Comparison of the Effect of Spinal Manipulation by Gender
NCT Number: NCT06578208
Acronym: CESMG
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mechanical Low Back Pain|Chronic Pain|Gender|Neuromuscular Subluxation of Joint
Interventions: OTHER: Spinal Manipulation
Sponsor: SEFA HAKTAN HATIK
Sex: ALL
Age: ADULT
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-04-01
Completion Date: 2024-07-01
Locations: Sefa Haktan Hatik, Sinop, Turkey

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.

Primary Outcome Measures: 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)., 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., 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., 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"., 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., 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., 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)., 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).