An interventional study of Culturally sensitive pain education and Standard pain education program in Chronic Low Back Pain, sponsored by Hacettepe University. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-05.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Behavioral: Culturally sensitive pain education
Behavioral: Standard pain education program
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.
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.
Pain intensity
"0-10" Numerical Pain Scale
Time frame: 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.
Time frame: Change from baseline disability status at 4 week
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.
Time frame: change from baseline pain pressure thresholds at 4 weeks
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.
Time frame: change from baseline pain knowledge at 4 weeks
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.
Time frame: change from baseline pain beliefs at 4 weeks
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.
Time frame: change from baseline pain catastrophization at 4 weeks
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.
Time frame: change from baseline kinesiophobia at 4 weeks
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.
Time frame: change from baseline illness perceptions at 4 weeks
Plan to share: Undecided
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Hacettepe University