Influence of Cryotherapy Combined to TENS Burst in Patients With Non-specific Chronic Lombar Pain

April 6, 2017 updated by: Wouber Hérickson de Brito Vieira

Influence of Cryotherapy Combined to TENS Burst in Pain, Functional Capacity and Quality of Life Patients With Non-specific Chronic Lombar Pain: A Blind Controlled Randomized Clinical Trial

The purpose of this study is to analyze the effects of TENS Burst combined Cryotherapy on painful sensation, functional capacity and quality of life of patients with non-specific chronic pain.

Study hypothesis:

The TENS Burst combined with Cryotherapy offers a better response in the pain sensation, functional capacity and quality of life of patients with non-specific chronic low back pain when compared to the application of these resources in isolation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a blind, randomized, controlled clinical trial. The first investigator (PI) will be responsible for evaluations and reassessments; The second investigator (PII) for the process of randomization and instruction of the subjects in the intervention protocol and the third investigator (PIII) for the statistical analyzes. The study collections will take place from April 2017 until November 2017, after approval by the Ethics and Research and Qualification Committee and will be developed at the Rehabilitation Outpatient Clinic of the University Hospital Onofre Lopes - HUOL.

The investigators will select 48 individuals recruited non-probabilistically for convenience in HUOL. The sample calculation performed in G POWER software version 3.0.0.1 with 80% "power" defined the number of 40 individuals, adding to that number the 20% of possible losses during the survey. Allocation of the groups will be random, through the website http://www.randomization.com, which will include information such as sample size and number of groups. From this, the site will generate a specific coding for each group, randomly and in the form of blocks, with the following characteristics: sex, women in active cycle and use of oral contraceptives and use of analgesics. In this study, four groups will be considered: control-placebo group (gCP), cryotherapy group (gCrio), TENS Burst group (gTENSb) and Cryotherapy + TENS Burst group (gCrioTENSb). The four groups will receive educational sessions on chronic low back pain. The gCP will also undergo TENS bound in placebo mode, gCrio will undergo cryotherapy, gTENSb will undergo TENS in Burst mode and gCrioTENSb will undergo TENS Cryotherapy + Burst (combined). This protocol is in compliance with the recommendations of the Consolidated Standards of Reporting Trials - CONSORT (http://www.consort-statement.org/) for the execution of randomized clinical trials.

At the outset, all subjects will receive general instructions on the procedures to be performed, as well as information about the possible risks and benefits of all stages of the research. Individuals will then be enrolled in the survey through a specially prepared assessment form containing information on identification, sex, age, body mass index, level of education, work activity, employment status, stress, and beliefs about pain, marital status, time of onset of symptoms, presence of dermal conditions, sensitivity, ice allergy and treatment perspective. These subjects will be subject to the evaluation measures under the IP instruction, the IP will not know to which group the subjects belong. The evaluations will be performed before the 1st intervention session and will consist of the evaluation of the pain through the EVA when performing the movement and the pressure pain; Functional ability by the Roland-Morris Questionnaire, Functional Oswestry Index and Finger-to-Ground Distance; Quality of life, questionnaire SF 36 and pleasure / dissatisfaction of the intervention by Felling Scale. To maintain the blindness of the study, each individual at the time of intervention will spend 30 minutes in the intervention room and each group will have a corresponding color for the convenience of P2 (being white, blue, green and yellow).

The remaining AV2 and AV3 evaluations will be performed two days after the 10th treatment session and 4 weeks after the last treatment session, respectively, for gCP, gCrio, gTENSb and gCrioTENSb. The women will be evaluated and reassessed in the same phase, the follicular phase of the menstrual cycle to present higher thresholds of sensory perception, and will be used to identify the phases of the cycle of each volunteer following the proposed calendar method and the confirmation of regularity by, at least Less, six posterior menstrual cycles. The evaluations and interventions will be carried out in the evening shift and in the same room with a standard temperature of 24º C. A pilot study will be carried out in order to reproduce what will be done during the evaluation and intervention processes, in order to identify and correcting possible flaws with regard to the proposed procedures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • RN
      • Natal, RN, Brazil, 59072-970
        • Federal University of Rio Grande do Norte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Women who present a regular menstrual cycle of 21-35 days;
  • Body mass index between 18.5 and 30 kg / m2;
  • Low back pain for at least 12 weeks;
  • Diagnosis for the treatment of chronic lumbar of non-specific origin;
  • Not used electrotherapy before;
  • No presenting skin alteration, vascular sensitivity or that hinder a perception of electrical stimulation and allergy to ice.

