Low Back PainNCT07419256
Rehabilitation Programs in Grade I-II Spondylolisthesis
A study testing Kinesiotherapy, Physical Therapy and Myofascial Trigger Point Therapy in people with Low Back Pain and Spondylolisthesis, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
This interventional clinical study evaluated the effectiveness of two different 4-week rehabilitation programs in older adults aged 60-75 years with radiologically confirmed grade I or II spondylolisthesis. Participants were assigned to one of two parallel treatment groups. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Low Back Pain, Spondylolisthesis
- What is being tested?
- Kinesiotherapy, Physical Therapy and Myofascial Trigger Point Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2020to 30 Jun 2021
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-75 years.
- Radiologically confirmed grade I or II spondylolisthesis (ICD-10: M43.1).
- No neurological symptoms.
- Pain intensity tolerated by the patient.
- Written informed consent.
Who cannot join
- Epilepsy.
- Vertebral fractures.
- Previous spine surgery.
- Dizziness.
- Internal organ diseases under specialist treatment.
- Cardiovascular and pulmonary diseases.
- Vestibular system disorders.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Independent Public Trust of Ambulatory Care Units Warszawa Praga-Północ Warsaw, Poland
Warsaw
About this study
Official title: Evaluation of the Effectiveness of Two 4-Week Rehabilitation Programs in Patients With Grade I or II Spondylolisthesis
This interventional clinical study evaluated the effectiveness of two different 4-week rehabilitation programs in older adults aged 60-75 years with radiologically confirmed grade I or II spondylolisthesis. Participants were assigned to one of two parallel treatment groups. One group received a standardized kinesiotherapy program combined with physical therapy modalities, while the second group received the same kinesiotherapy program combined with myofascial trigger point therapy. Treatment effectiveness was assessed using pain intensity, functional disability, postural stability, and trunk muscle strength measures.
Read the detailed description
The study was conducted as an interventional clinical trial in an outpatient rehabilitation setting in Warsaw, Poland. Participants aged 60-75 years with radiologically confirmed degenerative or isthmic spondylolisthesis grade I or II were enrolled after providing written informed consent. The study protocol was approved by the Senate Ethics Committee for Scientific Research of the Józef Piłsudski University of Physical Education in Warsaw (approval number SKE 01-47/2021).
Participants were randomly assigned to one of two parallel intervention groups using sealed envelopes. Both groups followed the same standardized kinesiotherapy exercise program. In Group 1, the exercise program was combined with physical therapy modalities. In Group 2, the same exercise program was combined with myofascial trigger point therapy instead of physical therapy. Each participant completed a 4-week rehabilitation program, with a total duration of approximately 16 hours of physiotherapy procedures.
Outcome measures included pain intensity assessed using the Visual Analogue Scale (VAS), functional disability measured with the Oswestry Disability Index (ODI), postural stability assessed by static stabilography, and trunk muscle strength measured under static conditions. Assessments were performed at baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
- Conditions
- Low Back Pain, Spondylolisthesis
- Being tested
- Kinesiotherapy, Physical Therapy, Myofascial Trigger Point Therapy
- Keywords
- low back pain, rehabilitation, kinesiotherapy, physical therapy, myofascial trigger point therapy, Oswestry Disability Index, postural stability, spondylolisthesis
- Medical subject headings
- Low Back Pain, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotherapyOther
A standardized therapeutic exercise program delivered over 4 weeks, aimed at improving trunk muscle strength, stability, and functional performance in participants with grade I-II spondylolisthesis.
Physical TherapyOther
Physical therapy modalities provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period.
Myofascial Trigger Point TherapyOther
Manual myofascial trigger point therapy provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotherapy plus Physical Therapy | Experimental | Participants received a standardized kinesiotherapy exercise program combined with physical therapy modalities over a 4-week rehabilitation period. Receives: Other: Kinesiotherapy; Other: Physical Therapy |
| Kinesiotherapy plus Myofascial Trigger Point Therapy | Experimental | Participants received the same standardized kinesiotherapy exercise program as the first group, combined with myofascial trigger point therapy instead of physical therapy, over a 4-week rehabilitation period. Receives: Other: Kinesiotherapy; Other: Myofascial Trigger Point Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity assessed using the Visual Analogue Scale (VAS). The patient points with their finger on the scale to indicate the intensity of pain from 0 (no pain) to 10 (the most severe pain imaginable).
Measured: Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Functional disability
Functional disability assessed using the Oswestry Disability Index (ODI). A Polish translation of the questionnaire consisting of 10 questions concerning activities of daily living was used. For each question, there are 6 possible scores from A to F. Responses are classified from 0 to 5 points, respectively. The test result is the sum of points from all questions in the questionnaire. The higher the score (maximum being 50, minimum 0) the more severe the disability.
Measured: Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Secondary outcomes (2)
Trunk muscle strength
Static strength of trunk flexor and extensor muscles assessed using torque measurements under static conditions.
Measured: Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Postural stability on a force platform interpreted from meassurement of shift of the center of foot-pressure on the ground, expressed in millimeters.
Postural stability assessed using static stabilography parameters during quiet standing. Body posture balance measurements were taken on a force platform (JBA Staniak, Poland) with dedicated software. The assessment of the body balance method consisted in the participant performing two 30-second attempts to maintain a vertical body position on a force platform, according to the procedure de-scribed by Wychowański et al. The trials took place while: standing on two lower limbs with eyes open (EO) and eyes closed (EC). As the result of the body balance test, the Trace Length (TL), plotted by the center of foot-pressure on the ground (COP), expressed in millimeters, was taken.
Measured: Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Oct 2020
- Primary completion1 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Participants were assigned to one of two parallel intervention groups receiving different rehabilitation programs.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justyna Rdzanek, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419256
- Sponsor's protocol ID
- Rdzanek-Spondylolisthesis-2021
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
000000
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Two 4-Week Rehabilitation Programs in Patients With Grade I or II Spondylolisthesis
- ClinicalTrials.gov ID
- NCT07419256
- Acronym / sponsor ID
- Rdzanek-Spondylolisthesis-2021
- Conditions
- Low Back Pain, Spondylolisthesis
- Keywords
- low back pain, rehabilitation, kinesiotherapy, physical therapy, myofascial trigger point therapy, Oswestry Disability Index, postural stability, spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Feb 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 interventional clinical study evaluated the effectiveness of two different 4-week rehabilitation programs in older adults aged 60-75 years with radiologically confirmed grade I or II spondylolisthesis. Participants were assigned to one of two parallel treatment groups. One group received a standardized kinesiotherapy program combined with physical therapy modalities, while the second group received the same kinesiotherapy program combined with myofascial trigger point therapy. Treatment effectiveness was assessed using pain intensity, functional disability, postural stability, and trunk muscle strength measures.
Detailed description
The study was conducted as an interventional clinical trial in an outpatient rehabilitation setting in Warsaw, Poland. Participants aged 60-75 years with radiologically confirmed degenerative or isthmic spondylolisthesis grade I or II were enrolled after providing written informed consent. The study protocol was approved by the Senate Ethics Committee for Scientific Research of the Józef Piłsudski University of Physical Education in Warsaw (approval number SKE 01-47/2021).
Participants were randomly assigned to one of two parallel intervention groups using sealed envelopes. Both groups followed the same standardized kinesiotherapy exercise program. In Group 1, the exercise program was combined with physical therapy modalities. In Group 2, the same exercise program was combined with myofascial trigger point therapy instead of physical therapy. Each participant completed a 4-week rehabilitation program, with a total duration of approximately 16 hours of physiotherapy procedures.
Outcome measures included pain intensity assessed using the Visual Analogue Scale (VAS), functional disability measured with the Oswestry Disability Index (ODI), postural stability assessed by static stabilography, and trunk muscle strength measured under static conditions. Assessments were performed at baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel intervention groups receiving different rehabilitation programs.
| Arm | Type | Receives |
|---|---|---|
| Kinesiotherapy plus Physical Therapy | Experimental | Other: Kinesiotherapy, Other: Physical TherapyParticipants received a standardized kinesiotherapy exercise program combined with physical therapy modalities over a 4-week rehabilitation period. |
| Kinesiotherapy plus Myofascial Trigger Point Therapy | Experimental | Other: Kinesiotherapy, Other: Myofascial Trigger Point TherapyParticipants received the same standardized kinesiotherapy exercise program as the first group, combined with myofascial trigger point therapy instead of physical therapy, over a 4-week rehabilitation period. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60-75 years.
- Radiologically confirmed grade I or II spondylolisthesis (ICD-10: M43.1).
- No neurological symptoms.
- Pain intensity tolerated by the patient.
- Written informed consent.
Key exclusion criteria (7 listed)
- Epilepsy.
- Vertebral fractures.
- Previous spine surgery.
- Dizziness.
- Internal organ diseases under specialist treatment.
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 |
|---|---|---|
| KinesiotherapyA standardized therapeutic exercise program delivered over 4 weeks, aimed at improving trunk muscle strength, stability, and functional performance in participants with grade I-II spondylolisthesis. | Other | Kinesiotherapy plus Myofascial Trigger Point Therapy, Kinesiotherapy plus Physical Therapy |
| Physical TherapyPhysical therapy modalities provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period. | Other | Kinesiotherapy plus Physical Therapy |
| Myofascial Trigger Point TherapyManual myofascial trigger point therapy provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period. | Other | Kinesiotherapy plus Myofascial Trigger Point Therapy |
Primary outcome
Pain intensity
Time frame: Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Pain intensity assessed using the Visual Analogue Scale (VAS). The patient points with their finger on the scale to indicate the intensity of pain from 0 (no pain) to 10 (the most severe pain imaginable).
Functional disability
Time frame: Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Functional disability assessed using the Oswestry Disability Index (ODI). A Polish translation of the questionnaire consisting of 10 questions concerning activities of daily living was used. For each question, there are 6 possible scores from A to F. Responses are classified from 0 to 5 points, respectively. The test result is the sum of points from all questions in the questionnaire. The higher the score (maximum being 50, minimum 0) the more severe the disability.
2 secondary outcomes
Trunk muscle strength
Time frame: Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Postural stability on a force platform interpreted from meassurement of shift of the center of foot-pressure on the ground, expressed in millimeters.
Time frame: Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
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 18 Feb 2026.
- Background000000
- Individual participant dataSharing planned: No
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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 Kinesiotherapy, Physical Therapy and Myofascial Trigger Point Therapy in people with Low Back Pain and Spondylolisthesis, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 5 inclusion and 7 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 18 Feb 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 Poland. 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?
Pain intensity (time frame: Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.). 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?
On the ClinicalTrials.gov record for NCT07419256, which also lists 1 linked publication.
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 18 Feb 2026.