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Clinical Trials/NCT06291168
NCT06291168UnknownNot Applicable

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

SEFA HAKTAN HATIK0 sites60 target enrollmentStarted: March 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Primary Endpoint
Hospital Anxiety and Depression Scale (HADS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Chiropractic Manipulation (CM) Group

Experimental

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.

Intervention: Chiropractic Manipulation (HVLA - High Velocity Low Amplitude) (Other)

Yoga-based Exercise (YBE) Group

Experimental

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.

Intervention: Yoga-Based Exercise Program (Other)

Conventional Exercise (Control) Group (CG)

Experimental

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.

Intervention: Conventional Exercises (Other)

Outcomes

Primary Outcomes

Hospital Anxiety and Depression Scale (HADS)

Time Frame: 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.

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.

Numeric Rating Scale (NRS)

Time Frame: 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.

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.

Roland-Morris Disability Questionnaire

Time Frame: 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.

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.

Range of Motion (ROM)

Time Frame: 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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
SEFA HAKTAN HATIK
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

SEFA HAKTAN HATIK

Assistant Professor

Sinop University

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