- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- University of Management & Technology
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Intensity (Numeric Pain Rating Scale)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RE-172-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The results data collected , de-identified individual participant data will be shared.
Tidsram för IPD-delning
6 months after the publication of the manuscript
Kriterier för IPD Sharing Access
The data can be requested from the corresponding author
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
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