- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07932743
Calf Strengthening With or Without Hip Strengthening for Athletes With Recurring Shin Splints
Effects of Progressive Loading of Soleus With and Without Hip Strengthening on Pain, Strength, Dynamic Balance and Return to Sports in Athletes With Recurrent Medial Tibial Stress Syndrome
The goal of this clinical trial is to learn whether adding hip strengthening exercises to a calf strengthening program works better than the calf program alone for athletes aged 18 to 40 who keep getting shin splints (pain along the inner edge of the shin bone during or after running). The study will find out which program better reduces shin pain, increases calf and hip muscle strength, improves balance while reaching on one leg, and helps athletes return to their sport without pain. Researchers will compare a progressive calf (soleus) strengthening program alone with the same calf program plus hip strengthening exercises. Participants will receive one of the two programs 3 times a week for 8 weeks (24 sessions), along with advice on managing training load, stretching, balance exercises and a gradual return-to-running plan. They will complete tests of pain, muscle strength, balance, daily function and return to sport at the start, at week 4 and at week 8.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- University of Management & Technology
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-
Athletes aged 18-40 years participating in competitive or recreational sports.
- Both male and female athletes.
- Diagnosis of recurrent medial tibial stress syndrome according to the Yates and White criteria, characterized by exercise-induced pain along the posteromedial border of the tibia with tenderness extending over 5 cm or more.
- Pain intensity ranging from 4 to 6 on the Numeric Pain Rating Scale (NPRS).
- Pain occurring during running or within 24 hours following running activity.
- History of two or more symptomatic episodes of MTSS within the previous 12 months.
Exclusion Criteria:
-
● Confirmed chronic exertional compartment syndrome.
- History of lower-limb surgery within the previous six months.
- Clinically confirmed tibial stress fracture or any other bony pathology.
- Acute lower-limb injury (sprain, strain, or fracture) within the previous six weeks.
- Use of systemic corticosteroids, bisphosphonates, or non-steroidal anti-inflammatory drugs (NSAIDs) for more than 14 consecutive days within 30 days before enrolment.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Progressive Loading of Soleus (PLS)
Progressive soleus loading program plus basic rehabilitation, 3 supervised sessions per week for 8 weeks (24 sessions). |
Structured progressive soleus loading exercises to improve plantar-flexor strength, muscular endurance and tibial load tolerance. Load and intensity are progressed gradually according to each participant's tolerance and clinical response. |
|
Eksperimentel: Progressive Loading of Soleus Combined with Hip Strengthening
The same progressive soleus loading program and basic rehabilitation as Arm 1, plus hip strengthening, 3 supervised sessions per week for 8 weeks (24 sessions). |
Strengthening exercises for the hip abductors, extensors and external rotators, performed for approximately 15 to 20 minutes per session, with individualized progression. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity (Numeric Pain Rating Scale)
Tidsramme: Baseline (Week 0), Week 4 and Week 8.
|
An 11-point self-reported scale from 0 (no pain) to 10 (worst imaginable pain), rating average pain during running or sports activities. Lower scores indicate less pain. |
Baseline (Week 0), Week 4 and Week 8.
|
|
Muscle Strength (Handheld Dynamometer)
Tidsramme: Baseline (Week 0), Week 4 and Week 8.
|
Isometric strength of the plantar-flexor and hip muscles, measured with a handheld dynamometer. Higher values indicate greater strength. |
Baseline (Week 0), Week 4 and Week 8.
|
|
Dynamic Balance (Y-Balance Test)
Tidsramme: Baseline (Week 0), Week 4 and Week 8.
|
Single-leg reach in the anterior, posteromedial and posterolateral directions, normalized to limb length and reported as a composite score (% of limb length). Higher scores indicate better dynamic balance. |
Baseline (Week 0), Week 4 and Week 8.
|
|
Pain-Free Return to Sport
Tidsramme: Baseline (Week 0), Week 4 and Week 8.
|
Whether the participant completes the graded return-to-running program and resumes sport without reproduction of medial tibial stress syndrome symptoms (achieved / not achieved). |
Baseline (Week 0), Week 4 and Week 8.
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RE-172-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The results data collected , de-identified individual participant data will be shared.
IPD-delingstidsramme
6 months after the publication of the manuscript
IPD-delingsadgangskriterier
The data can be requested from the corresponding author
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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