NCT05834166

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

April 18, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    up to 4 weeks

Study Arms (2)

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.

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

Interventions

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.

Upper back strengthening and Postural correction:

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age : 20-40 years Pregnant females in 3rd trimester
  • Positive Painful rib syndrome history(6)
  • Primigravida

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avicenna Hospital

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 30515249BACKGROUND
  • Dunn 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.

    PMID: 30991911BACKGROUND
  • Watelain 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.

    PMID: 28678599BACKGROUND
  • Zaruba RA, Wilson E. IMPAIRMENT BASED EXAMINATION AND TREATMENT OF COSTOCHONDRITIS: A CASE SERIES. Int J Sports Phys Ther. 2017 Jun;12(3):458-467.

    PMID: 28593100BACKGROUND
  • Germanovich 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.

    PMID: 27008303BACKGROUND
  • Zaremba 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.

    PMID: 25905714BACKGROUND
  • Yoo 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.

    PMID: 24396221BACKGROUND

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nayab Naina, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

April 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 15, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations