Whiplash-associated Disorders - Needling Treatments Pilot Study (NCT01824810) | Clinical Trial Compass
UnknownNot Applicable
Whiplash-associated Disorders - Needling Treatments Pilot Study
Canada32 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Needle-based treatment (including any of the treatments in this study, cortisone or botox injection, etc.) for the whiplash injury in the past 3 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Brief Pain Inventory - Short Form at 6 months post-treatment
Timeframe: baseline and 6 months after 12-week treatment is complete