Low Back PainNCT03386084
Efficacy of Motor Control and Diathermy Treatment in Acute Low Back Pain
A study testing microwave diathermy in people with Low Back Pain, run by University of Alcala at 1 site in Spain.
Trial summary
Lumbar pain is considered one of the most frequent health problems faced by human populations on a global scale. This study will be carried out to evaluate the efficiency of motor control treatments combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the potential for accelerated… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- microwave diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2018to 31 May 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute low back pain (no more of 4 weeks)
- Spanish speaker
- Between 18-65 years
Who cannot join
- Patients in whom diathermy is a contraindicated therapy
- Pacemaker
- Pregnant
- Not intact skin
- Thrombophlebitis
- Hypotension
- Anticoagulated patient or with local surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Motor Control Treatment Combined With Resistive Capacitive Diathermy in Acute Low Back Pain
Lumbar pain is considered one of the most frequent health problems faced by human populations on a global scale.
This study will be carried out to evaluate the efficiency of motor control treatments combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the potential for accelerated patient recuperation if both treatments are applied simultaneously and jointly.
- Conditions
- Low Back Pain
- Being tested
- microwave diathermy
- Keywords
- capacitive resistive diathermy, motor control
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microwave diathermyDevice
Application of microwave diathermy with Monopolar CapacitiveResistive Radiofrequency Therapy (INDIBA)
| Study group | Role | What they receive |
|---|---|---|
| direct application of microwave diathermy and motor control | Experimental | Not described Receives: Device: microwave diathermy |
| application of microwave diathermy without therapeutic effects | Placebo comparator | Not described Receives: Device: microwave diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
An unpleasant sensation induced by noxious stimuli which are detected by nerve endings of nociceptive neurons.
The measurement tool that will be used is Visual Analog Scale. This scale is a unidimensional measure of pain intensity. It has a continuous scale comprised of a horizontal line with an interval of 10 points, where 1 is the minimum intensity of pain the patient can endure and 10 is the maximum intensity of pain the patient can endure.
Measured: 4 weeks
Secondary outcomes (2)
Disability
Determination of the degree of a physical patient´s handicap. The measurement tool that will be used is Roland Morris Disability Questionnaire. This questionnaire is used to establish physical disability degree of people with non specific acute low back pain. It has 24 questions the patient should point out to determinate his/her limitation for make normal activities.
Measured: 4 weeks
Satisfaction
To evaluate the assessment of the satisfaction regarding the attention and quality of the services received and the degree of compliance with the patient's expectations about the treatment.
The measurement tool that will be used is Client Satisfaction Questionnaire. This questionnaire is used to evaluate patient's satisfaction with the care and quality of the health services received. It has 8 items from 1 to 4 points (where 1 is the minimum satisfaction and 4 is the maximum satisfaction) to assess the satisfaction degree.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start10 Jan 2018
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MIGUEL ANGEL CAÑADAS GARCIA, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386084
- Sponsor's protocol ID
- CEIM/HU/2017/19
- Status last verified
- Jun 2018
- First submitted
- 29 Nov 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Motor Control Treatment Combined With Resistive Capacitive Diathermy in Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT03386084
- Acronym / sponsor ID
- CEIM/HU/2017/19
- Conditions
- Low Back Pain
- Keywords
- capacitive resistive diathermy, motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 29 Dec 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.
Lumbar pain is considered one of the most frequent health problems faced by human populations on a global scale.
This study will be carried out to evaluate the efficiency of motor control treatments combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the potential for accelerated patient recuperation if both treatments are applied simultaneously and jointly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct application of microwave diathermy and motor control | Experimental | Device: microwave diathermy |
| application of microwave diathermy without therapeutic effects | Placebo comparator | Device: microwave diathermy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute low back pain (no more of 4 weeks)
- Spanish speaker
- Between 18-65 years
Key exclusion criteria (7 listed)
- Patients in whom diathermy is a contraindicated therapy
- Pacemaker
- Pregnant
- Not intact skin
- Thrombophlebitis
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 |
|---|---|---|
| microwave diathermyApplication of microwave diathermy with Monopolar CapacitiveResistive Radiofrequency Therapy (INDIBA) | Device | application of microwave diathermy without therapeutic effects, direct application of microwave diathermy and motor control |
Primary outcome
Pain
Time frame: 4 weeks
An unpleasant sensation induced by noxious stimuli which are detected by nerve endings of nociceptive neurons. The measurement tool that will be used is Visual Analog Scale. This scale is a unidimensional measure of pain intensity. It has a continuous scale comprised of a horizontal line with an interval of 10 points, where 1 is the minimum intensity of pain the patient can endure and 10 is the maximum intensity of pain the patient can endure.
2 secondary outcomes
Disability
Time frame: 4 weeks
Satisfaction
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 6 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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 microwave diathermy in people with Low Back Pain, run by University of Alcala at 1 site in Spain.
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 3 inclusion and 7 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 6 Jun 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 Spain. 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?
Pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2018.