Ciropractic Care and Pregnant Women

NCT04919278 | Completed DMC

• 1 other identifier: BCC2018AJ
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Back; Pregnancy Related; Sleep; Quality of Life

Keywords

Chiropractic

Outcome Measures

Primary Outcomes (3)

• 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

  4 weeks

• 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.

  4 weeks

• 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.

  4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Barcelona College of Chiropractic: lead

Study Sites (1)

Barcelona College of Chiropractic

Barcelona, 08034, Spain

Location

MeSH Terms

Conditions

Back Pain

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 9, 2021
• Study Start: October 1, 2017
• Primary Completion: May 10, 2018
• Study Completion: June 15, 2018
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)