- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07573254
The Effects of Spinal Mobilization Added to an Exercise Program in Recreational Tennis Players With Mechanical Low Back Pain
1 maja 2026 zaktualizowane przez: Mirsad Alkan, Istinye University
The Effects of Spinal Mobilization Added to an Exercise Program on Pain and Physical Fitness in Recreational Tennis Players With Mechanical Low Back Pain
This prospective, single-blind, randomized controlled trial investigates whether the addition of spinal mobilization to a structured home exercise program improves pain, flexibility, lower-extremity strength, dynamic balance, and jump performance in recreational tennis players (aged 18-45 years; BMI 18-30 kg/m²) with non-radiating mechanical low back pain.
Participants were allocated to two parallel groups: a Control Group performing a 21-session home exercise program for 3 weeks, and an Experimental Group performing the same program plus four physiotherapist-administered spinal mobilization sessions (one at baseline and one weekly for 3 weeks).
Outcomes were the Visual Analog Scale (VAS) for pain during physical activity, at rest, and at night; the Y-Balance Test; the Vertical Jump Test; the Sit-and-Reach Test; and isometric strength measured with a back-chest-leg dynamometer.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Design: prospective, randomized, single-blind, parallel-group controlled clinical trial.
The study was conducted under the supervision of the Department of Physiotherapy and Rehabilitation, Chiropractic Master's Program.
Recreational tennis players (aged 18-45 years; BMI 18-30 kg/m²) with mechanical low back pain of more than 1 week duration and a baseline pain intensity exceeding 4 on the Visual Analog Scale (VAS) who played tennis at least twice per week (≥2 hours/week) were enrolled after providing written informed consent.
Allocation was performed using sealed opaque envelopes combined with computer-assisted randomization, with masking applied to the outcome assessor.
Participants were randomized to: (1) Control Group (CG) - structured home exercise program comprising posterior pelvic tilt, erector spinae stretching (double knee-to-chest), combined hamstring/lumbar extensor stretching (long-sit toe touch), piriformis stretching, and static hamstring stretching (5 repetitions of 30-second holds for stretches; 5 repetitions of 10-second holds for posterior pelvic tilt); the program was performed daily for 21 sessions over 3 weeks and supported by written instructions, visual materials, and weekly telephone follow-up; (2) Experimental Group (EG) - the identical home exercise program plus four sessions of supervised spinal mobilization delivered by a physiotherapist (one at baseline and once weekly for 3 weeks).
Mobilization was administered according to the Maitland classification (graded I to V; end-range was not forced) and included thoracic posteroanterior mobilization (T5-T12), rotational thoracic mobilization ("butterfly/screw" technique), sacroiliac mobilization, side-lying lumbar mobilization, and anteroposterior lumbar mobilization.
Each technique was applied as five sets of one-minute oscillations with 20-second rest intervals across the posteroanterior, mediolateral, and transverse planes.
Outcome assessments were performed at baseline (Week 0) and at the end of the intervention (Week 3) by a single blinded assessor.
Pain was quantified with three 10-cm Visual Analog Scales (physical activity, rest, and night).
Dynamic balance was assessed with the Y-Balance Test in three directions (anterior, posteromedial, posterolateral).
Lower-extremity power was measured with the Vertical Jump Test using the validated My Jump Lab application (iPhone 15 Pro Max).
Hamstring and lumbar flexibility were measured with a Baseline sit-and-reach box.
Isometric strength of the back, chest, and leg extensors was measured with a calibrated Baseline back-chest-leg dynamometer (New York, USA).
Statistical plan: normality was tested by Shapiro-Wilk; within-group changes were analysed by paired-samples t-test, between-group differences by independent-samples t-test, and categorical variables by Chi-square; Cohen's d was calculated for parameters with significant within-group changes.
Analyses were performed in IBM SPSS 25.0.
A priori sample size estimation (G*Power 3.1.9.2) with 85% power, an effect size of d = 0.8, and α = 0.05 yielded a target of 30 participants; 32 were enrolled to allow for attrition.
Post hoc power analysis based on the post-intervention VAS during physical activity (d = 1.24, α = 0.05) yielded a power of 0.91.
No external funding; no conflicts of interest declared.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
31
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Istanbul, Turcja (Türkiye)
- Istinye University
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- Adults aged 18-45 years.
- Body mass index (BMI) between 18 and 30 kg/m².
- Mechanical low back pain that decreases in the supine position and increases with activity or in various postures.
- Low back pain of more than one week duration with a baseline intensity greater than 4 on the Visual Analog Scale (VAS) and unrelated to any defined medical condition.
- Playing tennis on a recreational basis at least 2 days per week, totalling at least 2 hours per week.
- Able to communicate in Turkish or English in both written and spoken form.
Exclusion Criteria:
- Pain in the lower back, hip, or groin lasting longer than 6 months.
- Pain accompanied by a sensory deficit.
- Pain radiating to the hip or lower extremity.
- History of long-term steroid use.
- Regular medication use.
- History of injury or surgery resulting in residual deficits.
- Previous interventional treatment to the lumbar region.
- Pregnancy or suspected pregnancy.
Termination Criteria During Study:
- Onset of an acute illness requiring treatment (e.g., influenza, pneumonia).
- Use of analgesic or sedative medication.
- An increase in VAS pain score greater than 3 points during exercise or treatment.
- Failure to perform the home exercise programme on three consecutive days.
- Missed manual therapy session.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Control Group (CG):Home Exercise Program Only
Structured home-based exercise program performed daily for 3 weeks (21 sessions).
The program included posterior pelvic tilt, double knee-to-chest erector spinae stretching, combined hamstring and lumbar extensor stretching (long-sit toe touch), piriformis stretching, and static hamstring stretching.
Adherence was supported by written instructions, visual materials, and weekly telephone follow-up.
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21 daily sessions over 3 weeks; 5 repetitions per exercise (30-second holds for stretches; 10-second hold for posterior pelvic tilt); supported by written instructions, visual materials, and weekly telephone follow-up.
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Eksperymentalny: Experimental Group (EG): Spinal Mobilization Plus Home Exercise Program
The identical home exercise program (21 sessions over 3 weeks) plus four sessions of supervised spinal mobilization administered by a physiotherapist - one at baseline and one per week for 3 weeks - using Maitland-graded techniques (Levels I-V; end-range not forced).
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21 daily sessions over 3 weeks; 5 repetitions per exercise (30-second holds for stretches; 10-second hold for posterior pelvic tilt); supported by written instructions, visual materials, and weekly telephone follow-up.
Four supervised sessions over 3 weeks (one at baseline and weekly thereafter).
Techniques included thoracic posteroanterior mobilization (T5-T12), rotational thoracic mobilization ("butterfly/screw"), sacroiliac mobilization, side-lying lumbar mobilization, and anteroposterior lumbar mobilization.
Each technique was applied as five sets of one-minute oscillations with 20-second rest intervals in the posteroanterior, mediolateral, and transverse planes.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Visual Analog Scale (VAS) for pain during physical activity (cm
Ramy czasowe: Baseline to Week 3
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Self-reported pain intensity during physical activity recorded on a 10-cm horizontal Visual Analog Scale anchored from 0 ("no pain") to 10 ("worst imaginable pain").
Lower values indicate less pain.
Safety Issue: No.
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Baseline to Week 3
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Visual Analog Scale (VAS) for pain at rest (cm)
Ramy czasowe: Baseline to Week 3
|
Self-reported pain intensity at rest recorded on a 10-cm horizontal Visual Analog Scale anchored from 0 ("no pain") to 10 ("worst imaginable pain").
Lower values indicate less pain.
Safety Issue: No.
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Baseline to Week 3
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Visual Analog Scale (VAS) for night pain (cm)
Ramy czasowe: Baseline to Week 3
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Self-reported pain intensity during sleep/night recorded on a 10-cm horizontal Visual Analog Scale anchored from 0 ("no pain") to 10 ("worst imaginable pain").
Lower values indicate less pain.
Safety Issue: No.
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Baseline to Week 3
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Y-Balance Test (cm)
Ramy czasowe: Baseline to Week 3
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Dynamic balance and neuromuscular control assessed by the maximum reach distance for each lower extremity in three directions (anterior, posteromedial, posterolateral).
Three trials per leg per direction; the maximum reach distance for each direction is recorded.
Higher values indicate better dynamic postural control.
Safety Issue: No.
|
Baseline to Week 3
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Vertical Jump Test (cm)
Ramy czasowe: Baseline to Week 3
|
Maximal vertical jump height assessed using the validated My Jump Lab smartphone application (iPhone 15 Pro Max mounted on a flexible tripod 20 cm above the ground).
Three trials are performed barefoot on a hard surface with hands fixed on the hips; minimum, maximum, and mean values are recorded.
Higher values indicate better lower-extremity power.
Safety Issue: No.
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Baseline to Week 3
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Sit-and-Reach Test (cm)
Ramy czasowe: Baseline to Week 3
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Hamstring and lumbar flexibility assessed using a Baseline sit-and-reach box.
From a long-sit position with the feet flat against the box and the knees fully extended, the participant reaches forward with both hands three times; the maximum reach distance from the foot reference line is recorded (positive when reaching beyond the toes; negative when not reaching the toes).
Higher values indicate greater flexibility.
Safety Issue: No.
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Baseline to Week 3
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Isometric Back-Chest-Leg Strength (kg-force)
Ramy czasowe: Baseline to Week 3
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Maximal isometric strength of the back, chest, and lower-extremity extensor chain measured with a calibrated Baseline back-chest-leg dynamometer (New York, USA).
Following one practice trial, three trials are performed with 30-second rest intervals; the highest value is used in analysis.
Higher values indicate greater isometric strength.
Safety Issue: No.
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Baseline to Week 3
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 kwietnia 2025
Zakończenie podstawowe (Rzeczywisty)
1 sierpnia 2025
Ukończenie studiów (Rzeczywisty)
20 sierpnia 2025
Daty rejestracji na studia
Pierwszy przesłany
1 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
1 maja 2026
Pierwszy wysłany (Rzeczywisty)
7 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
7 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Tennis - Spinal Mob 25-49
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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