Clinical trial NCT01824810: Whiplash-associated Disorders - Needling Treatments Pilot Study
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Whiplash Injury
Keywords: Intramuscular Stimulation
myoActivation
Neural Prolotherapy
Whiplash-Associated Disorders
myofascial pain
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Change in Neck Disability Index at 6-months post treatment
timeFrame: baseline and 6 months after 12-week treatment is complete
measure: Change in cervical range of motion at 6 months post-treatment
timeFrame: baseline and 6 months after 12-week treatment is complete
measure: Change in 7-item Generalized Anxiety Disorder Scale (GAD-7) 6 months post-treatment
timeFrame: baseline and 6 months after 12-week treatment is complete
measure: Change in Depression as measured by the 9-item Patient Health Questionnaire (PHQ-9) 6 months post-treatment
timeFrame: baseline and 6 months after 12-week treatment is complete
measure: Change in catastrophizing as measured by the Pain-Related Self-Statements Questionnaire (PRSS) 6 months post-treatment
timeFrame: baseline and 6 months after 12-week treatment is complete
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: CHANGEpain Clinic
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Brenda Lau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Krista B Friesen, MSc
role: STUDY_DIRECTOR
References: