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临床试验/CTRI/2026/01/101065
CTRI/2026/01/101065招募中1 期

Studies on understanding and managing sleep, cognition, Autonomic and Physical function in patients with non-specific chronic low back pain

Jamia Millia Islamia1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2026年1月30日最近更新:

试验速览

阶段
1 期
状态
招募中
入组人数
39
试验地点
1

研究概览

简要总结

This study will be carried out at human performance laboratory and sleep laboratory .the patients with chronic low back pain will be recruited from out patient department, centre for physiotherapy and Rehabilitation Sciences (CPRS), Jamia Millia Islamia. Subjects  will be recruited on the basis of inclusion and exclusion criteria and informed about the study. Subject will be explained the purpose and the possible risks of the study. They will be given an informed consent explaining their rights as research subjects (According to Helsinki declaration,1964). All the patients will be examined for demographics and baseline measures including pain, cognition, subjective sleep parameters (sleep quality, sleep health, sleep hygiene, sleep-related quality of life), objective sleep parameter (polysomnography), autonomic function, physical function (muscle activation pattern and lumbar movement control) and psychosocial factors (fear avoidance, kinesiophobia and pain catastrophising) by using respective outcome measures. After assessing the baseline criterion measures, they shall further be randomly divided into three groups (two intervention and one control group). Group A will receive modern neuroscience approach (Pain neuroscience education and cognition targeted exercise therapy) along with interferential therapy (IFT) and hot pack. Group B will receive cranial 16 electrostimulation in addition to modern neuroscience approach along with IFT and hot pack and group C (control) will receive general trunk stabilization exercises along with IFT and hot pack. Assessment of criterion measures will be taken in 2 subsequent days. On day one, P300 evoked potentials, EMG, interleukin-6 biomarker (saliva) and other subjective parameters will be recorded and participants are requested to come to sleep lab in the night for polysomnography familiarization session. On day two, heart rate variability and also subjects will be asked to come to lab at around 9:30 pm, after having dinner, at their regular bed time for complete polysomnography recording using EEG, EOG and EMG electrodes for the whole night. Moreover, all the subjects will be asked to fill consensus sleep diary daily to get a clearer picture of their sleep/ wake cycle for the complete study duration. The interventions will be given three days per week for a period of eight weeks. After the completion of eight weeks of intervention period, assessment of the outcome variables will be carried out again post intervention. A follow up will be conducted after 12 weeks, assessing all the outcome measures except polysomnography.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Medical diagnosis of non-specific chronic low back pain (NCLBP) with pain and
  • symptoms persisting for longer than 3 months and lesser than 7 years in accordance with standard diagnostic criteria and prior research conventions (Airaksinen et al., 2006; Wand et al., 2011).
  • Age between 19 and 55 years (Heffner et al., 2011)
  • NPRS more than 3 and less than 7 (moderate pain intensity, which is clinically significant yet not severely limiting)
  • Both male and female
  • Participants with working knowledge of english language in order to complete the questionnaires.
  • Willing to participate in a structured exercise program
  • Willing to stay overnight for polysomnography.

排除标准

  • 1.History of spinal surgery (Uchmanowicz et al., 2018)
  • Spinal and lower limb deformities
  • Inflammatory joint disease
  • Traumatic spine and lower limb injuries
  • Pregnant women
  • History or evidence of cardiovascular disease (history of angina, myocardial infarction, shortness of breath, uncontrolled hypertension) (Bandeira et al., 2021)
  • Participants suffering from any diagnosed psychiatric, neurological or cognitive, systematic, medical diseases/disorders
  • Use of centrally active medications and sleep medications (Aldabbas et al., 2021)
  • Previously diagnosed and treated sleep disorders (Uchmanowicz et al., 2018).

研究者

申办方类型
Contract research organization
责任方
Principal Investigator
主要研究者

Zubia Veqar

Jamia Millia Islamia

研究点 (1)

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