- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07834151
Additional Effects of Kinetic Chain Training Combined With Standard Shoulder Exercises in Subacromial Pain Syndrome
This randomized controlled trial aims to evaluate the additional effects of kinetic chain training combined with standard shoulder exercises in patients with Subacromial Pain Syndrome (SAPS). SAPS is one of the most common causes of shoulder pain and is associated with altered scapular mechanics, reduced thoracic mobility, and impaired lumbopelvic stability. Conventional rehabilitation primarily targets the shoulder joint and local musculature, often overlooking the contribution of the kinetic chain. This study wil investigate whether integrating kinetic chain training into standard rehabilitation provides superior clinical outcomes.A single-blinded, parallel-group randomized controlled trial will be conducted involving 46 participants aged 35-60 years diagnosed with unilateral SAPS. Participants will be recruited through purposive sampling and randomly allocated into either a control group receiving standard shoulder rehabilitation or an experimental group receiving standard rehabilitation plus kinetic chain training for six weeks. The kinetic chain intervention includes lower trapezius strengthening, thoracic spine and rib mobilization, longissimus and multifidus activation, and gluteus maximus strengthening.
Primary outcomes will include pain intensity, shoulder range of motion, functional disability, scapular dyskinesis, and shoulder muscle strength. These will be assessed using the Numeric Pain Rating Scale (NPRS), Shoulder Pain and Disability Index (SPADI), universal goniometer, bubble inclinometer, and handheld dynamometer before and after the intervention. The findings of this study are expected to determine whether a biomechanically integrated rehabilitation approach offers greater improvements than conventional shoulder-focused exercises alone, thereby providing evidence to guide physiotherapy management of SAPS.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Subacromial Pain Syndrome (SAPS) is one of the most prevalent causes of non-traumatic shoulder pain, accounting for approximately 44-65% of shoulder pain cases. It is characterized by pain around the acromion that is aggravated during arm elevation, overhead activities, and lying on the affected side. Although SAPS has traditionally been considered a localized shoulder disorder, current evidence suggests that efficient shoulder function depends on coordinated movement throughout the kinetic chain, including the thoracic spine, trunk, pelvis, and lower extremities. Dysfunction of these proximal segments may alter scapular biomechanics, reduce thoracic mobility, impair muscle activation patterns, and contribute to scapular dyskinesis, ultimately increasing mechanical stress within the subacromial space. Despite this evidence, conventional rehabilitation primarily focuses on local shoulder structures, such as the rotator cuff and scapular muscles, with limited emphasis on restoring kinetic chain function.This study aims to determine whether combining kinetic chain training with standard shoulder exercises produces superior clinical outcomes compared with standard shoulder rehabilitation alone in individuals with SAPS. A single-blinded, parallel-group randomized controlled superiority trial will be conducted over one year. Forty-six participants aged 35-60 years with unilateral SAPS, symptom duration of six weeks to three months, pain intensity of 4-7 on the Numeric Pain Rating Scale (NPRS), thoracic extension range of motion below 20°, and positive clinical impingement tests will be recruited from Fauji Foundation Hospital, Rawalpindi, and Foundation University School of Health Sciences. Participants will be recruited using purposive sampling and randomly allocated into either the control or experimental group using a coin toss method. The outcome assessor will remain blinded to minimize detection bias.
Both groups will receive a standardized six-week shoulder rehabilitation program consisting of patient education, activity modification, pain-free range of motion exercises, rotator cuff \strengthening, stretching of tight musculature, and scapular muscle activation. In addition to this program, the experimental group will receive a structured kinetic chain training protocol comprising progressive lower trapezius strengthening, thoracic spine central posterior-anterior and costotransverse mobilization, activation of the longissimus and multifidus muscles using bird dog exercises, and progressive gluteus maximus strengthening through bridging exercises. All interventions will be performed within a pain-free or minimally painful range and progressed according to the participant's tolerance.
Outcome measures will be assessed at baseline and after completion of the six-week intervention. Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS), functional disability using the Shoulder Pain and Disability Index (SPADI), shoulder abduction and external rotation range of motion using a universal goniometer, scapular upward rotation and thoracic extension using a bubble inclinometer, and shoulder and gluteus maximus muscle strength using a handheld dynamometer. Data will be analyzed using SPSS version 21. Depending on data distribution, appropriate parametric or non-parametric statistical tests will be applied for both within-group and between-group comparisons. Ethical approval will be obtained before participant recruitment, written informed consent will be secured from all participants, confidentiality will be maintained, and participants will retain the right to withdraw from the study at any stage. The findings are expected to clarify whether a biomechanically integrated rehabilitation approach incorporating kinetic chain training provides greater improvements in pain, shoulder mobility, muscle strength, scapular function, and disability than conventional shoulder rehabilitation alone, thereby strengthening the evidence for comprehensive physiotherapy management of Subacromial Pain Syndrome.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Iqra Naeem, DPT
- Telefoonnummer: +92 3200514211
- E-mail: driqranaeempt@gmail.com
Studie Contact Back-up
- Naam: Hafiz Ali Bin Asim, MS-SPT
- Telefoonnummer: 03135088144
- E-mail: ali.asim@fui.edu.pk
Studie Locaties
-
-
Punjab Province
-
Islamabad, Punjab Province, Pakistan, 44000
- Werving
- Foundation University College of Physical Therapy
-
Contact:
- Hafiz Ali Bin Asim, MS-SPT
- Telefoonnummer: 03135088144
- E-mail: ali.asim@fui.edu.pk
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion criteria
- Age between 35-60 years
- Both Gender
- Unilateral shoulder pain consistent with SAPS.
