Recruiting

Needling TreatmentsWhiplash-associated Disorders - Needling Treatments Pilot Study

Sponsor:

University of British Columbia

Code:

NCT01824810

Conditions

Whiplash Injury

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Intramuscular Stimulation

myoActivation

Neural Prolotherapy

Sham Needling Control

Study Details

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.

Conditions

Whiplash Injury

Study ID

NCT01824810

Start date

Jun, 2013

Status verified date

Aug, 2015

Completion date

Mar, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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 comparator: 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.

Interventions

Intramuscular Stimulation

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.

myoActivation

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.

Neural Prolotherapy

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.

Sham Needling Control

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.

Primary outcome measure

Change from baseline in Brief Pain Inventory - Short Form at 6 months post-treatment [ Time Frame: baseline and 6 months after 12-week treatment is complete ]

Central Contacts and Locations

Central contacts

Krista B Friesen, MSc

604-566-9101 krista.friesen@changepain.ca

Locations

CHANGEpain Clinic

Recruiting

Vancouver, British Columbia, Canada, V5Z3A4

Contacts

Daphne S Galario

(604)566-9101

Principal Investigator:

Brenda Lau, MD

More Information

Sponsor

University of British Columbia

Last update posted

Aug 26, 2015

Last verified

Aug, 2015

Keywords

Intramuscular Stimulation
myoActivation
Neural Prolotherapy
Whiplash-Associated Disorders
myofascial pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2015-08-26.