Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04874571 |
| Other study ID # |
MSerpil |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 11, 2021 |
| Est. completion date |
May 30, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Eastern Mediterranean University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary aim of this study is to examine the effect on pain characteristics by applying
muscle energy technique to patients with moderate chronic obstructive pulmonary
disease.Secondary aim, clinical status of muscle energy technique in moderate chronic
obstructive pulmonary patients: assessment of dyspnea and functional levels: kinesiophobia,
muscle strength and endurance of neck muscles, hand grip strength, functional capacity, daily
living activity, exercise habits, exercise efficiency, self-confidence, posture and to
examine its effects on quality of life.
52 volunteer participants, 35 and 65 years old, diagnosed with moderate COPD, will be divided
into muscle energy technique group (MET) (n = 26) and control group (CG) (n = 26) using
randomization (minimization) method.
Individuals in the KET group will be applied muscle energy technique to certain muscles
(Scalene(anterior-medius-posterior),Levator scapula,Sternocloidomastoideus, Upper trapezius,
Pectoral muscles, Serratus anterior, Latissimus dorsi muscles) 3 days a week for 4 weeks and
home exercise program applications will be requested. Individuals to be included in the study
as a control group will be asked to apply home exercise programs 3 days a week for 4 weeks.
All individuals included in the study will be re-evaluated parameters before, after and 6
weeks after the study.
In our study, the sociodemeographic information of the individuals who signed the voluntary
consent form will be recorded. Pain Intensity Visual Analogue Scale (VAS), pain screening and
evaluation of clinical features Brief Pain Inventory, pressure pain threshold of trapezoidal
muscle and cervical paravertebral muscles with algometer, assessment of dyspnea with Medical
Research Council (MRC) Dyspnea Scale, Fear of re-injury due to movement and activity Using
the Tampa Kinesophobia Scale (TKS), measurement of muscle strength of neck muscles Digital
Hand-Held Dynamometer (HHD), evaluation of neck muscles endurance with body weight and
sandbag measurement of hand grip strength Hand Grip dynamometer, with the six-minute walking
test of functional capacity, daily life activity with the Glittre GYA test, effectiveness of
exercise Exercise wounds and barriers scale, Postural analysis with Newyork Posture Scale,
health-related quality of life the St. George's Respiratory Questionnaire (SGRQ), general
health-related quality of life Short Form SF-36 questionnaire will be evaluated using.
Description:
DATA COLLECTION TOOLS AND FEATURES:
1. Demographic Information Age, gender, height, weight, body mass index (BMI), profession,
dominant side, educational status, history, family history, smoking and alcohol
consumption, medications used, pain, pain Exercise behavior, injury mechanism (previous
sports injuries, accidents) and location and duration of symptoms, COPD exacerbation
history, exercise effectiveness and self-confidence will be recorded.
2. Pain Assessment 2.1. Visual Analogue Scale (GAS) The severity of pain during rest,
activity and night time will be evaluated by VAS.
2.2. Brief Pain Inventory (BPI) The short pain questionnaire (BPI) is a
multi-dimensional pain assessment scale that has been validated in Turkish and is easy
to apply. This scale will evaluate the presence of pain, severity, character,
treatments, responses to this treatment, general activity, and social-emotional effects
on the basis of the last week of the patients. The severity of each item will be graded
from 0 (no obstacle) to 10 (obstruction). It consists of 32 questions in total.
2.3. Evaluation of Pressure Pain Thresholds The pressure pain threshold will be
evaluated with a digital algometer, which is an objective assessment method. The pain
thresholds of the upper trapezoidal and cervical paravertebral muscles will be evaluated
using the QST Pressure Pain Threshold branded algometer device. Trapezius muscle
tenderness will be evaluated from 3 points: medial of acromion, body of muscle and 7th
vertebra level. Cervical paravertebral muscle sensitivity will be evaluated from 3
points: C1 level, between C3 and C4, and C7. All measurements will be evaluated by the
same physiotherapist with the same algometer.
3. Assessment of Fear of Movement The Tampa Kinesophobia Scale (TKS) is a 17-question scale
developed to measure fear of re-injury due to movement and activity. This scale includes
fear, avoidance and re-injury parameters in work-related activities.
4. Evaluation of Cervical Region Muscle Strength 4.1.Muscle strength measurement of the
cervical flexor muscles will be evaluated in the supine position in the head and neck
neutral position, the arms at the side of the trunk, and the knees in the extension
position. With the help of Velcro, the body will be fixed to the bed over the spina
iliaca anterior superior and sternum. Contraction will be requested from individuals
against Hand-held Dynamometer(HHD) placed on the frontal bone.
4.2. Measurement of the strength of the cervical extensor muscles will be made in the prone
position, with the head and neck in neutral, and the arms in a free position next to the
body. With the help of Velcro, the measurement will be made by fixing the body to the bed
over the spina iliaca posterior superior and T3 vertebra. Contraction will be desired by
placing the HHD in the occipital area.
4.3. While the neck lateral flexor and rotator muscle strengths are measured, the patient
will be seated in a chair with back support, with his hands tied to his body. With the head
in a neutral position, the dynamometer for rotators will be placed on the external auditory
canal, in the center of rotation.
4.4. For lateral flexors, the dynamometer will be placed on the head over the ear in a
position that prevents movement. The patient will be told the movement to do with his head in
neutral, and measurements will be made in a way that does not allow the patient's head to
move.
5 seconds for each test. During the contraction will be requested and the tests will be
repeated 3 times and the best value will be recorded in kilograms (kg). There will be a
15-second rest break between repetitions and a 2-minute rest break between movements.
5. EVALUATION OF THE CERVICAL AREA ENDURANCE 5.1. Endurance Evaluation of Cervical Region
Flexor Muscles In evaluating the neck flexors muscles endurance, individuals will be asked to
lie on their back with the hands on the side of the body and the knees in a 90-degree
position. The hand of the physiotherapist will be placed under the head of the individuals
and they will be asked to gently press the chin backwards with two fingers (after the chin is
in the tuck position) and lift the head approximately 2.5 cm from the bed, to protect this
position without disturbing it. The time in which the individual can maintain this position
will be recorded in seconds. The test will be terminated when he is unable to maintain the
position due to any pain or fatigue or if the physiotherapist touches his hand.
5.2. Endurance Evaluation of Cervical Extensor Muscles In order to evaluate the endurance of
the deep and superficial extensor muscles of the neck, the patients will be asked to hang
down from the bed in the prone position, arms by the trunk, head to the thoracic 6 vertebra
level. While all individuals are in neutral position, 4 kg weight for men and 2 kg for women
will be fixed with the help of a velcro from the occiput level of the head and the test will
start, motivating words will not be used during the test. Individuals will be asked to
maintain this position and the time will be recorded in seconds. The test will be terminated
if there is a 5 degree change in the head position 6. Assessment of Hand Grip Strength The
procedure recommended by the American Association of Hand Therapists (ASHT) for hand grip
strength measurement will be applied.
7. Assessment of Shortness of Breath Modified Medical Research Council (MMRC) Dyspnea Scale
will be used to evaluate the perception of dyspnea.
8. Assessment of Functional Capacity The Six Minute Walking Test (6 MWT), which is considered
a gold standard in individuals with COPD, is an easy test that evaluates the distance that
individuals walk for six minutes. 6 DYT will be conducted according to the American Thoracic
Society (ATS) rules. Standardized 6 DYT will be applied according to ATS.
9.Glittre Daily Living Activity Assessment The test begins with the person sitting in a
chair. During the test, a backpack weighing 2.5 kg for women and 5 kg for men is attached.
Standing up from the chair, he walks 5 m and passes a 2-step ladder placed in the middle with
a width of 17 cm and a depth of 27 cm, and walks another 5 m to a 2-shelf setup that is
individually adjusted according to the shoulder and waist height of the individual. Three
bottles, each weighing 1 kg, placed on the upper rack must be transported one by one to the
lower rack, to the floor, to the lower rack, and finally to the upper rack. Then the
participants pass the 2-step stairs, return to the original chair, sit down and immediately
rise again and begin the next round. They will be allowed to rest if necessary, but the
stopwatch will continue to run during this time. Individuals are asked to complete 5 rounds
quickly, and the time is recorded in minutes after 5 rounds. Heart rate, blood pressure,
saturation, fatigue and shortness of breath are evaluated at the beginning and end of the
test.
10. Posture Evaluation The postures of the subjects participating in the study will be
evaluated with the "New York Posture Assessment Method (NYPDY)". In this evaluation system,
posture changes that may occur in 13 different parts of the body will be followed and scored.
11.Exercise Habits Exercise benefit / disability scale was developed by Sechrist, Walker, and
Pender to determine exercise benefit and disability perceptions of individuals participating
in exercise.The scale consists of 43 items in total.
12. Quality of Life 12.1. St. George Respiratory Questionnaire Among the tests measuring the
quality of life related to health, especially St. St. George's Respiratory Questionnaire
(SGRQ) is a specific test for respiratory diseases. SGRQ questions 50 items in the patient,
distributed over three areas = Symptoms (8 items), activities (16 items), effects of the
disease (26 items).
12.2. Short Form 36 (Short Form 36 / SF 36) Short Form 36 is a valid health questionnaire
with 36 questions providing information about functional health and well-being. It provides
valid and reliable information about psychometric-based mental and physical health, which can
be filled in as short as five to 10 minutes.
Treatment protocol:
All individuals will be divided into 2 groups by randomization method. In the first group,
according to Lewit's post-isometric relaxation (KET) method, scalene (anterior / medius /
posterior), levator scapula, sternocleidomastoid, trapezius, pectoral muscles, serratus
anterior and latismus dorsi muscles are set 3 days a week ( Each set includes three
repetitions) The treatment will be applied for 4 weeks. The hypertonic muscle will be taken
to the first point that resists movement without straining. The patient will be asked to
perform an isometric contraction for 7 seconds, corresponding to 20% of the maximum isometric
contraction force where the restriction is felt. After the application, the patient will be
asked to exhale and relax completely. 30 seconds will be waited for each stretching and then
the neck will be taken back to the barrier point and three repetitions per session will be
performed.
The individuals in the second group will be asked to do the home exercise program shown to
them for 4 weeks, 3 days a week. Individuals included in this group will be given a program
that includes stretching and posture exercises for the same muscle groups. Individuals in the
control group will be called weekly during the 4-week period. Before, after, and 6 weeks
after the study, re-evaluation parameters will be applied to all individuals included in the
study.
