Chronic Low Back PainPSWTNCT03240146

Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain

A study testing Pulsed Shortwave Therapy in people with Chronic Low Back Pain, run by BioElectronics Corporation 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Pulsed Shortwave Therapy
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 28 Sep 2017to 21 Dec 2017
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant is willing and able to give informed consent for participation in the trial.
In the Investigator's opinion, is able and willing to comply with all trial requirements.
Male or female ages 18 or above with stable chronic lower back pain
Females of childbearing must be on birth control or practice abstinence during the study period
o Women of childbearing age will be screened with a urine pregnancy test. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
≥3 months duration of chronic low back pain

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a current VAS pain rating ≥5/10
no radiating pain below the knee
Most of the pain in the body is present in the lower back or buttock, NOT in the lower extremities, as determined during screening by the principal investigator. The investigator will verbally ask the participant if most of the pain being experienced is in the lower back/buttock area, and rely on the response for inclusion into the study.
able to complete and tolerate treatment for the study period.

Who cannot join

Female participant who is pregnant.
Significant renal or hepatic impairment confirmed by medical history.
Prior home use of pulsed shortwave therapy.
Prior history of spinal fusion or failed spinal surgery syndrome.
Laminectomy, laminotomy or discectomy within 12 months of enrollment.
Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency neuroablation within 6 months of enrollment.

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The addition of strong opiates (hydrocodone, oxycodone, morphine), pregabalin and gabapentin to the treatment regime during the course of the trial
Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices.
Patients using personal home based electrical stimulation devices are excluded
Patients with other concomitant illnesses (e.g., malignancy, osteoporosis) which, in the opinion of the investigator, would preclude successful patient participation will also be excluded
Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia).
Patients diagnosed with history of significant mood disorder will be excluded (e.g., depression or anxiety with adequate control would be acceptable).
Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

North Alabama Primary Care
Athens, Alabama, 35611

Other trials in United States

About this study

Official title: Pulsed Shortwave Therapy (PSWT) Treatment for Chronic Musculoskeletal Low Back Pain

The ActiPatch is a cutaneous device which is CE marked approved for relief of pain and has FDA clearance as an over the counter device for the adjunctive treatment of osteoarthritis of the knee and plantar fasciitis. It is taped over the affected area and stimulation at a high frequency is reported to alleviate pain with no sensation. By randomising patients between application of an active device or a dummy device and assessment of disability and pain scores at four weeks the efficacy or otherwise can be established. Chronic low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.

Read the detailed description

Chronic low back pain is a major public heath challenge for a number of reasons including prevalence, seriousness, vulnerable populations, the utility of population health strategies, and the importance of prevention at both the population and individual levels. Its incidence and prevalence are increasing with an aging population and the rise in obesity. When considering the location of chronic pain and its aetiology, back pain was the most common location with arthritis/osteoarthritis being the most common cause. Chronic low back back pain is costly to nations-not just in terms of health care expenditures and disability compensation but also in terms of lost school days, lost productivity and employment, reduced incomes, and lost potential and quality of life.

Conditions: Chronic Low Back Pain
Being tested: Pulsed Shortwave Therapy

What participants receive

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

Pulsed Shortwave TherapyDevice
Pulsed Shortwave Therapy device

Study groups in NCT03240146
Study group	Role	What they receive
Study Group	Active comparator	Subjects in this group will receive an active pulsed shortwave therapy device. Receives: Device: Pulsed Shortwave Therapy
Control Group	Placebo comparator	Subjects in this group will receive a placebo pulsed shortwave device that it does not emit energy. Receives: Device: Pulsed Shortwave Therapy

What is being measured

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

Oswestry Disability Index
Quality of life measure for chronic lower back pain
Measured: 4 weeks

Secondary outcomes (3)

Visual Analogue Pain score
assessment of pain being experienced
Measured: 4 weeks
The Pain and Sleep Questionnaire three-item index
Assessment of the impact of pain on the subjects sleep
Measured: 4 weeks
Analgesic Medication use
Quantify the use of analgesic medications
Measured: 4 weeks

Timeline

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

28 Sep 201721 Dec 2017

First posted4 Aug 2017
Study start28 Sep 2017
Primary completion21 Dec 2017
Study completion21 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Low Back 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03240146
Sponsor's protocol ID: SAIRB-17-0057
Acronym: PSWT
Status last verified: Aug 2018
First submitted: 2 Aug 2017
Last updated: 2 Aug 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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

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

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pulsed Shortwave Therapy (PSWT) Treatment for Chronic Musculoskeletal Low Back Pain
ClinicalTrials.gov ID: NCT03240146
Acronym / sponsor ID: PSWT / SAIRB-17-0057
Conditions: Chronic Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: BioElectronics CorporationIndustry (pharma, biotech, devices)
Study start: 28 Sep 2017 (actual)
Primary completion: 21 Dec 2017 (actual)
Study completion: 21 Dec 2017 (actual)
First posted: 4 Aug 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study Group	Active comparator	Device: Pulsed Shortwave TherapySubjects in this group will receive an active pulsed shortwave therapy device.
Control Group	Placebo comparator	Device: Pulsed Shortwave TherapySubjects in this group will receive a placebo pulsed shortwave device that it does not emit energy.

Who may qualify

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

Key inclusion criteria (10 listed)

Participant is willing and able to give informed consent for participation in the trial.
In the Investigator's opinion, is able and willing to comply with all trial requirements.
Male or female ages 18 or above with stable chronic lower back pain
Females of childbearing must be on birth control or practice abstinence during the study period
o Women of childbearing age will be screened with a urine pregnancy test. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Key exclusion criteria (15 listed)

Female participant who is pregnant.
Significant renal or hepatic impairment confirmed by medical history.
Prior home use of pulsed shortwave therapy.
Prior history of spinal fusion or failed spinal surgery syndrome.
Laminectomy, laminotomy or discectomy within 12 months of enrollment.

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
Pulsed Shortwave TherapyPulsed Shortwave Therapy device	Device	Control Group, Study Group

Primary outcome

Oswestry Disability Index
Time frame: 4 weeks
Quality of life measure for chronic lower back pain

3 secondary outcomes

Visual Analogue Pain score
Time frame: 4 weeks
The Pain and Sleep Questionnaire three-item index
Time frame: 4 weeks
Analgesic Medication use
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 2 Aug 2018.
Individual participant dataSharing planned: No

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.

Chandra Koneru, MD principal investigator

North Alabama Primary Care

Sree Koneru, Ph.D study director

BioElectronics Corporation

Ian Rawe, Ph.D. study chair

BioElectronics Corporation

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

Questions about this trial

What is this clinical trial studying?

A study testing Pulsed Shortwave Therapy in people with Chronic Low Back Pain, run by BioElectronics Corporation 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 10 inclusion and 15 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 2 Aug 2018. 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. 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?

Oswestry Disability Index (time frame: 4 weeks). 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 NCT03240146.

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 2 Aug 2018.