Neck PainPhase 2NCT00587626
Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
A Phase 2 study testing Inactive InterX 5000 and InterX 5000 Treatment in people with Neck Pain and Shoulder Pain, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving chronic neck and shoulder pain. This study will focus on the efficacy of treating patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Neck Pain, Shoulder Pain, Cervical Pain
- What is being tested?
- Inactive InterX 5000 and InterX 5000 Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2007to Dec 2009
- Phase
- Phase 2
- 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 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic or recurrent neck or shoulder pain of at least 3 months duration with or without arm pain
- willing to sign consent for study participation
- able/willing to comply with treatment schedule
Who cannot join
- clinically significant herniated disc (defined as positive radicular arm pain aggravated by head position change or neural stretch signs from provocative arm movement, this will not exclude patients with any imaged herniation as this is a common finding in all populations)
- spinal fracture
- previous electrical stimulation treatment for this episode
- recent cervical spinal or shoulder surgery or implanted instrumentation/prostheses.
- patients with cardiac pacemaker or spinal cord stimulator, epilepsy, pregnancy, recent (3 months) chemotherapy/radiotherapy, phlebitis, cortisone use (30 days)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8S 1C7
Canadian Memorial Chiropractic College
Toronto, Ontario, M2H 3J1
About this study
The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving chronic neck and shoulder pain. This study will focus on the efficacy of treating patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain.
H1: InterX therapy will have a moderate effect to reduce pain.
H2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment.
H3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.
Read the detailed description
Electrical stimulation modalities of various types have been used as a therapeutic intervention for years in a wide variety of applications. Individuals with neck and shoulder pain represent a significant segment of the pain population seeking relief. However, there is a paucity of data from quality studies published in mainstream peer-reviewed journals supporting the effectiveness of this intervention. No well-designed prospective, randomized, controlled trials investigating the efficacy or effectiveness of this intervention in patients with chronic neck and shoulder pain have been reported. The need for such work is becoming increasingly important considering the progressively greater demands for evidence-based medicine to justify reimbursement for care.
- Conditions
- Neck Pain, Shoulder Pain, Cervical Pain
- Being tested
- Inactive InterX 5000, InterX 5000 Treatment
- Keywords
- neck pain, shoulder pain, cervical pain, chronic, recurrent
- Medical subject headings
- Neck Pain, Shoulder Pain, Bronchiolitis Obliterans Syndrome, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactive InterX 5000Device
Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.
InterX 5000 TreatmentDevice
Patients will receive will receive InterX treatment 3 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | InterX treatment plus rehabilitation exercises Receives: Device: InterX 5000 Treatment |
| 2 | Placebo comparator | Inactive InterX treatment plus rehabilitation exercises Receives: Device: Inactive InterX 5000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Measured: 4 weeks
Neck Disability Index (NDI)
Measured: 4 weeks
Medical Outcomes Study Short-Form 36 (SF-36) Health Survey
Measured: 4 weeks
Short-Form McGill Questionnaire
Measured: 4 weeks
Biomarkers (inflammatory cytokines and SP)
Measured: 4 weeks
Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA)
Measured: 4 weeks
Cervical Range of Motion (CROM)
Measured: 4 weeks
Grip strength
Measured: 4 weeks
Vibration threshold
Measured: 4 weeks
Pain Tolerance and Threshold - Pressure
Measured: 4 weeks
Pain Threshold and Tolerance - Current Perception
Measured: 4 weeks
Current Perception Threshold
Measured: 4 weeks
Neck Walk Index (NWI)
Measured: 4 weeks
Muscle Fatigue
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Memorial Chiropractic College, Neuro Resource Group
- Investigators
- Linda J Woodhouse, PhD, Principal investigator, McMaster UniversityJohn J Triano, DC, PhD, Principal investigator, Canadian Memorial Chiropractic CollegeVickie Galea, PhD, Principal investigator, McMaster UniversityH Stephen Injeyan, PhD, DC, Principal investigator, Canadian Memorial Chiropractic CollegeJoy MacDermid, PhD, Principal investigator, McMaster UniversityMarion McGregor, DC, PhD, Principal investigator, Canadian Memorial Chiropractic CollegeMichael Pierrynowski, PhD, Principal investigator, McMaster UniversityRichard Ruegg, PhD, DC, Principal investigator, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587626
- Sponsor's protocol ID
- NRG
- Status last verified
- Jun 2010
- First submitted
- 21 Dec 2007
- Last updated
- 25 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
- ClinicalTrials.gov ID
- NCT00587626
- Acronym / sponsor ID
- NRG
- Conditions
- Neck Pain, Shoulder Pain, Cervical Pain
- Keywords
- neck pain, shoulder pain, cervical pain, chronic, recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Memorial Chiropractic College, Neuro Resource Group
- Study start
- Aug 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Jan 2008 (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.
The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving chronic neck and shoulder pain. This study will focus on the efficacy of treating patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain.
H1: InterX therapy will have a moderate effect to reduce pain.
H2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment.
H3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.
Detailed description
Electrical stimulation modalities of various types have been used as a therapeutic intervention for years in a wide variety of applications. Individuals with neck and shoulder pain represent a significant segment of the pain population seeking relief. However, there is a paucity of data from quality studies published in mainstream peer-reviewed journals supporting the effectiveness of this intervention. No well-designed prospective, randomized, controlled trials investigating the efficacy or effectiveness of this intervention in patients with chronic neck and shoulder pain have been reported. The need for such work is becoming increasingly important considering the progressively greater demands for evidence-based medicine to justify reimbursement for care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: InterX 5000 TreatmentInterX treatment plus rehabilitation exercises |
| 2 | Placebo comparator | Device: Inactive InterX 5000Inactive InterX treatment plus rehabilitation exercises |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic or recurrent neck or shoulder pain of at least 3 months duration with or without arm pain
- willing to sign consent for study participation
- able/willing to comply with treatment schedule
Key exclusion criteria (5 listed)
- clinically significant herniated disc (defined as positive radicular arm pain aggravated by head position change or neural stretch signs from provocative arm movement, this will not exclude patients with any imaged herniation as this is a common finding in all populations)
- spinal fracture
- previous electrical stimulation treatment for this episode
- recent cervical spinal or shoulder surgery or implanted instrumentation/prostheses.
- patients with cardiac pacemaker or spinal cord stimulator, epilepsy, pregnancy, recent (3 months) chemotherapy/radiotherapy, phlebitis, cortisone use (30 days)
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 |
|---|---|---|
| Inactive InterX 5000Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks. | Device | 2 |
| InterX 5000 TreatmentPatients will receive will receive InterX treatment 3 times a week for 4 weeks. | Device | 1 |
Primary outcome
Visual Analog Scale
Time frame: 4 weeks
Neck Disability Index (NDI)
Time frame: 4 weeks
Medical Outcomes Study Short-Form 36 (SF-36) Health Survey
Time frame: 4 weeks
Short-Form McGill Questionnaire
Time frame: 4 weeks
Biomarkers (inflammatory cytokines and SP)
Time frame: 4 weeks
Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA)
Time frame: 4 weeks
Cervical Range of Motion (CROM)
Time frame: 4 weeks
Grip strength
Time frame: 4 weeks
Vibration threshold
Time frame: 4 weeks
Pain Tolerance and Threshold - Pressure
Time frame: 4 weeks
Pain Threshold and Tolerance - Current Perception
Time frame: 4 weeks
Current Perception Threshold
Time frame: 4 weeks
Neck Walk Index (NWI)
Time frame: 4 weeks
Muscle Fatigue
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
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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.
Linda J Woodhouse, PhD principal investigator
McMaster University
John J Triano, DC, PhD principal investigator
Canadian Memorial Chiropractic College
Vickie Galea, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inactive InterX 5000 and InterX 5000 Treatment in people with Neck Pain and Shoulder Pain, run by Hamilton Health Sciences Corporation at 2 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 4 weeks). The study lists 14 primary outcomes in all. 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 25 Jun 2010.