Comparison of the Effect of Spinal Manipulation by Gender (CESMG)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Mechanical Low Back Pain; Gender; Neuromuscular Subluxation of Joint
• Intervention / Treatment: Other: Spinal Manipulation

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sinop, Turkey
    • Sefa Haktan Hatik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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).
Experimental: 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.	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: SEFA HAKTAN HATIK
• Investigators: Study Director: SEFA HAKTAN HAKTIK, Sinop University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Spinal manipulation; Gender; Mechanical low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: CMT0004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No