Foot Manipulation for Pregnancy Related Pelvic Girdle Pain

NCT01894009 | Completed

• 1 other identifier: VGFOUSKB-43121
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Osteopathic manipulation; Exercise therapy; Pregnancy pelvic girdle pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in number of days of Sick leave

  Before and after treatment at assessments during 6 weeks.

Study Arms (2)

Foot manipulation

ACTIVE COMPARATOR

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.

Procedure: Foot manipulation

Sham foot manipulation

SHAM COMPARATOR

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.

Procedure: Sham foot manipulation

Interventions

Foot manipulation PROCEDURE

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.

Foot manipulation

Sham foot manipulation PROCEDURE

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.

Sham foot manipulation

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with suspected PPGP were referred by midwifes or physicians or contacted the physiotherapists directly.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Närhälsan Tibro Rehabmottagningen, Centrumgatan 11-17

Tibro, S-54381, Sweden

Location

Study Officials

• Camilla Melkersson, Physiother

  R&D Centre, Skaraborg Primary Care, Skövde, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: July 9, 2013
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 5, 2021

Record last verified: 2013-07

Locations

SE (1)