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Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain

This study is currently recruiting participants.
Verified April 2017 by Thais Cristina Chaves, University of Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT02546466
First Posted: September 10, 2015
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Thais Cristina Chaves, University of Sao Paulo
  Purpose

Background: Low back pain is a major public health problem that affects most people at some point in life, and results in major psychosocial, economic, functional and physical consequences that can last for days and months. Most cases are undiagnosed and become chronic non-specific low back pain. Studies showed that these patients presented changes in postural control, yet the information is inconsistent, as well as the effects of Functional Taping (FT).

Objectives: The aim of this study will be to investigate the immediate and one-month follow-up effects of the use of Functional Taping to lumbar spine on pain intensity and postural control in patients with chronic nonspecific low back pain (CLBP).

Methods: This study will be a sham-controlled and randomized clinical trial. Participants: One hundred and twenty participants (18 and 50 years) both genders. Interventions: Participants will be randomly allocated to receive three possible interventions: Functional Star-shape Taping, Sham Functional Taping (both interventions during seven days) and a Minimal Intervention (MI) (one session). Main outcome measures: Primary outcomes will be pain intensity and posturography to assess balance parameters. Low back pain related disability, global perceived effect of treatment and fear avoidance beliefs will be considered as secondary outcomes. Four measurements of static posturography will be conducted: pre-intervention, immediately after application of the tape, after seven days post-intervention (after removal of the tape) and after one month follow-up period. Secondary and primary outcomes will be assessed on three occasions: pre-intervention, seven days post-intervention and after one month follow-up period. All statistical analysis will be conducted following the principles of intention to treat, and the effects of treatment will be calculated using linear mixed models.


Condition Intervention
Low Back Pain Procedure: Functional Star-shape taping (SFT) Procedure: Sham Functional Taping (Sham-FT) Behavioral: Minimal Intervention Strategy (MIS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Functional Taping Compared to Sham and Minimal Intervention Strategy on Pain Intensity and Static Postural Control in Patients With Non-specific Chronic Low Back Pain: a Protocol for a Randomized Sham-controlled Trial

Resource links provided by NLM:


Further study details as provided by Thais Cristina Chaves, University of Sao Paulo:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: one month ]
    Measurement of pain intensity was accomplished by means of the application of the Numerical Pain Rating Scale (NPRS), which consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable." The volunteers will rate their pain based on these parameters.

  • Postural control on force platform - Static Posturography with and without a secondary task [ Time Frame: one month ]

    For evaluation on the force platform, a modified clinical test of sensory interaction for balance (CTSIBm) (Boulgarides et al. 2003) will be used by measuring the static balance in four sensory conditions: (1) eyes open on stable surface; (2) eyes closed on stable surface; (3) eyes open on unstable surface; (4) eyes closed on unstable surface. For each condition, the participant will be evaluated three times for a period of 40 seconds with a 30 second interval between each evaluation (Ruhe et al. 2011). For an unstable surface, a 13 cm-thick cushion with a density of 5kg/m3 will be used Caffaro et al. (2014).

    For the assessment of static posturography with a secondary task, participant will be requested to perform fast movement of shoulder flexion (bilateral). Participants will perform five movements (open and closed eyes) (Mok et al. 2011).



Secondary Outcome Measures:
  • Disability [ Time Frame: one month ]
    To assess disability from chronic low back pain, the Oswestry Low Back Disability Index, adapted to Brazilian Portuguese by Vigatto et al. (2007) will be used. This instrument consists of 10 items, each of which has six response options. The first response receives 0 points, and describes the absence or a small amount of low back pain and functional disability, while the sixth response, with five points, describes extreme pain or functional disability. The total score was calculated by summing up the points, the largest possible sum being 50. This result will be transformed into a percentage by multiplying it by two. The highest percentage represented greater disability related to back pain.

  • Fear avoidance beliefs questionnaire (FABQ) [ Time Frame: one month ]
    The FABQ, adapted for Brazil (Abreu et al. 2008), consists of 16 self- response items, and each item was rated on a seven-point Likert scale from 0 (completely disagree) to 6 (completely agree), subdivided into two subscales: one that addressed the fears and beliefs of individuals in relation to work, (FABQ - Work) and one that addressed their fears and beliefs about physical activities (FABQ - Phys). As in the original version, items 1, 8, 13, 14 and 16 were excluded from the sum of the final score, despite being part of the questionnaire. In addition, the score had to be obtained separately on each of the subscales, the distribution of subscale points being related to the work done, summing items 6, 7, 9, 10, 11, 12 and 15 (total ranging between 0 and 42) and the subscale related to physical activities, summing items 2, 3, 4 and 5 (total ranging between 0 and 24).

  • Participant ratings of global improvement and satisfaction with treatment - Patient Global Impression of Change (PGIC) [ Time Frame: one month ]
    The Patient Global Impression of Change scale is recommended for use in chronic pain clinical trials as a core outcome measure of global improvement with treatment. This measure is a single-item rating by participants of their improvement with treatment during a clinical trial on a 7-point scale that ranges from very much improved to much worse with no change as the mid-point (Dworkin et a. 2005).