- pain during activities with abduction, external rotation and overhead activities
- NPRS score 4-7 at baseline.
- Symptom duration six weeks to 3 months
- Pain reproduced with any two of the following tests Hawkins-Kennedy, painful arc sign, Infraspinatus (External Rotation) Resistance Tests
- Thoracic extension ROM < 20°
Exclusion criteria
- Age below 35 years or above 60 years
- History or clinical signs of complete supraspinatus or long-head biceps tendon tear
- History of fracture or dislocation of the shoulder, history of surgery around the shoulder with in last year
- Restrictions in passive movements of the GH joint (adhesive capsulitis)
- GH OA, RA, cervical rib
- Diagnosed bursitis, inflammatory arthropathies, active infection or systemic disease affecting shoulder
- Suspected cancer or red-flag symptoms.
- Bilateral shoulder pain.
- Sign of nerve root irritation
- Diagnosed with internal shoulder impingement
- History of shoulder pain from traumatic onset
- Positive sulcus sign and apprehension special tests pointing to ligamentous laxity
- Corticosteroid injection was administered to the shoulder within a year before the study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Group A (Standard shoulder exercises)
|
Participants in the control group will receive a standardized six-week shoulder rehabilitation program consisting of education and activity modification, pain-free range of motion exercises, isolated rotator cuff strengthening, stretching of tight muscles, and scapular muscle activation. Education will focus on avoiding aggravating overhead activities while encouraging use of the affected arm within pain-free limits. Range of motion exercises will include Codman pendulum exercises and active-assisted shoulder abduction and external rotation. Isometric strengthening will target shoulder external rotation and abduction, with progressive repetitions and hold durations. Stretching will include the pectoralis minor and upper trapezius. Scapular muscle activation will be performed using the Dynamic Hug (Plus) exercise with theraband resistance. Exercise dosage will be progressively increased over the six-week intervention according to participant tolerance and symptom response. |
|
Experimenteel: Group B (Kinetic chain training)
|
Participants will receive the same six-week standard shoulder rehabilitation program as the control group, supplemented with kinetic chain training. The kinetic chain protocol will include four components: progressive lower trapezius strengthening, thoracic spine and rib mobilization, longissimus and multifidus activation, and gluteus maximus strengthening. Lower trapezius strengthening will progress from supported scapular depression and retraction to modified and full prone cobra exercises. Thoracic mobilization will include central posterior-anterior mobilization and costotransverse unilateral posterior-anterior glides targeting the upper to mid-thoracic ribs (levels 1-6). Longissimus and multifidus activation will be performed through progressive bird-dog exercises. Gluteus maximus strengthening will involve progressive bilateral and unilateral bridging exercises. All exercises will be progressed over six weeks according to participant tolerance. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Shoulder Pain
Tijdsspanne: before and after 6 weeks
|
Measured using Numeric Pain Rating Scale (0-10), Eligibility cut-off of Numeric Pain Rating Scale is 4-7 at baseline. |
before and after 6 weeks
|
|
Shoulder abduction range of motion
Tijdsspanne: before and after 6 weeks
|
Active shoulder abduction ROM will be measured in sitting using a universal goniometer |
before and after 6 weeks
|
|
Shoulder external rotation range of motion
Tijdsspanne: before and after 6 weeks
|
External rotation ROM will be measured in supine with the shoulder at 90° abduction and elbow at 90° flexion using a universal goniometer. |
before and after 6 weeks
|
|
Functional disability
Tijdsspanne: before and after 6 weeks
|
Measured using the Shoulder Pain and Disability Index, consisting of 13 items assessing shoulder pain and functional limitations. |
before and after 6 weeks
|
|
Scapular dyskinesis
Tijdsspanne: before and after 6 weeks
|
Scapular upward rotation will be measured using a bubble inclinometer during arm elevation in the scapular plane, with three measurements recorded |
before and after 6 weeks
|
|
Thoracic extension
Tijdsspanne: before and after 6 weeks
|
Measured using two bubble inclinometers positioned at T1-T2 and T12-L1; the difference between readings at maximal extension represents thoracic extension ROM. Eligibility cut-off: <20°. |
before and after 6 weeks
|
|
Shoulder abduction strength
Tijdsspanne: before and after 6 weeks
|
Measured using a handheld dynamometer during a 6-second maximal isometric shoulder abduction contraction, with three repetitions recorded. |
before and after 6 weeks
|
|
Shoulder external rotation strength
Tijdsspanne: before and after 6 weeks
|
Measured using a handheld dynamometer during a 6-second maximal isometric external rotation contraction, with three repetitions recorded. |
before and after 6 weeks
|
|
Gluteus maximus strength
Tijdsspanne: before and after 6 weeks
|
Hip extension strength will be measured using a handheld dynamometer in prone with the knee flexed to 90° and hip maintained at 30° extension |
before and after 6 weeks
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- FUI/FUCP/CTR/MSMSK/IqraNaeem
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .