Clinical trial NCT03483168: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: change from baseline pain intensity at 4 week
measure: Disability status
timeFrame: Change from baseline disability status at 4 week
Secondary outcomes:
measure: Pain Pressure Thresholds
timeFrame: change from baseline pain pressure thresholds at 4 weeks
measure: Knowledge of pain
timeFrame: change from baseline pain knowledge at 4 weeks
measure: Pain related beliefs
timeFrame: change from baseline pain beliefs at 4 weeks
measure: Pain catastrophization
timeFrame: change from baseline pain catastrophization at 4 weeks
measure: Fear avoidance beliefs related to pain
timeFrame: change from baseline kinesiophobia at 4 weeks
measure: Illness perceptions
timeFrame: change from baseline illness perceptions at 4 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
References:
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.
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.
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.