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临床试验/CTRI/2025/09/094867
CTRI/2025/09/094867尚未招募4 期

Development and feasibility of a culturally adapted pain science education content for chronic neck pain in India

Ramaiah Hospitals Ramaiah College of Physiotherapy1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年9月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Feasibility outcomes

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Feasibility outcomes

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Clinical outcomes include(cervical range of motion)
  • Intervention Fidelity outcomes include(Adherence to intervention content)

研究者

发起方
Ramaiah Hospitals Ramaiah College of Physiotherapy
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Shobhalakshmi Sudarshan

Ramaiah College of Physiotherapy

研究点 (1)

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