Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04859127 |
Other study ID # |
kirikkaleuniversity1. |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 15, 2021 |
Est. completion date |
April 30, 2022 |
Study information
Verified date |
January 2023 |
Source |
Kirikkale University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
INTRODUCTION Non-specific chronic neck pain is one of the most common musculoskeletal
disorders today. Factors related to neck pain are diverse and can affect the person in
different ways. In order to determine the appropriate physical therapy and rehabilitation
program for patients, the functional status of the patients should be evaluated carefully and
the factors affecting this situation and the relationships between them should be taken into
account. Parameters such as pain, balance, disability, muscular performance are associated
with neck pain.
The aim of our study is to examine the relationship between pain and kinesophobia and muscle
performance, balance and dual task in individuals with nonspecific chronic neck pain and to
compare them with asymptomatic individuals.
Materials and Methods:
The study included 44 individuals aged 18-65 who applied to Kırıkkale University Faculty of
Medicine Physical Medicine and Rehabilitation Clinic and were diagnosed with non-specific
chronic neck pain by a specialist, and 44 asymptomatic individuals between the ages of 18-65
who did not experience neck pain for the last 1 year for the control group. will be. A total
of 88 individuals will be included. We will evaluate kinesiophobia, pain density, muscles
performance, dual task etc.
FINDINGS AND DISCUSSION: Data acquired at the end of this study will be compared by using
appropriate statistical methods and then it will be discussed in comparison with national and
international literature.
Description:
METHOD DETAIL
1. Pain Severity Assessment Pain assessment is a complex task with a number of goals,
including determining the meaning of pain for the patient, understanding the causes as
well as consequences of pain, and determining the effectiveness of pain management. The
Visual Analogue Scale (VAS) is one of the most widely used measurement methods in pain
measurement. GAS is a one-dimensional linear scale. It is easy to use, the results are
reproducible, and it can be used in a wide variety of environments. VAS is a continuous
scale consisting of a 10 cm (100 mm) horizontal or vertical line. While determining the
pain intensity; (0 points) qualifies as "no pain" and (100 points on a 100 mm scale)
"pain as bad as possible" or "worst pain imaginable". While calculating the pain
severity score, the patient chooses the appropriate point from the 10 cm line. It
indicates the presence of no pain on a scale of 100 mm (0-4 mm), mild pain (5-44 mm),
moderate pain (45-74 mm), severe pain (75-100 mm).
2. Posture Evaluation The postures of the subjects participating in the study will be
evaluated by the standard posture analysis method. Round shoulder, anterior tilt,
kyphosis, etc. postural disturbances will be recorded.
3. Joint Range of Motion Assessment (ARA) Normal range of motion will be evaluated using an
Electrogoniometer. In the sitting position, the flexion, extension, lateral flexion and
rotation movements of the relevant region will be measured and recorded. Evaluations of
joint movements will be made in 3 repetitions and the average value of these 3
measurements will be determined by calculating.
4. Muscular Strength Assessment Muscle strength of the neck flexor and extensor muscles
will be measured using the Stabilizer (Chattanooga Stabilizer Group Inc., Hixson, TN),
and Hand-Held Dynamometer.
5. Assessment of Muscular Endurance Resistance measurements will be made on the extensor
and flexor muscles of the neck in a stable position, in the supine and prone positions,
respectively. While measuring the endurance of the extensor neck muscles, the patient's
legs will be straight and his arms will be positioned around the head. Loads of 2 and 4
kilograms will be applied for women and men, respectively. The test will be done by
stretching the head just above the bed and lifting it up for as long (seconds) as
possible. Endurance evaluation of the deep cervical flexor muscles will be started with
the subject in the hooked position on the back and the hands in the free position on the
abdomen. The case will be asked to raise his head slightly high enough for the index and
middle finger of a hand to pass along with the instruction. After the patient is taught
this position, a slight amount (30%) of craniocervical flexion will be requested from
the beginning as if yes. While the subject is in this position, the hand support will be
pulled slightly and the test will be started in this position. The time in which the
craniocervical maintains the position while maintaining flexion will be recorded in
seconds. The test will be terminated when the patient does one of the four situations
stated below;
1- In cases where the patient feels a lot of pain and states that he cannot continue 2- In
cases where the patient does not feel any pain but endurance ends 3- If the physiotherapist
determines that the patient has lost the craniocervical flexion position despite maintaining
the position 4- If the physiotherapist observes that the subject lifts his head higher than
it should be, the endurance test ends.
The resistance of the case for 60 seconds will be considered sufficient for the termination
of the endurance test.
6.Muscular Shortness Assessment In order to determine the muscle shortness of individuals;
Standard shortness will be assessed for the pectoral muscles and the adductor and internal
rotator muscles.
7. Kinesiophobia Assessment In evaluating the level of kinesiophobia, the 17-question "Tampa
Kinesophobia Scale (TSI)" developed by Vlaeyen et al. and validated in Turkish by Tunca
Yılmaz and her colleagues will be used. The higher the calculated score, the higher the
person's fear of movement will be determined.
8. Spouse Apology Assessment The Neck Disability Index (NDI) is the most widely used tool to
measure perceived disability associated with neck pain. The Turkish version of the scale,
made by Aslan et al. consists of 10 parts. The questionnaire includes parameters of pain
intensity, self-care, lifting, reading, headaches, concentration, work, driving, sleep and
activities of daily living. As a result of scoring; (0-4 points) means no disability, (5-14
points) mild disability, (15-24 points) moderate disability, (25-34 points) severe disability
and (35 points and above) total disability .
9.Dynamic Balance Assessment
Star Balance Test (YDT) will be used in dynamic balance assessment. Participants stand in the
middle of a platform consisting of eight lines that extend at an angle of 45 ° to each other.
During the test, the person should rest on one lower limb while reaching as far as possible
along each of the eight lines with the other. 8 directions anterior (A), anterolateral (AL),
lateral (L), posterolateral (PL), posterior (P), posteromedial (PM), medial (M) and
anteromedial (AM). The person is asked to make a light touch on the determined lines and
return the reaching leg to the center, and to stand with one leg in the center. Then the
maximum distance reached is recorded. If it will be done with the left foot, it is requested
to lie counterclockwise, if it will be done with the right foot, it is desired to lie in a
clockwise direction. The following formula is used to calculate the star balance test score:
YDT score = (Reaching distance / Leg length) * 100 .
10. Static Balance Evaluation Static balance will be evaluated with the "One Leg Standing
Test (TBÜD)". This test measures static balance and static standing ability. It also provides
information about the fall risk of the person. The time starts when the person lifts one leg
from the ground, and ends when he puts it on the ground. The total time is recorded by the
clinician. If the person can keep one leg up for 30 seconds, the test is terminated. If the
position can be maintained for less than 10 seconds, the person has an imbalance, and if it
is maintained for less than 5 seconds, it can be interpreted that there is a risk of falling
for the person.
11. Dynamic Balance and Physical Performance Evaluation The "Timed Get Up and Go Test" will
be used for dynamic balance and physical performance evaluation. In this test, the
participant should get up without holding the arms of the standard chair in which he or she
sits, and after 3 meters of walking, he must return to the chair without touching anything.
12. Walking Speed Assessment The 10 meter walking test will be used to evaluate the walking
speed. The person will be asked to walk 14 meters, but the first 2 and the last 2 meters will
not be evaluated. It will be calculated in seconds in how long a person takes this distance
while walking normally. The time will be recorded in meters / second (m / s), provided that
the time starts when the person's foot is at the starting line of the 2nd meter and ends when
the 12 meter line is crossed.
13. Dual-Task Assessment The dual task will be evaluated motor-motor and motor-cognitively
during walking. Participants will be subjected to 6 different walks. Participants will be
given a clear explanation about the tests before the tests and will be informed about their
comfort. Participants will be given a trial test only once before the test.
- 10 m Walking Test (single duty)
- 10 m Walking Test + The task of carrying 2 glasses of water on a standard tray without
spilling the water in the glass (motor-motor dual duty)
- 10 m Walking Test + A task of counting 6 from any two-digit number selected by the
clinician during the test (motor-cognitive dual task)
- Timed Get Up and Go Test (single task)
- Timed Get Up and Go Test + The task of carrying 2 glasses of water on a standard tray
without spilling the water in the glass (motor-motor dual duty)
- Timed Get Up and Go Test + The task of counting 6 from any two-digit number selected by
the clinician during the test (motor-cognitive dual task)
During the tests, single tasks will be included for reference. The completion times of the
motor-motor and motor-cognitive dual tasks, which are evaluated 2 in 2 each with 4 different
walking forms, will be recorded and the result will be reached. The following calculation
method will be used for the result:
Dual Mission Effect = (Single Mission Performance - Dual Mission Performance) / Single
Mission Performance x 100