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Ciropractic Care and Pregnant Women (ChiroPW)

Primary Purpose

Pain, Back, Pregnancy Related, Sleep

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chiropractic adjustments
Sponsored by
Barcelona College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Back focused on measuring Chiropractic

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Barcelona College of Chiropractic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

SF-36 questionnaire Quality of Life
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)
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
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.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2021
Last Updated
June 4, 2021
Sponsor
Barcelona College of Chiropractic
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1. Study Identification

Unique Protocol Identification Number
NCT04919278
Brief Title
Ciropractic Care and Pregnant Women
Acronym
ChiroPW
Official Title
The Effects of Chiropractic on Quality of Life, Sleep and Pain in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barcelona College of Chiropractic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Back, Pregnancy Related, Sleep, Quality of Life
Keywords
Chiropractic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Chiropractic adjustments
Intervention Description
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.
Primary Outcome Measure Information:
Title
SF-36 questionnaire Quality of Life
Description
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
Time Frame
4 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
4 weeks
Title
Numeric pain rating scale
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Barcelona College of Chiropractic
City
Barcelona
ZIP/Postal Code
08034
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ciropractic Care and Pregnant Women

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