Skip to main content
OpenTrials
Completed

NCT Number: NCT06234891

The Effect of Physiotherapy on Chronic Low Back Pain

Demographic data of patients diagnosed with chronic low back pain and planned for medical treatment (n:30) and physical therapy in addition to medical treatment (n:30), as well as before and after treatment; Visual analog scale (VAS), Oswestry Disability Index (ODI) and Short form 36 (SF-36) quality of life scoring, Lumbar range of motion (LHA), straight leg raising test (DBK) and hand-finger ground distance (EPZM) were evaluated. Hot pack, transcutaneous electrical nerve stimulation (TENS) and ultrasound were given as physical therapy agents.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low-back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

About this study

Patients with VAS, ODI and SF-36 quality of life values before treatment, in addition to demographic data, who have applied to our Physical Medicine and Rehabilitation Policlinic in our hospital with chronic low back pain in the last 3 (three) months, are determined, and at least 30 above the age of 18 who received physiotherapy and who did not receive physiotherapy.

patient consents obtained and VAS, ODI and SF-36 quality of life values questioned.

Pre- and post-treatment values compared, and intragroup changes compared in both groups and evaluated whether physiotherapy contributes to pain, functionality and quality of life in treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who have been prescribed medical treatment or physiotherapy for mechanical back pain
  • Those with demographic information as well as VAS, ODI information in their files
  • Patients between the ages of 20-79 who applied to our hospital with the complaint of chronic low back pain

Exclusion criteria

  • Non-mechanical back pain
  • Patients with physiotherapy contraindications
  • Those with inflammatory diseases
  • Severe heart failure
  • Stroke, spinal cord injury, plegia due to traumatic brain injury
  • A history of malignancy
  • Active infection during treatment
  • Having metal implants in the waist area
  • Established osteoporosis
  • Those with pacemakers

Treatment and study plan

NSAID

Drug

Medical treatment

Other names: Medical treatment

Phsiotheraphy

Other

Nsaid and phsiotheraphy (hotpack-ultrasound therapy- tens)

Other names: Medical treatment and phsiotheraphy

Primary outcomes

  1. Visual Analog scale (VAS)

    Time frame: at baseline and immediately after treatment

    It is a scale used to evaluate pain intensity. Patients are asked to mark the severity of their pain on a 10 cm line. Patients are asked to mark the place expressing their pain on a line on the scale, where the starting point is no pain and the end point is the most severe pain experienced in life. When calculating, the distance between the marked point and the starting point is measured in cm. An increase in the score means that the severity of pain increases.

  2. Oswestry Disability Index (ODI)

    Time frame: at baseline and immediately after treatment

    It is a valid and reliable scoring in Turkish to evaluate the degree of loss of function in low back pain. It consists of 10 items that question pain severity, self-care, lifting and carrying loads, walking, sitting, standing, sleeping, degree of pain change, travel and social life. Each item is scored between "0" and "5". The maximum score is "100" and the minimum score is "0". The results are evaluated as 0-20 points if it minimally affects daily life, 20-40 points if it is moderate, 40-60 points if it is serious, 60-80 points if it completely restricts it, and 80-100 points if it is bedridden. The disability percentage can be calculated by converting the total score obtained into a percentage system. As the total score increases, the level of disability also increases.

Secondary outcomes

  1. SF 36

    Time frame: at baseline and immediately after treatment

    Short Form-36 (SF-36) Quality of Life Survey: It is a frequently used survey in studies to evaluate the quality of life. A Turkish adaptation study was conducted and its validity and reliability were demonstrated. It consists of a total of 36 items. SF-36 Quality of Life Questionnaire questions the quality of life considering the last 4 weeks. It has 8 subgroups: physical functions, social functions, role inhibition due to physical problems, physical pain, mental health, role inhibition due to emotional problems, life energy and general health.

  2. range of motion (ROM)

    Time frame: at baseline and immediately after treatment

    Lumbar flexion, extension and lateral flexion ROM measurements were evaluated as limited, painful, open.

  3. Straight leg raising

    Time frame: at baseline and immediately after treatment

    It was considered positive if the patient felt pain between 30-70 degrees when she lifted her leg straight while lying on her back and the knee was at 180 degrees.

  4. Finger-to-ground distance

    Time frame: at baseline and immediately after treatment

    When the patient lumbar flexed forward, the distance between the floor and the ground was measured in centimeters and evaluated.

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

The Effect of Physiotherapy on Pain, Functionality and Quality of Life Scores in Patients With Chronic Low Back Pain

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Feb 13, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.