CClinicalTrials.gg
CompletedNCT05726955Updated Feb 14, 2023

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

An interventional study of Exercise training program in Chronic Low-back Pain, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Our study, which was designed as a randomized controlled prospective clinical trial, was conducted in accordance with the Declaration of Helsinki. Ethics committee approval for this study was obtained from University Ethics Committee with decision number (Study protocol: 6). The study included 55 participants aged 25-65 years, who had LBP for more than 12 weeks and whose pain intensity was greater than 3 on the 10 cm Visual Analog Scale (VAS). Those who have structural deformity, circulatory disorder, and 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, and those diagnosed with vertigo and osteoporosis were not included in the study. All volunteers participating in the study were given an Informed Volunteer Consent Form and their signed consent was obtained.

2.2. Randomization The participants were randomized via the "Research Randomiser" website10. The numbers obtained as a result of randomization by entering the number of participants (n=55) and the number of groups (Group 1 and Group 2) were put into envelopes. Participants were assigned to groups according to the numbers on the envelopes they drew. Randomization was done in secret, blinding the groups and preventing the participants from meeting with the other group.

2.3. Groups Group 1 (n=27) were included in a conservative treatment program (CT) and the Group 2 (n=28) were included in an exercise training program applied with conservative treatment and a stretching platform (ETSP) 3 days a week for 6 weeks. Severity of pain, proprioception, mobility, balance, functionality, and quality of life (QoL) assessments of all participants were performed before and after the treatment. .

2.4. Assessments Demographic data including age, height, body weight, body mass index (BMI), previous diseases, and smoking habits of the participants who participated in the study were evaluated.

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 pain11.

In the method of actively recreating passive positioning without supporting the extremity, in which a goniometer is used to evaluate the proprioception sense, the extremity was passively moved to the target angle while the participant's eyes were closed, and the participant returned to the starting point after focusing on the position for 10 seconds. The participant tried to find the target angle by actively moving the same extremity, and the difference was recorded as the deviation angle12.

Modified Schober Test (MST), Hand Finger-Ground Distance Measurement (HFGDM), and Trunk Lateral Bending Measurement (TLBM) were used to evaluate the level of mobility. In the MST, 5 cm below and 10 cm above the line connecting the spinal iliaca posterior superior were marked with the help of a tape measure while the participant was in an upright position. While the participant was performing maximum trunk flexion, the distance between the two points was measured and 15 cm was subtracted from this measurement. If the difference is less than 5 cm, it is MST (+). This result indicates that lumbar region mobility decreases13-14. In HFGDM, the participant is asked to bend forward and perform maximum flexion while in an upright position. In TLBM, the participant was asked to lean to the side with his arms on both sides of the body, with his shoulder and gluteal region resting against the wall. In both measurements, the distance between the third finger and the ground was measured with the help of a tape measure. Lumbar mobility increases as the distance between the finger and the floor decrease in TLBM and HFGDM15.

Functional Reach Test (FRT) was used for balance assessment. The participant was positioned to stand sideways against the wall. The shoulder on the wall was brought to 90° flexion and the elbow to full extension, and the participant was asked to make a fist with the same arm. The alignment of the 3rd metacarpal head was marked on the wall. The participant reached forward with the knees fully extended and the level of the 3rd metacarpal head was marked again. The difference between the two marks was measured with a tape measure. The average value was obtained after 3 trials. The same application was repeated with the eyes closed. The greater the difference between the marked points in FRT, the better the balance16-17.

The Oswestry Disability Index (ODI) was used for functionality assessment. ODI is a scale that evaluates the degree of loss of function in low back pain between "0" and "100" points. As the score in ODI increases, the level of disability increases18.

The EuroQol Group 5-Dimension 3-Level (EQ-5D-3L) QoL Scale was used for QoL assessment. The 1st item of the parameters evaluated in the 1st part of the scale includes the expressions "no problem", the 2nd item "moderately severe problem" and the 3rd item "very severe problem". In scoring, '11111' represents complete well-being, and '33333' represents coma or death. Section 2 contains VAS, with 100 representing "excellent health" and 0 for "very poor health"19-20.

2.5. Treatment Program All participants included in the study received conservative treatment, 3 days a week for 6 weeks. Conservative treatment included a 20-minute hot pack and conventional Transcutaneous Electrical Nerve Stimulation (TENS) and William's flexion exercises applied to the lumbar region. The exercises performed on the stretching platform designed to stretch the lumbar, gluteal, and posterior parts of the lower extremity were applied only to the participants in Group 2 for 3 days a week for 6 weeks after Williams flexion exercises.

02

Conditions studied

  • Chronic Low-back Pain

Keywords

  • low back pain
  • exercise
  • balance
  • proprioception
  • mobility
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 54 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • No intervention
    Control

    Control

  • Experimental
    Exercise

    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

  • OtherExercise training program

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

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

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

    In the method of actively recreating passive positioning without supporting the extremity, in which a goniometer is used to evaluate the proprioception sense, the extremity was passively moved to the target angle while the participant's eyes were closed, and the participant returned to the starting point after focusing on the position for 10 seconds. The participant tried to find the target angle by actively moving the same extremity, and the difference was recorded as the deviation angle.

    Time frame: 6 months

  2. Modified Schober Test

    assessment of mobility, the MST, 5 cm below and 10 cm above the line connecting the spinal iliaca posterior superior were marked with the help of a tape measure while the participant was in an upright position. While the participant was performing maximum trunk flexion, the distance between the two points was measured and 15 cm was subtracted from this measurement. If the difference is less than 5 cm, it is MST (+). This result indicates that lumbar region mobility decreases.

    Time frame: 6 months

  3. Functional Reach Test (FRT)

    assessment of balance

    Time frame: 6 months

  4. The Oswestry Disability Index (ODI)

    assessment of functionality

    Time frame: 6 months

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

    assessment of quality of life

    Time frame: 6 months

  6. Hand Finger-Ground Distance Measurement

    In HFGDM, the participant is asked to bend forward and perform maximum flexion while in an upright position.In both measurements, the distance between the third finger and the ground was measured with the help of a tape measure. Lumbar mobility increases as the distance between the finger and the floor decrease in HFGDM.

    Time frame: 6 months

  7. Trunk Lateral Bending Measurement

    In TLBM, the participant was asked to lean to the side with his arms on both sides of the body, with his shoulder and gluteal region resting against the wall. In both measurements, the distance between the third finger and the ground was measured with the help of a tape measure. Lumbar mobility increases as the distance between the finger and the floor decrease in TLBM.

    Time frame: 6 months

07

Study locations

1 site
  • Fizyopedi
    Samsun, 55200, Turkey
08

References and documents

Publications

  • 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. PubMed 35035429 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05726955
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Gamze Aydin (Researcher, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Feb 14, 2023
Start date
Oct 20, 2021
Primary completion
Nov 20, 2022
Completion
Dec 28, 2022
Last update
Feb 14, 2023

Study contacts

Gamze Aydin, PhD
principal investigator · Firat University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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