Clinical trial NCT06578208: Comparison of the Effect of Spinal Manipulation by Gender
Official title: Comparison of Spinal Manipülasyon by Gender in Patients With Chronic Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Low Back Pain
Chronic Pain
Gender
Neuromuscular Subluxation of Joint
Keywords: Mechanical low back pain
Spinal manipulation
Gender
Lead sponsor: Sinop University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 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).
measure: World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
timeFrame: 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).
measure: Oswetry Disability Index (ODI)
timeFrame: 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).
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 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).
measure: McGill Pain Questionnare (MGPQ)
timeFrame: 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).
measure: Treatment Satisfaction Score
timeFrame: 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).
measure: Hip and Lumbal ROM Measurements
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Sinop
country: Turkey
facility: Sefa Haktan Hatik
Study officials:
affiliation: Sinop University
name: SEFA HAKTAN HAKTIK
role: STUDY_DIRECTOR
References: