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临床试验/NCT05355220
NCT05355220已完成不适用

Effects of Silver Spike Point Therapy on Pelvic Girdle Pain and Functional Activities in Pregnancy

Riphah International University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Numeric Pain Rating Scale (NPRS):

研究概览

简要总结

The aim of this study is to determine the effects of Silver Spike Point Therapy (SSPT) therapy on pelvic girdle pain and functional activities in pregnancy.The finding of this study will help to establish the role of SSPT therapy to relieve pelvic girdle pain in pregnant females along with exercises. SSP for pelvic girdle pain management can prove to be a useful method. The findings of this study can play a role to establish more rigorous treatment plans for pelvic girdle pain in the pregnant population in the future.

详细描述

This study will be a randomized clinical trial that will investigate the effectiveness of silver spike point therapy and manual therapy in subjects with pregnancy-related pelvic girdle pain. Subjects with pregnancy-related pelvic girdle pain meeting the predetermined inclusion & exclusion criteria will be divided into two groups using the lottery method. Pre-assessment will be done using NPRS and PGPQ as subjective measurements and PSFS as objective measurements. Subjects in one group will be treated with silver spike point therapy and manual therapy, the other will be treated with manual therapy only. Each subject will receive 10 treatment sessions, with 05 treatment sessions per week. Post-treatment reading for NPRS, PGPQ, and PSFS will be recorded after the end of the 10th treatment session. Recorded values will be analyzed for any significant difference between pre and post-treatment values SPSS 21.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female aged between 20 to 40 years of age
  • Healthy pregnancy
  • 14 to 38 weeks gestation
  • Expecting a singleton fetus
  • 2 out of 3 tests positive for PGP according to European guidelines for
  • pelvic girdle pain"(Posterior pelvic pain provocation (P4), Patrick's Faber, Modified Trendelenburg's test)

排除标准

  • High-risk pregnancy, Caudaequina Syndrome, Trauma, or spinal surgical history.
  • Inflammatory, infective, metabolic, neoplastic, or degenerative conditions.
  • Sensory symptoms associated with disc herniation or compressive spinal lesion.
  • Any contraindication to exercise.

结局指标

主要结局

Numeric Pain Rating Scale (NPRS):

时间窗: 2 weeks

Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI- NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change)

Pelvic Girdle Pain Questionnaire (PGPQ):

时间窗: 2 weeks

The Pelvic Girdle Questionnaire (PGQ) is a condition-specific measure for women with pelvic girdle pain (PGP). The PGQ includes items relating to activity/participation and bodily symptoms and has reliability, validity, and feasibility for use in research and clinical practice

Patient specific Functional Scale (PSFS)

时间窗: 2 weeks

Patient Specific Functional Scale was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. The aim of PSFS is to provide clinicians with a valid, reliable, responsive andefficient outcome measure that would be easy to use and applicable to a large number of clinical presentations. Patient- Specific Functional Scale is an efficient and valid measure for assessing disability and change in disability in persons with musculoskeletal diseases

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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