Whiplash-associated Disorders - Needling Treatments Pilot Study
A Pilot Case Randomized Control Study Analysing the Effectiveness of 3 Needling Techniques: Intramuscular Stimulation, Neural Prolotherapy, and Myofascial Release in the Treatment of Chronic Whiplash Associated Disorder.
1 other identifier
interventional
32
1 country
1
Brief Summary
This pilot study is being conducted to provide proof of concept for three recently developed needling treatments, in the treatment of whiplash associated disorder type 2 (WAD-II). The investigators aim to show that these techniques should be considered as regular, effective options for people suffering from WAD-II. These techniques are Intramuscular stimulation (IMS), neural prolotherapy (NPT), and myoActivation (mA). Additionally, the investigators plan to begin profiling responders and non-responders in an effort to identify which treatment is likely to work best for different people. In the future, this may help to expedite treatment for WAD-II, helping patients get the most appropriate treatment, more quickly. The investigators expect to show that all three treatments are significantly better than a placebo treatment, and to collect information on what makes each technique more or less likely to work for individual cases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2013
Typical duration for not_applicable
1 active site
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 2, 2013
CompletedFirst Posted
Study publicly available on registry
April 5, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedAugust 26, 2015
August 1, 2015
2.5 years
April 2, 2013
August 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Brief Pain Inventory - Short Form at 6 months post-treatment
baseline and 6 months after 12-week treatment is complete
Secondary Outcomes (5)
Change in Neck Disability Index at 6-months post treatment
baseline and 6 months after 12-week treatment is complete
Change in cervical range of motion at 6 months post-treatment
baseline and 6 months after 12-week treatment is complete
Change in 7-item Generalized Anxiety Disorder Scale (GAD-7) 6 months post-treatment
baseline and 6 months after 12-week treatment is complete
Change in Depression as measured by the 9-item Patient Health Questionnaire (PHQ-9) 6 months post-treatment
baseline and 6 months after 12-week treatment is complete
Change in catastrophizing as measured by the Pain-Related Self-Statements Questionnaire (PRSS) 6 months post-treatment
baseline and 6 months after 12-week treatment is complete
Study Arms (4)
Intramuscular Stimulation
EXPERIMENTALParticipants in this group will receive up to 12 sessions of Intramuscular Stimulation (IMS). Each session may last from 30 to 60 minutes. Primary and secondary outcome measures will be assessed prior to the first treatment, after completion of the last treatment, and 6 months after treatment is complete.
myoActivation
EXPERIMENTALParticipants in this group will receive up to 12 sessions of myoActivation treatment. Each treatment is approximately 15 minutes. Primary and Secondary outcome measures will be assessed prior to treatment, one week after all treatments have been completed, and again 6 months after treatment is complete.
Neural Prolotherapy
EXPERIMENTALParticipants in this group will receive up to 12 sessions of neural prolotherapy. treatment. Each treatment is approximately 30 to 60 minutes minutes. Primary and Secondary outcome measures will be assessed prior to treatment, one week after all treatments have been completed, and again 6 months after treatment is complete.
Sham Needling Control
SHAM COMPARATORParticipants in this group will receive up to 12 sessions of sham needle treatment. Each treatment is approximately 15 to 60 minutes. Primary and Secondary outcome measures will be assessed prior to treatment, one week after all treatments have been completed, and again 6 months after treatment is complete.
Interventions
Intramuscular Stimulation is the insertion of fine, flexible needles into shortened muscle tissue. No substance is injected. In shortened or supersensitive muscles, stimulation of stretch receptors in the muscle causes a lengthening response in the affected tissue. This reflex response is felt by the patient as a cramping sensation which releases as the muscle returns to a normal length. Needles may be inserted and removed immediately or inserted and left in the tissue for several minutes. Practitioners may also use the approach of "twirling" the needles to enhance the grasping response in the muscle.
In myoActivation treatments, a fine needle is used to administer a micro-injection (less than .2 mL) of saline (0.9%) targeted to muscle, fascia, connective tissue, and scar tissue. The needle is inserted into shortened muscle tissue to elicit a reflex response that lengthens the tissue and promotes a healing response. One session includes between 10 and 80 needle insertions, and is a combination of deep and shallow needling techniques. Additionally, the practitioner treats superficial fascia and scar tissue by using multiple shallow needle insertions to a scarred area and/or areas of abnormal elevation and depression in the skin.
Participants in the neural prolotherapy group will receive micro-injections of a dextrose or mannitol solution directly under the skin using a very fine needle. This treatment targets the superficial cutaneous nerves. It is suggested that these injections quickly reduce cutaneous nerve edema, allowing these nerves to freely cross the fascia to reach the skin. Treatments may include up to 200 micro-injections with a fine needle. Injections follow major nerve routes associated with neck and upper back pain.
The sham needling control group will receive up to 5 needle insertions in areas unrelated directly to whiplash pain. No injection will be given though participants in this group will not be aware of the presence or absence of a substance injection. Sham treatments will take anywhere from 15 to 60 minutes, to preserve blindness.
Eligibility Criteria
You may qualify if:
- Between 19 and 75 years of age
- At least 12 months post-trauma
- Present with neck and upper back pain (with or without headaches) , matching criteria for WAD-II
- Presence of palpable painful points, a necessary indicator that a patient is suitable candidate for treatment
You may not qualify if:
- Widespread pain
- History of pre-existing or comorbid chronic pain conditions
- Use of anti-coagulants (eg: Coumadin, Warfarin, other prescription anti-coagulants/blood thinners)
- Immune deficiency and/or use of immunosuppressants (especially those with splenectomy)
- Autoimmune disorders such as lupus or rheumatoid arthritis
- HIV, viral hepatitis and other blood borne communicable disease (for practitioner safety)
- Local infection around needle insertion site
- Fever or systemic infection (cold/flu)
- Pregnancy
- Unstable bleeding disorders
- Less than 6 months post-surgery
- Metal implants/screws in the gleno-humeral joint
- History of bacterial endocardititis
- Heart valve replacement
- Past history of any of the proposed needle treatments in the treatment of chronic pain disorders
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHANGEpain Clinic
Vancouver, British Columbia, V5Z3A4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Lau, MD
University of British Columbia
- STUDY DIRECTOR
Krista B Friesen, MSc
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2013
First Posted
April 5, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
August 26, 2015
Record last verified: 2015-08