Chronic Low Back PainNCT05331274
The Effect of Structured Pain Education on Pain and Performance Parameters in Patients With Chronic Low Back Pain
A study testing exercise group and pain training group in people with Chronic Low Back Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Structured Pain Education on Pain and Performance Parameters in Patients with Chronic Low Back Pain The aim of this study is to compare the effects of only Low Load Motor Control Exercises and Pain Education in addition to these exercises on pain, performance, disability and psychological factors, and to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- exercise group and pain training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- Chronic low back pain 3 days a week and ≥ 3 months
- Absence of spinal fracture or acute disc herniation
- Absence of existing psychiatric problems and mental deficiencies
- Absence of exercise contraindications [28] [29] [30]
Who cannot join
- Being diagnosed with lumbar radiculopathy
- Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
- Specific medical conditions (neck or back surgery in the previous 3 years, osteoporotic vertebral fractures or rheumatological diseases)
- Chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
- Receiving any other treatment for chronic low back pain during the study [28] [29] [30]
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University Sefakoy Hospital
Istanbul, 34515
Ayşe Yaşar, +90 5073018156, ayseyasar48@hotmail.com
About this study
The Effect of Structured Pain Education on Pain and Performance Parameters in Patients with Chronic Low Back Pain
The aim of this study is to compare the effects of only Low Load Motor Control Exercises and Pain Education in addition to these exercises on pain, performance, disability and psychological factors, and to present a generalizable pain education in patients with chronic low back pain. We think that DYMK exercises applied together with a general Pain Education given to the patients will provide more improvement on these factors.
Read more
The patients will be divided into 2 groups, as a pain training group and an exercise group, with 20 people in each group, in a randomized controlled manner. Only DYMK exercise training will be applied to the exercise group. In the pain training group, pain training will be applied in addition to the DYMK exercise training.
As an evaluation parameter to the participants; Numerical Rating Scale, Short-Form McGill Pain Questionnaire, Pain Catastrophizing Scale, Tampa Kinesiophobia Scale, Roland-Morris Disability Questionnaire, Pain Self-Efficacy Questionnaire, Passive Lumbar Extension Test, Finger-Place Test and Physical Performance Test Battery will be applied. Patients will be evaluated before the start of the study (T0) and at the end of the study (T1).
Low Load Motor Control Exercises will be applied to people in both groups for 4 weeks, 3 days a week, during 20-30 minute sessions. In addition to the DYMK exercise training, a session of 30 to 50 minutes of Pain Training in groups of 4 to 5 people will be given to the patients included in the Pain Training group at the beginning of the exercise training and the exercise training will begin.
- Conditions
- Chronic Low Back Pain
- Being tested
- exercise group, pain training group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise groupOther
1 stage
- In a sitting position, pull the leg up and extend the knee forward
- Standing, bending forward and bending the knee
- Supine, tucked legs
- Maintaining spinal smoothness in crawling
- Prone heel pull to buttock
Stage 2
- Prone on forearms-hands
- Extending the supine hands to the knees
- Rounding and hollowing the waist in crawling
- Progressive sit-stand
- Standing up from sitting and putting on and taking off socks
- Reaching up while standing and maintaining the straightness of the spine
- Squatting
- Climbing and descending stairs
Stage 3
- Maintaining standing, arms forward
- Slipping hands on the bed while standing
- Initiating the standing throw and maintaining the position until the final interval
- Putting on and taking off socks while standing
- Taking weight towards the ground from a certain height
- Picking up different weights from the ground
- Push-pull items
- Crossing obstacles of certain height
- Walking a certain distance
pain training groupOther
The training provides participants with the opportunity to explain the central sensitization mechanism and also integrates the behavioral, psychological and environmental aspects that contribute to the persistence of pain. It is intended to teach that education reduces pain and improves endogenous pain inhibition, mental health, physical function, vitality and self-rated disability in patients with chronic pain, and reduces passive coping, kinesiophobia, and catastrophizing.
The same exercises will be applied as the exercise group.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | Only DYMK exercise training will be applied to the exercise group. Receives: Other: exercise group |
| pain training group | Experimental | In the pain training group, pain training will be applied in addition to the DYMK exercise training. Receives: Other: pain training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain intensity on the Numerical Rating Scale at 3 weeks
It is an 11-point unidimensional measure of pain intensity. It is a segmented numerical version of the Visual Analog Scale (VAS), in which participants select an integer (0-10 integer) that best reflects the intensity of their pain. 0 represents no pain and 10 represents worst pain.
Measured: baseline and 3 weeks
Change from baseline in the multidimensional measure of pain on the Short-Form McGill Pain Questionnaire at 3 weeks
A multidimensional measure of pain. It consists of 2 subscales: 1) a sensory subscale consisting of 11 words or items, and 2) an emotional subscale consisting of 4 items rated on the intensity scale (0= none, 1= mild, 2= moderate, and 3= severe). It also includes 1 item for current pain intensity and 1 item for 10 cm Visual Analog Scale for mean pain.
Measured: baseline and 3 weeks
Change from baseline in assessing feelings, thoughts, and emotions related to pain and disaster on the Pain Catastrophizing Scale at 3 weeks
It is used to assess the patient's feelings, thoughts, and feelings about pain and disaster. It is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater destruction. The scores of each item are added to determine the subscales and the total score is calculated with the sum of all items. Scores range from 0 to 52 points.
Measured: baseline and 3 weeks
Change from baseline in measuring fear of movement and (re)injury on the Tampa Kinesiophobia Scale at 3 weeks
A 17-item questionnaire that measures fear of movement and (re)injury. Each question is answered on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree". The total score is calculated after reversing the individual scores of items 4, 8, 12, and 16.
Measured: baseline and 3 weeks
Change from baseline in questioning pain-related disability from low back pain on the Roland Morris Disability Questionnaire at 3 weeks
A 24-item self-reported outcome measure questioning pain-related disability from low back pain. Items are scored 0 if left blank or 1 if approved. The total score ranges from 0 to 24; higher scores represent higher pain-related disability.
Measured: baseline and 3 weeks
Change from baseline in the patient's ability to perform a range of activities despite pain in the Pain Self-Efficacy Questionnaire at 3 weeks
A 10-item questionnaire that measures both the strength and generality of a patient's beliefs about their ability to perform a range of activities despite pain. Scores can range from 0 to 60, with higher scores indicating stronger self-efficacy beliefs.
Measured: baseline and 3 weeks
Measuring pain intensity and disability in the Revised Graded Chronic Pain Scale at baseline
The new scale, consisting of 6 questions, was developed as a revised version of the original scale. There is a categorical rating scheme and numerical self-assessment scores for pain intensity and disability. The first 2 questions ask the frequency of pain, how the pain affects life and work activities and evaluate the last 3 months. It is scored from 0 to 4 (0 = never to 4 = every day). Questions between 3 and 5 (PEG scale) evaluate the severity of pain in the last 7 days and are scored between 0-10 points. The third question questions the severity of the pain. Questions 4 and 5, respectively, ask how pain interferes with enjoying life and how it affects general activities. Question 6 has 2 answers (1=yes and 2=no) and asks if the person is not working or unable to work because of pain or painful condition.
Measured: baseline
Change from baseline in assessing internal factors and emotions influencing the experience of health-threatening physical injury and pain in the Pain Beliefs Questionnaire at 3 weeks
The consists of two subscales. The organic beliefs subscale (PBQ-O) questions the user about physical injury or physiological pain that threaten wellness, while the psychological pain beliefs subscale (PBQ-P) evaluates intrinsic factors and emotions affecting the pain experience that may potentially threaten wellness.
Measured: baseline and 3 weeks
Identifying subjective neuropathic pain experience on the Pain Perception Questionnaire at baseline
It is a symptom-based assessment tool performed by clinicians to specify the subjective neuropathic pain experience of patients.
Measured: baseline
Change from baseline in assessing overall quality of Sleep at 3 weeks
It's about the overall quality of sleep about most nights in the last 7 days. It is scored between 1 and 10. High scores represent good sleep quality.
Measured: baseline and 3 weeks
Secondary outcomes (3)
Change from baseline in detecting structural lumbar segmental instability on Passive Lumbar Extension Test at 3 weeks
It is a passive test that detects structural lumbar segmental instability. Participants are placed in a prone position and the physiotherapist then lifts both lower extremities simultaneously to a height of approximately 30 cm from the bed while keeping the knees extended and gently pulling the legs. The test is considered positive if the participant reports low back pain during testing.
Measured: baseline and 3 weeks
Change from baseline on trunk mobility on the Finger-Place Test at 3 weeks
It is a test that provides information about trunk mobility. The participant stands upright on a 20 cm high platform, with shoes off and feet glued together. He is asked to bend forward as much as possible, fully extending his knees, arms and fingers. The vertical distance between the tip of the middle finger and the platform is measured with a flexible tape measure and expressed in centimeters. The vertical distance between the platform and the tip of the middle finger is considered positive when the participant does not reach the platform, and negative when they can go further.
Measured: baseline and 3 weeks
Change from baseline in maintaining a neutral lumbar spine in the Physical Performance Test Battery at 3 weeks
Includes bias bridge, side bridge, Biering-Sørensen test and a motion control test battery. . All tests will be performed in standard positions. In the bias bridge, side bridge and Biering-Sørensen testing, emphasis will be placed on maintaining a neutral lumbar spine for as long as possible (seconds).
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Apr 2022
- Primary completion15 Jun 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Yaşar, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331274
- Sponsor's protocol ID
- MedipolUniversity
- Status last verified
- May 2022
- First submitted
- 15 Mar 2022
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Structured Pain Education on Pain and Performance Parameters in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05331274
- Acronym / sponsor ID
- MedipolUniversity
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Jun 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Effect of Structured Pain Education on Pain and Performance Parameters in Patients with Chronic Low Back Pain
The aim of this study is to compare the effects of only Low Load Motor Control Exercises and Pain Education in addition to these exercises on pain, performance, disability and psychological factors, and to present a generalizable pain education in patients with chronic low back pain. We think that DYMK exercises applied together with a general Pain Education given to the patients will provide more improvement on these factors.
The patients will be divided into 2 groups, as a pain training group and an exercise group, with 20 people in each group, in a randomized controlled manner. Only DYMK exercise training will be applied to the exercise group. In the pain training group, pain training will be applied in addition to the DYMK exercise training.
As an evaluation parameter to the participants; Numerical Rating Scale, Short-Form McGill Pain Questionnaire, Pain Catastrophizing Scale, Tampa Kinesiophobia Scale, Roland-Morris Disability Questionnaire, Pain Self-Efficacy Questionnaire, Passive Lumbar Extension Test, Finger-Place Test and Physical Performance Test Battery will be applied. Patients will be evaluated before the start of the study (T0) and at the end of the study (T1).
Low Load Motor Control Exercises will be applied to people in both groups for 4 weeks, 3 days a week, during 20-30 minute sessions. In addition to the DYMK exercise training, a session of 30 to 50 minutes of Pain Training in groups of 4 to 5 people will be given to the patients included in the Pain Training group at the beginning of the exercise training and the exercise training will begin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: exercise groupOnly DYMK exercise training will be applied to the exercise group. |
| pain training group | Experimental | Other: pain training groupIn the pain training group, pain training will be applied in addition to the DYMK exercise training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 65 years old
- Chronic low back pain 3 days a week and ≥ 3 months
- Absence of spinal fracture or acute disc herniation
- Absence of existing psychiatric problems and mental deficiencies
- Absence of exercise contraindications [28] [29] [30]
Key exclusion criteria (5 listed)
- Being diagnosed with lumbar radiculopathy
- Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
- Specific medical conditions (neck or back surgery in the previous 3 years, osteoporotic vertebral fractures or rheumatological diseases)
- Chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
- Receiving any other treatment for chronic low back pain during the study [28] [29] [30]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise group1 stage * In a sitting position, pull the leg up and extend the knee forward * Standing, bending forward and bending the knee * Supine, tucked legs * Maintaining spinal smoothness in crawling * Prone heel pull to buttock Stage 2 * Prone on forearms-hands * Extending the supine hands to the knees * Rounding and hollowing the waist in crawling * Progressive sit-stand * Standing up from sitting and putting on and taking off socks * Reaching up while standing and maintaining the straightness of the spine * Squatting * Climbing and descending stairs Stage 3 * Maintaining standing, arms forward * Slipping hands on the bed while standing * Initiating the standing throw and maintaining the position until the final interval * Putting on and taking off socks while standing * Taking weight towards the ground from a certain height * Picking up different weights from the ground * Push-pull items * Crossing obstacles of certain height * Walking a certain distance | Other | exercise group |
| pain training groupThe training provides participants with the opportunity to explain the central sensitization mechanism and also integrates the behavioral, psychological and environmental aspects that contribute to the persistence of pain. It is intended to teach that education reduces pain and improves endogenous pain inhibition, mental health, physical function, vitality and self-rated disability in patients with chronic pain, and reduces passive coping, kinesiophobia, and catastrophizing. The same exercises will be applied as the exercise group. | Other | pain training group |
Primary outcome
Change from baseline of pain intensity on the Numerical Rating Scale at 3 weeks
Time frame: baseline and 3 weeks
It is an 11-point unidimensional measure of pain intensity. It is a segmented numerical version of the Visual Analog Scale (VAS), in which participants select an integer (0-10 integer) that best reflects the intensity of their pain. 0 represents no pain and 10 represents worst pain.
Change from baseline in the multidimensional measure of pain on the Short-Form McGill Pain Questionnaire at 3 weeks
Time frame: baseline and 3 weeks
A multidimensional measure of pain. It consists of 2 subscales: 1) a sensory subscale consisting of 11 words or items, and 2) an emotional subscale consisting of 4 items rated on the intensity scale (0= none, 1= mild, 2= moderate, and 3= severe). It also includes 1 item for current pain intensity and 1 item for 10 cm Visual Analog Scale for mean pain.
Change from baseline in assessing feelings, thoughts, and emotions related to pain and disaster on the Pain Catastrophizing Scale at 3 weeks
Time frame: baseline and 3 weeks
It is used to assess the patient's feelings, thoughts, and feelings about pain and disaster. It is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater destruction. The scores of each item are added to determine the subscales and the total score is calculated with the sum of all items. Scores range from 0 to 52 points.
Change from baseline in measuring fear of movement and (re)injury on the Tampa Kinesiophobia Scale at 3 weeks
Time frame: baseline and 3 weeks
A 17-item questionnaire that measures fear of movement and (re)injury. Each question is answered on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree". The total score is calculated after reversing the individual scores of items 4, 8, 12, and 16.
Change from baseline in questioning pain-related disability from low back pain on the Roland Morris Disability Questionnaire at 3 weeks
Time frame: baseline and 3 weeks
A 24-item self-reported outcome measure questioning pain-related disability from low back pain. Items are scored 0 if left blank or 1 if approved. The total score ranges from 0 to 24; higher scores represent higher pain-related disability.
Change from baseline in the patient's ability to perform a range of activities despite pain in the Pain Self-Efficacy Questionnaire at 3 weeks
Time frame: baseline and 3 weeks
A 10-item questionnaire that measures both the strength and generality of a patient's beliefs about their ability to perform a range of activities despite pain. Scores can range from 0 to 60, with higher scores indicating stronger self-efficacy beliefs.
Measuring pain intensity and disability in the Revised Graded Chronic Pain Scale at baseline
Time frame: baseline
The new scale, consisting of 6 questions, was developed as a revised version of the original scale. There is a categorical rating scheme and numerical self-assessment scores for pain intensity and disability. The first 2 questions ask the frequency of pain, how the pain affects life and work activities and evaluate the last 3 months. It is scored from 0 to 4 (0 = never to 4 = every day). Questions between 3 and 5 (PEG scale) evaluate the severity of pain in the last 7 days and are scored between 0-10 points. The third question questions the severity of the pain. Questions 4 and 5, respectively, ask how pain interferes with enjoying life and how it affects general activities. Question 6 has 2 answers (1=yes and 2=no) and asks if the person is not working or unable to work because of pain or painful condition.
Change from baseline in assessing internal factors and emotions influencing the experience of health-threatening physical injury and pain in the Pain Beliefs Questionnaire at 3 weeks
Time frame: baseline and 3 weeks
The consists of two subscales. The organic beliefs subscale (PBQ-O) questions the user about physical injury or physiological pain that threaten wellness, while the psychological pain beliefs subscale (PBQ-P) evaluates intrinsic factors and emotions affecting the pain experience that may potentially threaten wellness.
Identifying subjective neuropathic pain experience on the Pain Perception Questionnaire at baseline
Time frame: baseline
It is a symptom-based assessment tool performed by clinicians to specify the subjective neuropathic pain experience of patients.
Change from baseline in assessing overall quality of Sleep at 3 weeks
Time frame: baseline and 3 weeks
It's about the overall quality of sleep about most nights in the last 7 days. It is scored between 1 and 10. High scores represent good sleep quality.
3 secondary outcomes
Change from baseline in detecting structural lumbar segmental instability on Passive Lumbar Extension Test at 3 weeks
Time frame: baseline and 3 weeks
Change from baseline on trunk mobility on the Finger-Place Test at 3 weeks
Time frame: baseline and 3 weeks
Change from baseline in maintaining a neutral lumbar spine in the Physical Performance Test Battery at 3 weeks
Time frame: baseline and 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise group and pain training group in people with Chronic Low Back Pain, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Yaşar (+90 5073018156, ayseyasar48@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of pain intensity on the Numerical Rating Scale at 3 weeks (time frame: baseline and 3 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.