Neck PainPhase 1/2NCT01168986

The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain

A Phase 1/2 study testing Pulstar Multiple Impulse Therapy and Exercise in people with Neck Pain, run by University of Florida 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

This study is comparing the effectiveness of a mechanical manual therapy device to a specific exercise to no treatment in individuals experiencing neck pain. We are interested in the effects of the interventions on neck pain, disability related to neck pain, and pain sensitivity. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Neck Pain
What is being tested?: Pulstar Multiple Impulse Therapy and Exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Sep 2009to May 2015
Phase: Phase 1/2
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

currently experiencing neck pain which does not extend below the elbow
pain at least 4/10 over the past 24 hours
appropriate for conservative management of neck pain
english speaking

Who cannot join

surgery to the neck within the past 6 months
systemic problem know to affect sensation
other chronic pain condition other than neck pain
neck pain as the result of trauma such as whiplash
neck pain as the result of a fracture

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida
Gainesville, Florida, 32610

Other trials in United States

About this study

Conditions: Neck Pain
Being tested: Pulstar Multiple Impulse Therapy, Exercise
Keywords: neck pain, manual therapy, exercise
Medical subject headings: Neck Pain, Motor Activity

What participants receive

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

Pulstar Multiple Impulse TherapyOther
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
ExerciseOther
Participants perform an exercise to strengthen the deep neck flexors

Study groups in NCT01168986
Study group	Role	What they receive
Pulstar Multiple Impulse Therapy	Active comparator	Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. Receives: Other: Pulstar Multiple Impulse Therapy
Exercise	Active comparator	Participants perform an exercise to strengthen the deep neck flexors Receives: Other: Exercise
No intervention	No intervention	Participants receive/perform no intervention

What is being measured

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

2 Week Change in Pain Score on a Numeric Rating Scale
a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable
Measured: 2 weeks
2 Week Change in Disability on the Neck Disability Index
A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.
Measured: 2 weeks
Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale
Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.
Measured: Immediate within session change pre to post intervention

Secondary outcomes (1)

Change From Baseline in Neck Extension Range of Motion at 2 Weeks
change in neck extension range of motion over a 2 week period
Measured: 2 weeks

Timeline

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

Sep 2009May 2015

First posted23 Jul 2010 (estimated)
Study startSep 2009
Primary completionMay 2015
Study completionMay 2015

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.
Other trials for Neck PainStudies of the same condition, open and under way.
More trials run by University of FloridaThe 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01168986
Sponsor's protocol ID: 340-2009
Other IDs: 340-2009
Status last verified: May 2016
First submitted: 22 Jul 2010
Last updated: 20 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
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All Neck Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain
ClinicalTrials.gov ID: NCT01168986
Acronym / sponsor ID: 340-2009
Conditions: Neck Pain
Keywords: neck pain, manual therapy, exercise
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: Sep 2009
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 23 Jul 2010 (estimated)
Results: Posted 20 Jun 2016

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Pulstar Multiple Impulse Therapy	Active comparator	Other: Pulstar Multiple Impulse TherapyUse of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Exercise	Active comparator	Other: ExerciseParticipants perform an exercise to strengthen the deep neck flexors
No intervention	No intervention	–Participants receive/perform no intervention

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

currently experiencing neck pain which does not extend below the elbow
pain at least 4/10 over the past 24 hours
appropriate for conservative management of neck pain
english speaking

Key exclusion criteria (5 listed)

surgery to the neck within the past 6 months
systemic problem know to affect sensation
other chronic pain condition other than neck pain
neck pain as the result of trauma such as whiplash
neck pain as the result of a fracture

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
Pulstar Multiple Impulse TherapyUse of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.	Other	Pulstar Multiple Impulse Therapy
ExerciseParticipants perform an exercise to strengthen the deep neck flexors	Other	Exercise

Primary outcome

2 Week Change in Pain Score on a Numeric Rating Scale
Time frame: 2 weeks
a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable
2 Week Change in Disability on the Neck Disability Index
Time frame: 2 weeks
A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.
Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale
Time frame: Immediate within session change pre to post intervention
Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.

1 secondary outcome

Change From Baseline in Neck Extension Range of Motion at 2 Weeks
Time frame: 2 weeks

Results and safety

Results posted to the registry on 20 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pulstar Multiple Impulse Therapy	20	18
Exercise	21	20
No Intervention	21	21

Primary outcome: 2 Week Change in Pain Score on a Numeric Rating Scale

Time frame: 2 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Pulstar Multiple Impulse Therapy n = 18	Exercise n = 19	No Intervention n = 19
Value	6.39 (24.23)	20.37 (23.67)	6.45 (19.88)

Pulstar Multiple Impulse Therapy vs Exercise vs No Intervention: p = 0.10, Mixed Models Analysis

Population analysed: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data

Primary outcome: 2 Week Change in Disability on the Neck Disability Index

Time frame: 2 weeks. Mean (Standard Deviation). Unit: 2 week change in units a scale

Measure	Pulstar Multiple Impulse Therapy n = 18	Exercise n = 20	No Intervention n = 19
Value	4.44 (8.53)	5.50 (9.53)	0.42 (8.37)

Pulstar Multiple Impulse Therapy vs Exercise vs No Intervention: p = 0.18, Mixed Models Analysis

Population analysed: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data

Primary outcome: Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale

Time frame: Immediate within session change pre to post intervention. Mean (Standard Deviation). Unit: units on a scale

Measure	Pulstar Multiple Impulse Therapy n = 17	Exercise n = 19	No Intervention n = 18
Value	0.58 (15.39)	-0.76 (16.66)	1.62 (10.83)

Pulstar Multiple Impulse Therapy vs Exercise vs No Intervention: p = 0.87, Mixed Models Analysis

Population analysed: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pulstar Multiple Impulse Therapy	0 of 20 (0%)	0 of 20 (0%)	Not reported
Exercise	0 of 21 (0%)	0 of 21 (0%)	Not reported
No Intervention	0 of 21 (0%)	0 of 21 (0%)	Not reported

Limitations and caveats (from the sponsor): Participants were individuals with neck pain responding to a study and not necessarily seeking care. As a result, the findings may not directly translate to individuals with neck pain seeking care from a healthcare provider.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Neck Pain

Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
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Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
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Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
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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.

Joel E Bialosky, PhD principal investigator

University of Florida

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pulstar Multiple Impulse Therapy and Exercise in people with Neck Pain, run by University of Florida 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 4 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 20 Jun 2016. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 20 Jun 2016). 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?

2 Week Change in Pain Score on a Numeric Rating Scale (time frame: 2 weeks). The study lists 3 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 NCT01168986.

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 20 Jun 2016.