- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07575542
The Effects of Spinal Mobilization Added to an Exercise Program in Recreational Tennis Players With Mechanical
The Effects of Spinal Mobilization Added to an Exercise Program on Pain and Physical Fitness in Recreational Tennis Players With Mechanical
Przegląd badań
Status
Szczegółowy opis
Design: Prospective, single-blind, randomized controlled, two-arm parallel-group superiority trial. Eligible adults aged 18-45 years (BMI 18-30 kg/m²) who were recreational tennis players (playing tennis at least twice weekly, ≥2 hours/week) and presented with mechanical neck pain (>1 week duration, VAS > 4, reduced cervical range of motion confirmed by the cervical flexion-rotation test, and tenderness on external pressure over at least one cervical joint) were enrolled after providing written informed consent. Participants were allocated 1:1 to one of two groups using simple randomization with sealed opaque envelopes. The outcome assessor was blinded to group allocation (single-blind, assessor masking).
Interventions: Both groups completed an identical structured home exercise program lasting three weeks (21 daily sessions). The program comprised stretching of the upper trapezius, right and left levator scapulae, hamstring, and lumbar extensor muscles (30-second holds, 5 repetitions, 3 sets), isometric resistance exercises for cervical flexion, extension, and right and left lateral flexion (10-second holds with 10-second rests, 5 repetitions, 3 sets), the chin-tuck exercise (10-second holds, 5 repetitions, 3 sets), and the cat-camel exercise (10-second holds in each position, 5 repetitions, 3 sets). Written instructions illustrated by figures were provided to ensure correct execution and adherence. The Experimental Group received the same home program plus a Maitland-concept spinal mobilization protocol delivered by a physiotherapist over four supervised sessions (one at baseline and one per week, total of four sessions across three weeks). Cervical mobilization was applied with the participant prone, the therapist standing at the head, and bilateral thumb pressure applied over the facet joint or spinous process of the targeted hypomobile vertebra; grades I-II were used when pain preceded the motion limit and grades III-IV when the motion limit preceded pain, with oscillations at 2-3 Hz performed for approximately 30 seconds per bout, 3-4 bouts per segment, with 1-minute rest between bouts. Upper thoracic mobilization aimed to increase upper-thoracic extension, applying the same dosage as the cervical mobilization, performed with anterior-to-posterior pressure on the transverse processes of the targeted segments.
Assessments: Pre-intervention (Week 0) and post-intervention (Week 3) measurements were performed in a fixed order with rest intervals. Pain intensity was assessed using a 10 cm Visual Analog Scale (VAS) for pain during physical activity, at rest, and during sleep. Cervical active range of motion (flexion, extension, right and left lateral flexion, right and left rotation) was measured with a Cervical Range of Motion (CROM) device with the participant in upright sitting (three measurements per direction, recorded in degrees). Isometric neck muscle strength for flexion, extension, and bilateral lateral flexion was measured using a handheld dynamometer (JTECH Medical Commander Echo MMT) with the participant seated; the maximum of three 3-second contractions was averaged and recorded in kilograms-force. Hand grip strength (hydraulic hand dynamometer) and pinch grip strength (pinch meter) were measured bilaterally in standardized seated posture with elbow at 90° flexion (mean of three trials, kilograms). Reaction time was assessed bilaterally using the Ruler Drop Test with a 60 cm ruler. Vertical jump height was measured using the validated My Jump Lab smartphone application (iPhone 15 Pro Max on a tripod 20 cm above the floor), with three trials and the highest, lowest, and mean values recorded. Flexibility was measured by the sit-and-reach test (three trials, recorded in centimeters).
Statistical Analysis: Sample size of 30 (15 per group) was based on study termination criteria. Descriptive statistics included mean ± standard deviation, median with 25th-75th percentiles, and frequencies. Normality was tested with the Shapiro-Wilk test. Within-group changes were analyzed using paired-samples t-tests for normally distributed variables and the Wilcoxon signed-rank test for non-normally distributed variables; between-group comparisons of change scores used independent-samples t-tests or the Mann-Whitney U test as appropriate. Categorical variables were compared using chi-square tests. Statistical significance was set at p < 0.05. Analyses were performed in IBM SPSS Statistics. There was no external funding for this study and the investigators declare no conflicts of interest.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Istanbul, Turcja (Türkiye)
- Istinye University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Age between 18 and 45 years.
