Clinical trial NCT04643756: Investigation of the Effects of Two Different Treatment Programs on Chronic Low Back Pain
Official title: Investigation of the Effects of Two Different Treatment Programs on Pain Severity, Low Back Awareness, Functional and Psychosocial Factors in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: chronic low back pain, kinesiotape, physiotherapy, awareness
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 52
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: This study was planned to examine the effects of two different treatment programs on pain intensity, back awareness, functional and psychosocial factors in patients with chronic low back pain.

Detailed description: Recent study will be carried out on volunteer patients who applied to the Physical Therapy Clinic of "Mugla Sitki Kocman University" Training and Research Hospital, who were diagnosed with chronic non-specific low back pain and who comply with the study criteria.

The sample size has been calculated that 80% power can be obtained at 95% confidence level. It was found that at least 21 cases, a total of 44 cases, were required for each group.

Volunteers will be divided into 2 groups by randomization. Conventional physiotherapy applications will be applied to the control group. In addition to conventional physiotherapy methods, kinesio-taping (KT) will be applied to the study group. Patients in both groups will be treated 5 days a week for a total of 10 sessions for 2 weeks. KT will be renewed in each session on weekdays.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 to 60 years with chronic low back pain
* Those who have complained of low back pain for at least 3 months
* Individuals whose pain intensity is above 3.5 cm according to VAS
* Pain and numbness that does not spread to the legs

Exclusion Criteria:

* Situations that prevent the evaluation or communication with the individual
* Illiterate individuals
* Individuals who have undergone surgical operations on the spine and / or extremities
* Conditions where specific pathological conditions are proven such as malignant condition, fracture, systemic rheumatoid disease
* Orthopedic and neurological problems that prevent evaluation and / or treatment
* Complaints of pain and numbness spreading to the lower extremities
* Individuals with a diagnosed psychiatric illness
* Individuals who have received physiotherapy in the last 6 months
* Individuals who use another treatment method during the study
* Individuals with musculoskeletal pain in any other part of the body during work
* Pregnant

Primary outcomes:
measure: Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
timeFrame: Baseline, 3 weeks, 6 weeks
measure: Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.
timeFrame: Baseline, 3 weeks, 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Emine Aslan Telci
Study officials:
affiliation: Pamukkale University
name: Emine PT Aslan Telci, Prof. Dr
role: STUDY_DIRECTOR
References:
citation: Nelson NL. Kinesio taping for chronic low back pain: A systematic review. J Bodyw Mov Ther. 2016 Jul;20(3):672-81. doi: 10.1016/j.jbmt.2016.04.018. Epub 2016 Apr 27.
citation: Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24.
citation: Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
citation: Li Y, Yin Y, Jia G, Chen H, Yu L, Wu D. Effects of kinesiotape on pain and disability in individuals with chronic low back pain: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2019 Apr;33(4):596-606. doi: 10.1177/0269215518817804. Epub 2018 Dec 11.