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Cervical OsteoarthritisNCT03542955

Pulse Shortwave Therapy in Cervical Osteoarthritis

A study testing ActiPatch and Etoricoxib 60 mg in people with Cervical Osteoarthritis, run by BioElectronics Corporation at 1 site in Lebanon.

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

The ActiPatch is an FDA cleared pain therapy device that uses pulsed shortwaves to interrupt pain signals at the nerve. 200 patients will be randomized and divided into an ActiPatch treatment group and comparison analgesic drug therapy group . Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Cervical Osteoarthritis
What is being tested?
ActiPatch and Etoricoxib 60 mg
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteLebanon
Study dates
1 May 2018to 30 Jul 2019
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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Chronic Neck Pain of > 2 months
  • Cervical Osteoarthritis - Radiological Evidence
  • Males \& females
  • Age: 30-60 years

Who cannot join

  • Neck Pain <2 months
  • Pregnancy
  • Irreversible neck injury
  • Congenital Neurological/Muscular Diseases
  • Osteo-articular Disorders
  • Auto-immune Diseases
Show all 11Show fewer
  • Osteoporosis
  • Hematological Diseases (Thalassemia/Sickle Cell Anemia)
  • Cancer
  • Contra-indication to Etoricoxib 60 mg
  • Age <30 or >60 years

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

  • New Mazloum Hospital

    Tripoli

Other trials in Lebanon

About this study

Official title: The Efficacy/Safety Profile Of Pulsed Shortwave Therapy in Cervical Osteoarthritis: A Comparison Study Against Etoricoxib

The ActiPatch is an FDA cleared pain therapy device that uses pulsed shortwaves to interrupt pain signals at the nerve. 200 patients will be randomized and divided into an ActiPatch treatment group and comparison analgesic drug therapy group . Subjects will be assessed with the Neck Disability Index (NDI) at baseline and at four weeks and VAS scores will be recorded in order to determine the efficacy of the ActiPatch device compared to Etoricoxib. Cervical osteoarthritis causes chronic neck pain which could potentially be alleviated by the ActiPatch without the use of medication.

Read the detailed description

Cervical Osteoarthritis causes chronic pain in the neck due to the discs of the spine breaking down, losing fluid, and becoming stiffer over time. As obesity and age increase, the likelihood of cervical osteoarthritis increases as well. When the pain caused by the broken down discs becomes severe, it may result in a loss of mobility in the neck region. Chronic neck pain has a serious impact on not only quality of life, but can also negatively affect a persons ability to lead a healthy active lifestyle. Standard analgesic therapy it limited in efficacy and can result in serious adverse effects specially with long term use.

Being tested
ActiPatch, Etoricoxib 60 mg

What participants receive

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

  • ActiPatchDevice

    Also called pulsed shortwave therapy

    A Pulsed Shortwave Therapy Device

  • Etoricoxib 60 mgDrug

    Also called analgesic

    nonsteroidal anti-inflammatory drug used as standard therapy

Study groups in NCT03542955
Study groupRoleWhat they receive
ActiPatch GroupActive comparatorSubjects in this group will receive an active pulsed shortwave therapy device to wear 24 hours a day for 4 weeks.
Receives: Device: ActiPatch
Control GroupPlacebo comparatorSubjects in this group will take Etoricoxib 60mg, once daily for 4 weeks.
Receives: Drug: Etoricoxib 60 mg

What is being measured

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

  1. Neck Disability Index (NDI)

    It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain.

    The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Al the points can be summed to a total score. The test can be interpretated as a raw score, with a maximum score of 50, or as a percentage. A higher score indicates more patient-rated disability.

    Measured: 4 weeks

Secondary outcomes (3)

  1. Visual Analog Scale (VAS)

    Visual analog scale [VAS] is a measure of pain intensity. It is a continuous scale comprised of a horizontal (called horizontal visual analogue scale) or,vertical called vertical visual analog scale usually 10 cm or 100 mm length [both the gradations are used]. It is anchored by two verbal descriptors, one for each symptom extreme.

    There could be variation in verbal descriptor anchors depending on intended use of the scale.

    For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [on 100-mm scale]

    Measured: 4 weeks

  2. Side Effects

    Gastric Pain, Constipation/Diarrhea, Blood Pressure, Dizziness, Headache, Elevated Creatinine, Bronchospasm, LFT's, Edema/Fluid Retention.

    Measured: 4 weeks

  3. Patient Satisfaction Rate

    Patient Satisfaction Rate will be determined a 5 point scale (0 -not at satisfied to 4 - completely satisfied)

    Measured: 4 weeks

Timeline

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

  1. First posted1 Jun 2018
  2. Study start1 May 2018
  3. Primary completion30 Jul 2019
  4. Study completion30 Jul 2019

Resources

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
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03542955
Sponsor's protocol ID
PRO180402
Status last verified
May 2018
First submitted
16 May 2018
Last updated
30 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ActiPatch and Etoricoxib 60 mg in people with Cervical Osteoarthritis, run by BioElectronics Corporation at 1 site in Lebanon.

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 11 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 30 Aug 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 Lebanon. 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?

Neck Disability Index (NDI) (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 NCT03542955.

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 30 Aug 2019.

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