Acupuncture as a complement to standard treatment for the treatment of well-defined pelvic girdle pain in pregnant women
| ISRCTN | ISRCTN11374571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11374571 |
| Secondary identifying numbers | VGFOUREG-5463 |
- Submission date
- 22/05/2006
- Registration date
- 20/06/2006
- Last edited
- 29/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen Elden
Scientific
Scientific
The Sahlgrenska Academy
The University of Gothenburg
Institute of Health and Care Sciences
Box 457
Göteborg
405 30
Sweden
Study information
| Study design | Single-blind, randomised controlled interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | ethics approval received from the Regional Ethics Committee in Gothenburg on the 20th February 2006 (ref: 059-06). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2006 |
| Completion date | 15/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 120 |
| Key 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 |
| Key exclusion criteria | 1. Acupuncture experience 2. Other pain conditions 3. Systemic disorders 4. Contraindications to treatment |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 15/05/2007 |
Locations
Countries of recruitment
- Sweden
Study participating centre
The Sahlgrenska Academy,
Göteborg
405 30
Sweden
405 30
Sweden
Sponsor information
University of Gothenburg (Sweden)
University/education
University/education
KK East Hospital
Göteborg
416 85
Sweden
| Website | http://www.fou.nu/is/vgregion/ansokan/5463 |
|---|---|
"ROR" |
https://ror.org/01tm6cn81 |
Funders
Funder type
Government
The Health and Medical Care Committee of the Region of Västra Götaland (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2008 | Yes | No |
