Chronic Low Back PainNCT02356783

Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain

A study testing Pedometer in people with Chronic Low Back Pain, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Our aim is to assess usability and compliance of a wireless pedometer for monitoring step count after a lumbar epidural steroid injection for the treatment of radicular pain in low back pain patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Pedometer
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years of age and older
Patients receiving lumbar epidural steroid injections as pain management to be scheduled at least one week away (-2 days/1 month).
Patients who are able to understand how the Fitbit instrument works and are willing to consent to the study.
Patient who used web-based communication frequently, e.g. Email.
Patients who can speak, understand, and write in English.
Prior MRI or an appointment to obtain an MRI prior to the procedure.

Who cannot join

Workers' compensation cases.
Patient does not have a computer at home.
Non-ambulatory patients.
Patients who have received a lumbar epidural steroid injection in the past 6 months.
Nursing or pregnant women.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital For Special Surgery
New York, New York, 10021

Other trials in United States

About this study

Official title: Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.

Conditions: Chronic Low Back Pain
Being tested: Pedometer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PedometerDevice
Wireless pedometer

Study groups in NCT02356783
Study group	Role	What they receive
Interlaminar	Other	Approach for lumbar epidural steroid injection for this arm will be interlaminar. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. Receives: Device: Pedometer
Transforaminal	Other	Approach for lumbar epidural steroid injection for this arm will be transforaminal. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. Receives: Device: Pedometer

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With Available Step Count Data at Baseline.
Percentage of patients with available step count data 7 days pre-procedure. Step count will be obtained daily for 7 days using a wireless pedometer.
Measured: A week pre-procedure.
Percentage of Patients With Available Step Count Data Post-procedure.
Percentage of patients with available step count data 60 days post-procedure. Step count will be obtained using a wireless pedometer daily for a period of 60 days post-procedure.
Measured: Duration of 60 days after procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Sep 2016

First posted5 Feb 2015 (estimated)
Study startFeb 2015
Primary completionAug 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe 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: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02356783
Sponsor's protocol ID: #2014-135
Status last verified: Oct 2019
First submitted: 13 Jan 2015
Last updated: 15 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cohen SP, Bicket MC, Jamison D, Wilkinson I, Rathmell JP. Epidural steroids: a comprehensive, evidence-based review. Reg Anesth Pain Med. 2013 May-Jun;38(3):175-200. doi: 10.1097/AAP.0b013e31828ea086.
PubMed 23598728
MacVicar J, King W, Landers MH, Bogduk N. The effectiveness of lumbar transforaminal injection of steroids: a comprehensive review with systematic analysis of the published data. Pain Med. 2013 Jan;14(1):14-28. doi: 10.1111/j.1526-4637.2012.01508.x. Epub 2012 Oct 30.
PubMed 23110347

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.
ClinicalTrials.gov ID: NCT02356783
Acronym / sponsor ID: #2014-135
Conditions: Chronic Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Collaborators: Memorial Sloan Kettering Cancer Center
Study start: Feb 2015
Primary completion: Aug 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 5 Feb 2015 (estimated)
Results: Posted 9 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Interlaminar	Other	Device: PedometerApproach for lumbar epidural steroid injection for this arm will be interlaminar. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.
Transforaminal	Other	Device: PedometerApproach for lumbar epidural steroid injection for this arm will be transforaminal. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

18 years of age and older
Patients receiving lumbar epidural steroid injections as pain management to be scheduled at least one week away (-2 days/1 month).
Patients who are able to understand how the Fitbit instrument works and are willing to consent to the study.
Patient who used web-based communication frequently, e.g. Email.
Patients who can speak, understand, and write in English.

Key exclusion criteria (5 listed)

Workers' compensation cases.
Patient does not have a computer at home.
Non-ambulatory patients.
Patients who have received a lumbar epidural steroid injection in the past 6 months.
Nursing or pregnant women.

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
PedometerWireless pedometer	Device	Interlaminar, Transforaminal

Primary outcome

Percentage of Patients With Available Step Count Data at Baseline.
Time frame: A week pre-procedure.
Percentage of patients with available step count data 7 days pre-procedure. Step count will be obtained daily for 7 days using a wireless pedometer.
Percentage of Patients With Available Step Count Data Post-procedure.
Time frame: Duration of 60 days after procedure.
Percentage of patients with available step count data 60 days post-procedure. Step count will be obtained using a wireless pedometer daily for a period of 60 days post-procedure.

Results and safety

Results posted to the registry on 9 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interlaminar	16	15
Transforaminal	17	14

Primary outcome: Percentage of Patients With Available Step Count Data at Baseline.

Time frame: A week pre-procedure.. Number. Unit: percentage of patients with step data

Measure	Interlaminar n = 15	Transforaminal n = 14
Value	93.3	71.4

Primary outcome: Percentage of Patients With Available Step Count Data Post-procedure.

Time frame: Duration of 60 days after procedure.. Number. Unit: percentage of patients with step data

Measure	Interlaminar n = 15	Transforaminal n = 14
Value	73.3	57.1

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interlaminar	0 of 15 (0%)	0 of 15 (0%)	Not reported
Transforaminal	0 of 14 (0%)	0 of 14 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23598728Cohen SP, Bicket MC, Jamison D, Wilkinson I, Rathmell JP. Epidural steroids: a comprehensive, evidence-based review. Reg Anesth Pain Med. 2013 May-Jun;38(3):175-200. doi: 10.1097/AAP.0b013e31828ea086.
Background: PubMed 23110347MacVicar J, King W, Landers MH, Bogduk N. The effectiveness of lumbar transforaminal injection of steroids: a comprehensive review with systematic analysis of the published data. Pain Med. 2013 Jan;14(1):14-28. doi: 10.1111/j.1526-4637.2012.01508.x. Epub 2012 Oct 30.

Related trials for Chronic Low Back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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.

Robert Griffin, MD, PhD principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pedometer in people with Chronic Low Back Pain, run by Hospital for Special Surgery, New York at 1 site in United States.

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 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 15 Oct 2019. 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 United States. 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. 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?

Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients With Available Step Count Data at Baseline. (time frame: A week pre-procedure.). The study lists 2 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 NCT02356783, which also lists 2 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 15 Oct 2019.