Muscle StiffnessNCT07826260
Immediate Effect of Lumbar Mobilization on Paraspinal Muscle Stiffness
A study testing Maitland Grade III++ Central Posteroanterior Mobilization in people with Muscle Stiffness, run by University of Primorska at 1 site in Slovenia.
Trial summary
This randomized controlled crossover study will investigate the immediate effect of central posteroanterior lumbar mobilization on the intrinsic stiffness of the erector spinae and multifidus muscles in healthy adults without low back pain. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Stiffness
- What is being tested?
- Maitland Grade III++ Central Posteroanterior Mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSlovenia
- Study dates
- 30 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men and women aged 21 to 38 years.
- Resident of the Republic of Slovenia.
- No current low back pain.
- No contraindications to lumbar manual mobilization.
- Ability to assume and maintain the required prone testing position.
- Provision of written informed consent.
Who cannot join
- Current low back pain.
- Spondylolisthesis.
- Severe osteoporosis.
- Spinal stenosis.
- Lumboischialgia or other significant structural spinal deformity.
- Fibromyalgia.
Show all 16Show fewer
- Recent spinal surgery or lumbar spinal fixation.
- Cauda equina syndrome.
- Nerve root compression associated with neurological deficits.
- Malignancy.
- Recent relevant trauma.
- Joint instability.
- Active rheumatoid arthritis.
- Acute local or systemic infection.
- Long-term local corticosteroid use.
- Inability to assume or maintain the required testing position.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University of Primorska, Faculty of Health Sciences, Izola
Izola, 6310
Žiga Kozinc, PhD, 040161503 ext. +386, ziga.kozinc@s2p.si
About this study
Official title: Immediate Effect of Maitland Grade III++ Central Posteroanterior Mobilization on Erector Spinae and Multifidus Muscle Stiffness in Healthy Adults: A Randomized Crossover Trial
This randomized controlled crossover study will investigate the immediate effect of central posteroanterior lumbar mobilization on the intrinsic stiffness of the erector spinae and multifidus muscles in healthy adults without low back pain. Twenty-four participants will complete two experimental visits in randomized order. During one visit, participants will receive Maitland Grade III++ central posteroanterior mobilization at the L4 vertebral level, while during the other visit they will receive a sham mobilization condition involving gentle rhythmic pressure. Muscle stiffness will be assessed using shear wave elastography immediately before and after each intervention.
Read the detailed description
The study will be designed as a randomized controlled crossover trial to investigate the immediate effects of manual spinal mobilization on lumbar paraspinal muscle stiffness in healthy adults without low back pain. Each participant will attend two separate study visits and will receive both experimental conditions in a randomized order.
In the experimental condition, Maitland Grade III++ central posteroanterior mobilization will be applied over the spinous process of L4. The intervention will consist of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets. In the control condition, participants will receive a sham mobilization presented as a Grade I mobilization technique. The sham intervention will follow the same timing structure but will consist of gentle rhythmic pressure over the L4 spinous process.
Intrinsic muscle stiffness of the right erector spinae and multifidus muscles will be assessed using shear wave elastography. Three measurements will be obtained immediately before and after each intervention, and the mean value will be expressed in kilopascals. Measurements will be performed in a standardized prone position at the L4-L5 level.
- Conditions
- Muscle Stiffness
- Being tested
- Maitland Grade III++ Central Posteroanterior Mobilization, Sham Lumbar Mobilization
- Keywords
- Manual Therapy, Spinal Mobilization, Posteroanterior Mobilization, Maitland Mobilization, Muscle Stiffness, Shear Wave Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maitland Grade III++ Central Posteroanterior MobilizationProcedure or surgery
Central posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position. The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total.
Sham Lumbar MobilizationProcedure or surgery
Sham mobilization is applied over the L4 spinous process with the participant in a prone position. The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets. The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization-Sham Sequence | Experimental | Participants receive Maitland Grade III++ central posteroanterior mobilization during the first study visit and sham mobilization during the second study visit. Receives: Procedure: Maitland Grade III++ Central Posteroanterior Mobilization; Procedure: Sham Lumbar Mobilization |
| Sham-Mobilization Sequence | Active comparator | Participants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit. Receives: Procedure: Maitland Grade III++ Central Posteroanterior Mobilization; Procedure: Sham Lumbar Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Erector Spinae Muscle Stiffness
Intrinsic stiffness of the right erector spinae muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa). Three measurements are obtained at each time point and averaged. The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
Measured: Immediately before and immediately after each intervention session
Change in Multifidus Muscle Stiffness
Intrinsic stiffness of the right multifidus muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa). Three measurements are obtained at each time point and averaged. The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
Measured: Immediately before and immediately after each intervention session
Secondary outcomes (2)
Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the erector spinae shear wave elastography assessment. Measurements will be performed immediately before and after each intervention condition. The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.
Measured: Immediately before and immediately after each intervention session
Change in Multifidus Muscle Stiffness Assessed by Myotonometry
Myotonometry will be used to assess mechanical muscle stiffness at the same measurement location used for the multifidus shear wave elastography assessment. Measurements will be performed immediately before and after each intervention condition. The outcome will be the change in muscle stiffness from pre-intervention to immediate post-intervention.
