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Completed

NCT Number: NCT04919278

Ciropractic Care and Pregnant Women

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.

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Key information

Conditions

Pain, Back Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pregnancy Related Quality of Life Signs and Symptoms Sleep

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barcelona College of Chiropractic

Barcelona, 08034, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Chiropractic adjustments

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Barcelona College of Chiropractic

Other

Registry information

Official study title

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

Acronym: ChiroPW

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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