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).
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
- Conditions the study is for
- Low Back Pain, Mechanical, Recreational Physical Activity, Tennis
- What is being tested?
- Home Exercise Program and Spinal Mobilization (Maitland-Graded Manual Therapy)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- 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.
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.
- Conditions
- Low Back Pain, Mechanical, Recreational Physical Activity, Tennis, Manual Therapy, Therapeutic Exercise, Physiotherapy and Rehabilitation
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). 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.
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)
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
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
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
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
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
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.
- First posted7 May 2026
- Study start1 Apr 2025
- Primary completion1 Aug 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirsad Alkan, Istinye University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07573254
- Acronym / sponsor ID
- Tennis - Spinal Mob 25-49
- Conditions
- Low Back Pain, Mechanical, Recreational Physical Activity, Tennis, Manual Therapy, Therapeutic Exercise, Physiotherapy and Rehabilitation
- Keywords
- low back pain, tennis, manual therapy, therapeutic exercise, Physiotherapy and rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled trial with two parallel arms; allocation by computer-assisted randomization with sealed opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG):Home Exercise Program Only | Active comparator | Behavioral: Home Exercise ProgramStructured 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. |
| Experimental Group (EG): Spinal Mobilization Plus Home Exercise Program | Experimental | Behavioral: Home Exercise Program, Procedure: Spinal Mobilization (Maitland-Graded Manual Therapy)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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Exercise Program21 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. | Behavioural | Control Group (CG):Home Exercise Program Only, Experimental Group (EG): Spinal Mobilization Plus Home Exercise Program |
| Spinal Mobilization (Maitland-Graded Manual Therapy)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. | Procedure or surgery | Experimental Group (EG): Spinal Mobilization Plus Home Exercise Program |
Primary outcome
Visual Analog Scale (VAS) for pain during physical activity (cm
Time frame: 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.
6 secondary outcomes
Visual Analog Scale (VAS) for pain at rest (cm)
Time frame: Baseline to Week 3
Visual Analog Scale (VAS) for night pain (cm)
Time frame: Baseline to Week 3
Y-Balance Test (cm)
Time frame: Baseline to Week 3
Vertical Jump Test (cm)
Time frame: Baseline to Week 3
Sit-and-Reach Test (cm)
Time frame: Baseline to Week 3
Isometric Back-Chest-Leg Strength (kg-force)
Time frame: Baseline to Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.