Exclusion Criteria:

  • Those who are not tolerant and respect the evaluation and / or intervention procedures;
  • Absence in less than two protocol treatment sessions;
  • Initiate during the protocol the use of analgesics and anti-inflammatories;
  • The participants to withdraw their consent to participate in the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control Placebo Group
The subjects of this group will be submitted to TENS bound in placebo mode in the lumbar spine.
Other: TENS Burst Placebo
The TENS Burst placebo therapy will be performed using the KLD Sonophasys EUS 0503 electrotherapy device connected in the current therapy mode with the following parameters: 4Hz frequency, high pulse duration of 200 μsec and the current intensity will be on but without Produce the effects of visible muscle contractions because the channel will not be properly coupled in the apparatus so that the stimulation does not reach the patient. A channel will be used using self-adhesive electrodes arranged parallel to the erector muscle of the spine, so that the region to be treated is between the electrodes.
Other: Education
After the electrophysical intervention, a moment of education and awareness will be held, in which the participants will receive information about the purpose of the treatment; Anatomy and biomechanics of the lumbar spine; Chronic non-specific back pain; Cognitive, emotional, genetic, social, and lifestyle factors; Intrinsic and extrinsic physical factors, biopsychosocial model: beliefs of pain and hypervigilance; Concepts of joint protection; Energy conservation and general guidelines.
Other Names:
  • Lesson
Experimental: Cryotherapy Group
The subjects of this group will be submitted to Cryotherapy in the lumbar spine.
Other: Education
After the electrophysical intervention, a moment of education and awareness will be held, in which the participants will receive information about the purpose of the treatment; Anatomy and biomechanics of the lumbar spine; Chronic non-specific back pain; Cognitive, emotional, genetic, social, and lifestyle factors; Intrinsic and extrinsic physical factors, biopsychosocial model: beliefs of pain and hypervigilance; Concepts of joint protection; Energy conservation and general guidelines.
Other Names:
  • Lesson
Other: Cryotherpy
Cryotherapy will be used by means of ice packs over a painful region. The ice will be crushed inside a bag so that it is in an ideal size that provides a coupling in a painful column in the lumbar spine; Once it has been inserted in the plastic bag and before closing it all the air must be removed to avoid a faster thawing of the ice and have difficulties of coupling.
Experimental: TENS Burst Group
The subjects of this group will be submitted to TENS Burst in the lumbar spine.
Other: TENS Burst Placebo
The TENS Burst placebo therapy will be performed using the KLD Sonophasys EUS 0503 electrotherapy device connected in the current therapy mode with the following parameters: 4Hz frequency, high pulse duration of 200 μsec and the current intensity will be on but without Produce the effects of visible muscle contractions because the channel will not be properly coupled in the apparatus so that the stimulation does not reach the patient. A channel will be used using self-adhesive electrodes arranged parallel to the erector muscle of the spine, so that the region to be treated is between the electrodes.
Other: Education
After the electrophysical intervention, a moment of education and awareness will be held, in which the participants will receive information about the purpose of the treatment; Anatomy and biomechanics of the lumbar spine; Chronic non-specific back pain; Cognitive, emotional, genetic, social, and lifestyle factors; Intrinsic and extrinsic physical factors, biopsychosocial model: beliefs of pain and hypervigilance; Concepts of joint protection; Energy conservation and general guidelines.
Other Names:
  • Lesson
Experimental: TENS Burst and Cryotherapy Group
The subjects of this group will be submitted to TENS Burst and Cryotherapy in the lumbar spine.
Other: Education
After the electrophysical intervention, a moment of education and awareness will be held, in which the participants will receive information about the purpose of the treatment; Anatomy and biomechanics of the lumbar spine; Chronic non-specific back pain; Cognitive, emotional, genetic, social, and lifestyle factors; Intrinsic and extrinsic physical factors, biopsychosocial model: beliefs of pain and hypervigilance; Concepts of joint protection; Energy conservation and general guidelines.
Other Names:
  • Lesson
Other: Cryotherpy
Cryotherapy will be used by means of ice packs over a painful region. The ice will be crushed inside a bag so that it is in an ideal size that provides a coupling in a painful column in the lumbar spine; Once it has been inserted in the plastic bag and before closing it all the air must be removed to avoid a faster thawing of the ice and have difficulties of coupling.
Other: TENS Burst
The TENS Burst therapy will be performed using the KLD Sonophasys EUS 0503 electrotherapy device connected in the current therapy mode with the following parameters: 4Hz frequency, high pulse duration of 200 μsec and the current intensity will be at the maximum amplitude To generate visible muscle contraction without generating pain / discomfort. A channel will be used using self-adhesive electrodes arranged parallel to the erector muscle of the spine, so that the region to be treated is between the electrodes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Pain evaluated by Visual Analog Scale at 1 month
Time Frame: 1 month
Evaluated from the participants' response to pain questioning on the visual analog scale.
1 month
Change from baseline Pain evaluated by Visual Analog Scale at 2 months
Time Frame: 2 months
Evaluated from the participants' response to pain questioning on the visual analog scale.
2 months
Change from baseline Pain evaluated by algometry at 1 month
Time Frame: 1 month
To evaluate the pain by the pain sensation through the pressure algometer.
1 month
Change from baseline Pain evaluated by algometry at 2 months
Time Frame: 2 months
To evaluate the pain by the pain sensation through the pressure algometer.study completion
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wouber Hérickson de Brito Vieira

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1.953.896

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Low Back Pain

Clinical Trials on TENS Burst Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings