Whiplash InjuryNCT01824810
Whiplash-associated Disorders - Needling Treatments Pilot Study
A study testing Intramuscular Stimulation, myoActivation and Neural Prolotherapy in people with Whiplash Injury, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Whiplash Injury
- What is being tested?
- Intramuscular Stimulation, myoActivation and Neural Prolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHANGEpain Clinic
Vancouver, British Columbia, V5Z3A4
Daphne S Galario, (604)566-9101
Brenda Lau, MD
About this 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.
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.
Read the 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.
- Conditions
- Whiplash Injury
- Being tested
- Intramuscular Stimulation, myoActivation, Neural Prolotherapy, Sham Needling Control
- Keywords
- Intramuscular Stimulation, myoActivation, Neural Prolotherapy, Whiplash-Associated Disorders, myofascial pain
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular StimulationProcedure or surgery
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.
myoActivationProcedure or surgery
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 ProlotherapyProcedure or surgery
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 ControlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular Stimulation | Experimental | 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. Receives: Procedure: Intramuscular Stimulation |
| myoActivation | Experimental | 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. Receives: Procedure: myoActivation |
| Neural Prolotherapy | Experimental | 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. Receives: Procedure: Neural Prolotherapy |
| Sham Needling Control | Sham comparator | 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. Receives: Procedure: Sham Needling Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Brief Pain Inventory - Short Form at 6 months post-treatment
Measured: baseline and 6 months after 12-week treatment is complete
Secondary outcomes (5)
Change in Neck Disability Index at 6-months post treatment
Measured: baseline and 6 months after 12-week treatment is complete
Change in cervical range of motion at 6 months post-treatment
cervical range of motion will be measured with a digital goniometer.
Measured: baseline and 6 months after 12-week treatment is complete
Change in 7-item Generalized Anxiety Disorder Scale (GAD-7) 6 months post-treatment
Measured: baseline and 6 months after 12-week treatment is complete
Change in Depression as measured by the 9-item Patient Health Questionnaire (PHQ-9) 6 months post-treatment
Measured: 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
Measured: baseline and 6 months after 12-week treatment is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda Lau, MD, Principal investigator, University of British ColumbiaKrista B Friesen, MSc, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824810
- Sponsor's protocol ID
- H13-00027
- Status last verified
- Aug 2015
- First submitted
- 2 Apr 2013
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01824810
- Acronym / sponsor ID
- H13-00027
- Conditions
- Whiplash Injury
- Keywords
- Intramuscular Stimulation, myoActivation, Neural Prolotherapy, Whiplash-Associated Disorders, myofascial pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intramuscular Stimulation | Experimental | Procedure: Intramuscular StimulationParticipants 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 | Experimental | Procedure: myoActivationParticipants 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 | Experimental | Procedure: Neural ProlotherapyParticipants 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 comparator | Procedure: Sham Needling ControlParticipants 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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular StimulationIntramuscular 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. | Procedure or surgery | Intramuscular Stimulation |
| myoActivationIn 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. | Procedure or surgery | myoActivation |
| Neural ProlotherapyParticipants 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. | Procedure or surgery | Neural Prolotherapy |
| Sham Needling ControlThe 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. | Procedure or surgery | Sham Needling Control |
Primary outcome
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
5 secondary outcomes
Change in Neck Disability Index at 6-months post treatment
Time frame: baseline and 6 months after 12-week treatment is complete
Change in cervical range of motion at 6 months post-treatment
Time frame: baseline and 6 months after 12-week treatment is complete
Change in 7-item Generalized Anxiety Disorder Scale (GAD-7) 6 months post-treatment
Time frame: baseline and 6 months after 12-week treatment is complete
Change in Depression as measured by the 9-item Patient Health Questionnaire (PHQ-9) 6 months post-treatment
Time frame: 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
Time frame: baseline and 6 months after 12-week treatment is complete
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Lau, MD principal investigator
University of British Columbia
Krista B Friesen, MSc study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular Stimulation, myoActivation and Neural Prolotherapy in people with Whiplash Injury, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krista B Friesen, MSc (604-566-9101, krista.friesen@changepain.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.