Neck PainNCT01382537
Efficacy of the InterX 5000 in the Treatment of Chronic Neck Pain
A study testing InterX 5000 in people with Neck Pain and Shoulder Pain, run by Canadian Memorial Chiropractic College at 1 site in Canada.
Trial summary
This study will focus on the efficacy of treating 80 patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain. Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks 1-2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Shoulder Pain
- What is being tested?
- InterX 5000
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Apr 2010
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males or females
- ages 18-65
- chronic or recurrent neck or shoulder pain
- pain of at least 3 months duration
- willing to sign consent form
- able/willing to comply with treatment schedule
Who cannot join
- age over 65 years
- clinically significant herniated disc
- spinal fracture
- previous electrical stimulation treatment for this episode
- recent cervical spine or shoulder surgery
- implanted instrumentation/prostheses
Show all 12Show fewer
- epilepsy
- pregnancy
- recent (3 months) chemotherapy/radiotherapy
- phlebitis
- cortisone use (30 days)
- hypersensitivity to tape used with EMG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
This study will focus on the efficacy of treating 80 patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain.
Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks 1-2.
Hypothesis 2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment.
Hypothesis 3: 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
Evaluation of subjects will be conducted at baseline (interval 0) and at 2, 4, 6 and 12 week time periods. At 26 weeks, the patient will be contacted to obtain follow-up questionnaires on pain and function. After informed consent, participants will be randomly assigned to a treatment group and a sham group using the InterX5002, hand held electrical stimulation unit. Treatment will be administered three times per week for six weeks.
During the interval of weeks 1-2 patients will have either the InterX treatment/sham alone. Weeks 3-4 will advance the patient adding a standardized rehabilitation exercise program typical for chronic neck patients. During weeks 5-6, the patient will be scheduled for treatment and will use a self-administered InterX treatment ("home" Flex) unit mimicking home care but accounting for compliance issues through attendance being monitored.
Baseline and follow-up assessments will consist of pain scores, NDI, neck fatigue testing, shoulder and arm reach tasks and walking on a treadmill at 2 MPH for 5 minutes (Neck-walk Index, NWI). Neck fatigue testing will consist of prone positioning and extensor muscle exertion against resistance to tolerance at 60% MVC. Myoelectric sensors will be taped to the skin to record muscle activity during fatigue and reach task testing. Electromagnetic sensors will be taped to a swimmers cap worn by the patient and on the skin at T1 over the spine at the shoulder level and S1 at the pelvis during the walk on the treadmill and on the shoulder and arm during reach testing.
Venipuncture will be performed at the evaluation intervals to collect blood samples for quantifying circulating inflammatory cytokines.
Analysis will focus on change in pain scores and inflammatory cytokines over the first two weeks for Hypothesis H1. Primary functional outcomes including neck fatigue and progression through neck rehabilitation exercise will be tested for Hypothesis2. The third hypothesis will be tested in two ways. First, quantification of degenerative changes (e.g.disc narrowing \& osteophyte formation) on x-ray (AP \& Lat screening views) will be contrasted to incidence in the published literature. Second, pain levels at baseline will be stratified into quartiles and compared to quantitative tally of degenerative changes. This data will serve as a basis for determining whether future studies using degenerative change criteria are warranted. Myoelectric activity, fatigue and head-pelvic position data will be used descriptively to assess functional differences from baseline to completion of treatment.
- Conditions
- Neck Pain, Shoulder Pain
- Being tested
- InterX 5000
- Keywords
- Neck, Chronic, Musculoskeletal, Shoulder
- Medical subject headings
- Neck Pain, Shoulder Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterX 5000Device
A computer driven electrical stimulation unit that contains a cutaneous impedance sensor.
InterX 5000Device
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Device: InterX 5000 |
| B | Placebo comparator | Not described Receives: Device: InterX 5000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain scores on the Visual Analog Scale.
Measured: 10 minutes
Neck Disability Index
Neck Disability Index pain scores.
Measured: 15 minutes
Shoulder Pain and Disability Index
Shoulder Pain and Disability Index scores.
Measured: 60 minutes
Medical Outcomes Study Short-Form (SF-36)
Change in Medical Outcomes Study Short-Form (SF-36) score.
Measured: 15 minutes
Neck Walk Index
Change in Neck Walk Index score.
Measured: 20 minutes
Upper Limb Coordination During and Overhead Reach
Change in range of motion.
