Exercise Therapy for Isotretinoin Users
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUşak University
About this trial
Isotretinoin (13-cis retinoic acid) is a retinoic acid that is a derivative of vitamin A. Isotretinoin has been used effectively alone in acne treatment for 35 years. However, it has many side effects. Among the musculoskeletal side effects of this treatment, acute sacroileitis is a common condition. In this clinical picture, recovery may last for a few months after discontinuation of isotretinoin treatment. However, it may become permanent in some cases. According to our current knowledge, there is no study in the literature that prescribes exercise therapy for this patient group. This study, planned to investigate the effects of stretching and sacroiliac mobilization exercises on musculoskeletal pain and quality of life, which are among the side effects of isotretinoin treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant is between the ages of 18-35,
Not having a regular exercise habit,
Starting Isotretinoin treatment for the first time.
Disqualifiers
Presence of any diagnosed rheumatologic disease,
The presence of any diagnosed neurological disease,
Having any diagnosed psychiatric illness,
Having a physical disability that prevents them from exercising for any reason.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionThe 18-Week Program Structure This program is divided into three 6-week phases. Each week consists of 5 sessions, mixing different focuses to ensure balanced development. Day 1: Foundational Strength \& Stability Day 2: Low-Impact Cardio \& Active Recovery Day 3: Core Focus \& Hip Stability Day 4: Low-Impact Cardio \& Mobility Day 5: Full Body Integration \& Strength
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Sacroiliac (SI) joint exercise groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pressure Algometer Testing
Device: Jtech Medical 801/478 USA™ digital pressure algometer. Data collected and processed from the human algometer will generate a specific nociceptive response to neurostimulation in the somatosensory cortex. The algometer head was applied at a 90° angle to trigger points at selected locations, with pressure increased at a speed of approximately 100 g/s. One measurement was taken at the first sensation of pain, after which the process stopped.
Time frame
Baseline / first month / third month / sixth month2
Short Form 36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.
Time frame
Baseline / first month / third month / sixth monthSecondary outcomes
1
VAS (visual analogue scale)
The VAS is a unidimensional measure of pain intensity that is used to record patients' pain progression or to compare the severity of pain between patients with similar conditions. Numerical rating scales will be used. The score is determined by measuring the distance (in millimetres) on the 10-centimetre line between the 'no pain' anchor and the patient's mark. This provides a range of scores from 0 to 100. A higher score indicates greater pain intensity.
Time frame
Baseline / first month / third month / sixth monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov