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

NCT02546466 | Completed

• 1 other identifier: 045641/2015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

low back pain; functional taping; balance; posture; rehabilitation; psychosocial factors; minimal intervention strategy

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  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.

  one month

• Postural control on force platform - Static Posturography with and without a secondary task

  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).

  one month

Secondary Outcomes (3)

• Disability

  one month

• Fear avoidance beliefs questionnaire (FABQ)

  one month

• Participant ratings of global improvement and satisfaction with treatment - Patient Global Impression of Change (PGIC)

  one month

Study Arms (3)

Functional Star-shape taping (FST)

EXPERIMENTAL

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)

Sham Functional Taping (Sham-FT)

SHAM COMPARATOR

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)

Minimal Intervention Strategy (MIS)

ACTIVE COMPARATOR

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)

Interventions

Functional Star-shape taping (SFT) PROCEDURE

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.

Functional Star-shape taping (FST)

Sham Functional Taping (Sham-FT) PROCEDURE

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.

Sham Functional Taping (Sham-FT)

Minimal Intervention Strategy (MIS) BEHAVIORAL

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.

Minimal Intervention Strategy (MIS)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Universidade Estadual do Norte do Paraná

Jacarezinho, Paraná, 86400000, Brazil

Location

Related Publications (2)

• Jassi FJ, Del Antonio TT, Azevedo BO, Moraes R, George SZ, Chaves TC. Star-Shape Kinesio Taping Is Not Better Than a Minimal Intervention or Sham Kinesio Taping for Pain Intensity and Postural Control in Chronic Low Back Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Jul;102(7):1352-1360.e3. doi: 10.1016/j.apmr.2021.03.007. Epub 2021 Apr 2.

  PMID: 33819489 DERIVED

• Jassi FJ, Del Antonio T, Moraes R, George SZ, Chaves TC. Effects of functional taping compared with sham taping and minimal intervention on pain intensity and static postural control for patients with non-specific chronic low back pain: a randomised clinical trial protocol. Physiotherapy. 2017 Jun;103(2):154-159. doi: 10.1016/j.physio.2016.05.008. Epub 2016 Jun 14.

  PMID: 27637736 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrício J Jassi, PhD student

  Universidade Estadual do Norte do Paraná

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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.

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: September 30, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

BR (1)