Measured: 20 minutes
Task Limitation (TL)/Upper Limb Function - FIT-HaNSA Protocol
Change in FIT-HaNSA score.
Measured: 20 min
EMG testing
Mean frequency shifts. Change in percentage of maximum voluntary contraction.
Measured: 30 minutes
Secondary outcomes (1)
Blood and serum biomarkers
Change in cytokine counts.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, John J Triano, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382537
- Sponsor's protocol ID
- 072131
- Status last verified
- Jul 2014
- First submitted
- 21 Sep 2009
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Brennan PC, Triano JJ, McGregor M, Kokjohn K, Hondras MA, Brennan DC. Enhanced neutrophil respiratory burst as a biological marker for manipulation forces: duration of the effect and association with substance P and tumor necrosis factor. J Manipulative Physiol Ther. 1992 Feb;15(2):83-9.
PubMed 1373431Godfrey CM, Morgan PP, Schatzker J. A randomized trial of manipulation for low-back pain in a medical setting. Spine (Phila Pa 1976). 1984 Apr;9(3):301-4. doi: 10.1097/00007632-198404000-00015.
PubMed 6233718Hurley DA, McDonough SM, Dempster M, Moore AP, Baxter GD. A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2207-16. doi: 10.1097/01.brs.0000142234.15437.da.
PubMed 15480130Pope MH, Phillips RB, Haugh LD, Hsieh CY, MacDonald L, Haldeman S. A prospective randomized three-week trial of spinal manipulation, transcutaneous muscle stimulation, massage and corset in the treatment of subacute low back pain. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2571-7. doi: 10.1097/00007632-199411001-00013.
PubMed 7855683Teodorczyk-Injeyan JA, Injeyan HS, Ruegg R. Spinal manipulative therapy reduces inflammatory cytokines but not substance P production in normal subjects. J Manipulative Physiol Ther. 2006 Jan;29(1):14-21. doi: 10.1016/j.jmpt.2005.10.002.
PubMed 16396725Teodorczyk-Injeyan JA, Triano JJ, McGregor M, Woodhouse L, Injeyan HS. Effect of Interactive Neurostimulation Therapy on Inflammatory Response in Patients With Chronic and Recurrent Mechanical Neck Pain. J Manipulative Physiol Ther. 2015 Oct;38(8):545-54. doi: 10.1016/j.jmpt.2015.08.006. Epub 2015 Oct 4.
PubMed 26435087
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
- ClinicalTrials.gov ID
- NCT01382537
- Acronym / sponsor ID
- 072131
- Conditions
- Neck Pain, Shoulder Pain
- Keywords
- Neck, Chronic, Musculoskeletal, Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Jun 2011 (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 study will focus on the efficacy of treating 80 patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain.
Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks 1-2.
Hypothesis 2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment.
Hypothesis 3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.
Detailed description
Evaluation of subjects will be conducted at baseline (interval 0) and at 2, 4, 6 and 12 week time periods. At 26 weeks, the patient will be contacted to obtain follow-up questionnaires on pain and function. After informed consent, participants will be randomly assigned to a treatment group and a sham group using the InterX5002, hand held electrical stimulation unit. Treatment will be administered three times per week for six weeks.
During the interval of weeks 1-2 patients will have either the InterX treatment/sham alone. Weeks 3-4 will advance the patient adding a standardized rehabilitation exercise program typical for chronic neck patients. During weeks 5-6, the patient will be scheduled for treatment and will use a self-administered InterX treatment ("home" Flex) unit mimicking home care but accounting for compliance issues through attendance being monitored.
Baseline and follow-up assessments will consist of pain scores, NDI, neck fatigue testing, shoulder and arm reach tasks and walking on a treadmill at 2 MPH for 5 minutes (Neck-walk Index, NWI). Neck fatigue testing will consist of prone positioning and extensor muscle exertion against resistance to tolerance at 60% MVC. Myoelectric sensors will be taped to the skin to record muscle activity during fatigue and reach task testing. Electromagnetic sensors will be taped to a swimmers cap worn by the patient and on the skin at T1 over the spine at the shoulder level and S1 at the pelvis during the walk on the treadmill and on the shoulder and arm during reach testing.
Venipuncture will be performed at the evaluation intervals to collect blood samples for quantifying circulating inflammatory cytokines.
