- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07573254
The Effects of Spinal Mobilization Added to an Exercise Program in Recreational Tennis Players With Mechanical Low Back Pain
1. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
31
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Istanbul, Tyrkiet (Türkiye)
- Istinye University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
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: 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.
|
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.
|
|
Eksperimentel: 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).
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analog Scale (VAS) for pain during physical activity (cm
Tidsramme: Baseline to Week 3
|
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.
|
Baseline to Week 3
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analog Scale (VAS) for pain at rest (cm)
Tidsramme: 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.
|
Baseline to Week 3
|
|
Visual Analog Scale (VAS) for night pain (cm)
Tidsramme: Baseline to Week 3
|
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.
|
Baseline to Week 3
|
|
Y-Balance Test (cm)
Tidsramme: Baseline to Week 3
|
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
|
|
Vertical Jump Test (cm)
Tidsramme: 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.
|
Baseline to Week 3
|
|
Sit-and-Reach Test (cm)
Tidsramme: Baseline to Week 3
|
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.
|
Baseline to Week 3
|
|
Isometric Back-Chest-Leg Strength (kg-force)
Tidsramme: Baseline to Week 3
|
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.
|
Baseline to Week 3
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2025
Primær færdiggørelse (Faktiske)
1. august 2025
Studieafslutning (Faktiske)
20. august 2025
Datoer for studieregistrering
Først indsendt
1. maj 2026
Først indsendt, der opfyldte QC-kriterier
1. maj 2026
Først opslået (Faktiske)
7. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tennis - Spinal Mob 25-49
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Home Exercise Program
-
National University, SingaporeNational University Hospital, SingaporeAfsluttet
-
Burapha UniversityAfsluttetRis serum | Ris maske | RisgeleThailand
-
Kasr El Aini HospitalUkendtUrologiske kirurgiske procedurerEgypten
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California...AfsluttetStress | Stress, psykologisk | Stress, følelsesmæssig | Stress, Fysiologisk | Stress reaktionForenede Stater
-
Rhode Island HospitalState of Rhode Island Department of Health; Providence Public School District og andre samarbejdspartnereAfsluttet
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... og andre samarbejdspartnereAfsluttetOverernæring | Ernæringsforstyrrelser | Overvægtig | Kropsvægt | Pædiatrisk fedme | Ændringer i kropsvægt | Fedme hos børn | Vægtøgning | Teenagers fedme | Fedme, barndom | Overvægt og fedme | Overvægt eller fedme | Overvægtige ungeForenede Stater
-
University of South CarolinaNational Heart, Lung, and Blood Institute (NHLBI)Afsluttet
-
Linnaeus UniversityIkke rekrutterer endnuRekonstruktion af forreste korsbåndSverige
-
Children's Hospital Medical Center, CincinnatiSeattle Children's Hospital; St. Jude Children's Research Hospital; University...AfsluttetKræft | Overholdelse, MedicinForenede Stater
-
National University Hospital, SingaporeAktiv, ikke rekrutterende