NCT05533879

Brief Summary

Chronic low back pain (CLBP) is the most common problem in the musculoskeletal system and causes disability. The prevalence of chronic low back pain is 80% in women. Although there are many causes of low back pain, it is often not possible to find the exact cause of the pain. The consequences of chronic low back pain include musculoskeletal problems, decreased sleep quality, decreased quality of life and limitation in activities of daily living, depression, anxiety, and decreased body awareness and kinesiophobia. Kinesiophobia is defined as the fear of re-injury gained after injury, which reduces physical movement and activity. Patients with kinesiophobia develop the idea that movement will cause re-injury and add to pain. This situation leads to avoidance of physical activity and functional disability in the long term. Body awareness, on the other hand, is the awareness of the messages that the brain receives from other parts of the body and from the outside. These messages that the person receives include not only his own body and movements, but also information such as the characteristics and locations of other objects in the environment. This information is blended over time and turns into experiences of the body. Today, a rehabilitation method consisting of exercise programs, in which the active participation of the individual is ensured, is recommended, especially in the treatment approach to chronic low back pain. Within the scope of physiotherapy programs; heat applications and other physical therapy agents, exercise applications are recommended. Yoga is an alternative exercise practiced in CLBP as a body-mind exercise. Yoga is an easy-to-apply, non-invasive, cost-effective, scientifically proven practice.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

September 5, 2022

Last Update Submit

September 5, 2022

Conditions

Keywords

yoga, chronic low back pain, women

Outcome Measures

Primary Outcomes (4)

  • Demographic information form

    This form was prepared by the researchers to obtain the demographic data of the people participating in the study. In this form, information about the age, gender and occupation of the participants is recorded.

    10 minutes

  • Visual Analog Scale (VAS)

    When Visual Analog Scale (VAS) is used, I have no pain at one end, very severe pain is written on the other end, and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.

    2 minutes

  • Body Awareness Questionnaire

    The questionnaire is based on people's ratings of the situations they feel about themselves. After reading each statement, the number 1 to 7 is marked in the space to the left of the statement, which is appropriate for the person who filled out the questionnaire. The most accurate answer is the experience of the person filling out the questionnaire.

    20 minutes

  • Tampa Kinesiophobia Scale

    It is a 17-item scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. As a result of the survey, the person gets a total score between 17-68 according to the answers he/she gives. The higher the score the person gets on the scale, the higher the kinesiophobia. shows that.

    20 minutes

Study Arms (1)

Yoga group

EXPERIMENTAL

Women with having received a minimum of 17 points from the kinesiophobia questionnaire, have chronic low back pain and aged between 25-65

Other: Tele-yoga

Interventions

Women with chronic low back pain will be taken to group-based Tele-Yoga sessions of 60 minutes three times a week for 4 weeks, in an internet-based telerehabilitation environment.

Yoga group

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with chronic low back pain
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having received a minimum of 17 points from the kinesiophobia questionnaire
  • Being between the ages of 25 and 65 and being a woman
  • Having a complaint of low back pain for at least 6 months
  • Not having cognitive, cognitive and mental problems

You may not qualify if:

  • Having had surgery involving the spine.
  • Being involved in any yoga group for the last 6 months
  • Actively exercising regularly
  • A previous or existing neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, 34662, Turkey (Türkiye)

RECRUITING

Study Officials

  • tuba kolaylı, MSc.

    Uskudar University

    STUDY DIRECTOR
  • Aleyna Yaren Bayrak, B.S.

    Uskudar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleyna Yaren Bayrak, B.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 9, 2022

Study Start

September 5, 2022

Primary Completion

January 31, 2023

Study Completion

March 3, 2023

Last Updated

September 9, 2022

Record last verified: 2022-09

Locations