The Effect of Exercise Applied With Stretching Platform in Patients With Chronic Low Back Pain

NCT05726955 | Completed

• 1 other identifier: FU
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to examine and compare the effects of exercises applied with a stretching platform in addition to conservative treatment and conservative treatment only on pain, proprioception, balance, and mobility in patients with chronic low back pain. 55 people with chronic low back pain were included in the study and randomly divided into 2 groups. The participants in group 1 were included in the conservative treatment program, while the participants in group 2 were included in the exercise program applied with a stretching platform in addition to the conservative treatment. Pain intensity with Visual Analog Scale (VAS), proprioception sense with the active re-creation of passive positioning method without extremity support, mobility with Modified Schober Test (MST), Hand Finger-Ground Distance Measurement and Trunk Lateral Bending Measurement, balance level with Functional Reach Test, functionality with Oswestry Disability Index and quality of life was assessed with the EuroQol Group 5D-3L Questionnaire. In the study, statistically significant differences were observed between the results of pain, proprioception, MST, HFGDM and TLBM, FRT, ODI and EuroQol Group 5D-3L in intragroup evaluations (p\<0,05). In intergroup analysis, the VAS score during activity and 15° right ankle plantar flexion in proprioception evaluation were superior in the Group 2 compared to the group 1 (p\<0.05). It was observed that CT and exercises applied with a stretching platform in the treatment of chronic low back pain had positive effects on pain, proprioception, mobility, balance, functionality, and quality of life.

Conditions

Chronic Low-back Pain

Keywords

low back pain; exercise; balance; proprioception; mobility

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  To evaluate the severity of pain, at night, at rest, and during activity, the VAS was used, which digitizes the parameter values that cannot be measured numerically, by numbering them from 0 to 10, where "0" is no pain and "10" is very severe pain.

  6 months

Secondary Outcomes (7)

• measurement of proprioception sense, the method of actively recreating passive positioning without supporting the extremity

  6 months

• Modified Schober Test

  6 months

• Functional Reach Test (FRT)

  6 months

• The Oswestry Disability Index (ODI)

  6 months

• The EuroQol Group 5-Dimension 3-Level (EQ-5D-3L)

  6 months

Study Arms (2)

Control

NO INTERVENTION

Control

Exercise

EXPERIMENTAL

Group 2 (n=28) were included in an exercise training program applied with conservative treatment and a stretching platform (ETSP)

Other: Exercise training program

Interventions

Exercise training program OTHER

an exercise training program applied with conservative treatment and a stretching platform (ETSP) 3 days a week for 6 weeks

Exercise

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants aged 25-65 years,
• who had LBP for more than 12 weeks
• whose pain intensity was greater than 3 on the 10 cm Visual Analog Scale (VAS).

You may not qualify if:

• have structural deformity, circulatory disorder,
• have a disease that will prevent mobility in the columna vertebralis,
• those who have undergone surgery for the columna vertebralis and lower extremity in the last year,
• those diagnosed with vertigo and osteoporosis

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Fizyopedi

Samsun, 55200, Turkey (Türkiye)

Location

Related Publications (1)

• Mohammad NS, Nazli R, Zafar H, Fatima S. Effects of lipid based Multiple Micronutrients Supplement on the birth outcome of underweight pre-eclamptic women: A randomized clinical trial. Pak J Med Sci. 2022 Jan-Feb;38(1):219-226. doi: 10.12669/pjms.38.1.4396.

  PMID: 35035429 RESULT

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Gamze Aydin, PhD

  Firat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The evaluations of pain, proprioception, mobility, balance, functionality and quality of life were performed by a physiotherapist, while treatment programs were performed by the other physiotherapist in this study. Physiotherapists were blind to each other. Face to face interview method was used for the data collection. A consultation was provided by the researchers when the patients had questions. It took about 30 min to complete all assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 14, 2023
• Study Start: October 20, 2021
• Primary Completion: November 20, 2022
• Study Completion: December 28, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)