The University of Lahore Teaching Hospital
Lahore, 54590, Pakistan
NCT Number: NCT07766148
Upper-back pain is common among breastfeeding mothers and may be associated with prolonged feeding positions, forward-bent posture, reduced thoracic mobility, and weakness of the muscles controlling the shoulder blades. This study will compare scapular stabilization exercises combined with thoracic spine mobilization with scapular stabilization exercises alone in breastfeeding mothers experiencing upper-back pain.
Seventy eligible breastfeeding mothers aged 18-35 years will be assigned to one of two treatment groups. Both groups will receive scapular stabilization exercises, while one group will additionally receive thoracic mobilization performed by a trained physiotherapist. Treatment will be provided three times per week for eight weeks.
Pain intensity, functional ability, and spinal range of motion will be assessed at baseline, Week 4, and Week 8. The study aims to determine whether adding thoracic mobilization to scapular stabilization exercises provides greater improvement in pain, mobility, and daily functioning than scapular stabilization exercises alone.
Looking for future studies?
Notify Me18 year–35 year
Female
Interventional
Not applicable
Lahore, 54590, Pakistan
This assessor-blinded, randomized clinical trial will be conducted at the University of Lahore Teaching Hospital, Lahore. Seventy breastfeeding mothers will be recruited using purposive sampling and randomly allocated by lottery method to two equal groups of 35 participants. Eligible participants will be women aged 18-35 years who are within three months after childbirth, exclusively breastfeeding, and experiencing breastfeeding-related upper-back pain rated between 4 and 7 on the Numeric Pain Rating Scale.
Before treatment, participants in both groups will receive a standardized warm-up consisting of a moist hot pack applied to the cervical and upper-thoracic regions, followed by gentle stretching. Group A will receive scapular stabilization exercises combined with thoracic mobilization. The exercise programme will include scapular retraction and depression, serratus anterior punches, wall slides, and prone horizontal abduction with scapular setting. Thoracic mobilization will be performed by a trained physiotherapist to improve thoracic extension and segmental mobility and reduce stiffness. Group B will receive the same scapular stabilization exercise programme without thoracic mobilization. Exercise difficulty will be progressively increased by adding repetitions and resistance.
The interventions will be delivered three times per week for eight weeks. Each exercise session will last approximately 30-35 minutes, with an additional 10-15 minutes of thoracic mobilization for Group A. The outcome assessor will remain unaware of participants' group assignments.
The primary outcome will be pain intensity, assessed using the 11-point Numeric Pain Rating Scale. Secondary outcomes will include functional ability measured using the Patient-Specific Functional Scale and spinal range of motion measured in degrees using a digital inclinometer. Assessments will be completed at baseline, Week 4, and Week 8.
Data will be analyzed using descriptive and inferential statistics. Data distribution will be assessed before analysis. Changes over time and differences between groups will be examined using repeated-measures analysis of variance, with post-hoc pairwise comparisons where appropriate. Statistical significance will be set at p≤0.05.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will perform a structured scapular stabilization programme three times per week for eight weeks. Each session will include scapular retraction and depression, serratus anterior punches, wall slides, and prone horizontal abduction with scapular setting. Exercises will be performed in three sets of 10-12 repetitions, with 5-second holds where appropriate. The programme will be progressively advanced every two weeks by increasing repetitions and introducing resistance bands. Sessions will include a standardized warm-up and stretching of the upper trapezius and levator scapulae.
A trained physiotherapist will administer manual mobilization to clinically identified hypomobile thoracic spinal segments. The intervention will focus on improving thoracic extension and segmental mobility and reducing stiffness and pain around the cervicothoracic region. Mobilization will be performed before the exercise programme for approximately 10-15 minutes per session, three times per week for eight weeks. The mobilization technique and intensity will be selected according to the participant's clinical presentation and tolerance.
Time frame: Baseline and immediately after completion of the intervention
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 ("no pain") to 10 ("worst imaginable pain"). Participants will rate their average upper-back pain experienced during the previous 24 hours. Higher scores indicate greater pain intensity. Change in NPRS score from baseline to post-intervention will be analyzed.
Time frame: Baseline and immediately after completion of the intervention
Thoracic and cervicothoracic range of motion will be measured in degrees using a digital inclinometer. Movements assessed will include flexion, extension, right and left lateral flexion, and right and left rotation. Measurements will be taken with the participant seated upright. Three trials will be performed for each movement, and the mean value will be used for analysis. Higher values indicate greater range of motion.
Time frame: Baseline and immediately after completion of the intervention
Functional ability will be assessed using the Patient-Specific Functional Scale (PSFS). Participants will identify three to five daily activities affected by upper-back pain, such as breastfeeding, lifting, or prolonged sitting. Each activity will be rated from 0 ("unable to perform") to 10 ("able to perform at the previous level"). The mean score of the identified activities will be calculated. Higher scores indicate better functional ability.
University of Lahore
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06621238
Anxiety, Anxiety Disorders
Mardin, Artuklu/Mardin, Turkey (Türkiye)
View Trial DetailsNCT06486922
Behavior, Behavior, Animal
New Hyde Park, New York, United States
View Trial DetailsNCT07726225
Behavior, Breast Feeding
Mersin, Turkey (Türkiye)
View Trial DetailsNCT05282485
Behavior, Breast Feeding
Stellenbosch, Western Cape, South Africa
View Trial Details