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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05301491
Other study ID # 2021/025
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date May 30, 2022

Study information

Verified date August 2022
Source Hasan Kalyoncu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 30, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dance Therapy Group
Dance therapy group patients are going to be treated 3 days a week for 8 weeks. Patients who started treatment are going to be randomly divided into groups that includes four individuals, due to COVID-19 pandemic preventions. Dance therapy is going to be applied with individualized choreographies specially prepared for the patients, taking the expert opinion of the dance therapist. Choreographies of different dance genres (step/aerobic dance, zumba, salsa, bachata, oriental etc.) are going to be used in the program. Sessions are going to be with the practitioner in a bright, clean, empty and noiseless room in front of a full-length wall mirror. The practitioner is going to participate to dance therapy throughout the sessions, allowing patients to imitate movements. Session duration is going to be 40 minutes. Patients will be given a one-minute rest period during music transitions.
Exercise Group
The patients in the control group is going to perform conventional low back exercises. The program of the patients will start with stretching and warming exercises, and will continue with strengthening exercises. Exercises planed for control group; Unilateral hip-knee flexion (self-assisted exercise) Bilateral hip-knee flexion (self-assisted exercise) Straight leg lifting with the aid of a sheet/rigid band Posterior pelvic tilt Bridge building exercise Cat-camel exercise Half shuttle in sagittal plane Right and left rotational shuttle Trunk hyperextension in prone position Rotational exercise with hip-knee flexed in supine position Patients are going to do exercises with ten repetitions. As the sessions progressed, the number of repetitions will be increased.
Pyhsiotherapy Modalities
20 minutes hotpack, 3-5 minutes ultrasound and 20 minutes conventional type Transcutaneous Electrical Nerve Stimulation (TENS) are going to be applied to lumbar region of all patients in prone position.

Locations

Country Name City State
Turkey Hasan Kalyoncu University Gaziantep

Sponsors (1)

Lead Sponsor Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Y balance test score Balance score is going to be assess by Y balance test to determine change from baseline. 8 weeks
Primary Change from baseline in Time Up and Go test seconds Falling risk is going to be assess by Time Up and Go test seconds to determine change from baseline. 8 weeks
Primary Change from baseline in body awareness ratio score Body awareness ratio score is going to be assess by Body Awareness Ratio Questionnaire to determine change from baseline. 8 weeks
Primary Change from baseline in functionality score Functionality score is going to be assess by Oswestry Disability Index to determine change from baseline. 8 weeks
Secondary Change from baseline in range of motion degree Range of motion degree is going to be assess by goniometric measurement to determine change from baseline. 8 weeks
Secondary Change from baseline in waist/hip ratio Waist/hip ratio is going to be assess by measuring tape from waist and hip circumference to determine change from baseline. 8 weeks
Secondary Change From Baseline in Pain Scores Pain score is going to be assess by Short Form Mc Gill Pain Questionnaire to determine change from baseline. 8 weeks
Secondary Change from baseline in kinesiophobia score Kinesiophobia score is going to be assess by Tampa Kinesiophobia Scale to determine change from baseline. 8 weeks
Secondary Change from baseline in quality of life score Quality of life score is going to be assess by WHOQoL Questionnaire to determine change from baseline. 8 weeks
Secondary Change from baseline in perceived health status score Perceived health status score is going to be assess by Nottingham Health Profile Questionnaire to determine change from baseline. 8 weeks
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