Chest PainNCT05834166
Effects of Upper Back Strengthening and Postural Correction in Pregnant Females With Costal Rib Pain
A study testing Upper back strengthening and Postural correction in people with Chest Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
1. Study will be a Non-Randomized clinical trial to check the effects of upper back strengthening and postural correction on pain, functional status and sleep quality in females with costal rib pain in 3rd trimester of pregnancy so that we can devise a treatment protocol for females during pregnancy suffering from… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Chest Pain
- What is being tested?
- Upper back strengthening and Postural correction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 15 Sep 2023
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age : 20-40 years Pregnant females in 3rd trimester
- Positive Painful rib syndrome history(6)
- Primigravida
Who cannot join
- • Tietze syndrome
- Rib Fractures
- Rib tip syndrome
- Slipping Rib Syndrome
- Any recent trauma (last 6 months)
- High Risk pregnancy
- Any bony or soft tissue systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Upper Back Strengthening and Postural Correction on Pain, Functional Status and Sleep Quality in Females With Costal Rib Pain in 3rd Trimester of Pregnancy
- Study will be a Non-Randomized clinical trial to check the effects of upper back strengthening and postural correction on pain, functional status and sleep quality in females with costal rib pain in 3rd trimester of pregnancy so that we can devise a treatment protocol for females during pregnancy suffering from costal rib pain. Duration of study was 6 months, Non-probability convenient sampling technique was used, subject following eligibility criteria from Avicenna Hospital were allocated in two groups, baseline assessment was done, Group A participants were given baseline treatment along with upper back strengthening and postural correction exercises, Group B participants were given baseline treatment along with no other specific treatment for 3 weeks. On 6th and 12th day, post intervention assessment was done via, Numeric Pain Rating Scale, Patient Specific Functional Scale and Pittsburgh Sleep Quality Index. 3 sessions per week were given, data was analyzed by using SPSS version 26.
Read the detailed description
Costal rib pain is very common in pregnancy, especially during the third trimester (weeks 28 to 40). After excluding other serious conditions, this condition can also be diagnosed as intercostal myalgia, costochondritis or muscular strain. There are a lot of causes which can result in costal rib pain such as ribs flaring, hormonal changes, increase in the breast size, inflammation of the ribs cartilage and the stretch on intercostal muscles. It can thus result in pain and discomfort due to which the pregnant females find it difficult to sleep at night and also have functional limitations. The prevalence rate of upper back and costal rib pain in pregnancy is almost 47%. The findings of this study can help physiotherapists to manage the costal rib pain in pregnancy more effectively. This will add valuable knowledge to provide the patients with non-invasive and non-pharmacological options for management of costal rib pain.
There are different structured program with exercises for flexibility, balance and strengthening for the majority of skeletal muscles specifically for the spinal ones, between the 24th and 36th week of pregnancy. Strengthening exercises centered on the trunk reduce pain, improve Quality of life and Physical health in late pregnancy and at two months in the postpartum period. Strengthening exercises also ease the delivery.
Upper back strengthening will involve exercises with light-to-moderate load of free weights (body weight or resistance bands) or with stability ball. Postural correction will involve maintaining the correct posture.
Soft tissue mobilization, chest muscle stretch, trunk muscle stretch and diaphragmatic breathing exercises were incorporated as baseline exercises in both groups.
- Conditions
- Chest Pain
- Being tested
- Upper back strengthening and Postural correction
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper back strengthening and Postural correctionOther
The treatment protocol will involve upper back strengthening exercises and postural correction exercises 3 times a week for 10 to 15 minutes. Upper back strengthening will involve exercises with light-to-moderate load of free weights (body weight or resistance bands) or with a stability ball. Postural correction will involve maintaining the correct posture.
| Study group | Role | What they receive |
|---|---|---|
| Upper back strengthening and Postural correction: | Experimental | Group A performed exercises for 3 weeks. Participants performed upper back strengthening exercises and postural correction exercises for 10 to 15 minutes per session. All exercises were performed for 3 sessions per week for a period of 4 weeks. The re-assessment will be done at the 6th and 9th visits. Receives: Other: Upper back strengthening and Postural correction |
| Control group: | No intervention | Group B: Group B will receive no intervention. Baseline treatment will include soft tissue mobilization, chest muscle stretch, trunk muscle stretch, and diaphragmatic breathing exercises for all patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes
Measured: up to 4 weeks
Patient Specific Functional Scale
The PSFS is an activity specific 10 points scale (0-10) in which an initial assessment and a follow up assessment is done. Its average score is 4.5. The rater assigns different activities that are difficult to perform by the patient. It quantifies the activity limitation and measure the functional outcomes after assessment
Measured: up to 4 weeks
Pittsburgh Sleep Quality Index
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.. A global PSQI score greater than 5 helps to distinguish good and poor sleepers.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayab Naina, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834166
- Sponsor's protocol ID
- REC/RCR & AHS/23/0524
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kesikburun S, Guzelkucuk U, Fidan U, Demir Y, Ergun A, Tan AK. Musculoskeletal pain and symptoms in pregnancy: a descriptive study. Ther Adv Musculoskelet Dis. 2018 Nov 19;10(12):229-234. doi: 10.1177/1759720X18812449. eCollection 2018 Dec.
