Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain

NCT ID: NCT06291168

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-06-01

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.

Conditions

Low Back Pain; Spinal Manipulation; Yoga

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Chiropractic Manipulation (CM) Group

Sacroiliac joint manipulation and manipulations to be applied to the lumbar region will be applied twice a week for 8 weeks in the side lying position.

Group Type: EXPERIMENTAL

Chiropractic Manipulation (HVLA - High Velocity Low Amplitude)

Intervention Type: OTHER

Participants in the groups receiving DNS will be asked to hold the lower leg in the side lying position with the lower leg in the extended position and to clamp the upper leg to the lower leg with hip and knee flexion. During the application, the HLVA technique will be applied once by positioning the hypothenar part of the physiotherapist's hand on the transverse process of the lumbar vertebra where tenderness is felt by palpation and vertebral subluxation is thought to be present.

After determining that the movement disorder of the sacroiliac joints of the participant is caused by the impaired movement of the ilium in the posterior and inferior direction or the impaired movement of the ilium in the anterior and superior direction, the participant will be asked to take a side lying position.HVLA spinal manipulation was performed for less than one second from posterior to anterior, inferior to superior and medial to lateral directions.

Yoga-based Exercise (YBE) Group

Yoga treatment includes exercise, respiration, balance and coordination, and stretching and will be performed by a physiotherapist with yoga certification.

Yoga exercises will be practiced with the classical yoga program, divided into groups of 3-4 people, for 8 weeks, 2 days a week, 60 minutes a day.

Group Type: EXPERIMENTAL

Yoga-Based Exercise Program

Intervention Type: OTHER

Yoga treatment includes exercise, respiration, balance and coordination, and stretching and will be performed by a physiotherapist with yoga certification. Patients will be evaluated before treatment, two weeks later, after treatment (at the end of the 8th week) and at the end of the 12th week after treatment (control).

Yoga exercises will be practiced with the classical yoga program, divided into groups of 3-4 people, for 8 weeks, 2 days a week, 60 minutes a day.

It will be applied as a yoga session program including breathing and warm-up exercises, suyanamaskar, various relaxation techniques and asanas.

Conventional Exercise (Control) Group (CG)

Spinal stabilization exercises for the lumbar region will be given in 3 phases following the protocol given to the chiropractic manipulation group. The exercises will be performed two days a week under the supervision of a physiotherapist. Individuals will be called to the hospital two days a week for 8 weeks and will be advised to continue the exercises during the follow-up period. At the end of the 12th week, the exercises will be repeated and progressed with the physiotherapist.

Group Type: EXPERIMENTAL

Conventional Exercises

Intervention Type: OTHER

Spinal stabilization exercises for the lumbar region will be given in 3 phases following the protocol given to the chiropractic manipulation group. The exercises will be performed two days a week with a physiotherapist. In order to facilitate the memorization and follow-up of the exercises, short videos will be made to facilitate compliance with the exercises by showing the exercises and methods of prevention of low back pain. Individuals will be called to the hospital two days a week for 8 weeks.

Interventions

Chiropractic Manipulation (HVLA - High Velocity Low Amplitude)

Participants in the groups receiving DNS will be asked to hold the lower leg in the side lying position with the lower leg in the extended position and to clamp the upper leg to the lower leg with hip and knee flexion. During the application, the HLVA technique will be applied once by positioning the hypothenar part of the physiotherapist's hand on the transverse process of the lumbar vertebra where tenderness is felt by palpation and vertebral subluxation is thought to be present.

After determining that the movement disorder of the sacroiliac joints of the participant is caused by the impaired movement of the ilium in the posterior and inferior direction or the impaired movement of the ilium in the anterior and superior direction, the participant will be asked to take a side lying position.HVLA spinal manipulation was performed for less than one second from posterior to anterior, inferior to superior and medial to lateral directions.

Intervention Type: OTHER

Yoga-Based Exercise Program

Yoga treatment includes exercise, respiration, balance and coordination, and stretching and will be performed by a physiotherapist with yoga certification. Patients will be evaluated before treatment, two weeks later, after treatment (at the end of the 8th week) and at the end of the 12th week after treatment (control).

Yoga exercises will be practiced with the classical yoga program, divided into groups of 3-4 people, for 8 weeks, 2 days a week, 60 minutes a day.

It will be applied as a yoga session program including breathing and warm-up exercises, suyanamaskar, various relaxation techniques and asanas.

Intervention Type: OTHER

Conventional Exercises

Spinal stabilization exercises for the lumbar region will be given in 3 phases following the protocol given to the chiropractic manipulation group. The exercises will be performed two days a week with a physiotherapist. In order to facilitate the memorization and follow-up of the exercises, short videos will be made to facilitate compliance with the exercises by showing the exercises and methods of prevention of low back pain. Individuals will be called to the hospital two days a week for 8 weeks.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SEFA HAKTAN HATIK

OTHER

Sponsor Role: lead

Responsible Party

SEFA HAKTAN HATIK

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

SEFA HAKTAN HATIK

Role: STUDY_DIRECTOR

Sinop University

Central Contacts

SEFA HAKTAN HATIK

Role: CONTACT

haktanhtk@gmail.com

+905058761553

ILKER CAN BUYUKKIRLI

Role: CONTACT

ilkerbuyukkirli@gmail.com

+905333060797

Other Identifiers

CMT002

Identifier Type: -

Identifier Source: org_study_id