Clinical trial NCT01866332: Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain
Official title: Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonspecific Chronic Low Back Pain
Keywords: back pain
tape
chronic
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of the addition of the use of Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional physical therapy.

Detailed description: One hundred and forty-eight patients will be randomized to receive either conventional physical therapy, which consist of a combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization (Conventional Physical Therapy Group) or to receive conventional physical therapy plus the addition of the Kinesio Taping in the lumbar spine (Conventional Physical Therapy plus Kinesio Taping), over a period of 5 weeks (10 sessions of treatment).

Clinical outcomes (pain intensity, disability and global perceived effect ) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. Data will be collected by a blinded examiner who will be unaware about the group allocation. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

Eligibility criteria: Inclusion Criteria:

* Patients with non-specific low back pain longer than 12 weeks
* Seeking care for low back pain

Exclusion Criteria:

* Contra indications to physical exercise
* Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
* Nerve root compromise
* Contra indications to the Kinesio Taping (e.g. intolerance to tapes, band aids etc)
* Pregnancy
* Severe cardiorespiratory conditions

Primary outcomes:
measure: Pain Intensity
timeFrame: Five weeks after randomization
measure: Disability
timeFrame: Five weeks after randomization
Secondary outcomes:
measure: Pain Intensity
timeFrame: 3 and 6 months after randomization
measure: Disability
timeFrame: 3 and 6 months after randomization
measure: Global impression of recovery
timeFrame: 5 weeks, 3 and 6 months after randomization
Other outcomes:
measure: Satisfaction with care
timeFrame: 5 weeks after randomization
Locations:
city: São Paulo
country: Brazil
facility: Physical Therapy Outpatient Department
state: SP
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Luciola CM Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Added MA, Costa LO, de Freitas DG, Fukuda TY, Monteiro RL, Salomao EC, de Medeiros FC, Costa Lda C. Kinesio Taping Does Not Provide Additional Benefits in Patients With Chronic Low Back Pain Who Receive Exercise and Manual Therapy: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Jul;46(7):506-13. doi: 10.2519/jospt.2016.6590. Epub 2016 Jun 6.