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

Low Back Pain Clinical Trial

— CTESMYCLBP  

Official title:

Comparison of The Effectiveness of Chiropractic Manipulation and Yoga-Based Exercise Approach in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06291168
• Other study ID #: CMT002
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: Sinop University
• Contact: SEFA HAKTAN HATIK
• Phone: +905058761553
• Email: haktanhtk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Spinal Manipulation
• Yoga

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SEFA HAKTAN HATIK

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS)	The numeric rating scale is a pain screening tool commonly used to assess current pain intensity using a 0-10 scale, with zero meaning "no pain" and 10 meaning "worst pain imaginable". Numbers from zero to ten are placed on the visual pain scale. It will be used to subjectively measure patients' pain levels.	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.
Primary	Roland-Morris Disability Questionnaire	The Roland Morris Disability Questionnaire consists of 24 items related to low back pain and related perceptions of disability and is a scale used to determine functional status and disability. The questionnaire includes items related to physical ability, activity, home management, eating, psychosocial, sleep/rest and pain frequency. For each item, there are two Yes/No responses. A score of 1 is given for yes and 0 for no. The final score is obtained by summing the scores of the data obtained.	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.
Primary	Hospital Anxiety and Depression Scale (HADS)	The HADS consists of 14 items. Seven of the items measure anxiety and the remaining seven items measure depression. Odd-numbered items measure anxiety and even-numbered items measure depression. The response format provides four response options that are scored on a 0-3 scale. This results in scale values between 0 and 21 for this scale.	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.
Primary	Range of Motion (ROM)	Range of motion is the movement potential of a joint from full extension to full flexion. Measuring the degree of joint mobility is an important guide in the assessment of injury. Range of motion, also known as ROM, is a measure of flexibility involving ligaments, tendons, muscles, bones and joints, so ROM testing plays an essential role in determining fitness and assessing potential damage. Bilateral leg and hip extension and flexion, bilateral hip adduction and abduction, internal and external rotation angles, lumbar extension, flexion and lateral flexion angles of motion will be measured bilaterally.	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.