Low Back PainNCT04048902
Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back
A study testing Pilates and Shortwave active in people with Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The aim of this study is to verify the effectiveness of the association of Shortwave Diathermy and Pilates exercises in patients with chronic non-specific low back pain, on the reduction of pain, functional disability and improvement of the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pilates and Shortwave active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Mar 2018to 30 Sep 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals diagnosed with chronic non-specific low back pain for a period of more than 3 months, without irradiation for lower limbs;
- who present pain intensity greater than 3 points in the Numerical Pain Scale;
- to sign the Free and Informed Consent Form.
Who cannot join
- BMI> 30;
- previous surgeries in the spine;
- severe spinal affection (tumors, infection, unconsolidated or vicious consolidation fractures, inflammatory diseases);
- rheumatic disease;
- contraindication to performing the exercises according to the American College of Sports Medicine Guidelines;
- degenerative or inflammatory joint and other body segments;
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- patients who are in labor litigation;
- pregnancy;
- patients who are undergoing other type of physiotherapeutic or drug treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo
São Paulo, 05360-160
About this study
Official title: Effects of Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back Pain: a Protocol of a Randomized Controlled Trial
The aim of this study is to verify the effectiveness of the association of Shortwave Diathermy and Pilates exercises in patients with chronic non-specific low back pain, on the reduction of pain, functional disability and improvement of the quality of life.
Read the detailed description
The drawing of the study will be a prospective, randomized controlled trial and double-blind with quantitative approach. Study participants 36 subjects diagnosed with non-specific chronic low back pain, which will be divided in two groups with 18 subjects in each: experimental group, which will be submitted to placebo + exercise shortwave diathermy and the control group to do active + exercise shortwave diathermy. There will be 12 one-hour sessions twice a week. The subjects will apply Shortwave Diathermy for 20 minutes, followed by Pilates mat.
- Conditions
- Low Back Pain
- Being tested
- Pilates and Shortwave placebo, Pilates and Shortwave active
- Keywords
- Exercise Therapy, Clinical Trial, Diathermy, Physical Therapy Modalities
- Medical subject headings
- Low Back Pain, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates and Shortwave placeboDevice
Pilates exercises and application of the device without produce thermal effects
Pilates and Shortwave activeDevice
Pilates exercises and application of the device producing thermal effects
| Study group | Role | What they receive |
|---|---|---|
| Pilates and Shortwave placebo | Placebo comparator | In this group the patients will receive 20 minutes of short wave placebo application. The equipment will keep the timer on and the intensity will remain at zero. The patient will be informed that the dose is subsensory and therefore there will be no perception of the passage of the short waves through the body.The application will be performed with two coplanar plates in parallel, arranged on the right and left side of the lumbar region, maintaining a distance of 5 to 10 cm between them, with the patient lying in the dorsal decubitus position Receives: Device: Pilates and Shortwave placebo |
| Pilates and Shortwave active | Active comparator | In this group the patients will receive 20 minutes of application of the Shortwave Active continuous mode (thermal effect), with vigorous local thermal sensation.The application will be performed with two coplanar plates in parallel, arranged on the right and left side of the lumbar region, maintaining a distance of 5 to 10 cm between them, with the patient lying in the dorsal decubitus position Receives: Device: Pilates and Shortwave active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain through Pain visual analogue scale
Scale with 11 centimeters is used for evaluate pain intensity, being "0" no pain and "10" the worst possible pain
Measured: Before the treatment, up to 3, 6 and 18 weeks
Change in pain through The McGill pain questionnaire
It is organized in four categories: sensory, affective, evaluative and mixed, with 20 subcategories and 78 words descriptors of pain, describing the quality of pain. The pain evaluation index is the sum of the values added, and each word chosen in each dimension is the maximum score of each category: Sensory = 34, Affective = 17, Evaluative = 5, Mixed = 11, Total = 67.
