Effect of Low-level Laser Therapy and Pelvic Stabilisation Exercises on Postpartum Pelvic Girdle Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain intensity:
研究概览
简要总结
This study will be conducted to show the effect of low level laser therapy 810 nm and pelvic stabilization exercises has Effect on pelvic girdle pain Postpartum Pelvic girdle pain (PPGP) is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life. PGP generally arises in relation with pregnancy, trauma and reactive arthritis. The onset of PGP is usually by weeks 17-19 of gestation, with a peak of incidence by weeks 24- 36. Postpartum follow-up studies have shown that 5- 27% of the women had persisting pain 1-3 months after delivery. However, it was report that 7% have remaining pain 6 years after delivery causing severe discomfort and reduced ability to work , ninety prime-gravid or multigravida postnatal women's were randomly classified into three groups, Group (A): composed of 30 patients who received low-level laser therapy and pelvic stabilization exercises for 12 sessions over six week's period by 2 sessions per week. Group (B): composed of 30 patients who low-level laser therapy only for 12 sessions over six week's period by 2 sessions per week and Group (C): composed of 30 patients who received pelvic stabilization exercises For 12 sessions over six week's period by 2 sessions per week. Pain Using Visual analogue scale, serum cortisol level, and disability using pelvic girdle questionnaire) were measured and compared at 0 and 6 weeks after the treatment in the 3 groups.
详细描述
Study design: This work were conducted in physical therapy department of Imbaba general Hospital and in outpatient clinic of National Institute of Laser Enhanced Sciences, Cairo University Design of the study: It is a clinical study. Eighteen women's with postpartum pelvic girdle pain was participate in this study, and were randomly into three equal groups.
Eligibility Criteria:
Female participants at least ≥18 years old. Group (A): composed of 30 patients who low level laser therapy and pelvic stabilization exercises For 12 sessions over six week's period by 2 sessions per week, Group it is the study group. (B): composed of 30 patients, who low level laser therapy only for 12 sessions, over six week's period by 2 sessions per week. Group(C) .composed of 30 women's ,who received pelvic stabilization exercises only, For 12 sessions over six week's period ,by 2 sessions per week. The ethical committee clearance and an informed consent of the subjects will be taken Subjects will have all rights to withdraw from the study at any time without any responsibility.
Inclusion criteria:
- Ongoing sacral pain with onset during the preceding pregnancy reported on a present pain drawing.
- Pain intensity ≥4 cm as worst during the past week on a 10 cm visual analogue scale (VAS).
- One positive pain provocation test of either Posterior Pelvic Pain Provocation test, Patrick's Faber test.
- Provoked pain by a gentle pressure on the ischial spine, ipsilateral to reported sacral pain, at least unilaterally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
If low level laser therapy 810nm and pelvic stabilization exercises can reduce pain and improve function there will be a new treatment option for this condition
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ongoing sacral pain with onset during the preceding pregnancy reported on a present pain drawing
- •Pain intensity ≥4 cm as worst during the past week on a 10 cm visual analogue scale (VAS)
- •One positive pain provocation test of either Posterior Pelvic Pain Provocation test, Patrick's Faber test.
- •Provoked pain by a gentle pressure on the ischial spine, ipsilateral to reported sacral pain, at least unilaterally.
排除标准
- •Nerve root affection in the lumbo-sacral spine
- •Inflammatory disease with pelvic bone and/or spinal manifestation
- •Known endometriosis, gynecologic cancer or ongoing malign disease.
- •Previous surgery of the lumbar spine.
- •Incapacity to complete the questionnaires.
- •Age <18 years.
- •Body mass index ≥35 kg/m
- •Intolerance to the treatment dose or negative reactions of the laser treatment.
- •A new pregnancy, during treatment or between the follow-ups. -
结局指标
主要结局
Pain intensity:
时间窗: Baseline to 6 weeks after treatment .
Pain will assessed by using VAS that is a 10 mm calibrated line with zero representing no pain and10 representing worst pain using Visual analogue scale"VAS" that is a 10 mm calibrated line with zero representing no pain and 10 representing worst pain.Worst during the past week Change from baseline to follow-up
Pelvic Girdle Questionnaire
时间窗: Baseline to 6 weeks after treatment
The Pelvic Girdle Questionnaire (PG Q) is a condition-specific measure for women with pelvic girdle pain (PGP). The questionnaire has 25 items under two sub-scales (20 items for activates and 5 items for symptoms), with percentage scores that range from 0 (no disability) to 100 (great disability),thus supplying a gap in research and clinical practice. The PG Q includes items relating to activity/participation and bodily symptoms and has reliability, validity, and feasibility for use in research and clinical practice.
Serum cortisol level:
时间窗: Baseline to 6 weeks after treatment
Cortisol is a hormone secreted by the adrenal gland. It is the major corticosteroids. It is responsible for about 95% of all glucocorticoids activity in the body.(Pool and Axford 2001) It released into our body when we are under stress. Cortisol is high in subjects suffering from pain as compared with healthy and pain free subjects, as there is positive correction between the intensity of pain and increased plasma cortisol level. The blood sample will take for the measurement of plasma cortisol from 9 a.m. to 1 p.m. Each patient will be drawn two 5 ml blood samples from cubital vein two time
次要结局
- FABER Test (Patrick's test)(Baseline to 6 weeks after treatment)
- Posterior pelvic pain provocation test (PPPPT)(Baseline to 6 weeks after treatment .)
研究者
saad shehata
Head of Physical Therapist department in Imbaba general hospital
Cairo University