NCT07573254

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Keywords

low back paintennismanual therapytherapeutic exercisePhysiotherapy and rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) for pain during physical activity (cm

    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

Secondary Outcomes (6)

  • Visual Analog Scale (VAS) for pain at rest (cm)

    Baseline to Week 3

  • Visual Analog Scale (VAS) for night pain (cm)

    Baseline to Week 3

  • Y-Balance Test (cm)

    Baseline to Week 3

  • Vertical Jump Test (cm)

    Baseline to Week 3

  • Sit-and-Reach Test (cm)

    Baseline to Week 3

  • +1 more secondary outcomes

Study Arms (2)

Control Group (CG):Home Exercise Program Only

ACTIVE COMPARATOR

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.

Behavioral: Home Exercise Program

Experimental Group (EG): Spinal Mobilization Plus Home Exercise Program

EXPERIMENTAL

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).

Behavioral: Home Exercise ProgramProcedure: Spinal Mobilization (Maitland-Graded Manual Therapy)

Interventions

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.

Control Group (CG):Home Exercise Program OnlyExperimental Group (EG): Spinal Mobilization Plus Home Exercise Program

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.

Experimental Group (EG): Spinal Mobilization Plus Home Exercise Program

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments were performed by a single assessor blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blind randomized controlled trial with two parallel arms; allocation by computer-assisted randomization with sealed opaque envelopes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor, PhD

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start

April 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 20, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations