search
Back to results

Culturally Sensitive Pain Education Program for Turkish Patients

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Culturally sensitive pain education
Standard pain education program
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 40 Turkish patients between the age of 18 and 65 years, with a diagnosis of non-specific chronic LBP (have pain at least 3 months and mean pain frequency is 3 or more days per week), who are diagnosed by a physician and not starting new treatments,medication or continuing usual care 6 weeks prior and during study participation will be included to the present study. First generation Turkish migrants who are born in turkey, being Turkish as a first language, and being of Turkish nationality will be eligible for inclusion in this study.

Exclusion Criteria:

  • Patients with uncontrolled mental health condition (eg, schizophrenia, bipolar disorder, major depressive disorder) that prevents the successful participation, specific pathologies, trauma, or pregnancy will be excluded. Study participants will be instructed to refrain from analgesics 48 hours prior to assessments.

Sites / Locations

  • Ghent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Culturally sensitive pain education

Standard pain education

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity
"0-10" Numerical Pain Scale
Disability status
Disability status will be assessed by using the Roland Morris Disability Questionnaire ranging from 0 to 24; higher scores represent higher levels of pain-related disability.

Secondary Outcome Measures

Pain Pressure Thresholds
Pain pressure thresholds will be assessed with a hand held pressure algometer (Wagner Force 50) with a circular probe of one cm diameter. Perpendicular pressure will be applied at a constant rate (1kg/s) to the tissue surface. 3 pressure-points will be evaluated bilaterally: One pressure points are on the Erector spinae muscle mass at 5 cm laterally of the processus spinosus vertebrae of L3, one pressure pain is on the middle of the quadriceps muscle (between the anterior superior iliac spine and base of the patella), one pressure point is on the middle of the trapezius muscle (between acromion and processus spinosus of C7). Two measurements will be taken with a 30 second interval and the mean of the measurements will be recorded.
Knowledge of pain
Knowledge of pain will be assessed by using the Revised Neurophysiology of Pain Questionnaire ranging from 0 to 13; higher scores represent higher levels of pain knowledge.
Pain related beliefs
Pain related beliefs will be assessed by using the Pain Beliefs Questionnaire consisting of two subscales: Organic Beliefs and Psychological Beliefs. Scores for each subscale ranges from 1 to 6; higher scores represent that having more negative pain beliefs.
Pain catastrophization
Catastrophization of pain will be evaluated by using the Pain Catastrophizing Scale ranging from 0 to 52; higher scores represent higher levels of catastrophizing.
Fear avoidance beliefs related to pain
Fear avoidance will be evaluated by using the Tampa Scale for Kinesiophobia ranging from 17 to 68; higher scores represent higher levels of kinesiophobia.
Illness perceptions
Illness perceptions will be evaluated by using the Brief Illness Perception Questionnaire; ranges from 0 to 80; higher scores represent a more threatening view of the illness.

Full Information

First Posted
March 16, 2018
Last Updated
October 4, 2018
Sponsor
Hacettepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT03483168
Brief Title
Culturally Sensitive Pain Education Program for Turkish Patients
Official Title
The Effects of Culturally Sensitive Pain Education Program in Turkish Patients With Chronic Low Back Pain: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culturally sensitive pain education
Arm Type
Experimental
Arm Title
Standard pain education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Culturally sensitive pain education
Intervention Description
The content of the PNE program include the characteristics of acute and chronic pain, purpose of acute pain, formation process of acute pain from the nervous system, the formation process of chronic pain, and potential sustaining factors for central sensitization.
Intervention Type
Behavioral
Intervention Name(s)
Standard pain education program
Intervention Description
For the standard translated PNE, The English translation of "Pain Neuroscience Education: slides for supporting and illustrating your explanation" at the Pain in Motion Group web page (http://www.paininmotion.be/education/tools-for-clinical-practice) and English translation of the Patient Information Leaflet will be used. The education materials will be translated using the forward/backward translation process. The English version of PNE presentation and information leaflet will be translated to Turkish by two independent translators.
Primary Outcome Measure Information:
Title
Pain intensity
Description
"0-10" Numerical Pain Scale
Time Frame
change from baseline pain intensity at 4 week
Title
Disability status
Description
Disability status will be assessed by using the Roland Morris Disability Questionnaire ranging from 0 to 24; higher scores represent higher levels of pain-related disability.
Time Frame
Change from baseline disability status at 4 week
Secondary Outcome Measure Information:
Title
Pain Pressure Thresholds
Description
Pain pressure thresholds will be assessed with a hand held pressure algometer (Wagner Force 50) with a circular probe of one cm diameter. Perpendicular pressure will be applied at a constant rate (1kg/s) to the tissue surface. 3 pressure-points will be evaluated bilaterally: One pressure points are on the Erector spinae muscle mass at 5 cm laterally of the processus spinosus vertebrae of L3, one pressure pain is on the middle of the quadriceps muscle (between the anterior superior iliac spine and base of the patella), one pressure point is on the middle of the trapezius muscle (between acromion and processus spinosus of C7). Two measurements will be taken with a 30 second interval and the mean of the measurements will be recorded.
Time Frame
change from baseline pain pressure thresholds at 4 weeks
Title
Knowledge of pain
Description
Knowledge of pain will be assessed by using the Revised Neurophysiology of Pain Questionnaire ranging from 0 to 13; higher scores represent higher levels of pain knowledge.
Time Frame
change from baseline pain knowledge at 4 weeks
Title
Pain related beliefs
Description
Pain related beliefs will be assessed by using the Pain Beliefs Questionnaire consisting of two subscales: Organic Beliefs and Psychological Beliefs. Scores for each subscale ranges from 1 to 6; higher scores represent that having more negative pain beliefs.
Time Frame
change from baseline pain beliefs at 4 weeks
Title
Pain catastrophization
Description
Catastrophization of pain will be evaluated by using the Pain Catastrophizing Scale ranging from 0 to 52; higher scores represent higher levels of catastrophizing.
Time Frame
change from baseline pain catastrophization at 4 weeks
Title
Fear avoidance beliefs related to pain
Description
Fear avoidance will be evaluated by using the Tampa Scale for Kinesiophobia ranging from 17 to 68; higher scores represent higher levels of kinesiophobia.
Time Frame
change from baseline kinesiophobia at 4 weeks
Title
Illness perceptions
Description
Illness perceptions will be evaluated by using the Brief Illness Perception Questionnaire; ranges from 0 to 80; higher scores represent a more threatening view of the illness.
Time Frame
change from baseline illness perceptions at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 40 Turkish patients between the age of 18 and 65 years, with a diagnosis of non-specific chronic LBP (have pain at least 3 months and mean pain frequency is 3 or more days per week), who are diagnosed by a physician and not starting new treatments,medication or continuing usual care 6 weeks prior and during study participation will be included to the present study. First generation Turkish migrants who are born in turkey, being Turkish as a first language, and being of Turkish nationality will be eligible for inclusion in this study. Exclusion Criteria: Patients with uncontrolled mental health condition (eg, schizophrenia, bipolar disorder, major depressive disorder) that prevents the successful participation, specific pathologies, trauma, or pregnancy will be excluded. Study participants will be instructed to refrain from analgesics 48 hours prior to assessments.
Facility Information:
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26928735
Citation
Louw A, Puentedura EJ, Zimney K, Schmidt S. Know Pain, Know Gain? A Perspective on Pain Neuroscience Education in Physical Therapy. J Orthop Sports Phys Ther. 2016 Mar;46(3):131-4. doi: 10.2519/jospt.2016.0602.
Results Reference
result
PubMed Identifier
24222526
Citation
Sleptsova M, Woessmer B, Grossman P, Langewitz W. Culturally sensitive group therapy for Turkish patients suffering from chronic pain: a randomised controlled intervention trial. Swiss Med Wkly. 2013 Nov 12;143:w13875. doi: 10.4414/smw.2013.13875. eCollection 2013.
Results Reference
result
PubMed Identifier
27881523
Citation
Holzel LP, Ries Z, Kriston L, Dirmaier J, Zill JM, Rummel-Kluge C, Niebling W, Bermejo I, Harter M. Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial. BMJ Open. 2016 Nov 23;6(11):e012008. doi: 10.1136/bmjopen-2016-012008.
Results Reference
result

Learn more about this trial

Culturally Sensitive Pain Education Program for Turkish Patients

We'll reach out to this number within 24 hrs