Clinical trial NCT04874571: Effect of Muscle Energy Technique on Clinical and Functional Levels in Chronic Obstructive Pulmonary
Official title: Effect of Muscle Energy Technique on Clinical and Functional Levels in Chronic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Keywords: muscle energy technique
pulmonary disease
pain
home exercise
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 52
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Individuals between the ages of 35-65,
* Moderate COPD diagnosed according to Gold criteria by a chest diseases specialist,
* Neck pain longer than 3 months
* Those who are not diagnosed with fibromyalgia will be included in the study.

Exclusion Criteria:

* COPD exacerbation period,
* Those with disc herniation, fracture, etc. musculoskeletal problems in the cervical and thoracic region
* Undergoing cervical surgery,
* Having problems preventing him from exercising,
* Those with uncontrolled diabetes, hypertension and coronary artery disease,
* Individuals who received physiotherapy due to neck pain in the last 3 months will not be included in the study.

Primary outcomes:
measure: Pain thresold
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
Secondary outcomes:
measure: Severity of pain
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Multidimensional pain assessment
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Assessment of Fear of Movement
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Evaluation of Cervical Region Muscle Strength
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Endurance Evaluation of Cervical Region Flexor Muscles
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Endurance Evaluation of Cervical Extensor Muscles
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Assessment of Hand Grip Strength
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Assessment of Shortness of Breath
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Assessment of Functional Capacity
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Glittre Daily Living Activity Assessment
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Posture Evaluation
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Exercise Habits
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: Measuring the quality of life related to health
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
measure: İnformation about functional health and well-being
timeFrame: change from baseline at 4 weeks and 6 weeks after the intervention
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Serpil MIHÇIOĞLU
Study officials:
affiliation: Eastern Mediterranean University
name: Mehtap MALKOÇ, Prof.Dr.
role: STUDY_DIRECTOR
References: