Post-Concussive Syndrome, ChronicNCT03949998
The Immediate Effects of Dry Needling on Post-concussion Syndrome
A study testing Dry Needling and Manual Therapy in people with Post-Concussive Syndrome, Chronic, run by University of Guelph at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Concussive Syndrome, Chronic
- What is being tested?
- Dry Needling and Manual Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesCanada
- Study dates
- 15 May 2019to 5 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- experiencing concussion symptoms at least 4 weeks following an external impact injury to the head
Who cannot join
- medical diagnoses of depression and/or anxiety
- skull fractures
- subdural or epidural haematomas
- parenchymal bleeds
- recent infection
- vascular anomaly
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Eramosa Physiotherapy - Elora
Elora, Ontario, N0B1S0
Eramosa Physiotherapy - Bullfrog Mall
Guelph, Ontario, N1E6R2
Health and Performance Centre
Guelph, Ontario, N1G2W1
About this study
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.
Read the 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.
- Conditions
- Post-Concussive Syndrome, Chronic
- Being tested
- Dry Needling, Manual Therapy
- Keywords
- Dry Needling
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
Also called Intramuscular Stimulation (Gunn IMS), Integrated Dry Needling (IDN)
Comparison between dry needling and/or manual therapy of the cervical region.
Manual TherapyOther
soft tissue release, cervical traction and/or cervical mobilization
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | Participants will receive dry needling of the following muscles as indicated: upper fibres trapezius, levator scapulae, cervical multifidus, suboccipitals. Receives: Device: Dry Needling |
| Dry Needling + Manual Therapy | Active comparator | Participants 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. Receives: Device: Dry Needling; Other: Manual Therapy |
| Manual Therapy | Active comparator | Participants 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. Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: within 10 minutes of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start15 May 2019
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Why it stopped: no participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussive Syndrome, ChronicStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Margo Mountjoy, University of Guelph
- Investigators
- Margo Mountjoy, MD, Principal investigator, Adjunct Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949998
- Sponsor's protocol ID
- 19-02-035
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2019
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Dry Needling on Post-concussion Syndrome
- ClinicalTrials.gov ID
- NCT03949998
- Acronym / sponsor ID
- 19-02-035
- Conditions
- Post-Concussive Syndrome, Chronic
- Keywords
- Dry Needling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 14 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Device: Dry NeedlingParticipants will receive dry needling of the following muscles as indicated: upper fibres trapezius, levator scapulae, cervical multifidus, suboccipitals. |
| Dry Needling + Manual Therapy | Active comparator | Device: Dry Needling, Other: Manual TherapyParticipants 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 comparator | Other: Manual TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- experiencing concussion symptoms at least 4 weeks following an external impact injury to the head
Key exclusion criteria (17 listed)
- medical diagnoses of depression and/or anxiety
- skull fractures
- subdural or epidural haematomas
- parenchymal bleeds
- recent infection
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 NeedlingAlso: Intramuscular Stimulation (Gunn IMS), Integrated Dry Needling (IDN)Comparison between dry needling and/or manual therapy of the cervical region. | Device | Dry Needling, Dry Needling + Manual Therapy |
| Manual Therapysoft tissue release, cervical traction and/or cervical mobilization | Other | Dry Needling + Manual Therapy, Manual Therapy |
Primary outcome
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, immediately after intervention
Time frame: within 10 minutes of 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)
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, 12-24 hours after intervention
Time frame: 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)
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, immediately after intervention
Time frame: within 10 minutes of 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)
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, 12-24 hours after intervention
Time frame: 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)
Change in baseline Cervical Range of Motion, immediately after intervention
Time frame: within 10 minutes of 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
Change in baseline pain score with Cervical Range of Motion, immediately after intervention
Time frame: within 10 minutes of 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)
Change in baseline pain score with Cervical Range of Motion, 12-24 hours after intervention
Time frame: 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)
Change in baseline of Pain Pressure Threshold (the smallest amount of pressure that evokes pain) as measured using a pressure algometer, immediately after baseline
Time frame: within 10 minutes of intervention
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Margo Mountjoy, MD principal investigator
Adjunct Professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Manual Therapy in people with Post-Concussive Syndrome, Chronic, run by University of Guelph at 3 sites in Canada.
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 1 inclusion and 17 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: withdrawn, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. 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 was withdrawn before enrolling participants, so there are no results.
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 from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, immediately after intervention (time frame: within 10 minutes of intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.