Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05726955 |
| Other study ID # |
FU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 20, 2021 |
| Est. completion date |
December 28, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Istanbul University - Cerrahpasa (IUC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
