Clinical trial NCT01894009: Foot Manipulation for Pregnancy Related Pelvic Girdle Pain
Official title: Effect of Foot Manipulation for Relief of Pregnancy Related Pelvic Girdle Pain. A Randomised Clinical Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Osteopathic manipulation
Exercise therapy
Pregnancy pelvic girdle pain
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2013-07-09
Enrollment: 97
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Women with:

* twin pregnancies
* lumbar pain
* rheumatic or other serious disease
* non-Swedish-speaking woman
* those who had had experinced foot manipulation earlier

Primary outcomes:
measure: Difference in Pregnancy related pelvic girdle pain and Vorlauf test outcome
timeFrame: Before and after treatment at assessments during 6 weeks and three months after childbirth.
Secondary outcomes:
measure: Change in number of days of Sick leave
timeFrame: Before and after treatment at assessments during 6 weeks.
Other outcomes:
Locations:
city: Tibro
country: Sweden
facility: Närhälsan Tibro Rehabmottagningen, Centrumgatan 11-17
Study officials:
affiliation: R&D Centre, Skaraborg Primary Care, Skövde, Sweden
name: Camilla Melkersson, Physiother
role: PRINCIPAL_INVESTIGATOR
References: