Clinical trial NCT05635682: Investigation of the Relationship Between Different Assesments in Individuals in Opioid Maintenance Treatment Process
Official title: Investigation of the Relationship Between Sensation, Balance, Gait, Posture and Reaction Time in Individuals in Opioid Maintenance Treatment Process
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Use Disorder
Keywords: opioid use disorder
plantar sensation
reaction time
balance
gait
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted with the participation of 138 individuals, 40 individuals and 40 healthy individuals, between the ages of 18-65, who voluntarily agreed to participate in the study, who had an opioid use disorder according to DSM V diagnostic criteria and who were in the process of maintenance treatment.

Brief summary: Opioid use disorder is the chronic use of opioids that causes clinically significant distress or impairment. More than 16 million people world wide are opioid addicts. The diagnosis of opioid use disorder is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Despite the social and personal consequences of opioid use disorder in individuals; It consists of an excessive desire to use opioids, increased opioid tolerance, and withdrawal syndrome when discontinued. Examples of opioids include heroin, morphine, codeine, synthetic opioids such as fentanyl and oxycodone.

In many countries, the main pharmacological approach in the treatment of opioid use disorder is maintenance therapy using opioid agonists. The combination of buprenorphine and naloxone is one of the most effective agents used in maintenance therapy. Due to the effects of both opioid use and maintenance therapy, these individuals have sensory problems, balance and gait disturbances, and a prolonged reaction time.

The aim of this study is to examine the relationship between sensation, balance, gait, posture and reaction time in individuals on opioid maintenance therapy and to compare them with healthy individuals.

Detailed description: This study will be conducted with the participation of 80 people between the ages of 18 and 65, including 40 individuals who have voluntarily agreed to participate in the study, who have received opioid use disorder according to the DSM V diagnostic criteria and are in the process of maintenance treatment, and 40 healthy individuals. Dec.

Within the scope of the study, the cognitive levels of the participants will be evaluated by Montreal Cognitive Assessment (MoCA).

Sensory evaluations will be made in the form of proprioception sense, light touch sense, vibration sense and two-point discrimination assessment. Proprioception assessments will be performed using a digital inclinometer for the neck and torso separately (J-Tech Dualer IQ, J-Tech Medical Industries, Salt Lake City, USA).

The posture assessment will be performed by the New York Posture Analysis Method.

The Semmes Weinstein Monofilament Test (SWMT) will be used to assess the sense of touch and pressure on the sole of the foot.The test will be applied to the first metatarsal head, medial foot, lateral foot and heel. 3 Repetitions will be performed for each zone. At the end of the test, the values of the four regions will be added and divided into four and the average value will be calculated. The right and left extremities will be evaluated separately.

A 128 Hz diaposon will be used to assess the sense of vibration. The test will be applied to the first metatarsal head, medial foot, lateral foot and heel. The right and left extremities will be evaluated separately.

Discriminator (Baseline ® Discrimin-A-Gon 2) for the assessment of the sense of two-point separation- Point Discriminator, New York, USA) will be used. The test will be applied to the first metatarsal head, medial foot, lateral foot and heel.The right and left extremities will be evaluated separately.

For balance and walking; Tinetti Balance and Walking Test will be applied. Reaction time will be assessed by the Nelson foot test. By taking five measurements, the best and worst values will be discarded, and the average of the remaining three measurements will be recorded as the distance at which the ruler fell.

Eligibility criteria: Inclusion Criteria:

1. To be male and between the ages of 18-65,
2. For the study group, diagnosed with opioid use disorder according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders V (DSM V) and being on maintenance treatment,
3. To voluntarily agree to participate in the study,

Exclusion Criteria:

1. Having any systemic or neurological disease,
2. To have a cognitive effect at a level that will affect communication,

Primary outcomes:
measure: Plantar sensation -Tactile sense-
timeFrame: 1. Day
measure: Plantar sensation - Vibration sense-
timeFrame: 1. Day
measure: Plantar sensation - Two-point discrimination sense-
timeFrame: 1. Day
measure: Reaction time - Foot reaction time-
timeFrame: 1. Day
measure: Proprioception-Neck proprioception
timeFrame: 1. Day
measure: Proprioception-Trunk proprioception
timeFrame: 1. Day
measure: Posture
timeFrame: 1. Day
measure: Balance and Gait-Tinetti Balance And Gait Test
timeFrame: 1. Day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References: