Rehabilitation Programs in Grade I-II Spondylolisthesis

N/ACompletedNCT07419256

Józef Piłsudski University of Physical Education58 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

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.

Outcomes

Primary Outcomes

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.

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

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.

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.