PubMed 30515249Dunn G, Egger MJ, Shaw JM, Yang J, Bardsley T, Powers E, Nygaard IE. Trajectories of lower back, upper back, and pelvic girdle pain during pregnancy and early postpartum in primiparous women. Womens Health (Lond). 2019 Jan-Dec;15:1745506519842757. doi: 10.1177/1745506519842757.
PubMed 30991911Watelain E, Pinti A, Doya R, Garnier C, Toumi H, Boudet S. Benefits of physical activities centered on the trunk for pregnant women. Phys Sportsmed. 2017 Sep;45(3):293-302. doi: 10.1080/00913847.2017.1351286. Epub 2017 Jul 27.
PubMed 28678599Zaruba RA, Wilson E. IMPAIRMENT BASED EXAMINATION AND TREATMENT OF COSTOCHONDRITIS: A CASE SERIES. Int J Sports Phys Ther. 2017 Jun;12(3):458-467.
PubMed 28593100Germanovich A, Ferrante FM. Multi-Modal Treatment Approach to Painful Rib Syndrome: Case Series and Review of the Literature. Pain Physician. 2016 Mar;19(3):E465-71.
PubMed 27008303Zaremba S, Mueller N, Heisig AM, Shin CH, Jung S, Leffert LR, Bateman BT, Pugsley LJ, Nagasaka Y, Duarte IM, Ecker JL, Eikermann M. Elevated upper body position improves pregnancy-related OSA without impairing sleep quality or sleep architecture early after delivery. Chest. 2015 Oct;148(4):936-944. doi: 10.1378/chest.14-2973.
PubMed 25905714Yoo WG. Effect of thoracic stretching, thoracic extension exercise and exercises for cervical and scapular posture on thoracic kyphosis angle and upper thoracic pain. J Phys Ther Sci. 2013 Nov;25(11):1509-10. doi: 10.1589/jpts.25.1509. Epub 2013 Dec 11.
PubMed 24396221
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Back Strengthening and Postural Correction on Pain, Functional Status and Sleep Quality in Females With Costal Rib Pain in 3rd Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT05834166
- Acronym / sponsor ID
- REC/RCR & AHS/23/0524
- Conditions
- Chest Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 28 Apr 2023 (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.
- Study will be a Non-Randomized clinical trial to check the effects of upper back strengthening and postural correction on pain, functional status and sleep quality in females with costal rib pain in 3rd trimester of pregnancy so that we can devise a treatment protocol for females during pregnancy suffering from costal rib pain. Duration of study was 6 months, Non-probability convenient sampling technique was used, subject following eligibility criteria from Avicenna Hospital were allocated in two groups, baseline assessment was done, Group A participants were given baseline treatment along with upper back strengthening and postural correction exercises, Group B participants were given baseline treatment along with no other specific treatment for 3 weeks. On 6th and 12th day, post intervention assessment was done via, Numeric Pain Rating Scale, Patient Specific Functional Scale and Pittsburgh Sleep Quality Index. 3 sessions per week were given, data was analyzed by using SPSS version 26.
Detailed description
Costal rib pain is very common in pregnancy, especially during the third trimester (weeks 28 to 40). After excluding other serious conditions, this condition can also be diagnosed as intercostal myalgia, costochondritis or muscular strain. There are a lot of causes which can result in costal rib pain such as ribs flaring, hormonal changes, increase in the breast size, inflammation of the ribs cartilage and the stretch on intercostal muscles. It can thus result in pain and discomfort due to which the pregnant females find it difficult to sleep at night and also have functional limitations. The prevalence rate of upper back and costal rib pain in pregnancy is almost 47%. The findings of this study can help physiotherapists to manage the costal rib pain in pregnancy more effectively. This will add valuable knowledge to provide the patients with non-invasive and non-pharmacological options for management of costal rib pain.
There are different structured program with exercises for flexibility, balance and strengthening for the majority of skeletal muscles specifically for the spinal ones, between the 24th and 36th week of pregnancy. Strengthening exercises centered on the trunk reduce pain, improve Quality of life and Physical health in late pregnancy and at two months in the postpartum period. Strengthening exercises also ease the delivery.
Upper back strengthening will involve exercises with light-to-moderate load of free weights (body weight or resistance bands) or with stability ball. Postural correction will involve maintaining the correct posture.
Soft tissue mobilization, chest muscle stretch, trunk muscle stretch and diaphragmatic breathing exercises were incorporated as baseline exercises in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper back strengthening and Postural correction: | Experimental | Other: Upper back strengthening and Postural correctionGroup A performed exercises for 3 weeks. Participants performed upper back strengthening exercises and postural correction exercises for 10 to 15 minutes per session. All exercises were performed for 3 sessions per week for a period of 4 weeks. The re-assessment will be done at the 6th and 9th visits. |
| Control group: | No intervention | –Group B: Group B will receive no intervention. Baseline treatment will include soft tissue mobilization, chest muscle stretch, trunk muscle stretch, and diaphragmatic breathing exercises for all patients |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age : 20-40 years Pregnant females in 3rd trimester
- Positive Painful rib syndrome history(6)
- Primigravida
Key exclusion criteria (7 listed)
- • Tietze syndrome
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 |
|---|---|---|
| Upper back strengthening and Postural correctionThe treatment protocol will involve upper back strengthening exercises and postural correction exercises 3 times a week for 10 to 15 minutes. Upper back strengthening will involve exercises with light-to-moderate load of free weights (body weight or resistance bands) or with a stability ball. Postural correction will involve maintaining the correct posture. | Other | Upper back strengthening and Postural correction: |
Primary outcome
Numeric Pain Rating Scale
Time frame: up to 4 weeks
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes
Patient Specific Functional Scale
Time frame: up to 4 weeks
The PSFS is an activity specific 10 points scale (0-10) in which an initial assessment and a follow up assessment is done. Its average score is 4.5. The rater assigns different activities that are difficult to perform by the patient. It quantifies the activity limitation and measure the functional outcomes after assessment
Pittsburgh Sleep Quality Index
Time frame: up to 4 weeks
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.. A global PSQI score greater than 5 helps to distinguish good and poor sleepers.
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 5 Mar 2024.
- Background: PubMed 30515249Kesikburun S, Guzelkucuk U, Fidan U, Demir Y, Ergun A, Tan AK. Musculoskeletal pain and symptoms in pregnancy: a descriptive study. Ther Adv Musculoskelet Dis. 2018 Nov 19;10(12):229-234. doi: 10.1177/1759720X18812449. eCollection 2018 Dec.
- Background: PubMed 30991911Dunn G, Egger MJ, Shaw JM, Yang J, Bardsley T, Powers E, Nygaard IE. Trajectories of lower back, upper back, and pelvic girdle pain during pregnancy and early postpartum in primiparous women. Womens Health (Lond). 2019 Jan-Dec;15:1745506519842757. doi: 10.1177/1745506519842757.
- Background: PubMed 28678599Watelain E, Pinti A, Doya R, Garnier C, Toumi H, Boudet S. Benefits of physical activities centered on the trunk for pregnant women. Phys Sportsmed. 2017 Sep;45(3):293-302. doi: 10.1080/00913847.2017.1351286. Epub 2017 Jul 27.
- Background: PubMed 28593100Zaruba RA, Wilson E. IMPAIRMENT BASED EXAMINATION AND TREATMENT OF COSTOCHONDRITIS: A CASE SERIES. Int J Sports Phys Ther. 2017 Jun;12(3):458-467.
- Background: PubMed 27008303Germanovich A, Ferrante FM. Multi-Modal Treatment Approach to Painful Rib Syndrome: Case Series and Review of the Literature. Pain Physician. 2016 Mar;19(3):E465-71.
- Background: PubMed 25905714Zaremba S, Mueller N, Heisig AM, Shin CH, Jung S, Leffert LR, Bateman BT, Pugsley LJ, Nagasaka Y, Duarte IM, Ecker JL, Eikermann M. Elevated upper body position improves pregnancy-related OSA without impairing sleep quality or sleep architecture early after delivery. Chest. 2015 Oct;148(4):936-944. doi: 10.1378/chest.14-2973.
- Background: PubMed 24396221Yoo WG. Effect of thoracic stretching, thoracic extension exercise and exercises for cervical and scapular posture on thoracic kyphosis angle and upper thoracic pain. J Phys Ther Sci. 2013 Nov;25(11):1509-10. doi: 10.1589/jpts.25.1509. Epub 2013 Dec 11.
- 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.
Nayab Naina, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper back strengthening and Postural correction in people with Chest Pain, run by Riphah International University at 1 site in Pakistan.
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 7 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 5 Mar 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 Pakistan. 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?
Numeric Pain Rating Scale (time frame: up to 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?
On the ClinicalTrials.gov record for NCT05834166, which also lists 7 linked publications.
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 5 Mar 2024.