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Completed

NCT Number: NCT06578208

Comparison of the Effect of Spinal Manipulation by Gender

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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Key information

Conditions

Mechanical Low Back Pain Back Pain Behavior Chronic Pain Coitus Gender Low Back Pain Neurologic Manifestations Neuromuscular Subluxation of Joint Pain Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sefa Haktan Hatik

Sinop, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Visual Analog Scale

    Time frame: 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).

    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).

  2. World Health Organization Quality-of-Life Scale (WHOQOL-BREF)

    Time frame: 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).

    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.

  3. Oswetry Disability Index (ODI)

    Time frame: 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).

    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.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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).

    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".

  5. McGill Pain Questionnare (MGPQ)

    Time frame: 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).

    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.

  6. Treatment Satisfaction Score

    Time frame: 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).

    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.

  7. Hip and Lumbal ROM Measurements

    Time frame: 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).

    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).

Sponsors and collaborators

Lead sponsor

SEFA HAKTAN HATIK

Other

Registry information

Official study title

Comparison of Spinal Manipülasyon by Gender in Patients With Chronic Mechanical Low Back Pain

Acronym: CESMG

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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