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Completed

NCT Number: NCT04048902

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05360-160, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates and Shortwave placebo

Device

Pilates exercises and application of the device without produce thermal effects

Pilates and Shortwave active

Device

Pilates exercises and application of the device producing thermal effects

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Functional disability

    Time frame: Before the treatment, up to 3, 6 and 18 weeks

    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.

  2. 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

    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.

  3. Perception of global effect

    Time frame: Before the treatment, up to 3, 6 and 18 weeks

    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.

  4. Emotional Functioning

    Time frame: Before the treatment, up to 3, 6 and 18 weeks

    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.

  5. Depressive Symptom

    Time frame: Before the treatment, up to 3, 6 and 18 weeks

    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.

  6. Symptoms and adverse events

    Time frame: Before the treatment, up to 3, 6 and 18 weeks

    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).

  7. Patient Satisfaction: The MedRisk scale

    Time frame: Patients will be evaluated up to 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Effects of Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back Pain: a Protocol of a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2019
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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