Rehabilitation Programs in Grade I-II Spondylolisthesis

February 16, 2026 updated by: Justyna Rdzanek, Józef Piłsudski University of Physical Education

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other: Physical Therapy
Physical therapy modalities provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period.
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
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.
Other: Myofascial 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
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.
Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk muscle strength
Time Frame: Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.
Static strength of trunk flexor and extensor muscles assessed using torque measurements under static conditions.
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.
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.
Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Józef Piłsudski University of Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 000000

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rdzanek-Spondylolisthesis-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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