Low Back PainNCT05301491
The Effects of Dance Therapy in Women With Chronic Low Back Pain
A study testing Dance Therapy Group, Exercise Group and Pyhsiotherapy Modalities in people with Low Back Pain and Chronic Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Chronic Pain, Chronic Low-back Pain
- What is being tested?
- Dance Therapy Group, Exercise Group and Pyhsiotherapy Modalities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Low Back Pain, Chronic Pain, Chronic Low-back Pain
- Being tested
- Dance Therapy Group, Exercise Group, Pyhsiotherapy Modalities
- Keywords
- Low back pain, Chronic low back pain, Dance Therapy, Balance, Falling risk, Functionality, Body awareness
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Therapy GroupOther
Also called Study 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 GroupOther
Also called Control 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 ModalitiesOther
Also called Both Groups
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.
| Study group | Role | What they receive |
|---|---|---|
| Dance therapy group | Experimental | This group included in the dance therapy program throughout the study. Receives: Other: Dance Therapy Group; Other: Pyhsiotherapy Modalities |
| Control group | Experimental | This group included in the conventional low back pain exercise program throughout the study. Receives: Other: Exercise Group; Other: Pyhsiotherapy Modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Y balance test score
Balance score is going to be assess by Y balance test to determine change from baseline.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Change from baseline in functionality score
Functionality score is going to be assess by Oswestry Disability Index to determine change from baseline.
Measured: 8 weeks
Secondary outcomes (6)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Change from baseline in kinesiophobia score
Kinesiophobia score is going to be assess by Tampa Kinesiophobia Scale to determine change from baseline.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Feb 2022
- Primary completion1 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Dinler, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301491
- Sponsor's protocol ID
- 2021/025
- Status last verified
- Aug 2022
- First submitted
- 25 Feb 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Dance Therapy on Balance, Falling, Body Awareness and Functionality in Women With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05301491
- Acronym / sponsor ID
- 2021/025
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dance therapy group | Experimental | Other: Dance Therapy Group, Other: Pyhsiotherapy ModalitiesThis group included in the dance therapy program throughout the study. |
| Control group | Experimental | Other: Exercise Group, Other: Pyhsiotherapy ModalitiesThis group included in the conventional low back pain exercise program throughout the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance Therapy GroupAlso: Study GroupDance 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 | Dance therapy group |
| Exercise GroupAlso: Control GroupThe 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; 1. Unilateral hip-knee flexion (self-assisted exercise) 2. Bilateral hip-knee flexion (self-assisted exercise) 3. Straight leg lifting with the aid of a sheet/rigid band 4. Posterior pelvic tilt 5. Bridge building exercise 6. Cat-camel exercise 7. Half shuttle in sagittal plane 8. Right and left rotational shuttle 9. Trunk hyperextension in prone position 10. 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. | Other | Control group |
| Pyhsiotherapy ModalitiesAlso: Both Groups20 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 | Control group, Dance therapy group |
Primary outcome
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.
Change from baseline in Time Up and Go test seconds
Time frame: 8 weeks
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
Time frame: 8 weeks
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
Time frame: 8 weeks
Functionality score is going to be assess by Oswestry Disability Index to determine change from baseline.
6 secondary outcomes
Change from baseline in range of motion degree
Time frame: 8 weeks
Change from baseline in waist/hip ratio
Time frame: 8 weeks
Change From Baseline in Pain Scores
Time frame: 8 weeks
Change from baseline in kinesiophobia score
Time frame: 8 weeks
Change from baseline in quality of life score
Time frame: 8 weeks
Change from baseline in perceived health status score
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Therapy Group, Exercise Group and Pyhsiotherapy Modalities in people with Low Back Pain and Chronic Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Y balance test score (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.