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Low Back Pain, MechanicalNCT07573254

The Effects of Spinal Mobilization Added to an Exercise Program in Recreational Tennis Players With Mechanical Low Back Pain

A study testing Home Exercise Program and Spinal Mobilization (Maitland-Graded Manual Therapy) in people with Low Back Pain, Mechanical and Recreational Physical Activity, run by Istinye University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Home Exercise Program and Spinal Mobilization (Maitland-Graded Manual Therapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2025to 20 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istinye University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Home Exercise Program, Spinal Mobilization (Maitland-Graded Manual Therapy)
Keywords
low back pain, tennis, manual therapy, therapeutic exercise, Physiotherapy and rehabilitation
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home Exercise ProgramBehavioural

    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.

  • Spinal Mobilization (Maitland-Graded Manual Therapy)Procedure or surgery

    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.

Study groups in NCT07573254
Study groupRoleWhat they receive
Control Group (CG):Home Exercise Program OnlyActive comparatorStructured 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.
Receives: Behavioral: Home Exercise Program
Experimental Group (EG): Spinal Mobilization Plus Home Exercise ProgramExperimentalThe 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).
Receives: Behavioral: Home Exercise Program; Procedure: Spinal Mobilization (Maitland-Graded Manual Therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 3

Secondary outcomes (6)
  1. Visual Analog Scale (VAS) for pain at rest (cm)

    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.

    Measured: Baseline to Week 3

  2. Visual Analog Scale (VAS) for night pain (cm)

    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.

    Measured: Baseline to Week 3

  3. Y-Balance Test (cm)

    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.

    Measured: Baseline to Week 3

  4. Vertical Jump Test (cm)

    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.

    Measured: Baseline to Week 3

  5. Sit-and-Reach Test (cm)

    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.

    Measured: Baseline to Week 3

  6. Isometric Back-Chest-Leg Strength (kg-force)

    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.

    Measured: Baseline to Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start1 Apr 2025
  3. Primary completion1 Aug 2025
  4. Study completion20 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind randomized controlled trial with two parallel arms; allocation by computer-assisted randomization with sealed opaque envelopes.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07573254
Sponsor's protocol ID
Tennis - Spinal Mob 25-49
Status last verified
May 2026
First submitted
1 May 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Home Exercise Program and Spinal Mobilization (Maitland-Graded Manual Therapy) in people with Low Back Pain, Mechanical and Recreational Physical Activity, run by Istinye University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) for pain during physical activity (cm (time frame: Baseline to Week 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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