Whiplash-associated Disorders - Needling Treatments Pilot Study

Not Applicable

• Conditions: Whiplash Injury
• Interventions: Procedure: Intramuscular Stimulation; Procedure: myoActivation; Procedure: Neural Prolotherapy; Procedure: Sham Needling Control

• Registration Number: NCT01824810
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-05
• Study Start: 2013-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramuscular Stimulation	Intramuscular Stimulation	Participants 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	myoActivation	Participants 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	Neural Prolotherapy	Participants 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 Needling Control	Participants 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 7-item Generalized Anxiety Disorder Scale (GAD-7) 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
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	cervical range of motion will be measured with a digital goniometer.

Trial Locations

Locations (1)

CHANGEpain Clinic; 🇨🇦 Vancouver, British Columbia, Canada