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Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates and Shortwave placebo
Pilates and Shortwave active
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Exercise Therapy, Clinical Trial, Diathermy, Physical Therapy Modalities

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • patients who are in labor litigation;
  • pregnancy;
  • patients who are undergoing other type of physiotherapeutic or drug treatment.

Sites / Locations

  • Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Pilates and Shortwave placebo

Pilates and Shortwave active

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).
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.

Full Information

First Posted
April 15, 2019
Last Updated
October 1, 2020
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04048902
Brief Title
Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Exercise Therapy, Clinical Trial, Diathermy, Physical Therapy Modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates and Shortwave placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Pilates and Shortwave active
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Pilates and Shortwave placebo
Intervention Description
Pilates exercises and application of the device without produce thermal effects
Intervention Type
Device
Intervention Name(s)
Pilates and Shortwave active
Intervention Description
Pilates exercises and application of the device producing thermal effects
Primary Outcome Measure Information:
Title
Change in pain through Pain visual analogue scale
Description
Scale with 11 centimeters is used for evaluate pain intensity, being "0" no pain and "10" the worst possible pain
Time Frame
Before the treatment, up to 3, 6 and 18 weeks
Title
Change in pain through The McGill pain questionnaire
Description
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.
Time Frame
Before the treatment, up to 3, 6 and 18 weeks
Secondary Outcome Measure Information:
Title
Functional disability
Description
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.
Time Frame
Before the treatment, up to 3, 6 and 18 weeks
Title
Patients' perceptions of their health-related quality of life: The Short-Form Health Survey questionnaire (SF-36)
Description
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.
Time Frame
Before the treatment, up to 3, 6 and 18 weeks
Title
Perception of global effect
Description
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.
Time Frame
Before the treatment, up to 3, 6 and 18 weeks
Title
Emotional Functioning
Description
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.
Time Frame
Before the treatment, up to 3, 6 and 18 weeks
Title
Depressive Symptom
Description
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.
Time Frame
Before the treatment, up to 3, 6 and 18 weeks
Title
Symptoms and adverse events
Description
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).
Time Frame
Before the treatment, up to 3, 6 and 18 weeks
Title
Patient Satisfaction: The MedRisk scale
Description
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.
Time Frame
Patients will be evaluated up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; patients who are in labor litigation; pregnancy; patients who are undergoing other type of physiotherapeutic or drug treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel A Casarotto, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Amaral, Bachelor
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil

12. IPD Sharing Statement

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Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back

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