Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-01 @ 11:09 PM
Study NCT ID:
NCT03483168
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2018-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Sensitive Pain Education Program for Turkish Patients
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
The Effects of Culturally Sensitive Pain Education Program in Turkish Patients With Chronic Low Back Pain: A Pilot Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-10
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:
In last decade, the awareness has grown regarding the pain neuroscience education (PNE). In the literature, it has been found that there is strong evidence that the educational strategy of pain neuroscience education (PNE) can have positive effects on pain, disability, catastrophization, and physical performance in chronic musculoskeletal disorders. Nowadays, many physiotherapists integrate the PNE into the treatment of chronic pain. However, the importance of culturally sensitive approaches for the treatment of chronic pain has been proposed depending on the cultural differences of pain beliefs, pain cognitions, pain experiences and pain coping strategies in different ethnic populations. Therefore, the aim of this study is to compare the effects of a culturally sensitive PNE with a standard translated PNE on pain intensity, disability status, pain pressure thresholds and psychosocial factors (conceptualization of pain, pain beliefs, catastrophizing, kinesiophobia and illness perception) in Turkish patients with chronic low back pain (LBP).
The effects of culturally sensitive PNE format will be compared with the standard translated PNE in a pilot trial. 40 Turkish patients (first generation migrant living around Ghent) with chronic LBP, between the age of 18 and 65 years, will be randomized to the culturally sensitive PNE or standard translated PNE. The content of 2 sessions PNE include the explanation about differences of acute and chronic pain, purpose of acute pain, production of acute pain and chronic pain, and potential sustaining factors for central sensitization, but presented in different ways. They will be subjected to an individual education session and they will receive a home education program. In session 2 (after 1 week), they will come back to ascertain that everything is understood.
The effects of culturally sensitive PNE format will be compared with the standard translated PNE in a pilot trial. 40 Turkish patients (first generation migrant living around Ghent) with chronic LBP, between the age of 18 and 65 years, will be randomized to the culturally sensitive PNE or standard translated PNE. The content of 2 sessions PNE include the explanation about differences of acute and chronic pain, purpose of acute pain, production of acute pain and chronic pain, and potential sustaining factors for central sensitization, but presented in different ways. They will be subjected to an individual education session and they will receive a home education program. In session 2 (after 1 week), they will come back to ascertain that everything is understood.
Detailed Description:
In last decade, the awareness has grown regarding the pain neuroscience education (PNE). In the literature, it has been found that there is strong evidence that the educational strategy of pain neuroscience education (PNE) can have positive effects on pain, disability, catastrophization, and physical performance in chronic musculoskeletal disorders. Nowadays, many physiotherapists integrate the PNE into the treatment of chronic pain. However, the importance of culturally sensitive approaches for the treatment of chronic pain has been proposed depending on the cultural differences of pain beliefs, pain cognitions, pain experiences and pain coping strategies in different ethnic populations. Therefore, the aim of this study is to compare the effects of a culturally sensitive PNE with a standard translated PNE on pain intensity, disability status, pain pressure thresholds and psychosocial factors (conceptualization of pain, pain beliefs, catastrophizing, kinesiophobia and illness perception) in Turkish patients with chronic low back pain (LBP).
The effects of culturally sensitive PNE format will be compared with the standard translated PNE in a pilot trial. 40 Turkish patients (first generation migrant living around Ghent) with chronic LBP, between the age of 18 and 65 years, will be randomized to the culturally sensitive PNE or standard translated PNE. The content of 2 sessions PNE include the explanation about differences of acute and chronic pain, purpose of acute pain, production of acute pain and chronic pain, and potential sustaining factors for central sensitization, but presented in different ways. They will be subjected to an individual education session and they will receive a home education program. In session 2 (after 1 week), they will come back to ascertain that everything is understood.
The primary outcomes include pain intensity and disability status. Secondary outcome measures are pain pressure thresholds and psychosocial factors such as conceptualization of pain, pain Beliefs, catastrophizing, kinesiophobia and illness perceptions. Pain thresholds will be assessed with the pressure algometer. Pressure will be applied bilaterally at 3 pressure points: one on the mass of erector spinae muscle, one on the quadriceps muscle, and one on the trapezius muscle. All outcomes will be evaluated at baseline, day 7 (immediately after session 2) and after 1 month follow-up.
The effects of culturally sensitive PNE format will be compared with the standard translated PNE in a pilot trial. 40 Turkish patients (first generation migrant living around Ghent) with chronic LBP, between the age of 18 and 65 years, will be randomized to the culturally sensitive PNE or standard translated PNE. The content of 2 sessions PNE include the explanation about differences of acute and chronic pain, purpose of acute pain, production of acute pain and chronic pain, and potential sustaining factors for central sensitization, but presented in different ways. They will be subjected to an individual education session and they will receive a home education program. In session 2 (after 1 week), they will come back to ascertain that everything is understood.
The primary outcomes include pain intensity and disability status. Secondary outcome measures are pain pressure thresholds and psychosocial factors such as conceptualization of pain, pain Beliefs, catastrophizing, kinesiophobia and illness perceptions. Pain thresholds will be assessed with the pressure algometer. Pressure will be applied bilaterally at 3 pressure points: one on the mass of erector spinae muscle, one on the quadriceps muscle, and one on the trapezius muscle. All outcomes will be evaluated at baseline, day 7 (immediately after session 2) and after 1 month follow-up.
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?: