- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05301491
The Effects of Dance Therapy in Women With Chronic Low Back Pain
Investigation of the Effects of Dance Therapy on Balance, Falling, Body Awareness and Functionality in Women With Chronic Low Back Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Gaziantep, Turkey
- Hasan Kalyoncu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dance therapy group
This group included in the dance therapy program throughout the study.
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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.
Other Names:
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.
Other Names:
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Experimental: Control group
This group included in the conventional low back pain exercise program throughout the study.
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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.
Other Names:
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;
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Y balance test score
Time Frame: 8 weeks
|
Balance score is going to be assess by Y balance test to determine change from baseline.
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8 weeks
|
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Change from baseline in Time Up and Go test seconds
Time Frame: 8 weeks
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Falling risk is going to be assess by Time Up and Go test seconds to determine change from baseline.
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8 weeks
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Change from baseline in body awareness ratio score
Time Frame: 8 weeks
|
Body awareness ratio score is going to be assess by Body Awareness Ratio Questionnaire to determine change from baseline.
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8 weeks
|
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Change from baseline in functionality score
Time Frame: 8 weeks
|
Functionality score is going to be assess by Oswestry Disability Index to determine change from baseline.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in range of motion degree
Time Frame: 8 weeks
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Range of motion degree is going to be assess by goniometric measurement to determine change from baseline.
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8 weeks
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Change from baseline in waist/hip ratio
Time Frame: 8 weeks
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Waist/hip ratio is going to be assess by measuring tape from waist and hip circumference to determine change from baseline.
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8 weeks
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Change From Baseline in Pain Scores
Time Frame: 8 weeks
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Pain score is going to be assess by Short Form Mc Gill Pain Questionnaire to determine change from baseline.
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8 weeks
|
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Change from baseline in kinesiophobia score
Time Frame: 8 weeks
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Kinesiophobia score is going to be assess by Tampa Kinesiophobia Scale to determine change from baseline.
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8 weeks
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Change from baseline in quality of life score
Time Frame: 8 weeks
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Quality of life score is going to be assess by WHOQoL Questionnaire to determine change from baseline.
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8 weeks
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Change from baseline in perceived health status score
Time Frame: 8 weeks
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Perceived health status score is going to be assess by Nottingham Health Profile Questionnaire to determine change from baseline.
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8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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