ChiroPW: Ciropractic Care and Pregnant Women

Sponsor

Barcelona College of Chiropractic (Other)

Overall Status

Completed

CT.gov ID

NCT04919278

Collaborator

(none)

Enrollment

Location

Arms

8.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Back Pregnancy Related Sleep Quality of Life	Procedure: Chiropractic adjustments	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effects of Chiropractic on Quality of Life, Sleep and Pain in Pregnant Women

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

May 10, 2018

Actual Study Completion Date :

Jun 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 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	Procedure: Chiropractic adjustments Chiropractic adjustment is a procedure in which trained specialists (chiropractors) use their hands or a small instrument to apply a controlled, sudden force to a spinal joint. The goal of this procedure, also known as spinal manipulation, is to improve spinal motion and improve your body's physical function.
No Intervention: Control group Paticipants will be selected amongst thse attending predelivery sessions. They receive no chiropracti care. They will complete the outcomes at the same time as the Intervention group and then 4 weeks later.

Arm

Intervention/Treatment

Experimental: Intervention group

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

Procedure: Chiropractic adjustments

Chiropractic adjustment is a procedure in which trained specialists (chiropractors) use their hands or a small instrument to apply a controlled, sudden force to a spinal joint. The goal of this procedure, also known as spinal manipulation, is to improve spinal motion and improve your body's physical function.

No Intervention: Control group

Paticipants will be selected amongst thse attending predelivery sessions. They receive no chiropracti care. They will complete the outcomes at the same time as the Intervention group and then 4 weeks later.

Outcome Measures

Primary Outcome Measures

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
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barcelona College of Chiropractic	Barcelona		Spain	08034

Sponsors and Collaborators

Barcelona College of Chiropractic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pablo Perez de la Ossa, Head of Research, Barcelona College of Chiropractic

ClinicalTrials.gov Identifier:

NCT04919278

Other Study ID Numbers:

BCC2018AJ

First Posted:

Jun 9, 2021

Last Update Posted:

Jun 9, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pablo Perez de la Ossa, Head of Research, Barcelona College of Chiropractic

Chiropractic

Additional relevant MeSH terms:

Back Pain

Study Results

No Results Posted as of Jun 9, 2021