NCT05301491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

February 25, 2022

Last Update Submit

August 9, 2022

Conditions

Keywords

Low back painChronic low back painDance TherapyBalanceFalling riskFunctionalityBody awareness

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Change from baseline in range of motion degree

    8 weeks

  • Change from baseline in waist/hip ratio

    8 weeks

  • Change From Baseline in Pain Scores

    8 weeks

  • Change from baseline in kinesiophobia score

    8 weeks

  • Change from baseline in quality of life score

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Dance therapy group

EXPERIMENTAL

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

Other: Dance Therapy GroupOther: Pyhsiotherapy Modalities

Control group

EXPERIMENTAL

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

Other: Exercise GroupOther: Pyhsiotherapy Modalities

Interventions

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.

Also known as: Study Group
Dance therapy 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; 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.

Also known as: Control Group
Control group

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.

Also known as: Both Groups
Control groupDance therapy group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is going to be conducted only with female patients.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainChronic Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 29, 2022

Study Start

February 1, 2022

Primary Completion

April 1, 2022

Study Completion

May 30, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations