Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851495
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2022-12-22
Brief Title:
Different Exercise Trainings in Patients With Chronic Pain From Exercise Adherence Clinical and Economic Perspectives
Sponsor:
Hasan Kalyoncu University
Organization:
Hasan Kalyoncu University
Study Overview
Official Title:
Evaluation of Different Exercise Trainings Applied in Patients With Chronic Pain From Exercise Adherence Clinical and Economic Perspectives
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted with 519 patients in order to examine the clinical and cost-effectiveness of different exercise trainings in patients with chronic pain and the adherence of the patients to the exercises given The patients were divided into 3 groups as home-based exercise groups physiotherapist-led groups and home-based follow up groups and traditional physical therapy was applied for a total of 10 sessions The patients were offered exercises in the form of a brochure to the home-based exercise groups applied to the exercise group under the guidance of a physiotherapist and to the home-based follow up groups in a way that reminded them of the exercises by sending a daily text message SMS after they were given exercise training accompanied by a physiotherapist They were told to continue their exercises after the treatment All groups were evaluated in terms of economic clinical quality of life exercise adherence and satisfaction three times before the treatment after the treatment and three months after the treatment Cost utility analysis QALY and cost-effectiveness ratio ICER were used as part of the economic evaluation Oswestry Disability Index ODI and Neck Disability Index NDI were used for clinical evaluation Quality of life was assessed with the EuroQol General Quality of Life Scale EQ-5D-5L A scale consisting of 5 five questions prepared by us was used for adherence with the exercise In the evaluation of satisfaction individuals were asked to give a score between 0-100 All three groups were called to the hospital for control three months later and the 5-question scale prepared by us was directed to the patients and it was determined how the given exercises were done
Detailed Description:
This study was conducted to examine the clinical and cost-effectiveness of different exercise trainings in patients with chronic pain and the adherence of the patients to the exercises given As a result of the findings obtained it was carried out in order to contribute to the literature to make suggestions to the decision makers and to determine the applicability of the exercise training given by the patients 519 patients who were admitted to the Department of Physical Medicine and Rehabilitation TC Ministry of Health Kilis Prof Dr Alaeddin Yavaşca State Hospital with a complaint of low back and neck pain were included in the study This study was carried out at Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Patients were randomized by closed envelope randomization method as home-based exercise groups physiotherapist-led groups and home-based follow up groups respectively
The study protocol was approved by Hasan Kalyoncu University Ethical Committee No 2021063 03052021 Informed consent was obtained from all of the patients
Inclusion criteria for the study
40 years and older
Continuing low back or neck pain for 3 months or longer
Mini mental test score more than 24 points
Being able to speak Turkish
Being able to be contacted via phone
The patients participating in the study do not receive any other physiotherapy Exclusion criteria for the study
Patients diagnosed with serious pathologies that may be the main cause of chronic low back pain presence of lumbar stenosis spondylolisthesis fibromyalgia etc
Patients with a history of spinal surgery
Patients for whom physiotherapy is contraindicated
Our study was planned as a prospective randomized controlled study The patients were pre-assessed by the physiotherapist to determine their suitability for the inclusion criteria The first patient whose suitability was determined was allowed to choose his group using the closed envelope technique and the following patients were randomized as Group-1 home-based exercise groups Group-2 physiotherapist-led groups Group-3 home-based follow up groups
Patients whose suitability to the inclusion criteria was evaluated by the physiotherapist were enabled to select the group with the closed envelope technique for the first one and the subsequent patients were randomized as Group-1 home-based exercise groups Group-2 physiotherapist-led groups Group-3 home-based follow up groups respectively Then home exercise brochures were given to the home-based exercise groups according to their diagnosis at the end of the treatment The group involved in physiotherapists-led groups was shown the exercises in practice and under the supervision of the physiotherapist the patients applied their exercises throughout their treatment Home-based follow up groups after the exercise training was given to the patients with a physiotherapist daily text messages SMS were sent to the patients and the patients were reminded to do the exercises Then all three groups were called to the hospital for control after three months and the scale prepared by us and consisting of a total of 5 five questions was directed to the patients and it was determined how the exercises given were performed
Demographic information of all patients participating in this study was collected through the form prepared by us
Assessment of Exercise Adherence and Patient Satisfaction The scale consisting of a total of 5 five questions prepared by us three months after the treatment for exercise adherence was directed to the patients With these questions the patients adherence with the exercises given to the patients was asked the control of whether the given exercises were done correctly was as follows 0 forgotten 1 unable to do 2 correct position but wrong movement 3 correct position and movement no respiratory control and 4 absolutely doing was evaluated It was accepted that the patients who scored 3 and 4 points from the exercises remembered the exercises
Economic Evaluation Within the scope of the economic evaluation cost-utility and cost-effectiveness analyzes of the treatments were made The cost-utility analysis was calculated from the perspective of the Social Security Institution SGK as the ratio of the total payment to the QALY quality adjusted life years value For the cost-effectiveness analysis it was calculated with the incremental cost-effectiveness ratio ICER In terms of the home-based follow up groups the cost was calculated separately by adding the fees spent for home-based follow up groups purposes in addition to the SGK package fee The Turkish version of the EQ-5D-5L scale was used to calculate the QALY value The QALY value was calculated by evaluating the results with Germany score weights The reason for using Germany point weights is that there is no point weights for our country and Germany point weights are used in cost effectiveness analysis studies
Clinical Assesment Within the scope of clinical evaluation Oswestry Disability Index was applied to patients with low back pain and Neck Disability Index was applied to patients with neck pain and the effectiveness of the treatments were compared
The Oswestry Disability Index is a widely used scale that measures the functional status of individuals This scale was first described in 1980 by Fairbank et al 122 In this scale which consists of 10 questions in total each question is between 0-5 points and the highest result that can be obtained from the scale is 50 points The total score is multiplied by 2 and expressed as a percentage The Turkish validity and reliability study of the scale which shows that disability increases as the score obtained from the scale increases was conducted by Yakut et al 123
The Neck Disability Index is a widely used scale that measures the disability level of individuals related to neck pain This scale was defined by Vernon and Mior in 1991 124 Neck Disability Index It consists of 10 sections that include pain intensity personal care lifting reading headaches concentration workwork driving sleep and leisure activities Each question consists of 6 answer options that measure the severity of pain or limitation Scoring is done between 0-5 The highest score is 50 and the minimum score can be 0 According to the total score 0-4 no limitation 5-14 mild limitation 15-24 moderate limitation 25-34 severe limitation 34 and above fully restricted 124 The Turkish validity and reliability study of the scale was performed by Telci et al 125
Assesment of Quality of Life Quality of life was evaluated with the Turkish version of the EQ-5D-5L scale The scale developed by the Western European Quality of Life Research Society EuroQoL was introduced by the group in 2009 The scale consists of two parts the EQ-5D descriptor system and the EQ-VAS visual analog scale
EQ-5D identifier system It consists of 5 parts mobility self-care usual activities paindiscomfort and anxietydepression Each part has 5 options no problem mild problem moderate problem serious problem and extreme problem The patient is asked to indicate the state of health by ticking the box next to the most appropriate statement in each of the five sections This decision results in a 1-digit number for that part The digits of the five parts can be combined into a five-digit number describing the patients state of health The 5-digit number obtained from the scale is calculated using Microsoft Excel over the formulas calculated by the EuroQoL group The answers received from these patients are placed in the program and personal values between 0 and 1 are calculated According to this score a value of 0 indicates death and a value of 1 indicates excellent health
