Effect of Foot Manipulation for Relief of Pregnancy Related Pelvic Girdle Pain. A Randomised Clinical Trial in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Difference in Pregnancy related pelvic girdle pain and Vorlauf test outcome
研究概览
简要总结
Background: Asymmetrical foot posture influences the pelvic girdle stability and might give pain in the pelvic region. The objective was to investigate if foot manipulation to correct foot asymmetry can relieve pregnancy related pelvic girdle pain (PPGP) and shorten sick leave periods.
Design: Randomized single blinded (patients and evaluators) clinical trial comparing foot with sham manipulation at 6 weekly treatment sessions.
Setting: Five physiotherapy out-patient clinics (10 physiotherapists) in Skaraborg Primary Care, Sweden.
详细描述
The study was performed at the physiotherapy clinics at five Health Care Centres in Skaraborg from September 2009 to August 2011. Women with suspected PPGP were referred by midwifes or physicians or contacted the physiotherapists directly. Inclusion criteria were Swedish-speaking women in gestational weeks 12-31 with PPGP determined by specific provocation tests, including the 4P test (posterior pelvic pain provocation test), Patrick's test, ASLR (active straight leg raise test), modified Trendelenburg test and palpation of symphysis pubis. Women with twin pregnancies, lumbar pain, rheumatic or other serious disease were excluded as well as non-Swedish-speaking woman and those who had had foot manipulation earlier. The feet were inspected in standing position to estimate whether they were straight, rotated outwards or inwards and if the load was flat, pronated or supinated. Movement in the subtalar joints was investigated as well as elasticity of the tarsal bones and the lateral malleoli. All women that were included had asymmetric position of one or both feet.
Study procedure Patients were randomized to either foot or sham manipulation using sealed envelopes (n=150; 75 for each treatment). The envelopes were administered and mixed centrally and depending on size the physiotherapy clinic were assigned an appropriate number of envelopes. Ten physiotherapists participated pair-wise in the treatments, one treated the patient (physiotherapist unblinded, patient blinded), and the other made the evaluation (double blinded). All patients got the same information about PPGP and 6 visits once a week during 6 weeks, and follow-up visits one week after end of treatment and three months after delivery. All patients were encouraged not to talk to other pregnant women or to the evaluators about details of their treatment.
Data were registered in protocols separated from the medical records, not accessible for the evaluators, and included group assignment, results of diagnostic tests, Vorlauf tests and Visual Analogue Scales (VAS). The blinded evaluator administered the follow-up three months after delivery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with suspected PPGP were referred by midwifes or physicians or contacted the physiotherapists directly.
- •Inclusion criteria:
- •Swedish-speaking women in gestational weeks 12-31
- •Pregnancy Related Pelvic Girdle Pain (PPGP) determined by provocation tests (4P test, posterior pelvic pain provocation test; Patrick's test, ASLR (active straight leg raise test), modified Trendelenburg test and pain on palpation of symphysis pubis
排除标准
- •Women with:
- •twin pregnancies
- •lumbar pain
- •rheumatic or other serious disease
- •non-Swedish-speaking woman
- •those who had had experinced foot manipulation earlier
研究组 & 干预措施
Foot manipulation
Asymmetry of the feet was treated by thrusting of the cuboid bone and the subtalar joint was treated with gapping thrust. Mobilisation of the distal tibia-fibula was repeated 10 times. Home training programs in order to maintain the mobility in the joints were given with morning exercises. Four types of exercises were recommended: 1) Foot training with pro-and supination of the feet from dorsal to plantar flexion. 2)"Caterpillar walk". 3) Training the take off of the great toes along a normal walking line and 4) Mobility of lateral malleoli and the talo-crural joint by dorsal flexion of feet while bending the knees.
干预措施: Foot manipulation (Procedure)
Sham foot manipulation
Sham manipulation included downsizing (a massage technique) the section underneath the heel from back forwards with four grips and palpation of the five metatarsal bones with the patient in the supine position on a psoas pillow. Further, light pressure on the Achilles tendon, with the patient standing against a wall with the feet 40 cm off the wall with bent knees on order to simulate the tibio-fibular mobilisation. Home exercises in the mornings to be repeated 8 times.
干预措施: Sham foot manipulation (Procedure)
结局指标
主要结局
Difference in Pregnancy related pelvic girdle pain and Vorlauf test outcome
时间窗: Before and after treatment at assessments during 6 weeks and three months after childbirth.
Pain reduction: Pain in pelvic girdle,(pain in pelvis, sacroiliac joint (SIJ) and symphysis)during 6 weeks after start of treatment and 3 months after childbirth using VAS a diary with VAS graded from 0 to 100 rating their pain each morning and evening. Vorlauf test: Both posterior superior iliac spines (PSIS) were identified with the patient sitting by a grip underneath the lower edge of the spines. The grip was maintained as the patient rose and the levels of the PSIS were noted. If the levels differed (positive Vorlauf test), the lowest was compensated with a plate measuring 2-5 mm under the corresponding foot after which, the patient bent forward to evaluate Vorlauf. Thwew tests were performed by a physiotherapist blinded to the kind of treatment the woman was exposed to. An asymmetric movement of PSIS indicated a locking of the sacroiliac joint.
次要结局
- Change in number of days of Sick leave(Before and after treatment at assessments during 6 weeks.)