Trial for the Treatment of Pelvic and Back Pain in Pregnancy (GRIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University College Cork.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University College Cork
ClinicalTrials.gov Identifier:
NCT00830934
First received: January 27, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Pelvic Girdle Pain
Symphysio Pubic Dysfunction
Procedure: Individual care
Procedure: group care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial for the Treatment of Pelvic Girdle Pain in Pregnancy

Resource links provided by NLM:


Further study details as provided by University College Cork:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Admission to hospital with PGP [ Time Frame: From initial assessment and diagnosis until delivery. ] [ Designated as safety issue: No ]
  • Frequency of sick leave from work due to PGP [ Time Frame: From initial assessment and diagnosis to delivery. ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Number of patients requiring the combination of crutches and Tubigrip ® (elasticated tubular support bandage). [ Time Frame: During the antenatal period. ] [ Designated as safety issue: No ]
  • Number of patients induced or delivered earlier than their estimated date of delivery due to severe PGP. [ Time Frame: During course of current pregnancy ] [ Designated as safety issue: No ]
  • Patient satisfaction measured via the CSQ-18B [ Time Frame: Following the third treatment session i.e. 4 weeks following initial assessment and randomization. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Gestational age at delivery [ Time Frame: During current pregnancy ] [ Designated as safety issue: No ]
  • Birthweight at delivery. [ Time Frame: During current pregnancy ] [ Designated as safety issue: No ]
  • Mode of delivery: Either normal vaginal delivery, instrumental delivery or caesarean section. [ Time Frame: During current pregnancy ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: April 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Individual care
The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes.
Procedure: Individual care
The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes.
Experimental: Group 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 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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

    1. Posterior pelvic pain provocation test (P4)
    2. Gaenslen´s test.
    3. Compression of ASIS
    4. Distraction SIJ pain provocation test
    5. 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.

Exclusion Criteria:

  1. 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.
  2. If women volunteered a history of sexual abuse at any point of the study they would be excluded from the trial.
  3. Women who do not speak English fluently.
  4. Women with non viable pregnancies.
  5. Women who have already received treatment for PGP outside of this trial.
  6. Pregnant women who present who will not be booking at CUMH for their pregnancy or are not resident in the South West of Ireland
  7. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830934

Contacts
Contact: Richard A Greene, M.D. +353214920500 R.Greene@ucc.ie

Locations
Ireland
Cork University Maternity Hospital Not yet recruiting
Cork, Ireland
Contact: Fergus P McCarthy, MD    +353 214920500    Fergus.mccarthy@ucc.ie   
Sponsors and Collaborators
University College Cork
  More Information

Publications:
Stratford, 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

Responsible Party: Professor Richard A Greene, Cork University Maternity Hospital
ClinicalTrials.gov Identifier: NCT00830934     History of Changes
Other Study ID Numbers: GRIP1
Study First Received: January 27, 2009
Last Updated: January 27, 2009
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by University College Cork:
pelvic girdle pain
symphysio pubic dysfunction
group care
individual care

Additional relevant MeSH terms:
Pelvic Girdle Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Pelvic Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014