Evaluation of the Effectiveness of Two 4-Week Rehabilitation Programs in Patients With Grade I or II Spondylolisthesis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Józef Piłsudski University of Physical Education
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Pain intensity
Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
- •Epilepsy.
- •Vertebral fractures.
- •Previous spine surgery.
- •Dizziness.
- •Internal organ diseases under specialist treatment.
- •Cardiovascular and pulmonary diseases.
- •Vestibular system disorders.
Arms & Interventions
Kinesiotherapy plus Physical Therapy
Participants received a standardized kinesiotherapy exercise program combined with physical therapy modalities over a 4-week rehabilitation period.
Intervention: Kinesiotherapy (Other)
Kinesiotherapy plus Physical Therapy
Participants received a standardized kinesiotherapy exercise program combined with physical therapy modalities over a 4-week rehabilitation period.
Intervention: Physical Therapy (Other)
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.
Intervention: Kinesiotherapy (Other)
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.
Intervention: Myofascial Trigger Point Therapy (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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.)
Investigators
Justyna Rdzanek
Principal Investigator
Józef Piłsudski University of Physical Education