Clinical Trial: Trial for the Treatment of Pelvic and Back Pain in Pregnancy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomised Controlled Trial for the Treatment of Pelvic Girdle Pain in Pregnancy

Brief Summary: The investigators aim to conduct a prospective open label randomized controlled trial to test the hypothesis that following initial assessment by a physiotherapist, group care exercise class is as effective in reducing pain as individual physiotherapy care.

Detailed Summary:

Back pain is reported to affect at least 75% of women at some stage during their pregnancy. In the United States one review found that approximately a third of women find back pain in pregnancy a severe problem. It has been reported that 20% of all pregnant women suffer from the condition to such an extent that they require medical help. Six years after pregnancy, problems remain in about 7% of women with PGP, causing severe disability and reducing ability to work. The increase in back pain in pregnancy occurs most likely as a result of the natural underlying posture deviations been accentuated in pregnancy. Anterior displacement of the sacrum, posterior displacement of the trunk and a significant increase in the anterior tilt of the pelvis results in exaggerated lordosis of the lower back.

Stretching, weakness, and separation of abdominal muscles further impede neutral posture and place even more strain on paraspinal muscles. Joint laxity in the anterior and posterior longitudinal ligaments of the lumbar spine puts strain on the lumbar spine and there is widening and increased mobility of the sacroiliac joints and pubic symphysis to facilitate the baby's passage through the birth canal.

A significant cause of back pain in pregnancy appears to result from pelvic girdle pain (PGP). Back pain in pregnancy is more common in women with pre-existing back pain, back pain in a previous pregnancy, advanced maternal age and multiparity. Despite the high incidence of back pain in pregnancy (75% of women attending antenatal clinics at Cork University Maternity Hospital) only a fraction of women (25% in the same audit) report back pain to their health care providers presumably due to their perception that there are minimal interventions for the safe treatment of back pain in pregnancy. Similar results have been shown in other studies.
Sponsor: University College Cork

Current Primary Outcome: A reduction in the current intensity of PGP related to motion on a 100-point Visual analogue score (VAS). [ Time Frame: VAS recorded twice daily every morning and evening by the patient beginning at initial assessement (week one) and continuing until 1 week following the course of treatment. (week 5 for individual care group and week 6 for group treatment group) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Admission to hospital with PGP [ Time Frame: From initial assessment and diagnosis until delivery. ]
  • Frequency of sick leave from work due to PGP [ Time Frame: From initial assessment and diagnosis to delivery. ]
  • Representation at the physiotherapy department during the trial period. [ Time Frame: While receiving treatment which the patient has been randomized to.(from week 1 to week 5 for individual care group and week 6 for group treatment group) ]
  • Representation at the physiotherapy department [ Time Frame: After the trial treatment period prior to delivery. (week 5 for individual care group and week 6 for group treatment group) ]
  • Number of patients requiring the combination of crutches and Tubigrip ® (elasticated tubular support bandage). [ Time Frame: During the antenatal period. ]
  • Number of patients induced or delivered earlier than their estimated date of delivery due to severe PGP. [ Time Frame: During course of current pregnancy ]
  • Patient satisfaction measured via the CSQ-18B [ Time Frame: Following the third treatment session i.e. 4 weeks following initial assessment and randomization. ]
  • Patient specific functional scale (PSFS). [ Time Frame: This will be measured at initial assessment and following the third treatment i.e. 4 weeks following initial assessment and randomization. ]
  • Active straight leg raise. [ Time Frame: This will be measured at initial assessment and following the third treatment i.e. 4 weeks following initial assessment and randomization. ]
  • Gestational age at delivery [ Time Frame: During current pregnancy ]
  • Birthweight at delivery. [ Time Frame: During current pregnancy ]
  • Mode of delivery: Either normal vaginal delivery, instrumental delivery or caesarean section. [ Time Frame: During current pregnancy ]


Original Secondary Outcome: Same as current

Information By: University College Cork

Dates:
Date Received: January 27, 2009
Date Started: April 2009
Date Completion: September 2010
Last Updated: January 27, 2009
Last Verified: January 2009