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

NCT ID: NCT04048902

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2020-09-30

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pilates and Shortwave placebo

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

Group Type: PLACEBO_COMPARATOR

Pilates and Shortwave placebo

Intervention Type: DEVICE

Pilates exercises and application of the device without produce thermal effects

Pilates and Shortwave active

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

Group Type: ACTIVE_COMPARATOR

Pilates and Shortwave active

Intervention Type: DEVICE

Pilates exercises and application of the device producing thermal effects

Interventions

Pilates and Shortwave placebo

Pilates exercises and application of the device without produce thermal effects

Intervention Type: DEVICE

Pilates and Shortwave active

Pilates exercises and application of the device producing thermal effects

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Raquel A. Casarotto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raquel A Casarotto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Sandra Amaral, Bachelor

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

48391615.9.0000.0065

Identifier Type: -

Identifier Source: org_study_id