Low Back PainCTESMYCLBPNCT06291168
Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain
A study testing Chiropractic Manipulation (HVLA - High Velocity Low Amplitude), Yoga-Based Exercise Program and Conventional Exercises in people with Low Back Pain and Spinal Manipulation, run by SEFA HAKTAN HATIK.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Spinal Manipulation, Yoga
- What is being tested?
- Chiropractic Manipulation (HVLA - High Velocity Low Amplitude), Yoga-Based Exercise Program and Conventional Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Individuals with inflammatory low back pain
- Those who have undergone surgery and have neurological loss.
- Those with psychiatric problems
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of The Effectiveness of Chiropractic Manipulation and Yoga-Based Exercise Approach in Patients With Chronic Low Back Pain
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.
Read the 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
- Being tested
- Chiropractic Manipulation (HVLA - High Velocity Low Amplitude), Yoga-Based Exercise Program, Conventional Exercises
- Keywords
- Yoga, Chronic Low Back Pain, Chiropractic Manipulation, Exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic Manipulation (HVLA - High Velocity Low Amplitude)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 ProgramOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chiropractic Manipulation (HVLA - High Velocity Low Amplitude) |
| 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. Receives: Other: Yoga-Based Exercise Program |
| 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. Receives: Other: Conventional Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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 (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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
- Investigators
- SEFA HAKTAN HATIK, Study director, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291168
- Sponsor's protocol ID
- CMT002
- Acronym
- CTESMYCLBP
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effectiveness of Chiropractic Manipulation and Yoga-Based Exercise Approach in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06291168
- Acronym / sponsor ID
- CTESMYCLBP / CMT002
- Conditions
- Low Back Pain, Spinal Manipulation, Yoga
- Keywords
- Yoga, Chronic Low Back Pain, Chiropractic Manipulation, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Manipulation (CM) Group | Experimental | Other: Chiropractic Manipulation (HVLA - High Velocity Low Amplitude)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. |
| Yoga-based Exercise (YBE) Group | Experimental | Other: Yoga-Based Exercise ProgramYoga 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. |
| Conventional Exercise (Control) Group (CG) | Experimental | Other: Conventional ExercisesSpinal 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Chiropractic Manipulation (CM) Group |
| Yoga-Based Exercise ProgramYoga 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. | Other | Yoga-based Exercise (YBE) Group |
| Conventional ExercisesSpinal 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. | Other | Conventional Exercise (Control) Group (CG) |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEFA HAKTAN HATIK study director
Sinop University
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Manipulation (HVLA - High Velocity Low Amplitude), Yoga-Based Exercise Program and Conventional Exercises in people with Low Back Pain and Spinal Manipulation, run by SEFA HAKTAN HATIK.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEFA HAKTAN HATIK (+905058761553, haktanhtk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.