Pain, BackChiroPWNCT04919278
Ciropractic Care and Pregnant Women
A study testing Chiropractic adjustments in people with Pain, Back and Pregnancy Related, run by Barcelona College of Chiropractic at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Back, Pregnancy Related, Sleep
- What is being tested?
- Chiropractic adjustments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women over the age of 18
- of at least 14 weeks gestation,
- with a good understanding of English, Spanish or French.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Chiropractic on Quality of Life, Sleep and Pain in 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.
- Conditions
- Pain, Back, Pregnancy Related, Sleep, Quality of Life
- Being tested
- Chiropractic adjustments
- Keywords
- Chiropractic
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic adjustmentsProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Oct 2017
- Primary completion10 May 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, BackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona College of Chiropractic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Perez de la Ossa, Barcelona College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919278
- Sponsor's protocol ID
- BCC2018AJ
- Acronym
- ChiroPW
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Chiropractic on Quality of Life, Sleep and Pain in Pregnant Women
- ClinicalTrials.gov ID
- NCT04919278
- Acronym / sponsor ID
- ChiroPW / BCC2018AJ
- Conditions
- Pain, Back, Pregnancy Related, Sleep, Quality of Life
- Keywords
- Chiropractic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Barcelona College of ChiropracticUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Chiropractic adjustmentsParticipants 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 |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant women over the age of 18
- of at least 14 weeks gestation,
- with a good understanding of English, Spanish or French.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic adjustmentsChiropractic 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. | Procedure or surgery | Intervention group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic adjustments in people with Pain, Back and Pregnancy Related, run by Barcelona College of Chiropractic at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 questionnaire Quality of Life (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.