CClinicalTrials.gg
CompletedNCT07419256Updated Feb 18, 2026

Rehabilitation Programs in Grade I-II Spondylolisthesis

An interventional study of Kinesiotherapy and Physical Therapy in Low Back Pain and Spondylolisthesis, sponsored by Józef Piłsudski University of Physical Education. Completed at 1 site in Poland. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Józef Piłsudski University of Physical Education · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 4 months after the study started (first participant enrolled Oct 2020, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
60 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Low Back Pain
  • Spondylolisthesis

Keywords

  • low back pain
  • rehabilitation
  • kinesiotherapy
  • physical therapy
  • myofascial trigger point therapy
  • Oswestry Disability Index
  • postural stability
  • spondylolisthesis
03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 58 is close to the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Józef Piłsudski University of Physical Education is the lead sponsor of 34 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Epilepsy.
  • Vertebral fractures.
  • Previous spine surgery.
  • Dizziness.
  • Internal organ diseases under specialist treatment.
  • Cardiovascular and pulmonary diseases.
  • Vestibular system disorders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Kinesiotherapy plus Physical Therapy

    Participants received a standardized kinesiotherapy exercise program combined with physical therapy modalities over a 4-week rehabilitation period.

    Other: Kinesiotherapy · Other: Physical Therapy

  • Experimental
    Kinesiotherapy plus Myofascial Trigger Point Therapy

    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.

    Other: Kinesiotherapy · Other: Myofascial Trigger Point Therapy

Interventions

  • OtherKinesiotherapy

    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.

  • OtherPhysical Therapy

    Physical therapy modalities provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period.

  • OtherMyofascial Trigger Point Therapy

    Manual myofascial trigger point therapy provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.

  2. 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.

    Time frame: Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.

Secondary outcomes

  1. Trunk muscle strength

    Static strength of trunk flexor and extensor muscles assessed using torque measurements under static conditions.

    Time frame: Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.

  2. 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.

    Time frame: Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.

07

Study locations

1 site
  • Independent Public Trust of Ambulatory Care Units Warszawa Praga-Północ Warsaw, Poland
    Warsaw, Poland
08

References and documents

Publications

  • 000000

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07419256
Lead sponsor
Józef Piłsudski University of Physical Education
Responsible party
Justyna Rdzanek (Principal Investigator, Józef Piłsudski University of Physical Education) — Principal investigator
First posted
Feb 18, 2026
Start date
Oct 1, 2020
Primary completion
Jun 1, 2021
Completion
Jun 30, 2021
Last update
Feb 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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