On the Visual Analog Scale EQ-VAS there is a vertical line with numbers up to 0-100 and the person marks the health status heshe feels for that day as 100 points at best and 0 points at worst Thanks to this scale it can be used as a quantitative measure of health outcomes reflecting the patients own decision in the form of a record of the patients health status 126
The validity and reliability study for the Turkish version of the EQ-5D scale and the determination of population norm values were performed by Eser et al 127
Exercise Protocols Five different exercises were given to patients with low back and neck pain who participated in our study The patients were asked to do these exercises 3 times a day for 10 repetitions Cat-camel exercises lumbar stretching sit-ups bridge building and back extensor strengthening exercises were given to patients with low back pain For patients with neck pain neck flexion-extension neck lateral flexion neck rotation shoulder capsule stretching and shoulder flexion exercises were given
Exercises Given to Patients with Low Back Pain
1 Cat Camel Exercise Get up on your hands and knees Make sure your hands are at right angles to your shoulders and your knees to your hips First hollow your back as much as you can and lift your head try to get your back into a C shape Count to 5 straighten your back and head to straighten your spine Then lower your head arch your back and count to 5 This movement will help your back and abdominal muscles to become flexible and compatible with each other
2 Lumbal Stretch Exercise Sit on a flat surface Bend one knee and extend the other leg straight Try to touch the toe of the straight leg with both hands Meanwhile your knee should not lift off the ground and your toes should not be bent towards you Count to 10 in the lying down position and relax
3 Sit-up Exercise Lie on your back and bend your knees Get help from someone or fix it somewhere so that your feet do not get off the ground Raise your hands forward just below your shoulder blades Keep your back on the floor and your neck straight Count to 10 and lie on your back
4 Bridge Building Exercise Lie on your back with your knees bent Tighten your abdominal muscles Lift your hips off the ground until theyre in line with your knees and shoulders Count to 3 and lie on your back
5 Back Extensor Strengthening Exercise Lie face down Extend your arms straight forward Count backwards to 10 If you have difficulty during this movement someone can support you by holding your feet If there is pain straighten a little without too much difficulty
Exercises Given to Patients with Neck Pain
1 Neck Flexion-Extension Exercise Without causing excessive strain tilt your head forward so that your chin is close to your chest After staying in this position for 10 seconds return to your starting position and rest for 20 seconds Then repeat the same movement with your head facing the ceiling
2 Neck Lateral Flexion Exercise Tilt your head so that your right ear approaches your right shoulder without causing excessive strain and without moving your shoulder After staying in this position for 10 seconds return to your starting position and rest for 20 seconds Then repeat the same movement towards your left shoulder
3 Neck Rotation Exercise Without causing excessive strain and without moving your shoulder turn your head to the right so that your chin is facing your right shoulder After staying in this position for 10 seconds return to your starting position and rest for 20 seconds Then repeat the same movement towards your left shoulder
4 Shoulder Capsule Stretching Exercise Bring one arm from your shoulder level to the opposite shoulder without bending the elbow Feel your back muscles stretch between your shoulder blades by pushing at the elbow with your other arm Hold this position for 10 seconds then rest for 20 seconds to relax
5 Shoulder Fore-Back Rotation Standing or sitting lift both shoulders up pull them back well and try to join them behind At this time feel your back muscles energize Repeat the movement 20 times
The study protocol was approved by Hasan Kalyoncu University Ethical Committee No 2021063 03052021 Informed consent was obtained from all of the patients
Inclusion criteria for the study
40 years and older
Continuing low back or neck pain for 3 months or longer
Mini mental test score more than 24 points
Being able to speak Turkish
Being able to be contacted via phone
The patients participating in the study do not receive any other physiotherapy Exclusion criteria for the study
Patients diagnosed with serious pathologies that may be the main cause of chronic low back pain presence of lumbar stenosis spondylolisthesis fibromyalgia etc
Patients with a history of spinal surgery
Patients for whom physiotherapy is contraindicated
Our study was planned as a prospective randomized controlled study The patients were pre-assessed by the physiotherapist to determine their suitability for the inclusion criteria The first patient whose suitability was determined was allowed to choose his group using the closed envelope technique and the following patients were randomized as Group-1 home-based exercise groups Group-2 physiotherapist-led groups Group-3 home-based follow up groups
Patients whose suitability to the inclusion criteria was evaluated by the physiotherapist were enabled to select the group with the closed envelope technique for the first one and the subsequent patients were randomized as Group-1 home-based exercise groups Group-2 physiotherapist-led groups Group-3 home-based follow up groups respectively Then home exercise brochures were given to the home-based exercise groups according to their diagnosis at the end of the treatment The group involved in physiotherapists-led groups was shown the exercises in practice and under the supervision of the physiotherapist the patients applied their exercises throughout their treatment Home-based follow up groups after the exercise training was given to the patients with a physiotherapist daily text messages SMS were sent to the patients and the patients were reminded to do the exercises Then all three groups were called to the hospital for control after three months and the scale prepared by us and consisting of a total of 5 five questions was directed to the patients and it was determined how the exercises given were performed
Demographic information of all patients participating in this study was collected through the form prepared by us
Assessment of Exercise Adherence and Patient Satisfaction The scale consisting of a total of 5 five questions prepared by us three months after the treatment for exercise adherence was directed to the patients With these questions the patients adherence with the exercises given to the patients was asked the control of whether the given exercises were done correctly was as follows 0 forgotten 1 unable to do 2 correct position but wrong movement 3 correct position and movement no respiratory control and 4 absolutely doing was evaluated It was accepted that the patients who scored 3 and 4 points from the exercises remembered the exercises
Economic Evaluation Within the scope of the economic evaluation cost-utility and cost-effectiveness analyzes of the treatments were made The cost-utility analysis was calculated from the perspective of the Social Security Institution SGK as the ratio of the total payment to the QALY quality adjusted life years value For the cost-effectiveness analysis it was calculated with the incremental cost-effectiveness ratio ICER In terms of the home-based follow up groups the cost was calculated separately by adding the fees spent for home-based follow up groups purposes in addition to the SGK package fee The Turkish version of the EQ-5D-5L scale was used to calculate the QALY value The QALY value was calculated by evaluating the results with Germany score weights The reason for using Germany point weights is that there is no point weights for our country and Germany point weights are used in cost effectiveness analysis studies
Clinical Assesment Within the scope of clinical evaluation Oswestry Disability Index was applied to patients with low back pain and Neck Disability Index was applied to patients with neck pain and the effectiveness of the treatments were compared
The Oswestry Disability Index is a widely used scale that measures the functional status of individuals This scale was first described in 1980 by Fairbank et al 122 In this scale which consists of 10 questions in total each question is between 0-5 points and the highest result that can be obtained from the scale is 50 points The total score is multiplied by 2 and expressed as a percentage The Turkish validity and reliability study of the scale which shows that disability increases as the score obtained from the scale increases was conducted by Yakut et al 123
The Neck Disability Index is a widely used scale that measures the disability level of individuals related to neck pain This scale was defined by Vernon and Mior in 1991 124 Neck Disability Index It consists of 10 sections that include pain intensity personal care lifting reading headaches concentration workwork driving sleep and leisure activities Each question consists of 6 answer options that measure the severity of pain or limitation Scoring is done between 0-5 The highest score is 50 and the minimum score can be 0 According to the total score 0-4 no limitation 5-14 mild limitation 15-24 moderate limitation 25-34 severe limitation 34 and above fully restricted 124 The Turkish validity and reliability study of the scale was performed by Telci et al 125
Assesment of Quality of Life Quality of life was evaluated with the Turkish version of the EQ-5D-5L scale The scale developed by the Western European Quality of Life Research Society EuroQoL was introduced by the group in 2009 The scale consists of two parts the EQ-5D descriptor system and the EQ-VAS visual analog scale
EQ-5D identifier system It consists of 5 parts mobility self-care usual activities paindiscomfort and anxietydepression Each part has 5 options no problem mild problem moderate problem serious problem and extreme problem The patient is asked to indicate the state of health by ticking the box next to the most appropriate statement in each of the five sections This decision results in a 1-digit number for that part The digits of the five parts can be combined into a five-digit number describing the patients state of health The 5-digit number obtained from the scale is calculated using Microsoft Excel over the formulas calculated by the EuroQoL group The answers received from these patients are placed in the program and personal values between 0 and 1 are calculated According to this score a value of 0 indicates death and a value of 1 indicates excellent health
On the Visual Analog Scale EQ-VAS there is a vertical line with numbers up to 0-100 and the person marks the health status heshe feels for that day as 100 points at best and 0 points at worst Thanks to this scale it can be used as a quantitative measure of health outcomes reflecting the patients own decision in the form of a record of the patients health status 126
The validity and reliability study for the Turkish version of the EQ-5D scale and the determination of population norm values were performed by Eser et al 127
Exercise Protocols Five different exercises were given to patients with low back and neck pain who participated in our study The patients were asked to do these exercises 3 times a day for 10 repetitions Cat-camel exercises lumbar stretching sit-ups bridge building and back extensor strengthening exercises were given to patients with low back pain For patients with neck pain neck flexion-extension neck lateral flexion neck rotation shoulder capsule stretching and shoulder flexion exercises were given
Exercises Given to Patients with Low Back Pain
1 Cat Camel Exercise Get up on your hands and knees Make sure your hands are at right angles to your shoulders and your knees to your hips First hollow your back as much as you can and lift your head try to get your back into a C shape Count to 5 straighten your back and head to straighten your spine Then lower your head arch your back and count to 5 This movement will help your back and abdominal muscles to become flexible and compatible with each other
2 Lumbal Stretch Exercise Sit on a flat surface Bend one knee and extend the other leg straight Try to touch the toe of the straight leg with both hands Meanwhile your knee should not lift off the ground and your toes should not be bent towards you Count to 10 in the lying down position and relax
3 Sit-up Exercise Lie on your back and bend your knees Get help from someone or fix it somewhere so that your feet do not get off the ground Raise your hands forward just below your shoulder blades Keep your back on the floor and your neck straight Count to 10 and lie on your back
4 Bridge Building Exercise Lie on your back with your knees bent Tighten your abdominal muscles Lift your hips off the ground until theyre in line with your knees and shoulders Count to 3 and lie on your back
5 Back Extensor Strengthening Exercise Lie face down Extend your arms straight forward Count backwards to 10 If you have difficulty during this movement someone can support you by holding your feet If there is pain straighten a little without too much difficulty
Exercises Given to Patients with Neck Pain
1 Neck Flexion-Extension Exercise Without causing excessive strain tilt your head forward so that your chin is close to your chest After staying in this position for 10 seconds return to your starting position and rest for 20 seconds Then repeat the same movement with your head facing the ceiling
2 Neck Lateral Flexion Exercise Tilt your head so that your right ear approaches your right shoulder without causing excessive strain and without moving your shoulder After staying in this position for 10 seconds return to your starting position and rest for 20 seconds Then repeat the same movement towards your left shoulder
3 Neck Rotation Exercise Without causing excessive strain and without moving your shoulder turn your head to the right so that your chin is facing your right shoulder After staying in this position for 10 seconds return to your starting position and rest for 20 seconds Then repeat the same movement towards your left shoulder
4 Shoulder Capsule Stretching Exercise Bring one arm from your shoulder level to the opposite shoulder without bending the elbow Feel your back muscles stretch between your shoulder blades by pushing at the elbow with your other arm Hold this position for 10 seconds then rest for 20 seconds to relax
5 Shoulder Fore-Back Rotation Standing or sitting lift both shoulders up pull them back well and try to join them behind At this time feel your back muscles energize Repeat the movement 20 times
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None