Pelvic Girdle PainGRIPNCT00830934
Trial for the Treatment of Pelvic and Back Pain in Pregnancy
A study testing Individual care and group care in people with Pelvic Girdle Pain and Symphysio Pubic Dysfunction, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pelvic Girdle Pain, Symphysio Pubic Dysfunction
- What is being tested?
- Individual care and group care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women (primigravida and multigravida) from 20-35 weeks of gestation attending Cork University Maternity Hospital (CUMH) low risk antenatal clinics who are referred to the physiotherapy department by their health care provider or following self referral with back pain or pelvic pain will be assessed for inclusion in the trial.
- Women referred to the physiotherapy department with symptoms of PGP will be assessed on presentation by a one of six departmental physiotherapists specializing in women's health.
- To make the diagnosis of PGP the following tests will be performed as per the European Guidelines on the diagnosis and treatment of Pelvic Girdle Pain and a pain history taken as detailed.
- Sacroiliac joint assessment
- Posterior pelvic pain provocation test (P4)
- Gaenslen´s test.
Show all 14Show fewer
- Compression of ASIS
- Distraction SIJ pain provocation test
- Assessment of Sulci depth in lumbar spine in neutral and extension
- Functional pelvic test 6.Active straight leg raise test (ASLR).
- 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.
- The diagnosis of PGP will be made if the patient has 2 or more of criteria 1-4 (Laslett's criteria) in combination with a negative McKenzie and negative neurological examination. Criteria 5-9 will be performed and assessed to try and improve diagnostic sensitivity and specificity as well as help exclude other pathologies that may cause pelvic and back pain.
Who cannot join
- Women with other pain conditions, history of orthopaedic disease or surgery in the spine or pelvic girdle systemic disorders or if attending the high risk antenatal clinic in CUMH will be excluded from the study.
- If women volunteered a history of sexual abuse at any point of the study they would be excluded from the trial.
- Women who do not speak English fluently.
- Women with non viable pregnancies.
- Women who have already received treatment for PGP outside of this trial.
- Pregnant women who present who will not be booking at CUMH for their pregnancy or are not resident in the South West of Ireland
- Women with a history of severe PGP in previous pregnancies. Severe PGP will be defined as occurring less than 20 weeks gestation in a previous pregnancy or requiring crutches in a previous pregnancy or women with a history of PGP in 2 or more previous pregnancies.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Cork University Maternity Hospital
Cork, Cork
Fergus P McCarthy, MD, +353 214920500, Fergus.mccarthy@ucc.ie
About this study
Official title: Randomised Controlled Trial for the Treatment of Pelvic Girdle Pain in Pregnancy
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.
Read the detailed description
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.
- Conditions
- Pelvic Girdle Pain, Symphysio Pubic Dysfunction
- Being tested
- Individual care, group care
- Keywords
- pelvic girdle pain, symphysio pubic dysfunction, group care, individual care
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual careProcedure or surgery
The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes.
group careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual care | Active comparator | The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes. Receives: Procedure: Individual care |
| Group care | Experimental | 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. Receives: Procedure: group care |
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction in the current intensity of PGP related to motion on a 100-point Visual analogue score (VAS).
Measured: 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)
Secondary outcomes (12)
Admission to hospital with PGP
Measured: From initial assessment and diagnosis until delivery.
Frequency of sick leave from work due to PGP
Measured: From initial assessment and diagnosis to delivery.
Representation at the physiotherapy department during the trial period.
Measured: 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
Measured: 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).
Measured: During the antenatal period.
Number of patients induced or delivered earlier than their estimated date of delivery due to severe PGP.
Measured: During course of current pregnancy
Patient satisfaction measured via the CSQ-18B
Measured: Following the third treatment session i.e. 4 weeks following initial assessment and randomization.
Patient specific functional scale (PSFS).
Measured: 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.
Measured: 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
Measured: During current pregnancy
Birthweight at delivery.
Measured: During current pregnancy
Mode of delivery: Either normal vaginal delivery, instrumental delivery or caesarean section.
Measured: During current pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830934
- Sponsor's protocol ID
- GRIP1
- Acronym
- GRIP
- Status last verified
- Jan 2009
- First submitted
- 27 Jan 2009
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kristiansson P, Svardsudd K, von Schoultz B. Back pain during pregnancy: a prospective study. Spine (Phila Pa 1976). 1996 Mar 15;21(6):702-9. doi: 10.1097/00007632-199603150-00008.
PubMed 8882692Ostgaard HC, Zetherstrom G, Roos-Hansson E. Back pain in relation to pregnancy: a 6-year follow-up. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2945-50. doi: 10.1097/00007632-199712150-00018.
PubMed 9431631Foti T, Davids JR, Bagley A. A biomechanical analysis of gait during pregnancy. J Bone Joint Surg Am. 2000 May;82(5):625-32.
PubMed 10819273Gilleard W, Crosbie J, Smith R. Effect of pregnancy on trunk range of motion when sitting and standing. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1011-20. doi: 10.1034/j.1600-0412.2002.811104.x.
PubMed 12421168Marnach ML, Ramin KD, Ramsey PS, Song SW, Stensland JJ, An KN. Characterization of the relationship between joint laxity and maternal hormones in pregnancy. Obstet Gynecol. 2003 Feb;101(2):331-5. doi: 10.1016/s0029-7844(02)02447-x.
PubMed 12576258Pennick VE, Young G. Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001139. doi: 10.1002/14651858.CD001139.pub2.
PubMed 17443503Elden H, Fagevik-Olsen M, Ostgaard HC, Stener-Victorin E, Hagberg H. Acupuncture as an adjunct to standard treatment for pelvic girdle pain in pregnant women: randomised double-blinded controlled trial comparing acupuncture with non-penetrating sham acupuncture. BJOG. 2008 Dec;115(13):1655-68. doi: 10.1111/j.1471-0528.2008.01904.x. Epub 2008 Oct 15.
PubMed 18947338Elden H, Ladfors L, Olsen MF, Ostgaard HC, Hagberg H. Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial. BMJ. 2005 Apr 2;330(7494):761. doi: 10.1136/bmj.38397.507014.E0. Epub 2005 Mar 18.
PubMed 15778231Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.
PubMed 18259783Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
PubMed 11733293Stratford, P., Gill, C., Westaway, M., & Binkley, J., Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada, 47, 258-263. 1995
Leadbetter RE, Mawer D, Lindow SW. The development of a scoring system for symphysis pubis dysfunction. J Obstet Gynaecol. 2006 Jan;26(1):20-3. doi: 10.1080/01443610500363915.
PubMed 16390703Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
PubMed 11719741Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.
PubMed 9835471Ostgaard HC, Zetherstrom G, Roos-Hansson E, Svanberg B. Reduction of back and posterior pelvic pain in pregnancy. Spine (Phila Pa 1976). 1994 Apr 15;19(8):894-900. doi: 10.1097/00007632-199404150-00005.
PubMed 8009346
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial for the Treatment of Pelvic Girdle Pain in Pregnancy
- ClinicalTrials.gov ID
- NCT00830934
- Acronym / sponsor ID
- GRIP / GRIP1
- Conditions
- Pelvic Girdle Pain, Symphysio Pubic Dysfunction
- Keywords
- pelvic girdle pain, symphysio pubic dysfunction, group care, individual care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual care | Active comparator | Procedure: Individual careThe first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes. |
| Group care | Experimental | Procedure: group careThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Pregnant women (primigravida and multigravida) from 20-35 weeks of gestation attending Cork University Maternity Hospital (CUMH) low risk antenatal clinics who are referred to the physiotherapy department by their health care provider or following self referral with back pain or pelvic pain will be assessed for inclusion in the trial.
- Women referred to the physiotherapy department with symptoms of PGP will be assessed on presentation by a one of six departmental physiotherapists specializing in women's health.
- To make the diagnosis of PGP the following tests will be performed as per the European Guidelines on the diagnosis and treatment of Pelvic Girdle Pain and a pain history taken as detailed.
- Sacroiliac joint assessment
- Functional pelvic test 6.Active straight leg raise test (ASLR).
Key exclusion criteria (7 listed)
- Women with other pain conditions, history of orthopaedic disease or surgery in the spine or pelvic girdle systemic disorders or if attending the high risk antenatal clinic in CUMH will be excluded from the study.
- If women volunteered a history of sexual abuse at any point of the study they would be excluded from the trial.
- Women who do not speak English fluently.
- Women with non viable pregnancies.
- Women who have already received treatment for PGP outside of this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual careThe first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes. | Procedure or surgery | Individual care |
| group careThe 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 or surgery | Group care |
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)
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
- Background: PubMed 8882692Kristiansson P, Svardsudd K, von Schoultz B. Back pain during pregnancy: a prospective study. Spine (Phila Pa 1976). 1996 Mar 15;21(6):702-9. doi: 10.1097/00007632-199603150-00008.
- Background: PubMed 9431631Ostgaard HC, Zetherstrom G, Roos-Hansson E. Back pain in relation to pregnancy: a 6-year follow-up. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2945-50. doi: 10.1097/00007632-199712150-00018.
- Background: PubMed 10819273Foti T, Davids JR, Bagley A. A biomechanical analysis of gait during pregnancy. J Bone Joint Surg Am. 2000 May;82(5):625-32.
- Background: PubMed 12421168Gilleard W, Crosbie J, Smith R. Effect of pregnancy on trunk range of motion when sitting and standing. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1011-20. doi: 10.1034/j.1600-0412.2002.811104.x.
- Background: PubMed 12576258Marnach ML, Ramin KD, Ramsey PS, Song SW, Stensland JJ, An KN. Characterization of the relationship between joint laxity and maternal hormones in pregnancy. Obstet Gynecol. 2003 Feb;101(2):331-5. doi: 10.1016/s0029-7844(02)02447-x.
- Background: PubMed 17443503Pennick VE, Young G. Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001139. doi: 10.1002/14651858.CD001139.pub2.
- Background: PubMed 18947338Elden H, Fagevik-Olsen M, Ostgaard HC, Stener-Victorin E, Hagberg H. Acupuncture as an adjunct to standard treatment for pelvic girdle pain in pregnant women: randomised double-blinded controlled trial comparing acupuncture with non-penetrating sham acupuncture. BJOG. 2008 Dec;115(13):1655-68. doi: 10.1111/j.1471-0528.2008.01904.x. Epub 2008 Oct 15.
- Background: PubMed 15778231Elden H, Ladfors L, Olsen MF, Ostgaard HC, Hagberg H. Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial. BMJ. 2005 Apr 2;330(7494):761. doi: 10.1136/bmj.38397.507014.E0. Epub 2005 Mar 18.
- Background: PubMed 18259783Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.
- Background: PubMed 11733293Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
- BackgroundStratford, P., Gill, C., Westaway, M., & Binkley, J., Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada, 47, 258-263. 1995
- Background: PubMed 16390703Leadbetter RE, Mawer D, Lindow SW. The development of a scoring system for symphysis pubis dysfunction. J Obstet Gynaecol. 2006 Jan;26(1):20-3. doi: 10.1080/01443610500363915.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual care and group care in people with Pelvic Girdle Pain and Symphysio Pubic Dysfunction, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard A Greene, M.D. (+353214920500, R.Greene@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830934, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.