NCT07419256

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 2, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

low back painrehabilitationkinesiotherapyphysical therapymyofascial trigger point therapyOswestry Disability Indexpostural stabilityspondylolisthesis

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    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

    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.

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

Study Arms (2)

Kinesiotherapy plus Physical Therapy

EXPERIMENTAL

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

Other: KinesiotherapyOther: 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.

Other: KinesiotherapyOther: Myofascial Trigger Point Therapy

Interventions

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.

Kinesiotherapy plus Myofascial Trigger Point TherapyKinesiotherapy plus Physical Therapy

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

Kinesiotherapy plus Physical Therapy

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

Kinesiotherapy plus Myofascial Trigger Point Therapy

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, Poland

Location

Related Publications (1)

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    BACKGROUND

MeSH Terms

Conditions

Low Back PainSpondylolisthesis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of two parallel intervention groups receiving different rehabilitation programs.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 18, 2026

Study Start

October 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 30, 2021

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations