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The Effects of Dance Therapy in Women With Chronic Low Back Pain

Primary Purpose

Low Back Pain, Chronic Pain, Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dance Therapy Group
Exercise Group
Pyhsiotherapy Modalities
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Chronic low back pain, Dance Therapy, Balance, Falling risk, Functionality, Body awareness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dance therapy group

Control group

Arm Description

This group included in the dance therapy program throughout the study.

This group included in the conventional low back pain exercise program throughout the study.

Outcomes

Primary Outcome Measures

Change from baseline in Y balance test score
Balance score is going to be assess by Y balance test to determine change from baseline.
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.
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.
Change from baseline in functionality score
Functionality score is going to be assess by Oswestry Disability Index to determine change from baseline.

Secondary Outcome Measures

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.
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.
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.
Change from baseline in kinesiophobia score
Kinesiophobia score is going to be assess by Tampa Kinesiophobia Scale to determine change from baseline.
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.
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.

Full Information

First Posted
February 25, 2022
Last Updated
August 9, 2022
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05301491
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance therapy group
Arm Type
Experimental
Arm Description
This group included in the dance therapy program throughout the study.
Arm Title
Control group
Arm Type
Experimental
Arm Description
This group included in the conventional low back pain exercise program throughout the study.
Intervention Type
Other
Intervention Name(s)
Dance Therapy Group
Other Intervention Name(s)
Study Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Group
Other Intervention Name(s)
Control Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pyhsiotherapy Modalities
Other Intervention Name(s)
Both Groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Y balance test score
Description
Balance score is going to be assess by Y balance test to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in Time Up and Go test seconds
Description
Falling risk is going to be assess by Time Up and Go test seconds to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in body awareness ratio score
Description
Body awareness ratio score is going to be assess by Body Awareness Ratio Questionnaire to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in functionality score
Description
Functionality score is going to be assess by Oswestry Disability Index to determine change from baseline.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in range of motion degree
Description
Range of motion degree is going to be assess by goniometric measurement to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in waist/hip ratio
Description
Waist/hip ratio is going to be assess by measuring tape from waist and hip circumference to determine change from baseline.
Time Frame
8 weeks
Title
Change From Baseline in Pain Scores
Description
Pain score is going to be assess by Short Form Mc Gill Pain Questionnaire to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in kinesiophobia score
Description
Kinesiophobia score is going to be assess by Tampa Kinesiophobia Scale to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in quality of life score
Description
Quality of life score is going to be assess by WHOQoL Questionnaire to determine change from baseline.
Time Frame
8 weeks
Title
Change from baseline in perceived health status score
Description
Perceived health status score is going to be assess by Nottingham Health Profile Questionnaire to determine change from baseline.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study is going to be conducted only with female patients.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effects of Dance Therapy in Women With Chronic Low Back Pain

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