Whiplash-associated Disorders - Needling Treatments Pilot Study

NCT ID: NCT01824810

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-03-31

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.

Conditions

Whiplash Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intramuscular Stimulation

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

myoActivation

Intervention Type: PROCEDURE

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 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.

Group Type: EXPERIMENTAL

Neural Prolotherapy

Intervention Type: PROCEDURE

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

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.

Group Type: SHAM_COMPARATOR

Sham Needling Control

Intervention Type: PROCEDURE

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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenda Lau, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Krista B Friesen, MSc

Role: STUDY_DIRECTOR

University of British Columbia

Locations

CHANGEpain Clinic

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Krista B Friesen, MSc

Role: CONTACT

krista.friesen@changepain.ca

604-566-9101

Facility Contacts

Daphne S Galario

Role: primary

(604)566-9101

Other Identifiers

H13-00027

Identifier Type: -

Identifier Source: org_study_id