Analysis will focus on change in pain scores and inflammatory cytokines over the first two weeks for Hypothesis H1. Primary functional outcomes including neck fatigue and progression through neck rehabilitation exercise will be tested for Hypothesis2. The third hypothesis will be tested in two ways. First, quantification of degenerative changes (e.g.disc narrowing \& osteophyte formation) on x-ray (AP \& Lat screening views) will be contrasted to incidence in the published literature. Second, pain levels at baseline will be stratified into quartiles and compared to quantitative tally of degenerative changes. This data will serve as a basis for determining whether future studies using degenerative change criteria are warranted. Myoelectric activity, fatigue and head-pelvic position data will be used descriptively to assess functional differences from baseline to completion of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: InterX 5000 |
| B | Placebo comparator | Device: InterX 5000 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males or females
- ages 18-65
- chronic or recurrent neck or shoulder pain
- pain of at least 3 months duration
- willing to sign consent form
Key exclusion criteria (12 listed)
- age over 65 years
- clinically significant herniated disc
- spinal fracture
- previous electrical stimulation treatment for this episode
- recent cervical spine or shoulder surgery
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 |
|---|---|---|
| InterX 5000A computer driven electrical stimulation unit that contains a cutaneous impedance sensor. | Device | A |
| InterX 5000Placebo treatment | Device | B |
Primary outcome
Visual Analog Scale
Time frame: 10 minutes
Pain scores on the Visual Analog Scale.
Neck Disability Index
Time frame: 15 minutes
Neck Disability Index pain scores.
Shoulder Pain and Disability Index
Time frame: 60 minutes
Shoulder Pain and Disability Index scores.
Medical Outcomes Study Short-Form (SF-36)
Time frame: 15 minutes
Change in Medical Outcomes Study Short-Form (SF-36) score.
Neck Walk Index
Time frame: 20 minutes
Change in Neck Walk Index score.
Upper Limb Coordination During and Overhead Reach
Time frame: 20 minutes
Change in range of motion.
Task Limitation (TL)/Upper Limb Function - FIT-HaNSA Protocol
Time frame: 20 min
Change in FIT-HaNSA score.
EMG testing
Time frame: 30 minutes
Mean frequency shifts. Change in percentage of maximum voluntary contraction.
1 secondary outcome
Blood and serum biomarkers
Time frame: 20 minutes
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 Jul 2014.
- Background: PubMed 1373431Brennan PC, Triano JJ, McGregor M, Kokjohn K, Hondras MA, Brennan DC. Enhanced neutrophil respiratory burst as a biological marker for manipulation forces: duration of the effect and association with substance P and tumor necrosis factor. J Manipulative Physiol Ther. 1992 Feb;15(2):83-9.
- Background: PubMed 6233718Godfrey CM, Morgan PP, Schatzker J. A randomized trial of manipulation for low-back pain in a medical setting. Spine (Phila Pa 1976). 1984 Apr;9(3):301-4. doi: 10.1097/00007632-198404000-00015.
- Background: PubMed 15480130Hurley DA, McDonough SM, Dempster M, Moore AP, Baxter GD. A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2207-16. doi: 10.1097/01.brs.0000142234.15437.da.
- Background: PubMed 7855683Pope MH, Phillips RB, Haugh LD, Hsieh CY, MacDonald L, Haldeman S. A prospective randomized three-week trial of spinal manipulation, transcutaneous muscle stimulation, massage and corset in the treatment of subacute low back pain. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2571-7. doi: 10.1097/00007632-199411001-00013.
- Background: PubMed 16396725Teodorczyk-Injeyan JA, Injeyan HS, Ruegg R. Spinal manipulative therapy reduces inflammatory cytokines but not substance P production in normal subjects. J Manipulative Physiol Ther. 2006 Jan;29(1):14-21. doi: 10.1016/j.jmpt.2005.10.002.
- Derived from this study: PubMed 26435087Teodorczyk-Injeyan JA, Triano JJ, McGregor M, Woodhouse L, Injeyan HS. Effect of Interactive Neurostimulation Therapy on Inflammatory Response in Patients With Chronic and Recurrent Mechanical Neck Pain. J Manipulative Physiol Ther. 2015 Oct;38(8):545-54. doi: 10.1016/j.jmpt.2015.08.006. Epub 2015 Oct 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterX 5000 in people with Neck Pain and Shoulder Pain, run by Canadian Memorial Chiropractic College 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 6 inclusion and 12 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 Jul 2014. 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?
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: 10 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01382537, which also lists 6 linked publications.
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 Jul 2014.