Clinical trial NCT03949998: The Immediate Effects of Dry Needling on Post-concussion Syndrome
Official title: The Immediate Effects of Dry Needling on Post-concussion Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-Concussive Syndrome, Chronic
Keywords: Dry Needling
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In about 15% of adult concussion cases, symptoms last longer than 2 weeks and can largely impact the individual's ability to work, be physically active and participate in everyday life. These symptoms are often partially related to unresolved neck muscle tightness and other neck-related symptoms. Dry needling is a technique that uses acupuncture needles to release muscle knots, decrease neck muscle tightness and decrease neck pain. As far as the investigators are aware, there have been no studies looking at the effects of dry needling on symptoms of chronic concussion. This study will compare the effects of dry needling to traditional hands-on physiotherapy treatment of the neck for concussion-related symptoms. Participants with chronic concussion symptoms will receive either dry needling, hands-on manual physiotherapy or both. Concussion symptoms, symptom severity, neck range of motion and pain with pressure over neck muscles will be compared before and after treatment, and the day after treatment. The investigators expect that the greatest improvement in all of these will be seen in the group receiving both interventions, both immediately after treatment and the following day. If dry needling can immediately improve concussion symptoms, patients may better tolerate therapeutic exercise and experience quicker resolution of chronic symptoms.

Detailed description: All participants will be tested in clinic once, for approximately a half hour. For all groups, outcome measures relating to concussion symptoms, cervical range of motion and pain pressure thresholds will be taken prior to and after the intervention.

In the DN group, four muscles (upper fibres trapezius, cervical multifidus, levator scapulae and suboccipitals) will be palpated by a physiotherapist trained in dry needling. If a palpable trigger point is found, the physiotherapist will perform dry needling until a local twitch response is elicited. If a trigger point is not found, no dry needling will take place. In this way, up to 8 total muscles will be needled during the session. The participant will be in prone for the above procedure.

In the MT group, soft tissue release will be performed on the above four muscles bilaterally. Cervical traction (unilateral grade 3 oscillatory distraction technique, any cervical segment between C0/C1 and C7/C7, 3-5 sets of 30 seconds) and mobilization (unilateral inferior-medial-posterior or superior-anterior-lateral, grade 3 oscillatory, any cervical segment between C0/C1 and C7/C7, 3-5 sets of 30 seconds ) will also be performed if the physiotherapist deems it necessary, specific to the spinal level noted to be involved. In the DN+MT group, MT interventions will be performed first, followed by DN, of the four above muscles. Immediately following intervention, the outcome measures will all be re-tested. The participants will also be instructed to fill out the SCAT-5 Step 2 upon waking the next morning. Additionally, if one or more of the cervical motions caused pain during initial testing, they will be asked to repeat the motion and report the current level of pain on the VAS scale.

Eligibility criteria: Inclusion Criteria:

* experiencing concussion symptoms at least 4 weeks following an external impact injury to the head

Exclusion Criteria:

* medical diagnoses of depression and/or anxiety
* skull fractures
* subdural or epidural haematomas
* parenchymal bleeds
* recent infection
* vascular anomaly
* hypertension
* current or past smoker
* high cholesterol
* family history of stroke
* migraine
* malignant/inflammatory disease
* osteoporosis
* bleeding disorde
* damaged heart valves
* pacemaker or other electrical implants
* fear of needles

Primary outcomes:
measure: Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, immediately after intervention
timeFrame: within 10 minutes of intervention
measure: Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, 12-24 hours after intervention
timeFrame: 12-24 hours after intervention
measure: Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, immediately after intervention
timeFrame: within 10 minutes of intervention
measure: Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, 12-24 hours after intervention
timeFrame: 12-24 hours after intervention
measure: Change in baseline Cervical Range of Motion, immediately after intervention
timeFrame: within 10 minutes of intervention
measure: Change in baseline pain score with Cervical Range of Motion, immediately after intervention
timeFrame: within 10 minutes of intervention
measure: Change in baseline pain score with Cervical Range of Motion, 12-24 hours after intervention
timeFrame: 12-24 hours after intervention
measure: Change in baseline of Pain Pressure Threshold (the smallest amount of pressure that evokes pain) as measured using a pressure algometer, immediately after baseline
timeFrame: within 10 minutes of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Elora
country: Canada
facility: Eramosa Physiotherapy - Elora
state: Ontario
city: Guelph
country: Canada
facility: Eramosa Physiotherapy - Bullfrog Mall
state: Ontario
city: Guelph
country: Canada
facility: Health and Performance Centre
state: Ontario
Study officials:
affiliation: Adjunct Professor
name: Margo Mountjoy, MD
role: PRINCIPAL_INVESTIGATOR
References: