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Clinical Trials/NCT03483168
NCT03483168
Completed
Not Applicable

The Effects of Culturally Sensitive Pain Education Program in Turkish Patients With Chronic Low Back Pain: A Pilot Randomized Controlled Trial

Hacettepe University1 site in 1 country29 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Hacettepe University
Enrollment
29
Locations
1
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
October 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ceren Gürşen

Principal investigator

Hacettepe University

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.

Outcomes

Primary Outcomes

Pain intensity

Time Frame: change from baseline pain intensity at 4 week

"0-10" Numerical Pain Scale

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 Outcomes

  • Knowledge of pain(change from baseline pain knowledge at 4 weeks)
  • Pain catastrophization(change from baseline pain catastrophization at 4 weeks)
  • Pain Pressure Thresholds(change from baseline pain pressure thresholds at 4 weeks)
  • Pain related beliefs(change from baseline pain beliefs at 4 weeks)
  • Fear avoidance beliefs related to pain(change from baseline kinesiophobia at 4 weeks)
  • Illness perceptions(change from baseline illness perceptions at 4 weeks)

Study Sites (1)

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