Clinical trial NCT05301491: The Effects of Dance Therapy in Women With Chronic Low Back Pain
Official title: Investigation of the Effects of Dance Therapy on Balance, Falling, Body Awareness and Functionality in Women With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Pain
Chronic Low-back Pain
Keywords: Low back pain
Chronic low back pain
Dance Therapy
Balance
Falling risk
Functionality
Body awareness
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized controlled groups

Forty female patients who were diagnosed with chronic low back pain and met the inclusion criteria of the study were divided into two groups.These individuals are going to be divided into groups as the odd numbers to study group and even numbers to the control group.

Inclusion criteria of patients;

* Those who agree to participate in the study voluntarily
* Having low back pain lasting longer than 3 months,
* Having values between 4 and 7 on the Visual Analog Scale.
* Female individuals between the ages of 18-65

Exclusion criteria of patients; Those with a Body Mass Index (BMI) greater than 35 kg/m², pregnant women, those with following problems; neural findings, malignancy, inflammation, arthritis, metabolic bone disease, column vertebralis or lower extremity surgery, cardiovascular system diseases, severe osteoporosis, communication and hearing disorders, and those who illiterate, receive other treatment for low back pain.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of dance therapy on balance, falling, body awareness and functionality parameters in patients with chronic low back pain. As a result of our study, it is thought that dance therapy will positively affect balance, falling, body awareness and functionality in patients with chronic low back pain compared to conventional therapy.

H 1: Dance therapy improves balance in women with chronic low back pain.

H 2: Dance therapy reduces the risk of falling in women with chronic low back pain.

H 3: Dance therapy increases body awareness in women with chronic low back pain.

H 4: Dance therapy increases functionality in women with chronic low back pain.

H 5: Dance therapy provides more improvement in the parameters investigated compared to conventional therapy in women with chronic low back pain.

Detailed description: Individuals diagnosed with chronic low back pain and meeting the inclusion criteria are going to be included in the study. These individuals are going to be divided into groups as the odd numbers to study group and even numbers to the control group. Hotpack, ultrasound and Transcutaneous Electrical Nerve Stimulation (TENS) are going to be applied to the patients in the both groups for 3 days a week for 2 months. Besides that, control group is going to perform 40-minute classical exercise program 3 days a week for 2 months. Study group is going to perform dance therapy protocol as indicated below;

* 10 minutes warm-up (stepping),
* 25 minutes of dance (such as; steps, figures using hip and knee flexions, hip circulation, and hip rotations)
* 5 minutes stretching (relaxation) exercises.

Demographic information form is going be filled out patients including information about; age, height (cm), weight (kg), occupation, educational status, bilateral leg length (cm), previous and present diseases, waist/hip ratio, previous surgeries, trunk range of motions, low back pain duration, smoking, falling story. Additionally, following questionnaires are going to be applied to both groups;

* Short Form Mc Gill Pain Questionnaire,
* Oswestry Disability Index,
* Body Awareness Ratio Questionnaire,
* Nottingham Health Profile Questionnaire,
* Tampa Kinesiophobia Scale,
* The World Health Organization Quality of Life (WHOQoL) Scale,
* Y balance test
* Time Up and Go (TUG) test

SPSS version 23 (SPSS Inc, Armonk, NY) program will be used in the analysis of the data. Mann Whitney U test, Wilcoxon test and student t test will be analyse methods.

Eligibility criteria: Inclusion criteria;

* Those who agree to participate in the study voluntarily
* Having low back pain lasting longer than 3 months,
* Having values between 4 and 7 on the Visual Analog Scale.
* Female individuals between the ages of 18-65

Exclusion criteria; Those with a Body Mass Index (BMI) greater than 35 kg/m², pregnant women, those with following problems; neural findings, malignancy, inflammation, arthritis, metabolic bone disease, column vertebralis or lower extremity surgery, cardiovascular system diseases, severe osteoporosis, communication and hearing disorders, and those who illiterate, receive other treatment for low back pain.

Primary outcomes:
measure: Change from baseline in Y balance test score
timeFrame: 8 weeks
measure: Change from baseline in Time Up and Go test seconds
timeFrame: 8 weeks
measure: Change from baseline in body awareness ratio score
timeFrame: 8 weeks
measure: Change from baseline in functionality score
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in range of motion degree
timeFrame: 8 weeks
measure: Change from baseline in waist/hip ratio
timeFrame: 8 weeks
measure: Change From Baseline in Pain Scores
timeFrame: 8 weeks
measure: Change from baseline in kinesiophobia score
timeFrame: 8 weeks
measure: Change from baseline in quality of life score
timeFrame: 8 weeks
measure: Change from baseline in perceived health status score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References: