Whiplash Injury Clinical Trial
Official title:
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.
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.
Evidence shows that people who do not recover from whiplash symptoms within the acute phase
(3 months post-injury) may continue to have neck pain and disability years later. The
investigators hope to show that these novel treatments offer long-lasting improvement in
chronic whiplash symptoms long after the acute phase has passed and other more traditional
treatments (standard physiotherapy, massage, etc) fail.
Each of these needling techniques has small bodies of research, anecdotal evidence, and/or
patient feedback to support its use. All are currently used in clinical practice throughout
British Columbia for the treatment of many types of chronic pain symptoms. However, because
they are quite new, many clinicians and insurance companies are resistant to them and will
not recommend them to clients/patients, or they may only suggest these treatments as a last
resort. Studies like this one are needed to provide concrete evidence of the efficacy of
these treatments and increase their use.
The objective of this project is to show proof of concept - all three needling techniques
are valid and not because of a placebo effect. The investigators plan to use results from
this study to support efforts to secure funding for large-scale, adequately powered studies.
Our long-term objective is to make these types of treatments more readily available to those
who need more than traditional therapies currently offer.
Secondary objectives are to show relationships between pain and our secondary measures
(function, depression, anxiety). The investigators plan to begin profiling patients who are
more or less likely to respond to each type of needling treatment. This profiling will help
identify people most likely to benefit from each treatment and to get patients the best
treatment, sooner.
This is a double-blind, randomized control trial. The person evaluating change in
participants will not know what treatment the participant has received. Additionally, the
patient will not know if they are in a treatment or a placebo group (though they may be able
to use a process of elimination to determine what treatments they are NOT getting, but that
is acceptable and unavoidable). Once volunteers have been confirmed as eligible, they will
be randomly assigned to one of four groups - three treatment groups or the control group.
The investigators will be assessing pain levels (and several secondary outcome measures) at
three timepoints: pre-treatment, post-treatment, and 6-months post-treatment. At each
timepoint, our primary and secondary outcome measures will be evaluated, and a number of
general questions will be asked.
the investigators hope to show that these three techniques, though somewhat novel and not
yet well-supported in the literature, are all effective in treating WAD-II. Additionally,
the investigators hope to show that these effects are long-lasting and provide pilot data
that these treatments reduce the need to access other types of treatments and reduce the
need for medications.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01360138 -
A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches
|
N/A | |
| Completed |
NCT00206271 -
Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury
|
Phase 3 | |
| Completed |
NCT03784196 -
Changes of Pain Sensitivity During Rehabilitation of Patients Suffering From Whiplash Associated Disorders
|
||
| Enrolling by invitation |
NCT01544075 -
Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash
|
Phase 0 |