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Craniosacral therapy as a complement to standard treatment for the treatment of well-defined pelvic girdle pain in pregnant women

Craniosacral therapy as a complement to standard treatment for the treatment of well-defined pelvic girdle pain in pregnant women: a randomised single-blind controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30566933
Enrollment
120
Registered
2009-09-03
Start date
2009-08-24
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic girdle pain Signs and Symptoms Pain

Interventions

An independent specially trained physiotherapist will assess patients who are eligible and willing to participate in the study. This assessment will include a detailed standardised physical examinatio

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Healthy women with singleton fetuses who have completed between 12 - 28 weeks of the gestational period 2. Patients must be cranio-sacral therapy naive 2. Patients must be well integrated in the Swedish language 3. Patients should have well defined pregnancy-related pelvic girdle pain according to the European Guidelines of diagnosis and treatment of Pelvic Girdle Pain 4. They have to have experienced an evening pain (according to the patient-kept diary) of more than 40 mm (visual analogue scale [VAS]) during the baseline week to be eligible

Exclusion criteria

Exclusion criteria: 1. Cranio-sacral therapy experience 2. Other pain conditions 3. Systemic disorders

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Function (Oswestery and Disability Rating Index [DRI] will be measured before screening and at follow-up within one week after end of treatment 2. Health functioning (EuroQoL questionnaire) will be measured at screening and at follow-up within one week after end of treatment 3. Discomfort of PGP on a 100-point visual analogue scale (VAS) will be measured at screening and at follow-up within one week after end of treatment 4. Recovery from symptoms as assessed by an independent examiner will be measured at follow-up within one week after end of treatment 5. 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% . 6. (Amended 12/04/2011) Open-ended interviews will be conducted with some of the women and their partners during the treatment period. and after delivery. This part of the study will be focused of the womens experiences of living with PGP and their experience of getting CST. Their partners will be interviewed of their experiences of living with a women with PGP.They will be re-interwieved after delivery. Then the women will be asked to describe how they experienced PGP during their pregnancies, and their experiences of receiving CST. Consequently, the partners will be asked to describe their lived experiences regarding everyday life with their pregnant partner, and their opinions of CST for PGP. 7. Credibility of the interventions will be evaluated after two weeks of treatment. An item adapted from previous literature will be used. Previous secondary outcome measure: 6. Open-ended interviews will be conducted with some of the women and their partners during the treatment period. This part of the study will be focused of the womens experiences of living with pelvic girdle pain and their experience of getting cranio-sacral therapy. Their partners will be interviewed of

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026