- Body Mass Index (BMI) between 18 and 30 kg/m².
- Recreational tennis player, playing tennis at least 2 days per week and at least 2 hours per week.
- Mechanical neck pain triggered by neck movement or sustained positions on the symptomatic side.
- Reduced cervical range of motion as confirmed by a positive cervical flexion-rotation test.
- Pain elicited by external pressure over at least one cervical zygapophyseal (facet) joint.
- Neck pain of at least 1 week duration, with intensity greater than 4/10 on the Visual Analog Scale (VAS), not associated with any specific medical history.
- Able to communicate in Turkish or English (verbal and written).
- Free from systemic, orthopedic, neurological, chronic, or psychiatric disease.
Exclusion Criteria:
- Neck pain of more than 6 months duration.
- Concomitant sensory loss (paresthesia, hypoesthesia, or anesthesia).
- Pain radiating to the upper extremities (radicular symptoms).
- History of long-term systemic corticosteroid use.
- Regular use of medications affecting musculoskeletal performance or pain perception.
- Sequelae from prior injury or any surgical history involving the cervical or thoracic spine.
- Prior interventional procedures targeting the neck region (e.g., injection therapy).
- Pregnancy or suspected pregnancy.
- During the study: pain greater than 3/10 on VAS during sessions, three consecutive missed sessions, incident illness or trauma, withdrawal request, or failure to meet exercise progression criteria.
Plan studiów
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: Active Comparator: Control Group (CG)
Control Group (CG, n=15): Participants performed an unsupervised structured home therapeutic exercise program for three weeks (one session per day; 21 sessions total).
The program comprised bilateral stretching of the upper trapezius and levator scapulae muscles, hamstring and lumbar extensor stretching, isometric resistance exercises for cervical flexion, extension, and bilateral lateral flexion, the chin-tuck exercise, and the cat-camel exercise.
Written instructions with illustrations were provided
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Three weeks (21 daily sessions) of unsupervised home exercises supported by written and illustrated instructions.
Components included bilateral upper trapezius and levator scapulae stretching, hamstring and lumbar extensor stretching, isometric cervical flexion / extension / bilateral lateral flexion exercises, chin-tuck exercise, and cat-camel exercise.
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Eksperymentalny: Experimental: Experimental Group (EG)
Experimental Group (EG, n=15): Participants performed the identical home therapeutic exercise program as the Control Group AND received four supervised sessions of Maitland-concept spinal mobilization (cervical and upper thoracic) delivered by a physiotherapist (one session at baseline and one session per week thereafter, total of four sessions across three weeks).
Mobilizations used grades I-IV depending on the relationship between pain and motion limit, with oscillations at 2-3 Hz, ~30 seconds per bout, 3-4 bouts per segment, and 1-minute rest between bouts.
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Three weeks (21 daily sessions) of unsupervised home exercises supported by written and illustrated instructions.
Components included bilateral upper trapezius and levator scapulae stretching, hamstring and lumbar extensor stretching, isometric cervical flexion / extension / bilateral lateral flexion exercises, chin-tuck exercise, and cat-camel exercise.
Therapist-delivered passive oscillatory mobilization to hypomobile cervical and upper thoracic segments using grades I-IV per the Maitland concept; oscillation rate 2-3 Hz; ~30-second bouts; 3-4 bouts per segment; 1-minute rest between bouts.
Total of four supervised sessions (one at baseline, then once per week) across three weeks.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pain intensity - Visual Analog Scale (VAS) during physical activity (0-10 cm)
Ramy czasowe: Baseline (Week 0) and Post-Intervention (Week 3)
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Self-reported pain intensity rated by the participant on a 10 cm horizontal Visual Analog Scale anchored from "no pain" (0) to "worst imaginable pain" (10), scored to one decimal in centimeters; lower scores indicate less pain.
