An interventional study of Individual care and group care in Pelvic Girdle Pain and Symphysio Pubic Dysfunction, sponsored by University College Cork. Status unknown at 1 site in Ireland. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-01-28.
Sponsored by University College Cork · Not applicable, Interventional, and Treatment
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.
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.
A Cochrane review on interventions for preventing and treating pelvic and back pain in pregnancy republished in October 2008 found no studies dealing specifically with prevention of back or pelvic pain in pregnancy. They included eight studies (1305 participants) that examined the effects of adding various pregnancy-specific exercises, physiotherapy, acupuncture and pillows compared with usual prenatal care. They concluded that all but one study had moderate to high potential for bias. Adding pregnancy specific exercises, physiotherapy or acupuncture to usual prenatal care appears to relieve back or pelvic pain more than usual prenatal care alone, although the effects appear small. Recent trials investigating the effect of acupuncture on PGP concluded that acupuncture and stabilising exercises constitute efficient complements to standard treatment for the management of PGP in pregnancy but acupuncture alone has no significant effect on pain or on the degree of sick leave compared with non penetrating sham acupuncture.
The pain of PGP is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints. The endurance capacity for standing, walking and sitting is diminished. Diagnosis can only be reached after exclusion of lumbar causes and this diagnosis should be based on a medical history, a physical standardised examination with specific clinical tests that reproduce pain in the pelvic girdle.
The European guidelines state that available evidence is insufficient to recommend any particular treatment modality.
55 studies on the registry are indexed under Pelvic Girdle Pain; 12 are open to participants now.
This study's planned enrollment of 226 is above the median of 57 across 39 interventional studies indexed under Pelvic Girdle Pain.
Browse Pelvic Girdle Pain studies →University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sacroiliac joint assessment
Pain history (according to the criteria of Ostgaard)
7.It is recommended that a pain history be taken with specific attention paid to pain patterns and irritability of PGP.
8.There must be no nerve root syndrome. 9.The severity of pain must be related to motion.
Exclusion Criteria:
The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes.
Procedure: Individual care
The second treatment group (group care group) will be assigned to weekly group exercise classes, focusing on core stability and strengthening exercises. Classes will last one hour and will be conducted for 4 weeks. In both treatment groups pain scores will be followed up for 1 week post last treatment.
Procedure: group care
The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes.
The second treatment group (group care group) will be assigned to weekly group exercise classes, focusing on core stability and strengthening exercises. Classes will last one hour and will be conducted for 4 weeks. In both treatment groups pain scores will be followed up for 1 week post last treatment.
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)
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
This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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University College Cork