Upper Back PainNCT06745752
Late Postpartum Period and Pain
An observational study of Upper Back Pain and Lower Back Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Upper back, lower back and pelvic girdle pain significantly affect women's lives, especially in the postpartum period. This study aimed to characterize the frequency and severity of upper back, lower back and pelvic girdle pain in the 0 to 2 months postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Upper Back Pain, Lower Back Pain, Pelvic Girdle Pain
- How many people
- 243 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2023to 3 Apr 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants who had given birth, aged 18-49, were registered at a district family health center (FHC) in western Turkey, met the inclusion criteria, and volunteered to participate in the study.
Who may be able to join
- Participants who were 0-2 months postpartum,
- Could read and speak Turkish,
- Between the ages of 18-49.
Who cannot join
- Participants with past or current mental illness,
- Those taking antidepressant or anxiolytic medications,
- Rheumatoid arthritis,
- Ankylosing spondylitis,
- Scheuermann disease,
- Ehlers-danlos syndrome,
Show all 16Show fewer
- Spinal surgery,
- Nerve root compression,
- Spondylolisthesis,
- Perineal edema,
- Hematoma,
- Wound dehiscence,
- Bladder catheterization,
- serious postpartum complications (internal bleeding, femoral artery embolism, pelvic fracture),
- Those whose babies are in the neonatal intensive care unit,
- Those who left the research unfinished.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence, Severity, and Determinants of Upper Back, Lower Back, and Pelvic Girdle Pain in the Late Postpartum Period
Upper back, lower back and pelvic girdle pain significantly affect women's lives, especially in the postpartum period. This study aimed to characterize the frequency and severity of upper back, lower back and pelvic girdle pain in the 0 to 2 months postpartum period. The study will be conducted as a cross-sectional and correlational study. Data will be collected using the Information Form and Brief Pain Inventory designed by the researchers. Data will be collected face to face with the participants at the end of the first week, the end of the first month and the end of the second month after birth. IBM SPSS Statistics 29.0 software will be used in the analysis of the data.
Read the detailed description
Research questions
- What are the prevalence rates of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum period?
- What are the severity rates of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum period?
- What are the determinants of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum? The population of the study will consist of postpartum participants registered in a district family health center (FHC) in western Turkey, who meet the inclusion criteria and are willing to participate in the study. The total number of postpartum women registered in the family health center in the year before the study began was 383. Therefore, no sample calculation was made and all participants who gave birth within one year after the beginning of the study will be included in the study.
The data of the study will be collected using the Information Form, and Brief Pain Inventory.
Information Form: This form consists of 15 questions about sociodemographic and obstetric characteristics based on an extensive literature review on the topic.
Brief Pain Inventory: Developed by Cleeland and Ryan in 1994, the Pain Inventory consists of seven items related to pain intensity and the dimension of how pain interferes with daily activities.
Data collection The researcher will explain the purpose of the study to pregnant women who meet the inclusion criteria, invite them to participate, and obtain their consent. Data will be collected from participants at the end of the first postpartum week (when they attend the first postpartum follow-up visit and newborn heel prick test), at the end of the first month (day 28) (when they attend the second dose of neonatal hepatitis B vaccine), and at the end of the second month (week 8 postpartum) (when they attend the first dose of BCG, DTP-Hib-HBV, and IPV vaccines). At the first visit, participants will complete an information form and the Brief Pain Inventory. At the second and third meetings, they will complete only the Brief Pain Inventory.
Statistical analysis Statistical analysis will be performed using IBM SPSS Statistics 29.0 software (IBM Corp., Armonk, NY, USA). Sociodemographic data will be evaluated using descriptive statistical methods (frequency, percentage, mean, standard deviation). Kolmogorov-Smirnov test will be used as normality test. Independent samples analysis, correlation analysis and logistic regression analysis will be used in the analyses. Significance will be accepted as p<0.05.
- Conditions
- Upper Back Pain, Lower Back Pain, Pelvic Girdle Pain
- Keywords
- postpartum period, upper back pain, lower back pain, pelvic girdle pain, incidence
- Medical subject headings
- Back Pain, Low Back Pain, Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| postpartum women | In the study, the upper back, lower back and pelvic girdle pain status of the participants in the postpartum period will be monitored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
Measured: Postpartum day 7.
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
Measured: Postpartum day 28.
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
Measured: Postpartum day 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start3 Apr 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Back PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 243 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Dilek Aksoy, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745752
- Sponsor's protocol ID
- sdilek12
- Status last verified
- Apr 2024
- First submitted
- 13 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Severity, and Determinants of Upper Back, Lower Back, and Pelvic Girdle Pain in the Late Postpartum Period
- ClinicalTrials.gov ID
- NCT06745752
- Acronym / sponsor ID
- sdilek12
- Conditions
- Upper Back Pain, Lower Back Pain, Pelvic Girdle Pain
- Keywords
- postpartum period, upper back pain, lower back pain, pelvic girdle pain, incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 20 Dec 2024 (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.
Upper back, lower back and pelvic girdle pain significantly affect women's lives, especially in the postpartum period. This study aimed to characterize the frequency and severity of upper back, lower back and pelvic girdle pain in the 0 to 2 months postpartum period. The study will be conducted as a cross-sectional and correlational study. Data will be collected using the Information Form and Brief Pain Inventory designed by the researchers. Data will be collected face to face with the participants at the end of the first week, the end of the first month and the end of the second month after birth. IBM SPSS Statistics 29.0 software will be used in the analysis of the data.
Detailed description
Research questions
- What are the prevalence rates of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum period?
- What are the severity rates of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum period?
- What are the determinants of upper back, lower back, and pelvic girdle pain points during the 0-2 months postpartum? The population of the study will consist of postpartum participants registered in a district family health center (FHC) in western Turkey, who meet the inclusion criteria and are willing to participate in the study. The total number of postpartum women registered in the family health center in the year before the study began was 383. Therefore, no sample calculation was made and all participants who gave birth within one year after the beginning of the study will be included in the study.
The data of the study will be collected using the Information Form, and Brief Pain Inventory.
Information Form: This form consists of 15 questions about sociodemographic and obstetric characteristics based on an extensive literature review on the topic.
Brief Pain Inventory: Developed by Cleeland and Ryan in 1994, the Pain Inventory consists of seven items related to pain intensity and the dimension of how pain interferes with daily activities.
Data collection The researcher will explain the purpose of the study to pregnant women who meet the inclusion criteria, invite them to participate, and obtain their consent. Data will be collected from participants at the end of the first postpartum week (when they attend the first postpartum follow-up visit and newborn heel prick test), at the end of the first month (day 28) (when they attend the second dose of neonatal hepatitis B vaccine), and at the end of the second month (week 8 postpartum) (when they attend the first dose of BCG, DTP-Hib-HBV, and IPV vaccines). At the first visit, participants will complete an information form and the Brief Pain Inventory. At the second and third meetings, they will complete only the Brief Pain Inventory.
Statistical analysis Statistical analysis will be performed using IBM SPSS Statistics 29.0 software (IBM Corp., Armonk, NY, USA). Sociodemographic data will be evaluated using descriptive statistical methods (frequency, percentage, mean, standard deviation). Kolmogorov-Smirnov test will be used as normality test. Independent samples analysis, correlation analysis and logistic regression analysis will be used in the analyses. Significance will be accepted as p<0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postpartum women | – | –In the study, the upper back, lower back and pelvic girdle pain status of the participants in the postpartum period will be monitored. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants who had given birth, aged 18-49, were registered at a district family health center (FHC) in western Turkey, met the inclusion criteria, and volunteered to participate in the study.
Key inclusion criteria (3 listed)
- Participants who were 0-2 months postpartum,
- Could read and speak Turkish,
- Between the ages of 18-49.
Key exclusion criteria (16 listed)
- Participants with past or current mental illness,
- Those taking antidepressant or anxiolytic medications,
- Rheumatoid arthritis,
- Ankylosing spondylitis,
- Scheuermann disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Time frame: Postpartum day 7.
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Time frame: Postpartum day 28.
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
Evaluation of upper back pain, lower back pain, and pelvic girdle pain
Time frame: Postpartum day 56.
Filling out the tools used in the research (Information Form and Brief Pain Inventory)
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 20 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Upper Back Pain
Recruiting
Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy Surgery
Breast Cancer, Postoperative Pain
Recruiting
Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery
Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer
Recruiting
SPSIP Block Versus ESP Block for Chronic Pain After Unilateral Breast Surgery
Postoperative Pain, Opioid Use
Recruiting
Serratus vs ESP Block for Postoperative Pain in Unilateral Breast Surgery
Post Operative Pain, Opioid Use
Not yet recruitingObservational study
Pain Control and Recovery After Thoracic Surgery Using SPSIP Block
Postoperative Pain
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?
An observational study of Upper Back Pain and Lower Back Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 16 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 20 Dec 2024. 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 Turkey (Türkiye). 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?
Evaluation of upper back pain, lower back pain, and pelvic girdle pain (time frame: Postpartum day 7.). 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 20 Dec 2024.