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Culturally Sensitive Pain Education Program for Turkish Patients

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ClinicalTrials.gov Identifier: NCT03483168
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ceren Gürşen, Hacettepe University

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Culturally sensitive pain education Behavioral: Standard pain education program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Culturally Sensitive Pain Education Program in Turkish Patients With Chronic Low Back Pain: A Pilot Randomized Controlled Trial
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Back Pain

Arm Intervention/treatment
Experimental: Culturally sensitive pain education Behavioral: Culturally sensitive pain education
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.

Active Comparator: Standard pain education Behavioral: Standard pain education program
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 Measures :
  1. Pain intensity [ Time Frame: change from baseline pain intensity at 4 week ]
    "0-10" Numerical Pain Scale

  2. Disability status [ Time Frame: Change from baseline disability status at 4 week ]
    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 :
  1. Pain Pressure Thresholds [ Time Frame: change from baseline pain pressure thresholds at 4 weeks ]
    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.

  2. Knowledge of pain [ Time Frame: change from baseline pain knowledge at 4 weeks ]
    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.

  3. Pain related beliefs [ Time Frame: change from baseline pain beliefs at 4 weeks ]
    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.

  4. Pain catastrophization [ Time Frame: change from baseline pain catastrophization at 4 weeks ]
    Catastrophization of pain will be evaluated by using the Pain Catastrophizing Scale ranging from 0 to 52; higher scores represent higher levels of catastrophizing.

  5. Fear avoidance beliefs related to pain [ Time Frame: change from baseline kinesiophobia at 4 weeks ]
    Fear avoidance will be evaluated by using the Tampa Scale for Kinesiophobia ranging from 17 to 68; higher scores represent higher levels of kinesiophobia.

  6. Illness perceptions [ Time Frame: change from baseline illness perceptions at 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483168


Locations
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Belgium
Ghent University
Ghent, Belgium, 9000
Sponsors and Collaborators
Hacettepe University

Publications of Results:
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Responsible Party: Ceren Gürşen, Principal investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03483168     History of Changes
Other Study ID Numbers: EC UZG 2018/0228
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms