Clinical trial NCT04048902: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Exercise Therapy
Clinical Trial
Diathermy
Physical Therapy Modalities
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in pain through Pain visual analogue scale
timeFrame: Before the treatment, up to 3, 6 and 18 weeks
measure: Change in pain through The McGill pain questionnaire
timeFrame: Before the treatment, up to 3, 6 and 18 weeks
Secondary outcomes:
measure: Functional disability
timeFrame: Before the treatment, up to 3, 6 and 18 weeks
measure: Patients' perceptions of their health-related quality of life: The Short-Form Health Survey questionnaire (SF-36)
timeFrame: Before the treatment, up to 3, 6 and 18 weeks
measure: Perception of global effect
timeFrame: Before the treatment, up to 3, 6 and 18 weeks
measure: Emotional Functioning
timeFrame: Before the treatment, up to 3, 6 and 18 weeks
measure: Depressive Symptom
timeFrame: Before the treatment, up to 3, 6 and 18 weeks
measure: Symptoms and adverse events
timeFrame: Before the treatment, up to 3, 6 and 18 weeks
measure: Patient Satisfaction: The MedRisk scale
timeFrame: Patients will be evaluated up to 6 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Physical Therapy, Speech and Occupational Therapy of University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Raquel A Casarotto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Sandra Amaral, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: