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The Immediate Effects of Dry Needling on Post-concussion Syndrome

Primary Purpose

Post-Concussive Syndrome, Chronic

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dry Needling
Manual Therapy
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Concussive Syndrome, Chronic focused on measuring Dry Needling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eramosa Physiotherapy - Elora
  • Eramosa Physiotherapy - Bullfrog Mall
  • Health and Performance Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Dry Needling

Dry Needling + Manual Therapy

Manual Therapy

Arm Description

Participants will receive dry needling of the following muscles as indicated: upper fibres trapezius, levator scapulae, cervical multifidus, suboccipitals.

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.

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
April 29, 2019
Last Updated
November 5, 2020
Sponsor
University of Guelph
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1. Study Identification

Unique Protocol Identification Number
NCT03949998
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no participants
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussive Syndrome, Chronic
Keywords
Dry Needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
Participants will receive dry needling of the following muscles as indicated: upper fibres trapezius, levator scapulae, cervical multifidus, suboccipitals.
Arm Title
Dry Needling + Manual Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dry Needling
Other Intervention Name(s)
Intramuscular Stimulation (Gunn IMS), Integrated Dry Needling (IDN)
Intervention Description
Comparison between dry needling and/or manual therapy of the cervical region.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
soft tissue release, cervical traction and/or cervical mobilization
Primary Outcome Measure Information:
Title
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, immediately after intervention
Description
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)
Time Frame
within 10 minutes of intervention
Title
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom score, 12-24 hours after intervention
Description
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)
Time Frame
12-24 hours after intervention
Title
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, immediately after intervention
Description
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)
Time Frame
within 10 minutes of intervention
Title
Change from baseline Sport Concussion Assessment Tool v5 (SCAT-5) symptom severity, 12-24 hours after intervention
Description
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)
Time Frame
12-24 hours after intervention
Title
Change in baseline Cervical Range of Motion, immediately after intervention
Description
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
Time Frame
within 10 minutes of intervention
Title
Change in baseline pain score with Cervical Range of Motion, immediately after intervention
Description
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)
Time Frame
within 10 minutes of intervention
Title
Change in baseline pain score with Cervical Range of Motion, 12-24 hours after intervention
Description
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)
Time Frame
12-24 hours after intervention
Title
Change in baseline of Pain Pressure Threshold (the smallest amount of pressure that evokes pain) as measured using a pressure algometer, immediately after baseline
Description
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)
Time Frame
within 10 minutes of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margo Mountjoy, MD
Organizational Affiliation
Adjunct Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eramosa Physiotherapy - Elora
City
Elora
State/Province
Ontario
ZIP/Postal Code
N0B1S0
Country
Canada
Facility Name
Eramosa Physiotherapy - Bullfrog Mall
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1E6R2
Country
Canada
Facility Name
Health and Performance Centre
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The Immediate Effects of Dry Needling on Post-concussion Syndrome

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