NCT00974103

Brief Summary

The purpose of this study is to identify how many females have persistent low back pain and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can continue in the study and be examined by a chiropractor. They will then divide the females into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain will be invited to participate in a randomised controlled study where chiropractic intervention is compared to exercises.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

11 months

First QC Date

September 9, 2009

Last Update Submit

August 31, 2012

Conditions

Pelvic Girdle Pain Post PartumLow Back Pain Post Partum

Keywords

low back painpelvic painpelvic girdle painpost partum

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index

    20 weeks after the initial assessment

Study Arms (2)

Chiropractic treatment, exercise

EXPERIMENTAL

Chiropractic treatment and exercise

Other: chiropractic treatment and exercises

Exercises

EXPERIMENTAL

Exercise advise

Other: exercise advise

Interventions

exercise adviseOTHER

Exercises

Also known as: Pregnancy, Back pain, Exercise, Post partum, chiropractic
Exercises
chiropractic treatment and exercisesOTHER

Manipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments

Also known as: Manipulation, Pregnancy, Back pain, Exercise, Post partum, chiropractic
Chiropractic treatment, exercise

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Low back and\\or pelvic girdle pain during pregnancy
  • Fluent understanding of spoken and written Norwegian

You may not qualify if:

  • hospitalisation due to pain or complications post partum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger university hospital

Stavanger, 4011, Norway

Location

MeSH Terms

Conditions

Low Back PainPelvic PainPelvic Girdle Pain

Interventions

PregnancyExercisePostpartum PeriodManipulation, Chiropractic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMusculoskeletal Pain

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMusculoskeletal ManipulationsComplementary TherapiesTherapeutics

Study Officials

  • Jan P Larsen, MD Dr med

    Helse Stavanger HF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

NO(1)