Foot Manipulation for Pregnancy Related Pelvic Girdle Pain

NCT ID: NCT01894009

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-10-31

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Foot manipulation

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.

Group Type: ACTIVE_COMPARATOR

Foot manipulation

Intervention Type: 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.

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 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.

Group Type: SHAM_COMPARATOR

Sham foot manipulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camilla Melkersson, Physiother

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Närhälsan Tibro Rehabmottagningen, Centrumgatan 11-17

Tibro, , Sweden

Countries

Sweden

Other Identifiers

VGFOUSKB-43121

Identifier Type: -

Identifier Source: org_study_id