Effects of Foundation and Functional Inspiratory Muscle Training in Non-Specific Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKirsehir Ahi Evran Universitesi
About this trial
This study was planned to examine the effects of basic and functional respiratory muscle training on pain, disability level, and functionality. In this study, participants will be randomly divided into 3 groups. The first group will be treated with physical therapy applications applied in state hospitals for 10 weeks. The second group will receive basic respiratory muscle training treatment in addition to physical therapy in state hospitals. The third group will receive respiratory muscle training with exercise in addition to physical therapy in state hospitals. Evaluations will be made before the first session, after the 30th session, in the 3rd month, in the 6th month, and in the 1st year. There is no interventional method in the evaluations. Pain intensity, disability level, physical activity status, quality of life, fear of movement, pain catastrophizing, anxiety and depression levels will be questioned with scales. In physical measurements, participant's aerobic capacity will be measured with the 2-Minute Walk Test, participants's flexibility with the sit-and-long test, participants's respiratory muscle strength with the MIP/MEP device, participants's core endurance with the trunk flexor muscle endurance test, participants's lower and upper extremity muscle strength with a handheld dynamometer, participants's postural control with the Biodex balance device, and participants's muscle thickness with an ultrasound.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Volunteering to participate in the study,
Being between the ages of 18-65,
Having low back pain that has been ongoing for at least 3 months (12 weeks),
Having a Visual Analog Scale (VAS) of pain intensity of ≥3,
Disqualifiers
Not volunteering to participate in the study,
Having a history of cancer,
Having a spinal infection,
Having a rheumatological condition,
Trial design
Design model
Parallel
Treatments tested in this trial
Classical Physiotherapy Group
Other interventionClassical physiotherapy group (CF) will be treated face to face for 30 sessions in total, 3 days a week, 10 weeks. Hotpack, Ultrasound, TENS and Basic Exercises will be applied to the CF group. Hotpack will be applied superficially to the lumbar region for 15 minutes. Ultrasound 1MHz- 1.5 Wt/cm2 will be applied to the lumbar region. TENS 50 Hz will be applied for 15 minutes, leaving the painful area in the middle. Basic exercises will be applied as 8-12 repetitions, 2 sets. The number of repetitions and sets will be increased as the tolerance of the patients increases. Pelvic tilt exercises Supine hip flexor stretch Supine lumbar extensor stretch Crunches Cat-Camel Exercises
Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy
Other interventionIn addition to Classical Physiotherapy, Foundation Inspiratory Muscle Training (IKE) will be treated face to face for 30 sessions, 3 days a week, 10 weeks. On other days, IKE will be applied at home for 15 minutes in the morning and evening for a total of 30 minutes and will be followed up with a diary. IKE will be applied with a device that can load with threshold pressure. The IKE group will continue the exercise program for 10 weeks. The intensity of the exercise will be adjusted to 40-50% MIP for the exercise group. After 10 consecutive respiratory cycles, 3-4 respiratory controls will be asked. As tolerance increases, the consecutive respiratory cycle will be increased. The intensity will be adjusted by taking weekly MIP measurements. Daily monitoring forms will be created for each participant to ensure exercise follow-up.
Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy
Other interventionFunctional Inspiratory Muscle Training Group will receive functional inspiratory muscle training in addition to classical physiotherapy, 3 days a week, 10 weeks, 30 sessions in total, face-to-face treatment. On other days, foundation-ICE will be applied at home for 15 minutes in the morning and evening, for a total of 30 minutes, and will be followed with a diary. The same protocol will be applied with the foundation IKE group for teaching the respiratory cycle in the first 4 weeks, and resisted breathing will be worked simultaneously with the exercises in Table 2 in the last 6 weeks. The exercise program will be continued for a total of 10 weeks, including F-ICE, foundation IKE for the first 4 weeks, and F-ICE for 6 weeks thereafter. The intensity of the exercise will be adjusted to 40-50% MIP for the exercise group. After 10 consecutive respiratory cycles, 3-4 respiratory controls will be requested. As tolerance increases, the number of consecutive respiratory cycles will be increase
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Classical Physiotherapy GroupActive comparator 1 intervention
Group B: Foundation Inspiratory Muscle TrainingExperimental treatment 2 interventions
Group C: Functional Inspiratory Muscle Training GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Evaluation of Sociodemographic Information
Participants' sociodemographic information form will include body weight (kilogram).
Time frame
Baseline2
Evaluation of Sociodemographic Information
Participants' sociodemographic information form will include, height (centimeter).
Time frame
Baseline3
Evaluation of Sociodemographic Information
Participants' sociodemographic information form will include gender (male/female), age (years), dominant upper extremity (hand with which to eat), location of pain (middle, right, left), severity of pain (VAS), level of education, profession, occupational activity status, exercise habits (yes/no), alcohol and cigarette consumption (yes/no), family history, personal history, accompanying illnesses and medications used. Participants' body mass indexes will be calculated using the kg/m2 formula and recorded.
Time frame
Baseline4
Assessment of Pain Intensity
Pain intensity will be measured with Visual Analog Scale (VAS). VAS asks the patient to mark the intensity of pain he/she has felt during the past week between 0-10 cm (0- I have no pain, 10- I have the most severe pain I can feel). High scores indicate severe pain. VAS is a valid and reliable method for determining the intensity of pain in individuals with NSCLBP.
Time frame
Baseline- 10 weeks- 3 Months- 6 Months- 1 YearSecondary outcomes
1
Physical Activity Assessment
Physical activity will be assessed using the short form of the International Physical Activity Questionnaire (SFIPAQ). The seven-question questionnaire lists activities and asks about the duration and frequency of each activity during the past week. The MET values defined for walking (3.3 METs), moderate-intensity physical activity (4.0 METs), and vigorous-intensity physical activity (8.0 METs) are multiplied by the duration (minutes) and frequency (days) to calculate the physical activity score in terms of "MET-min/week". The question of sitting is not included in the physical activity score (103). Physical activity levels will be classified as inactive (\<600 MET-min/week), minimally active (600-3000 MET-min/week), and active (\>3000 MET-min/week).
Time frame
Baseline2
Evaluation of Exercise Capacity
Exercise capacity will be assessed with the "2-Minute Walk Test (2MWT)" before and after the interventions. The 2MWT is a frequently used, low-cost, clinically significant and recommended test for the assessment of functional exercise capacity. During the test, the person is asked to walk as fast as possible for two minutes in a 15-meter corridor. Before the test, the person is informed that they can stop and rest whenever they want, but this time will not be added. During the test, the person will be encouraged using standard expressions every minute. After the test, the total distance walked is recorded in meters.
Time frame
Baseline- 10 weeks- 3 Months- 6 Months- 1 Year3
Evaluation of Flexibility
The patient's flexibility will be assessed with the sit and reach test. The patient will be positioned with one foot resting on the S\&R Sit and Reach® measuring table, the sole of the other foot on the floor, and the leg bent at the knee. The patient performing the application will place their hands on top of each other and stretch forward slowly and in a controlled manner. Then, the therapist will ask them to reach out with their hands on the S\&R Sit and Reach® ruler three times and record the best degree. The data will be recorded in centimeters .
Time frame
Baseline- 10 weeks- 3 Months- 6 Months- 1 Year4
Lower and Upper Extremity Muscle Strength
Patients' knee extensor and shoulder abductor muscle strengths will be measured using a portable handheld dynamometer. Measurements will be repeated three times for the dominant and non-dominant sides, and the highest values will be recorded in kgF.
Time frame
Baseline- 10 weeks- 3 Months- 6 Months- 1 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kirsehir Ahi Evran Universitesi
Lead sponsor
Hacettepe University
Collaborator
Selcuk University
Collaborator
Source ClinicalTrials.gov