The Effect of Physiotherapy on Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Drug: Nsaid; Other: Phsiotheraphy

• Registration Number: NCT06234891
• Lead Sponsor: Kayseri City Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-11-26
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Nsaid	NSAID
Group 2	Phsiotheraphy	nsaid and physiotherapy
Group 2	Nsaid	nsaid and physiotherapy

Primary Outcome Measures

Name	Time	Method
Visual Analog scale (VAS)	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.
Oswestry Disability Index (ODI)	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 Outcome Measures

Name	Time	Method
Straight leg raising	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.
Finger-to-ground distance	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.
SF 36	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.
range of motion (ROM)	at baseline and immediately after treatment	Lumbar flexion, extension and lateral flexion ROM measurements were evaluated as limited, painful, open.

Trial Locations

Locations (1)

Kayseri City Hospital; 🇹🇷 Kayseri̇, Turkey