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- Essai clinique NCT07766148
Scapular Stabilization Exercises Combined With Thoracic Mobilization in Breast Feeding Mothers With Upper Back Pain
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Lahore, Pakistan, 54590
- The University of Lahore Teaching Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Women in the early postpartum period (0-3 months following childbirth) (Ratajczak & Górnowicz, 2024).
- Women who were exclusively breastfeeding and experiencing upper back pain associated with breastfeeding activities within the first 3 months postpartum (Ojukwu et al., 2025).
- Participants reporting moderate upper back pain, defined as a score of 4-7 on the Numeric Pain Rating Scale (NPRS) at the time of recruitment (Bharti et al., 2024).
Exclusion Criteria:
- History of cervical spine trauma, surgery, or fracture (Yan et al., 2023).
- Presence of neurological disorders, cervical radiculopathy, myelopathy, or musculoskeletal conditions unrelated to breastfeeding that could influence neck pain, cervical mobility, or functional performance (Yonus et al., 2025).
- Diagnosed systemic illnesses or medical conditions that may contraindicate exercise participation, such as rheumatoid arthritis, ankylosing spondylitis, osteoporosis, uncontrolled hypertension, cardiovascular disease, or other inflammatory or metabolic disorders affecting the musculoskeletal system (Womsi et al., 2025).
- Concurrent pain in other body regions (e.g., shoulder, thoracic spine, upper back, or upper extremity pain) that could interfere with exercise participation or influence outcome measurements (Rana et al., 2024).
- Ongoing physiotherapy, rehabilitation, or medical treatment for neck pain during the study period (Ratajczak & Górnowicz, 2024).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Scapular Stabilization Exercises With Thoracic Mobilization
Participants will receive scapular stabilization exercises combined with thoracic spine mobilization three times per week for eight weeks.
Exercises will include scapular retraction and depression, serratus anterior punches, wall slides, and prone horizontal abduction with scapular setting.
Each exercise will be performed in three sets of 10-12 repetitions, with 5-second holds where appropriate.
Exercise intensity will be progressively increased every two weeks by increasing repetitions and adding resistance bands.
A trained physiotherapist will also provide thoracic mobilization for approximately 10-15 minutes per session to improve thoracic mobility and reduce stiffness.
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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.
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Comparateur actif: Scapular Stabilization Exercises Alone
Participants will receive scapular stabilization exercises alone three times per week for eight weeks.
Exercises will include scapular retraction and depression, serratus anterior punches, wall slides, and prone horizontal abduction with scapular setting.
Each exercise will be performed in three sets of 10-12 repetitions, with 5-second holds where appropriate.
Exercise intensity will be progressively increased every two weeks by increasing repetitions and adding resistance bands.
Thoracic mobilization will not be provided to this group.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Pain Intensity Assessed Using the Numeric Pain Rating Scale
Délai: Baseline and immediately after completion of the intervention
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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.
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Baseline and immediately after completion of the intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Thoracic and Cervicothoracic Range of Motion
Délai: Baseline and immediately after completion of the intervention
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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.
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Baseline and immediately after completion of the intervention
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Change in Functional Ability Assessed Using the Patient-Specific Functional Scale
Délai: Baseline and immediately after completion of the intervention
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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.
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Baseline and immediately after completion of the intervention
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- El-Sadany, A., Mohamed, N., & Ibrahim, M. (2024). Effect of scapular stabilization training on pain and function in patients with postural neck pain: A randomized controlled study. Physiotherapy Theory and Practice, 40(5), 621-630. https://doi.org/10.1080/09593985.2023.2254771
- Ashfaq, A., Awan, W. A., & Ahmad, S. (2024). Responsiveness of numeric pain rating scale and visual analogue scale in patients with musculoskeletal pain: A prospective study. BMC Musculoskeletal Disorders, 25(1), 118. https://doi.org/10.1186/s12891-024-07245-8
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UOL/IREB/26/19/01/0015
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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