NCT01894009

Foot Manipulation for Pregnancy Related Pelvic Girdle Pain

Effect of Foot Manipulation for Relief of Pregnancy Related Pelvic Girdle Pain. A Randomised Clinical Trial in Primary Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
PROCEDURE	Foot manipulation	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.
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. Sham manipulations were repeated 10 times. This group was also recommended home exercises in the mornings.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2013-07-09
• Last updated: 2021-02-05

Locations

1 site across 1 country: Sweden