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Clinical Trials/NCT03838224
NCT03838224CompletedNot Applicable

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

University of Valencia1 site in 1 country40 target enrollmentStarted: March 12, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Change in Joint position error (JPE)

Study Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Previous cervical spine surgery
  • •Spine fracture
  • •Any neurological signs
  • •Cervical stenosis
  • •Needle phobia/fear of needles
  • •Anticoagulant medication consumption
  • •Pregnancy
  • •Known or suspected vestibular pathology
  • •Vertigo or dizziness from ear or brain disorders, sensory nerve pathways (e.g. BPPV).

Arms & Interventions

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.

Intervention: dry needling (Other)

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.

Intervention: Sham needling (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in Postural stability(Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up)
  • Change in Neck pain intensity(Baseline and one-week post-intervention follow-up)
  • Change in Cervical movement sense(Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up)
  • Change in Active cervical range of motion (rotation)(Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up)
  • Change in Cervical flexion-rotation test (CFRT)(Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up)
  • Change in Smooth pursuit neck torsion (SPNT)(Baseline, immediate post-intervention follow-up and one-week post-intervention follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Enrique Lluch Girbés

Principal investigator

University of Valencia

Study Sites (1)

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