Mechanical Low Back PainCESMGNCT06578208
Comparison of the Effect of Spinal Manipulation by Gender
A study testing Spinal Manipulation in people with Mechanical Low Back Pain and Chronic Pain, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study was to compare and evaluate the effects of spinal manipulation in patients with chronic mechanical low back pain by gender. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mechanical Low Back Pain, Chronic Pain, Gender
- What is being tested?
- Spinal Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jul 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with chronic mechanical low back pain
- Between the ages of 18 and 50
- Read and speak Turkish well enough to give informed consent and follow study instruction
- Being able to come for outpatient manipulation treatment
- Body mass index below 28
Who cannot join
- Currently involved in a legal proceeding related to back pain for which a workers' compensation claim is pending and have or have applied for permanent disability related to these problems
- Pregnancy
- Having any kind of malignancy
- Having any kind of osteoplastic disorders
- Having osteomyelitis, septic intervertebral discs and TB
- History of a spinal fracture and stenosis
Show all 12Show fewer
- Inflammatory low back pain
- History of severe osteoporosis
- History of any kind of bleeding disorders
- Taking steroids, anticoagulants, paracetamol, antidepressant drugs or drug-like substances
- Having any orthopedic and/or rheumatologic disease affecting the pelvic region
- Conservative or physical therapy for the lumbar region for the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Spinal Manipülasyon by Gender in Patients With Chronic Mechanical Low Back Pain
The purpose of the study was to compare and evaluate the effects of spinal manipulation in patients with chronic mechanical low back pain by gender.
Read the detailed description
Sixty-two participants with a diagnosis of mechanical low back pain participated in the research. 62 individuals were split into two groups based on gender. These were divided into male (n=31) and female (n=31) groups. For four weeks, spinal manipulation was applied twice a week to both groups. The World Health Organization Quality of Life Assessment Short Form (WHOQOL-Bref) was used to evaluate quality of life; the Pittsburg Sleep Quality Index (PSQI) and McGill Pain Questionnaire were used to evaluate sleep quality; Visual Analog Scale (VAS) was used to evaluate pain; Oswetry Disability Index (ODI) was used to evaluate pain-related disability; and a scale was used to evaluate the treatment quality. Range of motion in the hips and lumbar region was measured with a goniometer.
- Being tested
- Spinal Manipulation
- Keywords
- Mechanical low back pain, Spinal manipulation, Gender
- Medical subject headings
- Low Back Pain, Chronic Pain, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationOther
The patient was placed in the lateral decubitus position by the therapist. The foot was placed on the popliteal fossa of the lower leg while the upper knee was flexed. Once the patient was in this position, the therapist performed high velocity and low amplitude thrusts (HVLA; high velocity - low amplitude) on the vertebra with dysfunction (Fagundes Loss et al., 2020).
| Study group | Role | What they receive |
|---|---|---|
| Male Gruop | Experimental | The patient was placed in the lateral decubitus position by the therapist. The foot was placed on the popliteal fossa of the lower leg while the upper knee was flexed. Once the patient was in this position, the therapist performed high velocity and low amplitude thrusts (HVLA; high velocity - low amplitude) on the vertebra with dysfunction. Receives: Other: Spinal Manipulation |
| Female Group | Experimental | The patient was placed in the lateral decubitus position by the therapist. The foot was placed on the popliteal fossa of the lower leg while the upper knee was flexed. Once the patient was in this position, the therapist performed high velocity and low amplitude thrusts (HVLA; high velocity - low amplitude) on the vertebra with dysfunction. Receives: Other: Spinal Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The VAS used to assess pain intensity consists of a line 10 centimeters (100 millimeters) long. On the lowest score is the expression "I have no pain", on the highest score is the expression "my pain is the worst it can be" and pain is evaluated according to the score expressed between them. The higher the score, the more severe the pain (Sonmezer et al., 2020).
Measured: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
This questionnaire was used to assess quality of life. It consists of 26 questions and includes the categories of physical, psychological, social relations and environment. The higher the score, the higher the quality of life.
Measured: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
Oswetry Disability Index (ODI)
The ODI is a 10-question questionnaire that assesses the disabling effects of low back pain in people suffering from low back pain. Patients self-administer the questionnaire and it takes 7 to 8 minutes for the examiner to evaluate the results. Each question is scored from 0 to 5 and the total score is expressed as a percentage. The higher the score, the higher the level of disability.
