An interventional study of dry needling and Sham needling in Whiplash Syndrome and Neck Pain, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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.
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 40 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.
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Exclusion Criteria:
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.
Other: dry needling
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.
Other: Sham needling
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 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.
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.
Time frame: Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up
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.
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Baseline and one-week post-intervention follow-up
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of Valencia