Effectiveness of Low Level Laser Therapy in Persistent Pregnancy-related Pelvic Girdle Pain After Childbirth
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 6 minute walk test, 6MWT, distance (m)
研究概览
简要总结
Persistent pregnancy-related pelvic girdle pain is common, 2-5% av all women given birth is suffering from disabling daily pain with high impact on quality of life.
A prospective double-blinded randomised controlled trial will be performed with a baseline assessment 7-10 months after childbirth with follow-up directly and 6 months after a treatment period with low level laser therapy (LLLT) or sham laser treatment, given at 12 planned treatment sessions during four weeks. 60 women will be included in the study.
If LLLT can reduce pain and improve function there will be a new treatment option for this condition.
详细描述
A prospective double-blinded randomised controlled trial will be performed with a baseline assessment 7-10 months after childbirth with follow-up directly and 6 months after a treatment period with low level laser therapy (LLLT) or sham laser treatment, given at 12 planned treatment sessions during four weeks.
A total of 60 women will be sampled consecutively. Women eligible to participate will be those women who were registered at a maternal health care unit in the municipalities of Sundsvall and Timrå with subsequent childbirth registered at the Sundsvall-Härnösand County Hospital, Sweden. An invitation letter with a prepaid response envelope will be sent by postal mail to the eligible women by contact information retrieved from the labour ward. Women who respond will be enrolled and approve their participation by signed informed consent. The women will be included in the study according to inclusion and exclusion criteria following a baseline assessment that comprises a urinary test, questionnaires and clinical examination. After inclusion a blood sample, for serum and plasma, will be drawn at inclusion and directly after the treatment period.
Randomisation and blinding The randomisation sequence will be generated by a statistician not involved in the study. Randomisation will be done using block randomisation (block size 4 or 6) without stratification. The investigators will use sequentially numbered, opaque, sealed envelopes which have been pre-prepared in advance by the statistician. Women who fulfil the inclusion criteria will be randomised to active laser treatment or sham laser treatment. A research assistant not involved in the inclusion assessments will perform the randomisation, prepare and handle the allocated treatment device before and after each treatment session. The treatment will be given by a physiotherapist who is blinded to treatment group, the women's case history, questionnaires and clinical examinations.
All collected data will be handled, stored and analysed at the Department of Public Health and Caring Sciences at Uppsala University. The analysts will be blinded to the treatment allocation until data of primary outcomes have been analysed and conclusions have been drawn and signed in writing before the code is broken.
Questionnaires At baseline, the women will complete questionnaires which include questions on socio-demographic data, somatic and mental health, gynaecological and obstetric history, and lifestyle.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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 ≥40 mm as worst during the past week on a 100 mm visual analogue scale (VAS)
- •One positive pain provocation test of either Posterior Pelvic Pain Provocation (P4) test, Menell's test or Patrick's faber test
- •Provoked pain by a gentle pressure on the ischial spine, ipsilaterally to reported sacral pain, at least unilaterally
排除标准
- •A positive urinary human Chorionic Gonadotropin (hCG) test
- •Nerve root affection in the lumbo-sacral spine
- •Inflammatory disease with pelvic bone and/or spinal manifestation
- •Known endometriosis, gynaecologic cancer or ongoing malign disease
- •Previous surgery of the lumbar spine
- •Corticosteroid treatment during the past 6 months and during treatment
- •Incapacity to complete the questionnaires
- •Age <18 years
- •Body mass index ≥35 kg/m2
- •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
6 minute walk test, 6MWT, distance (m)
时间窗: Baseline to 6 months after treatment
Change from baseline to follow-up
Pain intensity (100 mm VAS) Worst during the past week
时间窗: Baseline to 6 months after treatment
Change from baseline to follow-up
P4-test Pressure (1, 5, 10 or 15kg) added to provoke sacral pain
时间窗: Baseline to 6 months after treatment
Change from baseline to follow-up
Disability rating index, DRI. Function past week %
时间窗: Baseline to 6 months after treatment
Change from baseline to follow-up
次要结局
- SF-36, questionnaire(Baseline to 6 months after treatment)
- Pain score (0-26) of provoked pain on intra-pelvic anatomical landmarks(Baseline to 6 months after treatment)
- Pelvic Girdle Questionnaire, PGQ, function %(Baseline to 6 months after treatment)
- Isometric muscle tests, isometric endurance (s)(Baseline to 6 months after treatment)
- Timed Up and Go Test,TUGT, time (s)(Baseline to 6 months after treatment)