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出境医 / 临床实验 / Ciropractic Care and Pregnant Women (ChiroPW)

Ciropractic Care and Pregnant Women (ChiroPW)

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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : October 1, 2017
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : June 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.
Outcome Measures
Primary Outcome Measures :
  1. SF-36 questionnaire Quality of Life [ Time Frame: 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

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 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.

  3. Numeric pain rating scale [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations

Locations
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Spain
Barcelona College of Chiropractic
Barcelona, Spain, 08034
Sponsors and Collaborators
Barcelona College of Chiropractic
Tracking Information
First Submitted Date  ICMJE June 4, 2021
First Posted Date  ICMJE June 9, 2021
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date May 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • SF-36 questionnaire Quality of Life [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ciropractic Care and Pregnant Women
Official Title  ICMJE The Effects of Chiropractic on Quality of Life, Sleep and Pain in Pregnant Women
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Back
  • Pregnancy Related
  • Sleep
  • Quality of Life
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Chiropractic adjustments
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2021) 		42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2018
Actual Primary Completion Date May 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04919278
Other Study ID Numbers  ICMJE BCC2018AJ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pablo Perez de la Ossa, Barcelona College of Chiropractic
Study Sponsor  ICMJE Barcelona College of Chiropractic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Barcelona College of Chiropractic
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP