Comparison of the Effect of Spinal Manipulation by Gender

NCT06578208 | Completed

• 1 other identifier: CMT0004
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Low Back Pain; Chronic Pain; Gender; Neuromuscular Subluxation of Joint

Keywords

Mechanical low back pain; Spinal manipulation; Gender

Outcome Measures

Primary Outcomes (7)

• 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).

Study Arms (2)

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.

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.

Other: Spinal Manipulation

Interventions

Spinal Manipulation 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; Male Gruop

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Patients diagnosed with mechanical low back pain were included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SEFA HAKTAN HATIK: lead

Study Sites (1)

Sefa Haktan Hatik

Sinop, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Coitus

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• SEFA HAKTAN HAKTIK

  Sinop University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 29, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

TU (1)