Safety Issue: No.
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Baseline (Week 0) and Post-Intervention (Week 3)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pain intensity - Visual Analog Scale (VAS) at rest and during sleep (0-10 cm)
Ramy czasowe: Baseline (Week 0) and Post-Intervention (Week 3)
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Self-reported pain intensity rated separately during rest and sleep on a 10 cm Visual Analog Scale; lower scores indicate less pain.
Safety Issue: No.
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Baseline (Week 0) and Post-Intervention (Week 3)
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Cervical Range of Motion (CROM) - degrees
Ramy czasowe: Baseline (Week 0) and Post-Intervention (Week 3)
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Active cervical range of motion in flexion, extension, right and left lateral flexion, and right and left rotation measured with a Cervical Range of Motion (CROM) device (three inclinometers with magnetic compass) in upright sitting; results recorded in degrees; higher values indicate greater mobility.
Safety Issue: No.
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Baseline (Week 0) and Post-Intervention (Week 3)
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Isometric Neck Muscle Strength - kilograms-force (kgf)
Ramy czasowe: Baseline (Week 0) and Post-Intervention (Week 3)
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Maximal isometric strength of cervical flexors, extensors, and right and left lateral flexors measured using a handheld dynamometer (JTECH Medical Commander Echo MMT) with the dynamometer placed on the forehead, external occipital protuberance, or above the right/left ear, respectively; participants performed three 3-second maximal contractions per direction and the mean was recorded in kgf.
Safety Issue: No
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Baseline (Week 0) and Post-Intervention (Week 3)
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Hand Grip Strength - kilograms (kg)
Ramy czasowe: Baseline (Week 0) and Post-Intervention (Week 3)
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Maximal isometric grip strength of the right and left hands measured using a hydraulic hand dynamometer with the participant seated, shoulder adducted in neutral rotation, elbow at 90° flexion, and forearm/wrist in neutral position; the mean of three trials per hand was recorded in kilograms.
Safety Issue: No.
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Baseline (Week 0) and Post-Intervention (Week 3)
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Pinch Grip Strength - kilograms (kg)
Ramy czasowe: Time Frame: Baseline (Week 0) and Post-Intervention (Week 3)
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Maximal pinch (key/lateral) strength of the right and left hands between the thumb and index finger measured using a calibrated pinch meter with the participant seated, elbow at 90° flexion, and wrist in neutral; the mean of three trials per hand was recorded in kilograms.
Safety Issue: No
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Time Frame: Baseline (Week 0) and Post-Intervention (Week 3)
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Reaction Time - Ruler Drop Test (centimeters)
Ramy czasowe: Baseline (Week 0) and Post-Intervention (Week 3)
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Reaction time of the right and left hands measured using the Ruler Drop Test with a 60 cm ruler; the participant attempts to catch the ruler as quickly as possible after an unannounced release, and the catch distance (in centimeters) is recorded.
Lower values indicate faster reaction time.
Safety Issue: No.
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Baseline (Week 0) and Post-Intervention (Week 3)
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Vertical Jump Height - centimeters (cm)
Ramy czasowe: Baseline (Week 0) and Post-Intervention (Week 3)
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Countermovement vertical jump height measured using the validated My Jump Lab smartphone application (iPhone 15 Pro Max mounted on a tripod 20 cm above the floor); participants performed three jumps with hands on the iliac crests; the highest, lowest, and mean jump heights were recorded in centimeters.
Higher values indicate greater lower-limb power.
Safety Issue: No.
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Baseline (Week 0) and Post-Intervention (Week 3)
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Sit-and-Reach Test (centimeters)
Ramy czasowe: Baseline (Week 0) and Post-Intervention (Week 3)
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Flexibility measured with the standard sit-and-reach test (legs extended, knees in extension, feet against a fixed reference platform); reach distance was recorded in centimeters as the mean of three trials.
Higher values indicate greater flexibility.
Safety Issue: No.
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Baseline (Week 0) and Post-Intervention (Week 3)
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- tennis neck 25-77
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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