Low Back PainT-CareNCT02736201
Capacitive Diathermy in the Lumbopelvic Pain
A study testing Capacitive diathermy (T-CaRe®) and Instrumental manual therapy in people with Low Back Pain, run by European University of Madrid at 1 site in Spain.
Trial summary
Objective: To determine the effectiveness of the capacitive diathermy in the mechanosensitivity, morphological, functional and contractility changes in patients with lumbopelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Capacitive diathermy (T-CaRe®) and Instrumental manual therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to Mar 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- bilateral lumbopelvic pain for 6 weeks
Who cannot join
- neuromuscular conditions
- negative straight leg raise test
- respiratory or congenital conditions
- surgeries
- neurologic signs
- lower extremities conditions
Show all 13Show fewer
- skin alterations
- cognitive disorders
- body mass index higher than 31 kg/cm2
- skin alterations
- pregnancy
- intensive physical activity
- Nijmegen test higher than 24
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
European University of Madrid
Villaviciosa de Odón, Madrid, 28670
César Calvo Lobo, PhD, MSc, PT, 0034-912-115-268 ext. 5268, cesar.calvo@universidadeuropea.es
César Calvo Lobo, PhD, MSc, PT
About this study
Official title: Mechanosensitivity, Morphological, Functional and Contractility Changes by the Capacitive Diathermy in Subjects With Lumbopelvic Pain: a Pilot Study, Single Blind, Randomized Controlled Clinical Trial
Objective: To determine the effectiveness of the capacitive diathermy in the mechanosensitivity, morphological, functional and contractility changes in patients with lumbopelvic pain.
Design: A pilot study, single blind, randomized controlled clinical trial, approved previously by The Princess University Hospital Ethics Committee (Feb 11, 2016) and the European University clinical intervention review board (CIPI/054/15).
Read more
Setting: Faculty of Health Sciences, Exercise and Sport. European University of Madrid.
Patients and intervention: A sample of 20 patients with bilateral lumbopelvic pain, between 18 and 60 years old, will be recruited and randomized into 2 intervention groups. The instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+ T-CaRe®on; n = 10) and the instrumental manual therapy with the switched off capacitive diathermy electrode (IMT+ T-CaRe®off; n = 10) will be bilaterally treated for 4 weeks (1 treatment per week during 10 minutes) in the lumbopelvic region.
Outcome measurements: Control variables such as the age, sex, height, weight, body mass index, Borg scale physical activity and distress respiratory test will be measured at the beginning of the treatment. Dependent variables such as the pain intensity, the pressure pain threshold, the contractility, the stiffness, the adverse effects, the Oswestry and Schöber test, as well as the ultrasound imaging cross sectional area and thickness of the skin, subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus anterior, externus oblique, internal oblique and transversus abdominis) will be assessed before and after each intervention by a blinded examiner.
Analysis data: The statistical analysis will be performed with a 95% confidence interval and the Statistic Package Social Sciences (SPSS) 22.0.
- Conditions
- Low Back Pain
- Being tested
- Capacitive diathermy (T-CaRe®), Instrumental manual therapy
- 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.
Capacitive diathermy (T-CaRe®)Device
The instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+ T-CaRe® on; n = 10) and the instrumental manual therapy with the switched off capacitive diathermy electrode (IMT+ T-CaRe® off; n = 10) will be bilaterally treated for 4 weeks (1 treatment per week during 10 minutes) in the lumbopelvic region.
Instrumental manual therapyOther
Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)
| Study group | Role | What they receive |
|---|---|---|
| IMT+ T-CaRe®on; n = 10 | Experimental | The instrumental manual therapy with the switched on capacitive diathermy electrode Receives: Device: Capacitive diathermy (T-CaRe®); Other: Instrumental manual therapy |
| IMT+ T-CaRe® off; n = 10 | Sham comparator | The instrumental manual therapy with the switched off capacitive diathermy electrode Receives: Device: Capacitive diathermy (T-CaRe®); Other: Instrumental manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity from 0 to 10
Visual analogue scale
Measured: 4 weeks
Secondary outcomes (8)
Pressure pain threshold in kg/cm^2
Analogue pressure algometer (Mechanical algometer)
Measured: 4 weeks
Contractility time in seconds
Electrical stimulator
Measured: 4 weeks
Stiffness by the mean strain ratio (proportion) by Sonoelastography
The mean strain ratio by Sonoelastography
Measured: 4 weeks
Adverse effects (yes or no)
Measured: 4 weeks
Oswestry test from 0 to 100
Measured: 4 weeks
Schöber test in centimeters
Measured: 4 weeks
Cross sectional area (cm^2) in centimeters
Ultrasound imaging (cm^2) in the L4 multifidus of the low back region and the rectus anterior of the abdominal wall. Diagnostic ultrasound system.
Measured: 4 weeks
Thickness in centimeters
Ultrasound imaging (cm) in the skin, subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus anterior, external oblique, internus oblique and transversus abdominis). Diagnostic ultrasound system
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 posted13 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- César Calvo Lobo, PhD, MSc, PT, Principal investigator, European University of MadridDavid Rodríguez Sanz, PhD, MSc, PT, Principal investigator, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736201
- Sponsor's protocol ID
- CIPI/054/15
- Acronym
- T-Care
- Status last verified
- Oct 2016
- First submitted
- 24 Mar 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanosensitivity, Morphological, Functional and Contractility Changes by the Capacitive Diathermy in Subjects With Lumbopelvic Pain: a Pilot Study, Single Blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02736201
- Acronym / sponsor ID
- T-Care / CIPI/054/15
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 13 Apr 2016 (estimated)
- 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.
Objective: To determine the effectiveness of the capacitive diathermy in the mechanosensitivity, morphological, functional and contractility changes in patients with lumbopelvic pain.
Design: A pilot study, single blind, randomized controlled clinical trial, approved previously by The Princess University Hospital Ethics Committee (Feb 11, 2016) and the European University clinical intervention review board (CIPI/054/15).
Setting: Faculty of Health Sciences, Exercise and Sport. European University of Madrid.
Patients and intervention: A sample of 20 patients with bilateral lumbopelvic pain, between 18 and 60 years old, will be recruited and randomized into 2 intervention groups. The instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+ T-CaRe®on; n = 10) and the instrumental manual therapy with the switched off capacitive diathermy electrode (IMT+ T-CaRe®off; n = 10) will be bilaterally treated for 4 weeks (1 treatment per week during 10 minutes) in the lumbopelvic region.
Outcome measurements: Control variables such as the age, sex, height, weight, body mass index, Borg scale physical activity and distress respiratory test will be measured at the beginning of the treatment. Dependent variables such as the pain intensity, the pressure pain threshold, the contractility, the stiffness, the adverse effects, the Oswestry and Schöber test, as well as the ultrasound imaging cross sectional area and thickness of the skin, subcutaneous tissue, connective tissue, L4 multifidus and the abdominal Wall (rectus anterior, externus oblique, internal oblique and transversus abdominis) will be assessed before and after each intervention by a blinded examiner.
Analysis data: The statistical analysis will be performed with a 95% confidence interval and the Statistic Package Social Sciences (SPSS) 22.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT+ T-CaRe®on; n = 10 | Experimental | Device: Capacitive diathermy (T-CaRe®), Other: Instrumental manual therapyThe instrumental manual therapy with the switched on capacitive diathermy electrode |
| IMT+ T-CaRe® off; n = 10 | Sham comparator | Device: Capacitive diathermy (T-CaRe®), Other: Instrumental manual therapyThe instrumental manual therapy with the switched off capacitive diathermy electrode |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- bilateral lumbopelvic pain for 6 weeks
Key exclusion criteria (13 listed)
- neuromuscular conditions
- negative straight leg raise test
- respiratory or congenital conditions
- surgeries
- neurologic signs
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 |
|---|---|---|
| Capacitive diathermy (T-CaRe®)The instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+ T-CaRe® on; n = 10) and the instrumental manual therapy with the switched off capacitive diathermy electrode (IMT+ T-CaRe® off; n = 10) will be bilaterally treated for 4 weeks (1 treatment per week during 10 minutes) in the lumbopelvic region. | Device | IMT+ T-CaRe® off; n = 10, IMT+ T-CaRe®on; n = 10 |
| Instrumental manual therapyBilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side) | Other | IMT+ T-CaRe® off; n = 10, IMT+ T-CaRe®on; n = 10 |
Primary outcome
Pain intensity from 0 to 10
Time frame: 4 weeks
Visual analogue scale
8 secondary outcomes
Pressure pain threshold in kg/cm^2
Time frame: 4 weeks
Contractility time in seconds
Time frame: 4 weeks
Stiffness by the mean strain ratio (proportion) by Sonoelastography
Time frame: 4 weeks
Adverse effects (yes or no)
Time frame: 4 weeks
Oswestry test from 0 to 100
Time frame: 4 weeks
Schöber test in centimeters
Time frame: 4 weeks
Cross sectional area (cm^2) in centimeters
Time frame: 4 weeks
Thickness in centimeters
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
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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.
César Calvo Lobo, PhD, MSc, PT principal investigator
European University of Madrid
David Rodríguez Sanz, PhD, MSc, PT principal investigator
European University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capacitive diathermy (T-CaRe®) and Instrumental manual therapy in people with Low Back Pain, run by European University of Madrid 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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cesar Calvo Lobo, PhD, MSc, PT (0034-912-115-268 ext. 5268, cesar.calvo@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity from 0 to 10 (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 7 Oct 2016.