Development and feasibility of a culturally adapted pain science education content for chronic neck pain in India
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Ramaiah Hospitals Ramaiah College of Physiotherapy
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Feasibility outcomes
Overview
Brief Summary
Recruitment not initiated as yet to provide any data .
Chronic neck pain is a highly prevalent musculoskeletal disorder that contributes significantly to disability and reduced quality of life globally. Pain Science Education (PSE), which aims to reconceptualize pain from a biomedical to a biopsychosocial perspective, has shown promising results in reducing pain and disability in chronic musculoskeletal conditions. However, standard PSE programs are often developed in Western contexts and may not fully align with the cultural narratives, health beliefs, and language diversity prevalent in Indian populations. The current study aims to develop and assess the feasibility of a culturally adapted pain science education in individuals with chronic non specific neck pain. Following screening of subjects the study involves exploring the cultural beliefs, attitudes and perceptions related to chronic neck pain among Indian patients and healthcare providers. Based on the beliefs, perceptions and attitudes a pain science education content focusing on some of the key concepts of pain shall be developed .The developed content shall then be validated by a panel of pain experts. The developed and validated content shall be administered along with conventional Physiotherapy on Indian subjects with chronic non specific neck pain and assessed for pilot feasibility. Qualitative feedback will be subjected to thematic analysis to identify common suggestions,common patterns and barriers. For validation of the developed content quantitative ratings will be summarized using measures of central tendency (mean, median, IQR). Quantitative component of pain behaviour will be analysed through paired t test / Wilcoxon sign ranked test to determine pre test post -test difference.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Non-specific neck pain with no neurological problems
- •Age 18 years – 55 years
- •Neck pain in the cervical region, possibly with referred or radiating pain in the occiput, nuchal muscles, shoulders and upper limbs without proven structural disorders in the cervical spine, nerve roots or spinal cord .
- •Pain more than 3 months
- •Speak and read English/ kannada fluently.
- •Educational qualification – more than 10th Std.
Exclusion Criteria
- •Signs and symptoms of neurological disorders
- •Recent history of fever or chills
- •Headache as a consequence of specific headache diagnosis (migraine, cervical headache)
- •History of specific signs of malignancy, infection
- •History of trauma with or without proven structural disorders in the region of the neck, shoulder and head
- •Signs and symptoms of cerebrovascular insufficiency
- •Severe chronic disease of the locomotor system
- •Osteoporosis
- •history of diagnosed severe mental health conditions( schizophrenia, severe depression , bipolar disorder ), that would limit conducting the trial procedures.
Outcomes
Primary Outcomes
Feasibility outcomes
Time Frame: Recruitment rate assessed at screening phase | Adherence to intervention at each session of week 1 & 2 | Participant Satisfaction , Perceived Relevance and Accepatbility or credibility of interventions assessed post intervention week 2
Recruitment rate
Time Frame: Recruitment rate assessed at screening phase | Adherence to intervention at each session of week 1 & 2 | Participant Satisfaction , Perceived Relevance and Accepatbility or credibility of interventions assessed post intervention week 2
Adherence to intervention Participant Satisfaction
Time Frame: Recruitment rate assessed at screening phase | Adherence to intervention at each session of week 1 & 2 | Participant Satisfaction , Perceived Relevance and Accepatbility or credibility of interventions assessed post intervention week 2
Perceived Relevance
Time Frame: Recruitment rate assessed at screening phase | Adherence to intervention at each session of week 1 & 2 | Participant Satisfaction , Perceived Relevance and Accepatbility or credibility of interventions assessed post intervention week 2
Acceptability / credibility of interventions
Time Frame: Recruitment rate assessed at screening phase | Adherence to intervention at each session of week 1 & 2 | Participant Satisfaction , Perceived Relevance and Accepatbility or credibility of interventions assessed post intervention week 2
Secondary Outcomes
- Clinical outcomes include(cervical range of motion)
- Intervention Fidelity outcomes include(Adherence to intervention content)
Investigators
Shobhalakshmi Sudarshan
Ramaiah College of Physiotherapy