The Effect of Physiotherapy on Chronic Low Back Pain

February 9, 2024 updated by: Havva Talay Çalış, Kayseri City Hospital

The Effect of Physiotherapy on Pain, Functionality and Quality of Life Scores in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri̇, Turkey, 38080
        • Kayseri City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
NSAID
Drug: Nsaid
Medical treatment
Other Names:
  • Medical treatment
Active Comparator: Group 2
nsaid and physiotherapy
Drug: Nsaid
Medical treatment
Other Names:
  • Medical treatment
Other: Phsiotheraphy
Nsaid and phsiotheraphy (hotpack-ultrasound therapy- tens)
Other Names:
  • Medical treatment and phsiotheraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline and immediately after treatment
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.
at baseline and immediately after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline and immediately after treatment
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.
at baseline and immediately after treatment
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.
at baseline and immediately after treatment
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.
at baseline and immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri City Hospital

Investigators

  • Study Director: Havva Talay Çalış, Prof, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2020

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kayseri city hospital (Kayseri city hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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