Influence of Cryotherapy Combined to TENS Burst in Patients With Non-specific Chronic Lombar Pain
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
April 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedApril 12, 2017
April 1, 2017
6 months
March 17, 2017
April 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change from baseline Pain evaluated by Visual Analog Scale at 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
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
To evaluate the pain by the pain sensation through the pressure algometer.
1 month
Change from baseline Pain evaluated by algometry at 2 months
To evaluate the pain by the pain sensation through the pressure algometer.study completion
2 months
Study Arms (4)
Control Placebo Group
PLACEBO COMPARATORThe subjects of this group will be submitted to TENS bound in placebo mode in the lumbar spine.
Cryotherapy Group
EXPERIMENTALThe subjects of this group will be submitted to Cryotherapy in the lumbar spine.
TENS Burst Group
EXPERIMENTALThe subjects of this group will be submitted to TENS Burst in the lumbar spine.
TENS Burst and Cryotherapy Group
EXPERIMENTALThe subjects of this group will be submitted to TENS Burst and Cryotherapy in the lumbar spine.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59072-970, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 17, 2017
First Posted
April 12, 2017
Study Start
April 17, 2017
Primary Completion
October 1, 2017
Study Completion
November 1, 2017
Last Updated
April 12, 2017
Record last verified: 2017-04