Comparison of the Effect of Spinal Manipulation by Gender

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mechanical Low Back Pain Chronic Pain Gender Neuromuscular Subluxation of Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Male Gruop

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.

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type OTHER

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).

Female Group

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.

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type OTHER

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).

Interventions

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Spinal Manipulation

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).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No