Measured: Immediately before and immediately after each intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion26 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StiffnessStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete both intervention conditions during two separate study visits. The order of Maitland Grade III++ central posteroanterior mobilization and sham mobilization will berandomized, with the alternate condition administered during the second visit.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Žiga Kozinc, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826260
- Sponsor's protocol ID
- UP-FHS-PA-SWE-2026
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in subsequent publications may be made available upon reasonable request to the study investigators. Data will be shared for scientifically justified purposes following approval by the investigators and, where appropriate, completion of a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Maitland Grade III++ Central Posteroanterior Mobilization on Erector Spinae and Multifidus Muscle Stiffness in Healthy Adults: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07826260
- Acronym / sponsor ID
- UP-FHS-PA-SWE-2026
- Conditions
- Muscle Stiffness
- Keywords
- Manual Therapy, Spinal Mobilization, Posteroanterior Mobilization, Maitland Mobilization, Muscle Stiffness, Shear Wave Elastography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Sep 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 randomized controlled crossover study will investigate the immediate effect of central posteroanterior lumbar mobilization on the intrinsic stiffness of the erector spinae and multifidus muscles in healthy adults without low back pain. Twenty-four participants will complete two experimental visits in randomized order. During one visit, participants will receive Maitland Grade III++ central posteroanterior mobilization at the L4 vertebral level, while during the other visit they will receive a sham mobilization condition involving gentle rhythmic pressure. Muscle stiffness will be assessed using shear wave elastography immediately before and after each intervention.
Detailed description
The study will be designed as a randomized controlled crossover trial to investigate the immediate effects of manual spinal mobilization on lumbar paraspinal muscle stiffness in healthy adults without low back pain. Each participant will attend two separate study visits and will receive both experimental conditions in a randomized order.
In the experimental condition, Maitland Grade III++ central posteroanterior mobilization will be applied over the spinous process of L4. The intervention will consist of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets. In the control condition, participants will receive a sham mobilization presented as a Grade I mobilization technique. The sham intervention will follow the same timing structure but will consist of gentle rhythmic pressure over the L4 spinous process.
Intrinsic muscle stiffness of the right erector spinae and multifidus muscles will be assessed using shear wave elastography. Three measurements will be obtained immediately before and after each intervention, and the mean value will be expressed in kilopascals. Measurements will be performed in a standardized prone position at the L4-L5 level.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will complete both intervention conditions during two separate study visits. The order of Maitland Grade III++ central posteroanterior mobilization and sham mobilization will berandomized, with the alternate condition administered during the second visit.
| Arm | Type | Receives |
|---|---|---|
| Mobilization-Sham Sequence | Experimental | Procedure: Maitland Grade III++ Central Posteroanterior Mobilization, Procedure: Sham Lumbar MobilizationParticipants receive Maitland Grade III++ central posteroanterior mobilization during the first study visit and sham mobilization during the second study visit. |
| Sham-Mobilization Sequence | Active comparator | Procedure: Maitland Grade III++ Central Posteroanterior Mobilization, Procedure: Sham Lumbar MobilizationParticipants receive sham mobilization during the first study visit and Maitland Grade III++ central posteroanterior mobilization during the second study visit. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women aged 21 to 38 years.
- Resident of the Republic of Slovenia.
- No current low back pain.
- No contraindications to lumbar manual mobilization.
- Ability to assume and maintain the required prone testing position.
Key exclusion criteria (16 listed)
- Current low back pain.
- Spondylolisthesis.
- Severe osteoporosis.
- Spinal stenosis.
- Lumboischialgia or other significant structural spinal deformity.
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 |
|---|---|---|
| Maitland Grade III++ Central Posteroanterior MobilizationCentral posteroanterior mobilization is applied over the L4 spinous process with the participant in a prone position. The intervention consists of three 60-second sets of passive rhythmic oscillatory pressures performed at approximately 2 Hz, with 30-second rest periods between sets, resulting in approximately 360 oscillatory pressures in total. | Procedure or surgery | Mobilization-Sham Sequence, Sham-Mobilization Sequence |
| Sham Lumbar MobilizationSham mobilization is applied over the L4 spinous process with the participant in a prone position. The procedure consists of three 60-second sets of gentle rhythmic pressures with 30-second rest periods between sets. The timing and therapist contact are matched to the experimental condition, while substantial mobilization pressure is avoided. | Procedure or surgery | Mobilization-Sham Sequence, Sham-Mobilization Sequence |
Primary outcome
Change in Erector Spinae Muscle Stiffness
Time frame: Immediately before and immediately after each intervention session
Intrinsic stiffness of the right erector spinae muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa). Three measurements are obtained at each time point and averaged. The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
Change in Multifidus Muscle Stiffness
Time frame: Immediately before and immediately after each intervention session
Intrinsic stiffness of the right multifidus muscle is assessed using shear wave elastography and expressed as shear modulus in kilopascals (kPa). Three measurements are obtained at each time point and averaged. The outcome is the change from the pre-intervention to the immediate post-intervention measurement.
2 secondary outcomes
Change in Erector Spinae Muscle Stiffness Assessed by Myotonometry
Time frame: Immediately before and immediately after each intervention session
Change in Multifidus Muscle Stiffness Assessed by Myotonometry
Time frame: Immediately before and immediately after each intervention session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in subsequent publications may be made available upon reasonable request to the study investigators. Data will be shared for scientifically justified purposes following approval by the investigators and, where appropriate, completion of a data-sharing agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maitland Grade III++ Central Posteroanterior Mobilization in people with Muscle Stiffness, run by University of Primorska at 1 site in Slovenia.
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 16 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: looking for participants now, as of the sponsor's last update on 17 Sep 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Žiga Kozinc, PhD (040161503 ext. +386, ziga.kozinc@s2p.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Erector Spinae Muscle Stiffness (time frame: Immediately before and immediately after each intervention session). The study lists 2 primary outcomes in all. 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 17 Sep 2026.