Ciropractic Care and Pregnant Women

Not Applicable

Completed

• Conditions: Pregnancy Related; Pain, Back; Sleep; Quality of Life
• Interventions: Procedure: Chiropractic adjustments

• Registration Number: NCT04919278
• Lead Sponsor: Barcelona College of Chiropractic

Brief Summary

Objective: The aim of this study is to investigate the effectiveness of Chiropractic care on pain, quality of life and sleep in pregnant women compared to a control group.

The study is designed as non-randomized controlled trial. Forty-two pregnant women at least on the 14th week of gestation will be included. Control group will include women receiving regular care, but no chiropractic care. Care will extend for 4 weeks.

Outcomes measures include sleep quality, pain and quality of life questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2018-05-10
• Study Completion: 2018-06-15
• Status Verified: 2021-06
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Last Update Submitted: 2021-06-04
• Study First Posted: 2021-06-09
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• pregnant women over the age of 18
• of at least 14 weeks gestation,
• with a good understanding of English, Spanish or French.

Exclusion Criteria

• women over the age of 45,
• pregnancies of more than 35 weeks gestation
• high-risk pregnancies (tobacco, alcohol or substance use, diagnosed medical conditions or high blood pressure).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Chiropractic adjustments	Participants will be evaluated for any health contraindication. Once reviewed they will received full spine chiropractic treatment for 4 weeks, at the rate of one adjustment per week. After three visits they will complete the outcome measures

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	4 weeks	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire, which evaluates sleep quality and disturbances over a period of one month. It is composed of nineteen individual items creating seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction and the total PSQI score.
SF-36 questionnaire Quality of Life	4 weeks	The Short Form-36 Health Survey (SF-36) is one of the most frequently used and evaluated health-related quality of life measures for pregnancy. It is composed of 36 questions (items) that evaluate both positive and negative states of health. The questionnaire assesses eight dimensions: physical functioning, role limitation from physical health problems, bodily pain, general health, vitality, social functioning, and role limitation from emotional health problems
Numeric pain rating scale	4 weeks	The Numeric Rating Scale (NRS) is among the most commonly used measures of pain intensity in clinical and research settings. The NRS is an 11-point scale, from 0 to 10 with 0 indicating "no pain" and 10 representing the "worst imaginable pain". Participants select the number that best represents their pain intensity.

Trial Locations

Locations (1)

Barcelona College of Chiropractic; 🇪🇸 Barcelona, Spain