Trial for the Treatment of Pelvic and Back Pain in Pregnancy

NCT00830934 | Unknown DMC

• 1 other identifier: GRIP1
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Girdle Pain; Symphysio Pubic Dysfunction

Keywords

pelvic girdle pain; symphysio pubic dysfunction; group care; individual care

Outcome Measures

Primary Outcomes (1)

• A reduction in the current intensity of PGP related to motion on a 100-point Visual analogue score (VAS).

  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

  From initial assessment and diagnosis until delivery.

• Frequency of sick leave from work due to PGP

  From initial assessment and diagnosis to delivery.

• Representation at the physiotherapy department during the trial period.

  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

  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).

  During the antenatal period.

Study Arms (2)

Individual care

ACTIVE COMPARATOR

The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes.

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.

Procedure: group care

Interventions

Individual care PROCEDURE

The first treatment group (individual care group) will involve 3 sessions held weekly. Each session will last approximately 45 minutes.

Individual care

group care PROCEDURE

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.

Group care

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• It is recommended that a pain history be taken with specific attention paid to pain patterns and irritability of PGP.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Maternity Hospital

Cork, Cork, Ireland

Location

Related Publications (18)

• 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.

  PMID: 8882692 BACKGROUND

• Ostgaard 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.

  PMID: 9431631 BACKGROUND

• Foti T, Davids JR, Bagley A. A biomechanical analysis of gait during pregnancy. J Bone Joint Surg Am. 2000 May;82(5):625-32.

  PMID: 10819273 BACKGROUND

• Gilleard 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.

  PMID: 12421168 BACKGROUND

• Marnach 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.

  PMID: 12576258 BACKGROUND

• Pennick 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.

  PMID: 17443503 BACKGROUND

• Elden 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.

  PMID: 18947338 BACKGROUND

• Elden 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.

  PMID: 15778231 BACKGROUND

• Vleeming 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.

  PMID: 18259783 BACKGROUND

• Bijur 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.

  PMID: 11733293 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16390703 BACKGROUND

• Gallagher 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.

  PMID: 11719741 BACKGROUND

• Kelly 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.

  PMID: 9835471 BACKGROUND

• Ostgaard 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.

  PMID: 8009346 BACKGROUND

• Laslett M, Young SB, Aprill CN, McDonald B. Diagnosing painful sacroiliac joints: A validity study of a McKenzie evaluation and sacroiliac provocation tests. Aust J Physiother. 2003;49(2):89-97. doi: 10.1016/s0004-9514(14)60125-2.

  PMID: 12775204 BACKGROUND

• Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.

  PMID: 11304107 BACKGROUND

• Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.

  PMID: 11323066 BACKGROUND

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Central Study Contacts

Richard A Greene, M.D.

CONTACT

+353214920500; R.Greene@ucc.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

IE (1)