Clinical trial NCT06291168: Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain
Official title: Comparison of The Effectiveness of Chiropractic Manipulation and Yoga-Based Exercise Approach in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Spinal Manipulation
Yoga
Keywords: Yoga
Chronic Low Back Pain
Chiropractic Manipulation
Exercise
Lead sponsor: Sinop University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 60 participants will be divided into three groups. These groups will be randomly divided into three groups as chiropractic manipulation group (n=20), yoga-based exercise group (n=20) and conventional exercise group (control group) (n=20). Exercise programs will be performed under the supervision of a physiotherapist. Chiropractic manipulation will be applied to the lumbar region and sacroiliac joint in the side lying position. Data will be analyzed in SPSS 29.0 IBM program. Kruskal-Wallis H test will be used for difference analysis between groups, Kruskal-Wallis H test will be used for comparisons between groups by taking the differences between measurement times and the significance level will be determined as p\<0.05.
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of our study was to compare the effectiveness of chiropractic manipulation and yoga-based exercise techniques on pain, functionality, depression and anxiety in patients with long-term low back pain.

Detailed description: The study will include 60 individuals between 18 and 65 who meet the inclusion criteria. Demographic and anthropological information will be recorded before starting the study. After these measurements, the participants will be randomly divided into three groups. These groups will be formed as chiropractic manipulation group (n=20), yoga-based exercise group (n=20) and conventional exercise group (control group) (n=20).

In the chiropractic manipulation group, chiropractic manipulation (HVLA maneuver) will be applied to the facet joints of the lumbar vertebrae and the sacroiliac joint 2 times a week for eight weeks.

The yoga-based exercise group will exercise with an exercise program that includes balance, coordination and stretching exercises. Yoga exercises will be done in groups of 3-4 people, including breathing exercises and various relaxation techniques, and will be done in 60-minute sessions 2 days a week for 8 weeks. This will include yoga techniques such as suyanamaskar and asana.

The control group will perform stabilization exercises for the lumbar region. These exercises will be given in 3 phases following the protocol given to the chiropractic manipulation group. The exercises will be explained to the participants via video. Individuals will perform this exercise program 2 days a week for 8 weeks.

Participants will then be assessed using the Numeric Pain Scale, Roland Morris Disability Questionnaire for functional status, Hospital Anxiety and Depression Scale for quality of life and range of motion of the hip and lumbar region.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Experiencing low back pain for at least 3 months
* Pain above 3 on the numeric pain scale
* The patient diagnosed with chronic low back pain by a specialist doctor does not have any contraindications to chiropractic applications
* No contraindications to exercise (systemic diseases, neurological diseases, etc.)
* Patients without joint-related listhesis, spinal stenosis and active discopathy
* Signing the voluntary consent form

Exclusion Criteria:

* Having a fracture or dislocation of the spine,
* Presence of malignancy and infectious disease
* Presence of joint-related listhesis, spinal stenosis and active discopathy
* Presence of osteoporosis
* Those with a history of trauma within at least 3 months
* Pregnancy and suspected pregnancy
* Individuals with inflammatory low back pain
* Those who have undergone surgery and have neurological loss.
* Those with psychiatric problems

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: It will be used for all groups before starting treatment, at 2 weeks and 8 weeks after starting treatment and at the completion of 12 weeks post-treatment.
measure: Roland-Morris Disability Questionnaire
timeFrame: It will be used for all groups before starting treatment, at 2 weeks and 8 weeks after starting treatment and at the completion of 12 weeks post-treatment.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: It will be used for all groups before starting treatment, at 2 weeks and 8 weeks after starting treatment and at the completion of 12 weeks post-treatment.
measure: Range of Motion (ROM)
timeFrame: It will be used for all groups before starting treatment, at 2 weeks and 8 weeks after starting treatment and at the completion of 12 weeks post-treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sinop University
name: SEFA HAKTAN HATIK
role: STUDY_DIRECTOR
References: