Evaluating the use of support shorts to manage chronic pelvic girdle pain in women following pregnancy

Not Applicable

Completed

Conditions: Chronic pelvic girdle pain following pregnancy
Pregnancy and Childbirth

Registration Number: ISRCTN67232113

Lead Sponsor: Royal Cornwall Hospital Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 24

Inclusion Criteria

1. Women aged greater than or equal to 18 years
2. Able and willing to provide informed consent
3. Self-reported persistent pelvic girdle pain (PGP) (=3 months postpartum)
4. Self-reported severe PGP (causing walking or stair climbing to be bothersome)
5. Diagnosed with PGP in line with European guidelines
6. PGP must have started or been aggravated during pregnancy, as determined by self report

Exclusion Criteria

1. Known allergy to lycra
2. Age <18 years
3. Currently pregnant
4. PGP for >2 years post partum
5. Self reported history of pathologies causative of lumbopelvic pain (e.g. Infection, trauma, cancer)
6. Participating in concurrent interventional research which may over-burden the patient or confound data collection
7. There are no special arrangements made for participants who are unable to adequately understand verbal and/or written English. There is no intention to exclude patients, therefore, if they have regular access to a friend or family member who is able to translate for them they would be able to participate
8. Participants who lack capacity to provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity in four categories (worst level of pelvic pain during the day, average level of pelvic pain during the day, worst level of pelvic pain during the night, average level of pelvic pain during the night) measured using the Numerical Rating of Pain Scale (NRPS) questionnaire at baseline then fortnightly for 24 weeks

Secondary Outcome Measures

Name	Time	Method
1. Symptoms and function assessed using the pelvic girdle questionnaire (PGQ) at baseline, 12 and 24 weeks<br>2. Quality of life assessed using EQ5D5L at baseline, 12 and 24 weeks<br>3. Quality of life assessed using SF36v2 at baseline, 12 and 24 weeks<br>4. Incontinence assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at baseline, 12 and 24 weeks<br>5. Depression assessed using the Edinburgh Postnatal Depression Scale (EPDS) at baseline, 12 and 24 weeks <br>6. Kinesiophobia/fear of movement assessed using Tamp Scale Kinesiophobia (TSK) at baseline, 12 and 24 weeks <br>7. Body perception assessed using Freemantle Back Awareness Questionnaire (FreBAQ) at baseline, 12 and 24 weeks <br>8. Resource use assessed using health resource use questionnaire at baseline, 12 and 24 weeks