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

NCT04048902 | Completed DMC

• 1 other identifier: 48391615.9.0000.0065
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Exercise Therapy; Clinical Trial; Diathermy; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Before the treatment, up to 3, 6 and 18 weeks

Secondary Outcomes (7)

• Functional disability

  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)

  Before the treatment, up to 3, 6 and 18 weeks

• Perception of global effect

  Before the treatment, up to 3, 6 and 18 weeks

• Emotional Functioning

  Before the treatment, up to 3, 6 and 18 weeks

• Depressive Symptom

  Before the treatment, up to 3, 6 and 18 weeks

Study Arms (2)

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

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

Device: Pilates and Shortwave active

Interventions

Pilates and Shortwave placebo DEVICE

Pilates exercises and application of the device without produce thermal effects

Pilates and Shortwave placebo

Pilates and Shortwave active DEVICE

Pilates exercises and application of the device producing thermal effects

Pilates and Shortwave active

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 05360-160, Brazil

Location

MeSH Terms

Conditions

Low Back Pain; Fever

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Study Officials

• Raquel A Casarotto, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Sandra Amaral, Bachelor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: August 7, 2019
• Study Start: March 6, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

BR (1)