Investigation of the Effects of Two Different Treatment Programs on Chronic Low Back Pain

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Low-back Pain

Intervention / Treatment
-----------------
* Other: conventional physiotherapy
* Other: conventional physiotherapy plus kinesiotaping


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Physiotherapy<br>Classical electrotherapy method consisting of tens, hotpack and ultrasound. Procedure/Device: Conventional Physiotherapy Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm2 and duration of 5 minute. TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes. | Other: conventional physiotherapy<br>* Classical electrotherapy method consisting of tens, hotpack and ultrasound.<br>|
| Active Comparator: Conventional Physiotherapy + Kinesiotaping<br>Kinesiotaping application in addition to classical electrotherapy method consisting of tens, hotpack and ultrasound.It will be applied to reduce pain, increase proprioception and awareness. Kinesiotaping will be re-applicated every day. Space taping will be applied to the waist area. Space taping creates a vacuum effect on the skin, loosening the adhesions in the tissue layers. With this lifting effect, it creates a space under the skin, causing an increase in circulation and a decrease in pain. Four pieces of I-tape will be used for taping. The middle point of the first tape will be attached with maximum tension. The ends of the tape will be tensionless. The second tape will also be applied at a 90 degree angle. The third and fourth tapes will be taped at an angle of 45 degrees. | Other: conventional physiotherapy plus kinesiotaping<br>* Conventional physiotherapy plus kinesiotaping<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks | Visual Analogue Scale (VAS): The patient is asked to mark the pain felt on a 10 cm. | Baseline, 3 weeks, 6 weeks | 
| Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks | Fremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness. | Baseline, 3 weeks, 6 weeks | 
| Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks | Repeated Sit-to-Stand Test | Baseline, 3 weeks, 6 weeks | 
| Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks | Hospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale. | Baseline, 3 weeks, 6 weeks | 
| Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks | Fear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain. | Baseline, 3 weeks, 6 weeks | 
| Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks | Timed Up and Go Test | Baseline, 3 weeks, 6 weeks | 
| Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks | Modified Schober Test | Baseline, 3 weeks, 6 weeks | 
| Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks. | Roland Morris Disability Questionnaire. | Baseline, 3 weeks, 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic low back pain, kinesiotape, physiotherapy, awareness