Efficacy of Motor Control and Diathermy Treatment in Acute Low Back Pain

Efficacy of Motor Control Treatment Combined With Resistive Capacitive Diathermy in Acute Low Back Pain

Lumbar pain is considered one of the most frequent health problems faced by human populations on a global scale.

This study will be carried out to evaluate the efficiency of motor control treatments combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the potential for accelerated patient recuperation if both treatments are applied simultaneously and jointly.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: microwave diathermy

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • San Sebastián De Los Reyes, Madrid, Spain, 28703
      • FisioWork

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acute low back pain (no more of 4 weeks)
• Spanish speaker
• Between 18-65 years

Exclusion Criteria:

• Patients in whom diathermy is a contraindicated therapy
• Pacemaker
• Pregnant
• Not intact skin
• Thrombophlebitis
• Hypotension
• Anticoagulated patient or with local surgical intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: direct application of microwave diathermy and motor control	Device: microwave diathermy; Application of microwave diathermy with Monopolar CapacitiveResistive Radiofrequency Therapy (INDIBA)
Placebo Comparator: application of microwave diathermy without therapeutic effects	Device: microwave diathermy; Application of microwave diathermy with Monopolar CapacitiveResistive Radiofrequency Therapy (INDIBA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	An unpleasant sensation induced by noxious stimuli which are detected by nerve endings of nociceptive neurons. The measurement tool that will be used is Visual Analog Scale. This scale is a unidimensional measure of pain intensity. It has a continuous scale comprised of a horizontal line with an interval of 10 points, where 1 is the minimum intensity of pain the patient can endure and 10 is the maximum intensity of pain the patient can endure.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	Determination of the degree of a physical patient´s handicap. The measurement tool that will be used is Roland Morris Disability Questionnaire. This questionnaire is used to establish physical disability degree of people with non specific acute low back pain. It has 24 questions the patient should point out to determinate his/her limitation for make normal activities.	4 weeks
Satisfaction	To evaluate the assessment of the satisfaction regarding the attention and quality of the services received and the degree of compliance with the patient's expectations about the treatment. The measurement tool that will be used is Client Satisfaction Questionnaire. This questionnaire is used to evaluate patient's satisfaction with the care and quality of the health services received. It has 8 items from 1 to 4 points (where 1 is the minimum satisfaction and 4 is the maximum satisfaction) to assess the satisfaction degree.	4 weeks

Collaborators and Investigators

• Sponsor: University of Alcala

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 2, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: motor control; capacitive resistive diathermy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Back Pain; Low Back Pain; Hyperthermia
• Other Study ID Numbers: CEIM/HU/2017/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No