Measured: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is an effective questionnaire for assessing sleep quality and patterns in adults. It consists of 7 components and sleep quality is rated as "poor" or "good".
Measured: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
McGill Pain Questionnare (MGPQ)
It is a questionnaire designed to measure the sensory, emotional and other effects of pain along with pain intensity in adults with chronic pain. It consists of 4 sections and includes 78 pain descriptive words. The higher the score, the more intense the pain.
Measured: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
Treatment Satisfaction Score
In order to assess the patients' satisfaction with the treatment, similar to the Visual Analog Scale, the expression "I am not satisfied with this treatment" is written on both ends of a 10 cm line at the point where the zero value is located and the expression "I am very satisfied with this treatment" is written at the point where the ten value is located. The patient is asked to mark his/her opinion about this.
Measured: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
Hip and Lumbal ROM Measurements
Range of motion measurements were performed with a goniometer. For hip flexion, supine position was used; the fixed arm of the goniometer was placed on the horizontal axis of the body and the movable arm was placed on the lateral midline of the thigh and the greater trochanter was used as the pivot point. For hip abduction and adduction in the same position, the anterior superior iliac spine was used as the pivot point and the movable arm was placed on the midline of the femur. For hip rotations, the subject's knee and hip were flexed 90°. The fixed arm was placed above the patella apex and parallel to the anterior superior spine and the measurement was made from there. Lumbar ROM measurement was performed according to the description of Otman and Köse (2013).
Measured: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Apr 2024
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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 study included 62 people diagnosed with mechanical low back pain. These 62 people were divided into two groups as male group (n=31) and female group (n=32). Spinal manipulation was performed in the side lying position twice a week for a total of 4 weeks. The evaluation methods were repeated 3 times: at the beginning, at the end and 1 month after the end of the treatment. The study used various statistical techniques to evaluate data, including Shapiro-Wilks test, Student's t test, Mann Whitney U test, repeated measures analysis of variance, Bonferroni test, Friedman's test, Wilcoxon sign test, Wilcoxon Signed Ranks test, and Chi-square test. These tests were used to compare normally distributed and non-normally distributed parameters, as well as within-group comparisons of parameters, and to determine the period causing the difference. Significance was evaluated at a p\<0.05 level.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
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 HAKTIK, Study director, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578208
- Sponsor's protocol ID
- CMT0004
- Acronym
- CESMG
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal Manipülasyon by Gender in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06578208
- Acronym / sponsor ID
- CESMG / CMT0004
- Keywords
- Mechanical low back pain, Spinal manipulation, Gender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 29 Aug 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 purpose of the study was to compare and evaluate the effects of spinal manipulation in patients with chronic mechanical low back pain by gender.
Detailed description
Sixty-two participants with a diagnosis of mechanical low back pain participated in the research. 62 individuals were split into two groups based on gender. These were divided into male (n=31) and female (n=31) groups. For four weeks, spinal manipulation was applied twice a week to both groups. The World Health Organization Quality of Life Assessment Short Form (WHOQOL-Bref) was used to evaluate quality of life; the Pittsburg Sleep Quality Index (PSQI) and McGill Pain Questionnaire were used to evaluate sleep quality; Visual Analog Scale (VAS) was used to evaluate pain; Oswetry Disability Index (ODI) was used to evaluate pain-related disability; and a scale was used to evaluate the treatment quality. Range of motion in the hips and lumbar region was measured with a goniometer.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study included 62 people diagnosed with mechanical low back pain. These 62 people were divided into two groups as male group (n=31) and female group (n=32). Spinal manipulation was performed in the side lying position twice a week for a total of 4 weeks. The evaluation methods were repeated 3 times: at the beginning, at the end and 1 month after the end of the treatment. The study used various statistical techniques to evaluate data, including Shapiro-Wilks test, Student's t test, Mann Whitney U test, repeated measures analysis of variance, Bonferroni test, Friedman's test, Wilcoxon sign test, Wilcoxon Signed Ranks test, and Chi-square test. These tests were used to compare normally distributed and non-normally distributed parameters, as well as within-group comparisons of parameters, and to determine the period causing the difference. Significance was evaluated at a p<0.05 level.
| Arm | Type | Receives |
|---|---|---|
| Male Gruop | Experimental | Other: Spinal ManipulationThe patient was placed in the lateral decubitus position by the therapist. The foot was placed on the popliteal fossa of the lower leg while the upper knee was flexed. Once the patient was in this position, the therapist performed high velocity and low amplitude thrusts (HVLA; high velocity - low amplitude) on the vertebra with dysfunction. |
| Female Group | Experimental | Other: Spinal ManipulationThe patient was placed in the lateral decubitus position by the therapist. The foot was placed on the popliteal fossa of the lower leg while the upper knee was flexed. Once the patient was in this position, the therapist performed high velocity and low amplitude thrusts (HVLA; high velocity - low amplitude) on the vertebra with dysfunction. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with chronic mechanical low back pain
- Between the ages of 18 and 50
- Read and speak Turkish well enough to give informed consent and follow study instruction
- Being able to come for outpatient manipulation treatment
- Body mass index below 28
Key exclusion criteria (12 listed)
- Currently involved in a legal proceeding related to back pain for which a workers' compensation claim is pending and have or have applied for permanent disability related to these problems
- Pregnancy
- Having any kind of malignancy
- Having any kind of osteoplastic disorders
- Having osteomyelitis, septic intervertebral discs and TB
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 |
|---|---|---|
| Spinal ManipulationThe patient was placed in the lateral decubitus position by the therapist. The foot was placed on the popliteal fossa of the lower leg while the upper knee was flexed. Once the patient was in this position, the therapist performed high velocity and low amplitude thrusts (HVLA; high velocity - low amplitude) on the vertebra with dysfunction (Fagundes Loss et al., 2020). | Other | Female Group, Male Gruop |
Primary outcome
Visual Analog Scale
Time frame: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
The VAS used to assess pain intensity consists of a line 10 centimeters (100 millimeters) long. On the lowest score is the expression "I have no pain", on the highest score is the expression "my pain is the worst it can be" and pain is evaluated according to the score expressed between them. The higher the score, the more severe the pain (Sonmezer et al., 2020).
World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
Time frame: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
This questionnaire was used to assess quality of life. It consists of 26 questions and includes the categories of physical, psychological, social relations and environment. The higher the score, the higher the quality of life.
Oswetry Disability Index (ODI)
Time frame: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
The ODI is a 10-question questionnaire that assesses the disabling effects of low back pain in people suffering from low back pain. Patients self-administer the questionnaire and it takes 7 to 8 minutes for the examiner to evaluate the results. Each question is scored from 0 to 5 and the total score is expressed as a percentage. The higher the score, the higher the level of disability.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
The PSQI is an effective questionnaire for assessing sleep quality and patterns in adults. It consists of 7 components and sleep quality is rated as "poor" or "good".
McGill Pain Questionnare (MGPQ)
Time frame: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
It is a questionnaire designed to measure the sensory, emotional and other effects of pain along with pain intensity in adults with chronic pain. It consists of 4 sections and includes 78 pain descriptive words. The higher the score, the more intense the pain.
Treatment Satisfaction Score
Time frame: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
In order to assess the patients' satisfaction with the treatment, similar to the Visual Analog Scale, the expression "I am not satisfied with this treatment" is written on both ends of a 10 cm line at the point where the zero value is located and the expression "I am very satisfied with this treatment" is written at the point where the ten value is located. The patient is asked to mark his/her opinion about this.
Hip and Lumbal ROM Measurements
Time frame: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).
Range of motion measurements were performed with a goniometer. For hip flexion, supine position was used; the fixed arm of the goniometer was placed on the horizontal axis of the body and the movable arm was placed on the lateral midline of the thigh and the greater trochanter was used as the pivot point. For hip abduction and adduction in the same position, the anterior superior iliac spine was used as the pivot point and the movable arm was placed on the midline of the femur. For hip rotations, the subject's knee and hip were flexed 90°. The fixed arm was placed above the patella apex and parallel to the anterior superior spine and the measurement was made from there. Lumbar ROM measurement was performed according to the description of Otman and Köse (2013).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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 HAKTIK study director
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation in people with Mechanical Low Back Pain and Chronic Pain, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).). The study lists 7 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 29 Aug 2024.