跳至主要内容
临床试验/CTRI/2024/06/069614
CTRI/2024/06/069614已完成3 期

Effectiveness of Neural Tissue Mobilization along with Pain Neuroscience Education on Pain, Self-reported Function, and Quality of Life in Patients with Cervical Radiculopathy – A Pilot Randomized Controlled Trial.

MGM Institute of Physiotherapy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月8日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Pain

研究概览

简要总结

Patients with Cervical radiculopathy (n=30) will be included in the study trial if they met the inclusion criteria. The written and oral consent of all patients will be taken, and procedure will be explained to them. Demographic details will be noted of those participants who will provide their written informed consent to take part in the study. After completing the demographic data, outcome measures of the participants will be assessed by providing the scales (NPRS, PSFS, and SF-12). The participants will be asked to fill up the self-administrable scales, regarding their pain, function, and quality of life respectively. The Scales responses will be recorded prior to the treatment or intervention (pre-assessment). Thereafter, allocation will be done 1:1 through concealed envelope method into the two groups i.e. Group A (Intervention group) and Group B (Control group). Four weeks of treatment will be given to both the groups (5 sessions per week for 4 weeks). Group A (intervention group) will be given-

A)    A). Neural tissue mobilization - The neural tissue mobilization techniques will be given according to Michael Shacklock. The treatment protocol will be based on persons symptoms and assessment and may vary from person to person.

B)   B).  Pain neuroscience education - A total of 4 PNE sessions will be held, once each week, for four weeks in four separate meetings. The PNE sessions will be conducted by the same physiotherapist who will deliver the treatment. The sessions will be conducted face-to-face, one-on-one sessions lasting 20–30 minutes. The PNE will be through Power Point presentations.

C)    C). Conventional physiotherapy

Group B will be given only Conventional physiotherapy i.e. Exercises + TENS (Hot moist pack, cervical isometrics, stretching for trapezius and leavtor scapulae, chin nod and scapular retractions, and strengthening of the upper back muscles i.e. Y, W, T exercises). Second assessment will be done after 2 weeks and the final post-assessment will be done at the end of 4th week. Same scales will be used in post assessment (NPRS, PSFS, and SF-12). Statistical analysis of the collected data will be done. Conclusion will be established based on the obtained results of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Unilateral radicular symptoms in the arm.
  • Pain on NPRS ≥
  • Diagnosis of cervical radiculopathy (Clinical Prediction Rule) will be applied i.e. consisting of spurling’s test, distraction test, and ULTT (Upper Limb Tension Test) for Median Nerve positive.
  • No previous cervical spine surgeries.

排除标准

  • History of recent cervical trauma.
  • Sensory loss and motor weakness (e.g. Myelopathy).
  • Any neurological conditions (e.g. Stroke).
  • Patients affected with shoulder disorders (e.g. Instability, Rotator cuff tears)
  • Any systemic disease (e.g. Rheumatoid Arthritis).

结局指标

主要结局

Pain

时间窗: Pre intervention, 2nd week, post intervention(4th week)

次要结局

  • Self-reported function(Pre intervention, 2nd week, post intervention(4th week))
  • Quality of Life(Pre intervention, 2nd week, post intervention(4th week))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Gargee Deutkar

MGM Institute of Physiotherapy, Aurangabad.

研究点 (1)

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