Measured: Before the treatment, up to 3, 6 and 18 weeks
Secondary outcomes (7)
Functional disability
The Rolland and Morris Questionnaire, validated in Brazil, will quantify the functional limitations caused by low back pain. The questionnaire is composed of 24 questions related to normal activities of daily living, in which each affirmative answer corresponds to a point. The final score is determined by the sum of the values obtained. Values close to zero represent the best results (lower limitation), and values close to 24 the worst results. Values above 14 points are considered as a severe spinal impairment.
Measured: Before the treatment, up to 3, 6 and 18 weeks
Patients' perceptions of their health-related quality of life: The Short-Form Health Survey questionnaire (SF-36)
The Short-Form Health Survey questionnaire (SF-36) will assess the health-related quality of life of patients. This instrument contains 36 questions grouped into eight areas: functional capacity (10 items), physical aspects (2 items), pain (2 items), general state of health (5 items), vitality (4 items), social aspects (2 items), emotional (3 items) and mental health (5 items). The values in each domain vary from 0 to 100 and, more indicate a better quality of life.
Measured: Before the treatment, up to 3, 6 and 18 weeks
Perception of global effect
Evaluates the level of perception of patient recovery through a Scale Numbers of 11 points comparing the onset of symptoms at the beginning of treatment in relation to the last days. It varies from -5 to +5, being -5: extremely worse; zero: no modification; and +5: fully recovered, with the highest score representing greater recovery.
Measured: Before the treatment, up to 3, 6 and 18 weeks
Emotional Functioning
It will be evaluated by the Brazilian version of the Visual Analog Scale for anxiety. Analogic visual scale for anxiety is a horizontal line of 100 mm in length. The tip left without anxiety and the right tip means worse anxiety.
Measured: Before the treatment, up to 3, 6 and 18 weeks
Depressive Symptom
It will be evaluated by the Brazilian version of the Beck Depression Inventory, a self-assessment measure of depression. It is a questionnaire with 21 items whose intensity ranges from 0 to 3 points. Largest scores indicate more depressive symptoms.
Measured: Before the treatment, up to 3, 6 and 18 weeks
Symptoms and adverse events
The record of the symptoms and adverse events that occurred during the established behavior will be captured passively through spontaneous reports of the patient. The active catch will use a questionnaire with a record of the duration and intensity of the adverse symptom reported by the patient. You will then be asked to the patient graduates the certainty of their affirmations according to a Likert scale (being 1 not certain and 5 total certainty).
Measured: Before the treatment, up to 3, 6 and 18 weeks
Patient Satisfaction: The MedRisk scale
The MedRisk scale consists of 20 items, 10 items related to the therapist-patient interaction; 8 items involving evaluation of the infrastructure and work organization of the physical therapy clinic and 2 items that are considered as global evaluation of the treatment. The patient elects level of satisfaction in each item by selecting a Likert scale ranging from 1 "completely disagree" to 5 "agree completely" or through an option "not applicable", with high scores representing high satisfaction.
Measured: Patients will be evaluated up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start6 Mar 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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.
- More trials run by University of Sao Paulo General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel A. Casarotto, University of Sao Paulo General Hospital
- Investigators
- Raquel A Casarotto, PhD, Principal investigator, University of Sao PauloSandra Amaral, Bachelor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048902
- Sponsor's protocol ID
- 48391615.9.0000.0065
- Status last verified
- Oct 2020
- First submitted
- 15 Apr 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back Pain: a Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04048902
- Acronym / sponsor ID
- 48391615.9.0000.0065
- Conditions
- Low Back Pain
- Keywords
- Exercise Therapy, Clinical Trial, Diathermy, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 7 Aug 2019 (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.
The aim of this study is to verify the effectiveness of the association of Shortwave Diathermy and Pilates exercises in patients with chronic non-specific low back pain, on the reduction of pain, functional disability and improvement of the quality of life.
Detailed description
The drawing of the study will be a prospective, randomized controlled trial and double-blind with quantitative approach. Study participants 36 subjects diagnosed with non-specific chronic low back pain, which will be divided in two groups with 18 subjects in each: experimental group, which will be submitted to placebo + exercise shortwave diathermy and the control group to do active + exercise shortwave diathermy. There will be 12 one-hour sessions twice a week. The subjects will apply Shortwave Diathermy for 20 minutes, followed by Pilates mat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates and Shortwave placebo | Placebo comparator | Device: Pilates and Shortwave placeboIn this group the patients will receive 20 minutes of short wave placebo application. The equipment will keep the timer on and the intensity will remain at zero. The patient will be informed that the dose is subsensory and therefore there will be no perception of the passage of the short waves through the body.The application will be performed with two coplanar plates in parallel, arranged on the right and left side of the lumbar region, maintaining a distance of 5 to 10 cm between them, with the patient lying in the dorsal decubitus position |
| Pilates and Shortwave active | Active comparator | Device: Pilates and Shortwave activeIn this group the patients will receive 20 minutes of application of the Shortwave Active continuous mode (thermal effect), with vigorous local thermal sensation.The application will be performed with two coplanar plates in parallel, arranged on the right and left side of the lumbar region, maintaining a distance of 5 to 10 cm between them, with the patient lying in the dorsal decubitus position |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- individuals diagnosed with chronic non-specific low back pain for a period of more than 3 months, without irradiation for lower limbs;
- who present pain intensity greater than 3 points in the Numerical Pain Scale;
- to sign the Free and Informed Consent Form.
Key exclusion criteria (9 listed)
- BMI> 30;
- previous surgeries in the spine;
- severe spinal affection (tumors, infection, unconsolidated or vicious consolidation fractures, inflammatory diseases);
- rheumatic disease;
- contraindication to performing the exercises according to the American College of Sports Medicine Guidelines;
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 |
|---|---|---|
| Pilates and Shortwave placeboPilates exercises and application of the device without produce thermal effects | Device | Pilates and Shortwave placebo |
| Pilates and Shortwave activePilates exercises and application of the device producing thermal effects | Device | Pilates and Shortwave active |
Primary outcome
Change in pain through Pain visual analogue scale
Time frame: Before the treatment, up to 3, 6 and 18 weeks
Scale with 11 centimeters is used for evaluate pain intensity, being "0" no pain and "10" the worst possible pain
Change in pain through The McGill pain questionnaire
Time frame: Before the treatment, up to 3, 6 and 18 weeks
It is organized in four categories: sensory, affective, evaluative and mixed, with 20 subcategories and 78 words descriptors of pain, describing the quality of pain. The pain evaluation index is the sum of the values added, and each word chosen in each dimension is the maximum score of each category: Sensory = 34, Affective = 17, Evaluative = 5, Mixed = 11, Total = 67.
7 secondary outcomes
Functional disability
Time frame: Before the treatment, up to 3, 6 and 18 weeks
Patients' perceptions of their health-related quality of life: The Short-Form Health Survey questionnaire (SF-36)
Time frame: Before the treatment, up to 3, 6 and 18 weeks
Perception of global effect
Time frame: Before the treatment, up to 3, 6 and 18 weeks
Emotional Functioning
Time frame: Before the treatment, up to 3, 6 and 18 weeks
Depressive Symptom
Time frame: Before the treatment, up to 3, 6 and 18 weeks
Symptoms and adverse events
Time frame: Before the treatment, up to 3, 6 and 18 weeks
Patient Satisfaction: The MedRisk scale
Time frame: Patients will be evaluated up to 6 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 5 Oct 2020.
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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.
Raquel A Casarotto, PhD principal investigator
University of Sao Paulo
Sandra Amaral, Bachelor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Shortwave active in people with Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 9 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 5 Oct 2020. 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 Brazil. 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?
Change in pain through Pain visual analogue scale (time frame: Before the treatment, up to 3, 6 and 18 weeks). The study lists 2 primary outcomes in all. 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 5 Oct 2020.