also exhibit it. However, no conclusive results on JPE have been reported with articular techniques targeting the upper cervical spine. On the contrary, positive results on this test have been observed after the retraining of the upper cervical muscles. As OCI is a deep muscle, dry needling seems to be the most appropriate passive modality of treatment to target that muscle and restore the abnormal cervical sensorimotor control. However, this hypothesis has never been tested.
Detailed description
The aim of the proposed study is to investigate if a single dry needling (DN) session modifies the altered sensorimotor function in people with neck pain. The secondary objectives will be to investigate the effects of a single DN session on muscle length (indirectly measured with FRT) and to investigate the effects of a single DN session on self-reported pain.
With this aim, a random control trial (RCT) design will be conducted with two groups; intervention group (dry needling of the OCI) and placebo group (sham needling). Sham needling has shown to be a valid control method in dry needling research.
The study will take two days. In the first day, the outcome measures will be measured before (baseline) and immediately after the intervention (immediate follow-up). In the second day (one-week follow-up), outcome measures will be measured again. Pain intensity, measured with the visual analogue scale, will be only measured at baseline and one-week follow-up.
The baseline and follow-up assessments will be performed by an independent assessor who will be blinded to the intervention allocation. The interventions will be provided by a therapist with dry needling training and 3-years of musculoskeletal experience who will be blinded to outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: dry needlingParticipants allocated in this group will receive a single session of dry needling of the obliquus capitis inferior. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The needle was shown to the participant before the intervention. Participants will be requested to lie in prone on the plinth. Participants' skin will be sterilized with antiseptic spray for the skin. The therapist will clean his hands and use sterilized gloves. |
| sham needling | Sham comparator | Other: Sham needlingSham needling has shown to be a valid control method in dry needling research. The procedure in the sham group will be the same as the experimental group to guarantee the participants' blinding. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The sham needle (same appearance/material as the true needle) was shown to the participant before the intervention to guarantee the blinding. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neck pain longer than 3 months (traumatic or non-traumatic)
- Neck disability index (NDI) ≥10
- Visual analogue scale (VAS) ≥3
- Joint position error (JPE) ≥4.5º determined in the physical examination prior to enrollment
Key exclusion criteria (9 listed)
- Previous cervical spine surgery
- Spine fracture
- Any neurological signs
- Cervical stenosis
- Needle phobia/fear of needles
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 |
|---|---|---|
| dry needlingParticipants allocated in this group will receive a single session of dry needling of the obliquus capitis inferior. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The needle was shown to the participant before the intervention. Participants will be requested to lie in prone on the plinth. Participants' skin will be sterilized with antiseptic spray for the skin. The therapist will clean his hands and use sterilized gloves. The needle will be moved up and down within the muscle, using a "fast-in and fast-out" technique. Needle insertions will be repeated 12 times. | Other | Dry needling |
| Sham needlingSham needling has shown to be a valid control method in dry needling research. The procedure in the sham group will be the same as the experimental group to guarantee the participants' blinding. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The sham needle (same appearance/material as the true needle) was shown to the participant before the intervention to guarantee the blinding. | Other | sham needling |
Primary outcome
Change in Joint position error (JPE)
Time frame: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Cervical JPE will be measured using a laser-pointer attached to a lightweight headband. In sitting position, 90 cm away from a target and blindfolded, patients will be requested to rotate to the right and to the left. An absolute error between the starting and end points will be calculated in millimeters and then converted to degrees. Six repetitions will be performed each side according to recommendations and the mean will be calculated.
6 secondary outcomes
Change in Cervical movement sense
Time frame: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Postural stability
Time frame: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Active cervical range of motion (rotation)
Time frame: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Cervical flexion-rotation test (CFRT)
Time frame: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Smooth pursuit neck torsion (SPNT)
Time frame: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
Change in Neck pain intensity
Time frame: Baseline and one-week post-intervention follow-up
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 13 Aug 2019.
- Background: PubMed 17143898Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.
- Background: PubMed 11799407Kulkarni V, Chandy MJ, Babu KS. Quantitative study of muscle spindles in suboccipital muscles of human foetuses. Neurol India. 2001 Dec;49(4):355-9.
- Background: PubMed 30013605Mitchell UH, Stoneman P, Larson RE, Page GL. The Construction of Sham Dry Needles and Their Validity. Evid Based Complement Alternat Med. 2018 Jun 14;2018:9567061. doi: 10.1155/2018/9567061. eCollection 2018.
- Background: PubMed 24792139Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.
- Background: PubMed 2009044Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91.
- Background: PubMed 21890397Treleaven J, Clamaron-Cheers C, Jull G. Does the region of pain influence the presence of sensorimotor disturbances in neck pain disorders? Man Ther. 2011 Dec;16(6):636-40. doi: 10.1016/j.math.2011.07.008. Epub 2011 Sep 3.
- Background: PubMed 18627103Hallgren RC, Andary MT, Wyman AJ, Rowan JJ. A standardized protocol for needle placement in suboccipital muscles. Clin Anat. 2008 Sep;21(6):501-8. doi: 10.1002/ca.20660.
- Background: PubMed 20436238Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
- Background: PubMed 15522644Hall T, Robinson K. The flexion-rotation test and active cervical mobility--a comparative measurement study in cervicogenic headache. Man Ther. 2004 Nov;9(4):197-202. doi: 10.1016/j.math.2004.04.004.
- Background: PubMed 18486750Hall TM, Robinson KW, Fujinawa O, Akasaka K, Pyne EA. Intertester reliability and diagnostic validity of the cervical flexion-rotation test. J Manipulative Physiol Ther. 2008 May;31(4):293-300. doi: 10.1016/j.jmpt.2008.03.012.
- Background: PubMed 24433369Kamper SJ, Grootjans SJ, Michaleff ZA, Maher CG, McAuley JH, Sterling M. Measuring pain intensity in patients with neck pain: does it matter how you do it? Pain Pract. 2015 Feb;15(2):159-67. doi: 10.1111/papr.12169. Epub 2014 Jan 17.
- Background: PubMed 22515180Silva AG, Cruz AL. Standing balance in patients with whiplash-associated neck pain and idiopathic neck pain when compared with asymptomatic participants: A systematic review. Physiother Theory Pract. 2013 Jan;29(1):1-18. doi: 10.3109/09593985.2012.677111. Epub 2012 Apr 20.
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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.
Enrique Lluch, PhD study director
Physiotherapy Department University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling in people with Whiplash Syndrome and Neck Pain, run by University of Valencia 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 9 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 13 Aug 2019. 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?
Change in Joint position error (JPE) (time frame: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up). 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 NCT03838224, which also lists 15 linked publications.
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 13 Aug 2019.