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Chronic Low-back PainNCT05726955

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

A study testing Exercise training program in people with Chronic Low-back Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Chronic Low-back Pain
What is being tested?
Exercise training program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Oct 2021to 28 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Fizyopedi

    Samsun, 55200

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Exercise Applied With Stretching Platform on Pain, Proprioception, Balance, and Mobility in Patients With Chronic Low Back Pain

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.

Being tested
Exercise training program
Keywords
low back pain, exercise, balance, proprioception, mobility
Medical subject headings
Low Back Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise training programOther

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

Study groups in NCT05726955
Study groupRoleWhat they receive
ControlNo interventionControl
ExerciseExperimentalGroup 2 (n=28) were included in an exercise training program applied with conservative treatment and a stretching platform (ETSP)
Receives: Other: Exercise training program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (7)
  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.

    Measured: 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.

    Measured: 6 months

  3. Functional Reach Test (FRT)

    assessment of balance

    Measured: 6 months

  4. The Oswestry Disability Index (ODI)

    assessment of functionality

    Measured: 6 months

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

    assessment of quality of life

    Measured: 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.

    Measured: 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start20 Oct 2021
  3. Primary completion20 Nov 2022
  4. Study completion28 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726955
Sponsor's protocol ID
FU
Status last verified
Feb 2023
First submitted
13 Jan 2023
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training program in people with Chronic Low-back Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726955, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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