Complementary and Alternative Medicine (CAM) for the management of low back and/or pelvic pain (LBPP) in pregnancy

Complementary and Alternative Medicine (CAM) as an addition to usual care for the management of low back and/or pelvic pain in pregnancy: A feasibility randomised controlled trial (RCT) investigating the effectiveness of reflexology as an addition to usual care for the management of low back and/or pelvic pain (LBPP) in the third trimester of pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26607527

Enrollment

Registered

2012-12-06

Start date

2012-07-01

Completion date

Unknown

Last updated

2018-07-30

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

Conditions

Low back and/or pelvic pain in pregnancy Pregnancy and Childbirth Low back pain

Interventions

Three groups in the study, reflexology (intervention), footbath (sham) and usual care only (control) Reflexology and footbaths will be administered once a week over a 6 week period and will last a m

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. First time pregnant women 2.18 years of age or older 3. Presence of low back pain and/or pelvic pain 4. 20-29 weeks gestation 5. Able to understand written and verbal English

Exclusion criteria

Exclusion criteria: 1. Women pregnant with more than one baby 2. Smokers 3. Women with neurological diseases 4. Deep Vein Thrombosis (DVT) sufferers 5. Women with fungal foot infections or verrucae 6. Women currently using CAM therapies 7. Placenta Previa (low lying Placenta) Grade 3 or 4 8. Women already participating in a research study 9. Women with any serious spinal pathology e.g. cancer, Cauda Equina, infection in the spine 10. Those in a previous road traffic accident which resulted in LBPP or unresolved symptoms

Design outcomes

Primary

Measure	Time frame
Pain - using a 0-10 visual analogue scale where 0= no pain and 10 = worst pain possible, at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery	—

Secondary

Measure	Time frame
1. Back specific function using the Roland Morris Disability Questionnaire at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery 2. Quality of life using The Pregnancy Mobility Index at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery 3. Type of pain using the McGill Pain Questionnaire at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery 4. Stress and anxiety using The State Trait Anxiety Inventory at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery	—

Measure

Time frame

1. Back specific function using the Roland Morris Disability Questionnaire at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery 2. Quality of life using The Pregnancy Mobility Index at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery 3. Type of pain using the McGill Pain Questionnaire at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery 4. Stress and anxiety using The State Trait Anxiety Inventory at baseline, end of 6 week intervention period, 6 weeks and 6 months post delivery

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026