Foot Manipulation for Pregnancy Related Pelvic Girdle Pain

Pregnancy Clinical Trial

— PPGP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894009
• Other study ID #: VGFOUSKB-43121
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: October 2011

Study information

• Verified date: July 2013
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Girdle Pain
• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Närhälsan Tibro Rehabmottagningen, Centrumgatan 11-17	Tibro

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Pregnancy related pelvic girdle pain and Vorlauf test outcome	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.	Before and after treatment at assessments during 6 weeks and three months after childbirth.
Secondary	Change in number of days of Sick leave	Sick leave: During 6 weeks after start of treatment and 3 months after childbirth using a diary in which they indicated whether they were on sick leave 25%, 50%, 75% or 100% of full time. Net days of sick leave were calculated as the number of days multiplied with the degree of sick leave.	Before and after treatment at assessments during 6 weeks.