Study Stopped
no participants
The Immediate Effects of Dry Needling on Post-concussion Syndrome
1 other identifier
interventional
N/A
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2019
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2020
CompletedNovember 9, 2020
November 1, 2020
1.5 years
April 29, 2019
November 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, immediately after intervention
Symptom numeric rating tool validated for concussion patients, 22 listed symptoms that are either present (scored 1) or absent (scored 0), minimum = 0 (good outcome), maximum = 22 (poor outcome)
within 10 minutes of intervention
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, 12-24 hours after intervention
Symptom numeric rating tool validated for concussion patients, 22 listed symptoms that are either present (scored 1) or absent (scored 0), minimum = 0 (good outcome), maximum = 22 (poor outcome)
12-24 hours after intervention
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, immediately after intervention
Symptom numeric rating tool validated for concussion patients, 22 listed symptoms that are scored from 0 (absent) to 6 (worst imaginable), minimum = 0 (good outcome), maximum = 132 (poor outcome)
within 10 minutes of intervention
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, 12-24 hours after intervention
Symptom numeric rating tool validated for concussion patients, 22 listed symptoms that are scored from 0 (absent) to 6 (worst imaginable), minimum = 0 (good outcome), maximum = 132 (poor outcome)
12-24 hours after intervention
Change in baseline Cervical Range of Motion, immediately after intervention
Cervical Active Range in flexion, extension, bilateral side flexion, bilateral rotation, measured in degrees using a CROM (Cervical Range of Motion) tool that measures multidirectional movement, each of the 6 ranges will be reported on their own in degrees and the 6 will also be added together for a total range measurement in degrees
within 10 minutes of intervention
Change in baseline pain score with Cervical Range of Motion, immediately after intervention
Pain Rating Scale at end of range flexion, extension, bilateral side flexion, bilateral rotation (as measured in Outcome 5), scored 0 (no pain) - 10 (worst pain imaginable), 0 = best outcome, 10 = worst outcome, total score for all 6 movements will be computed out of 60 (0=best, 60=worst)
within 10 minutes of intervention
Change in baseline pain score with Cervical Range of Motion, 12-24 hours after intervention
Pain Rating Scale at end of range flexion, extension, bilateral side flexion, bilateral rotation (as measured in Outcome 5), scored 0 (no pain) - 10 (worst pain imaginable), 0 = best outcome, 10 = worst outcome, total score for all 6 movements will be computed out of 60 (0=best, 60=worst)
12-24 hours after intervention
Change in baseline of Pain Pressure Threshold (the smallest amount of pressure that evokes pain) as measured using a pressure algometer, immediately after baseline
The pressure algometer is applied to the test muscle (in this case bilateral upper fibres trapezius, levator scapulae, suboccipital group and cervical multifidus at the base of the neck) and pressure is applied incrementally until pain is reported, the outcome is the least amount of pressure (in kilograms) applied over a muscle that evokes pain (lowest = 0 kg, higher values are better outcomes)
within 10 minutes of intervention
Study Arms (3)
Dry Needling
EXPERIMENTALParticipants will receive dry needling of the following muscles as indicated: upper fibres trapezius, levator scapulae, cervical multifidus, suboccipitals.
Dry Needling + Manual Therapy
ACTIVE COMPARATORParticipants will receive dry needling of the following muscles as indicated: upper fibres trapezius, levator scapulae, cervical multifidus, suboccipitals IN ADDITION TO manual therapy of the above muscles and/or cervical joint traction and/or mobilization as indicated.
Manual Therapy
ACTIVE COMPARATORParticipants will receive manual therapy of the following muscles as indicated: upper fibres trapezius, levator scapulae, cervical multifidus, suboccipitals and/or cervical joint traction and/or mobilization as indicated.
Interventions
Comparison between dry needling and/or manual therapy of the cervical region.
soft tissue release, cervical traction and/or cervical mobilization
Eligibility Criteria
You may qualify if:
- experiencing concussion symptoms at least 4 weeks following an external impact injury to the head
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Eramosa Physiotherapy - Elora
Elora, Ontario, N0B1S0, Canada
Eramosa Physiotherapy - Bullfrog Mall
Guelph, Ontario, N1E6R2, Canada
Health and Performance Centre
Guelph, Ontario, N1G2W1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margo Mountjoy, MD
Adjunct Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 14, 2019
Study Start
May 15, 2019
Primary Completion
November 5, 2020
Study Completion
November 5, 2020
Last Updated
November 9, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share