The Effect of Physiotherapy on Chronic Low Back Pain

NCT06234891 | Completed

• 1 other identifier: Kayseri City Hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

physiotherapy; low back pain; quality of life; functionality

Outcome Measures

Primary Outcomes (2)

• Visual Analog scale (VAS)

  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)

  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 Outcomes (4)

• SF 36

  at baseline and immediately after treatment

• range of motion (ROM)

  at baseline and immediately after treatment

• Straight leg raising

  at baseline and immediately after treatment

• Finger-to-ground distance

  at baseline and immediately after treatment

Study Arms (2)

Group 1

ACTIVE COMPARATOR

NSAID

Drug: Nsaid

Group 2

ACTIVE COMPARATOR

nsaid and physiotherapy

Drug: Nsaid; Other: Phsiotheraphy

Interventions

Nsaid DRUG

Medical treatment

Also known as: Medical treatment

Group 1; Group 2

Phsiotheraphy OTHER

Nsaid and phsiotheraphy (hotpack-ultrasound therapy- tens)

Also known as: Medical treatment and phsiotheraphy

Group 2

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Havva Talay Çalış, Prof

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients in both groups were evaluated after treatment by a physiatrist blinded to the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: 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. By calling the patient on the phone and being called to our hospital; patient consents will be obtained and VAS, ODI and SF-36 quality of life values will be questioned.

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 31, 2024
• Study Start: November 26, 2020
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)