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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18947338
Publication citations
-
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.