Culturally Sensitive Pain Education Program for Turkish Patients

NCT03483168 | Completed

• 1 other identifier: EC UZG 2018/0228
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  "0-10" Numerical Pain Scale

  change from baseline pain intensity at 4 week

• 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.

  Change from baseline disability status at 4 week

Secondary Outcomes (6)

• Pain Pressure Thresholds

  change from baseline pain pressure thresholds at 4 weeks

• Knowledge of pain

  change from baseline pain knowledge at 4 weeks

• Pain related beliefs

  change from baseline pain beliefs at 4 weeks

• Pain catastrophization

  change from baseline pain catastrophization at 4 weeks

• Fear avoidance beliefs related to pain

  change from baseline kinesiophobia at 4 weeks

Study Arms (2)

Culturally sensitive pain education

EXPERIMENTAL

Behavioral: Culturally sensitive pain education

Standard pain education

ACTIVE COMPARATOR

Behavioral: Standard pain education program

Interventions

Culturally sensitive pain education BEHAVIORAL

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.

Culturally sensitive pain education

Standard pain education program BEHAVIORAL

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.

Standard pain education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 26928735 RESULT

• 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.

  PMID: 24222526 RESULT

• 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.

  PMID: 27881523 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 30, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

BE (1)