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

January 27, 2009 updated by: University College Cork

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Richard A Greene, M.D.
  • Phone Number: +353214920500
  • Email: R.Greene@ucc.ie

Study Locations

  • Ireland
      • Cork, Ireland
        • Cork University Maternity Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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 Outcome Measures

Outcome Measure
Time Frame
Admission to hospital with PGP
Time Frame: From initial assessment and diagnosis until delivery.
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.
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)
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)
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.
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
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.
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.
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.
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
During current pregnancy
Birthweight at delivery.
Time Frame: During current pregnancy
During current pregnancy
Mode of delivery: Either normal vaginal delivery, instrumental delivery or caesarean section.
Time Frame: During current pregnancy
During current pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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