Foot Manipulation for Pregnancy Related Pelvic Girdle Pain
Condition: Pregnancy
MeSH terms: Pelvic Girdle Pain
Study type: Interventional

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.
    

Intervention name(s): Foot manipulation; Sham foot manipulation
Intervention type(s): Procedure; Procedure
Intervention description(s): The subtalar joint was treated with gapping thrust with patient lying on the contra-lateral side. Mobilisation of the distal tibia-fibula was performed with the patient squatting and was repeated 10 times. Home training programs in order to maintain the mobility in the joints were given.; 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. Sham manipulations were repeated 10 times. This group was also recommended home exercises in the mornings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteopathic manipulation; Exercise therapy; Pregnancy pelvic girdle pain