Condition category
Pregnancy and Childbirth
Date applied
22/05/2006
Date assigned
20/06/2006
Last edited
29/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Elden

ORCID ID

Contact details

The Sahlgrenska Academy
The University of Gothenburg
Institute of Health and Care Sciences
Box 457
Göteborg
405 30
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VGFOUREG-5463

Study information

Scientific title

Acronym

Study hypothesis

Pelvic girdle pain generally arises in relation to pregnancy, trauma or reactive arthritis. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints. The pain may radiate in the posterior thigh and can occur in conjunction with or separately in the symphysis. The endurance capacity for standing, walking, and sitting is diminished. After pregnancy, problems are serious in about 7%, causing severe discomfort and reducing ability to work.

Null hypothesis: there is no difference in efficacy of acupuncture with penetrating needles or non-penetrating needles as an adjunct to standard treatment for the treatment of pelvic girdle pain in pregnant women.

Alternative hypothesis: there is a difference in efficacy of acupuncture with penetrating needles or non-penetrating needles as an adjunct to standard treatment for the treatment of pelvic girdle pain in pregnant women.

Ethics approval

ethics approval received from the Regional Ethics Committee in Gothenburg on the 20th February 2006 (ref: 059-06).

Study design

Single-blind, randomised controlled interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Well-defined pelvic girdle pain

Intervention

An independent specially trained physiotherapist will assess patients who are eligible and willing to participate in the study. This assessment will include a detailed standardized physical examination and collection of baseline data. The tests that will be used are the posterior pelvic pain provocation test, the active straight leg test, Patrick's or FABERE test, a modified Trendelenburg's test, Lasegue test and palpation of the symphysis pubis.

The study will comprise a one-week baseline period, eight weeks of treatment and follow up of the independent examiner within one week after the last treatment. All participants will get standard treatment as well as acupuncture. Standard treatment consists of general information about the condition and anatomy of the back and pelvis. Adequate advice and practice are given with respect to patient activities of daily living. The physiotherapist makes sure that the patient understands and respects the relationship between impairment, load demand, actual loading capacity, and importance of necessary rest. The purpose of this information is to reduce fear and to enable patients to become active in their own treatment. The patients will get a pelvic belt (Puff Igång AB, Sweden) and home programme exercises designed to increase strength in the abdominal and gluteal muscles.

The patients will be randomised to one of two interventions:
Group 1 will get standard treatment plus 12 acupuncture treatments with penetrating needles for eight weeks
Group 2 will get 12 acupuncture treatments with non-penetrating needles for eight weeks

Local acupuncture points will be selected individually after diagnostic palpation to identify sensitive spots. A total of 10 segmental points and 7 extra-segmental points will be used. The penetrating needles (Hegu: Hegu AB, Landsbro, Sweden) or the non-penetrating needles (Asiamed GmbH & Co., Konrad Streitberger is the developer) are made of stainless steel (Ø0.30). The penetrating needle is inserted intramuscularly to a depth of 15-70 mm to evoke needle sensation, described as tension, numbness and often a radiating sensation from the point of insertion, reflecting activation of muscle-nerve afferents. The Streitberger needle pricks the skin but it does not penetrate the skin. Both needles are left in situ for 30 minutes and manually stimulated every ten minutes. Treatment is given twice a week over four weeks and once a week over four weeks. Foetal heart rate, maternal heart rate and blood pressure are monitored before and after all acupuncture treatments.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patient scores the intensity of their present pelvic pain in relation to motion on a 100-point visual analogue scale (VAS) every morning and every evening in the diaries

Secondary outcome measures

1. Function (Oswestery and Disability Rating Index [DRI])
2. Health functioning (EuroQoL questionnaire)
3. Recovery from symptoms as assessed by an independent examiner
4. Every week during the study, the patient is asked if she has been sicklisted during the past week (yes or no). If the answer is yes, a note is then taken on the percentage of times the patient has been sicklisted, either 25%, 50%, 75% or 100%

Overall trial start date

01/06/2006

Overall trial end date

15/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy women who have completed between 12 - 29 weeks of the gestational period
2. Patients must be well integrated in the Swedish language with singleton fetuses
3. Patients should have well defined pregnancy-related pelvic girdle pain
4. Patients must be acupuncture naive
5. They have to have experienced an evening pain (according to the patient-kept diary) of more than 50 mm (visual analogue scale [VAS]) during the baseline week to be eligible

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120

Participant exclusion criteria

1. Acupuncture experience
2. Other pain conditions
3. Systemic disorders
4. Contraindications to treatment

Recruitment start date

01/06/2006

Recruitment end date

15/05/2007

Locations

Countries of recruitment

Sweden

Trial participating centre

The Sahlgrenska Academy,
Göteborg
405 30
Sweden

Sponsor information

Organisation

University of Gothenburg (Sweden)

Sponsor details

KK East Hospital
Göteborg
416 85
Sweden

Sponsor type

University/education

Website

http://www.fou.nu/is/vgregion/ansokan/5463

Funders

Funder type

Government

Funder name

The Health and Medical Care Committee of the Region of Västra Götaland (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18947338

Publication citations

  1. Results

    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, 115, 13, 1655-1668, doi: 10.1111/j.1471-0528.2008.01904.x.

Additional files

Editorial Notes