Estimated Enrollment: 120
Study Start Date: September 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional Star-shape taping (FST)
For the Functional Star-shape taping (FST) procedure, four tapes will be applied in the form of an elastic ''I'' with the aim of facilitating muscle activation. The taping will be applied when the participant is in a seated position. The taping will be positioned covering the entire lumbar region and lower part of the thoracic region (T11, T12), and placed first at the center and then on the ends (Castro-Sanchez et al. 2012).The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.
Procedure: Functional Star-shape taping (SFT)
For the SFT procedure, four tapes will be applied in the form of an elastic ''I'' with the aim of facilitating muscle activation. The taping will be applied when the participant is in a seated position. The taping will be positioned covering the entire lumbar region and lower part of the thoracic region (T11, T12), and placed first at the center and then on the ends (Castro-Sanchez et al. 2012).The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.
Sham Comparator: Sham Functional Taping (Sham-FT)
For the Sham-FT procedure, a single bandage 20 cm in length was positioned horizontally, passing through the spinous process of the second lumbar vertebra (Castro-Sanchez et al. 2012). The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.
Procedure: Sham Functional Taping (Sham-FT)
For the Sham-FT procedure, a single bandage 20 cm in length was positioned horizontally, passing through the spinous process of the second lumbar vertebra (Castro-Sanchez et al. 2012). The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.
Active Comparator: Minimal Intervention Strategy (MIS)
The MIS group will receive an educational and counseling booklet (The Back Book) as recommend by Dupeyron et al. (2011) containing information about the low back pain clinical features, risk factors and prognosis, fear avoidance beliefs, how to deal with an acute pain crisis, the early resumption of normal or vocational activities, even when still experiencing pain, and the importance of improvement in functional activity levels and posture, not just pain relief (Delitto et al. 2012). Participants from this group will not receive FT intervention and the investigator will encourage participants to not receive any kind of treatment during the one month epoch after the initial assessment. They will be followed by one of the investigators that will make phone calls to clarify doubts and reinforce the counseling.
Behavioral: Minimal Intervention Strategy (MIS)
The MIS group will receive an educational and counseling booklet (The Back Book) as recommend by Dupeyron et al. (2011) containing information about the low back pain clinical features, risk factors and prognosis, fear avoidance beliefs, how to deal with an acute pain crisis, the early resumption of normal or vocational activities, even when still experiencing pain, and the importance of improvement in functional activity levels and posture, not just pain relief (Delitto et al. 2012). Participants from this group will not receive FT intervention and the investigator will encourage participants to not receive any kind of treatment during the one month epoch after the initial assessment. They will be followed by one of the investigators that will make phone calls to clarify doubts and reinforce the counseling.

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  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) aged between 18 and 50 years;
  • (2) medical diagnosis of chronic non-specific low back pain in the last 3 months and/or pain during at least half of the days in the past 6 months (Deyo et al. 2014), that is located between T12 and the gluteal folds;
  • (3) pain intensity equal to or greater than three;
  • (4) pain caused by certain postures, activities and movements; and
  • (5) score greater than 14% on the Oswestry Lumbar Disability Index (Vibe Fersum et al. 2013).

Exclusion Criteria:

  • (1) red flags (neoplastic diseases or tumors in the spine, inflammatory diseases, infections and fractures);
  • (2) serious neurological (or central and peripheral neurological) symptoms, psychiatric, rheumatologic and cardiac diseases;
  • (3) disc herniation;
  • (4) lumbar stenosis;
  • (5) spondylolisthesis;
  • (6) history of spinal surgeries;
  • (7) pregnancy;
  • (8) menstrual period;
  • (9) underwent physical therapy treatments (less than 6 months before the evaluation period);
  • (10) participants with previously diagnosed balance disorders or with disorders that may interfere with balance (vestibular diseases, whiplash injuries, functional ankle instability or report of "giving" way sensation in ankle during the past 6 months); and
  • (11) using medications that alter or cause suppression of sensory perception.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546466


Contacts
Contact: Thais C Chaves, Doctor +5516996092206 ext +551633154418 chavestc@fmrp.usp.br
Contact: Fabrício J Jassi, PhD student +554399113613 ext +554335250498 fjjassi@uenp.edu.br

Locations
Brazil
Universidade Estadual do Norte do Paraná Recruiting
Jacarezinho, Paraná, Brazil, 86400000
Contact: Fabrício J Jassi, PhD student    +554399113613    fjjassi@uenp.edu.br   
Contact: Tiago P Del Antônio, PhD in progress    +5543999113613    tiagodantonio@uenp.edu.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Fabrício J Jassi, PhD student Universidade Estadual do Norte do Paraná
  More Information

Responsible Party: Thais Cristina Chaves, Professor, Department of Neuroscience and Behavioral Science at the Ribeirão Preto Medical School at the University of Sao Paulo. Coordinator, Laboratory of Interdisciplinary Research on Musculoskeletal Pain., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02546466     History of Changes
Other Study ID Numbers: 045641/2015
First Submitted: September 8, 2015
First Posted: September 10, 2015
Last Update Posted: November 22, 2017
Last Verified: April 2017

Keywords provided by Thais Cristina Chaves, University of Sao Paulo:
low back pain
functional taping
balance
posture
rehabilitation
psychosocial factors
minimal intervention strategy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms