Investigation of the Relationship Between Different Assesments in Individuals in Opioid Maintenance Treatment Process

NCT ID: NCT05635682

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-03-24

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.

Conditions

Opioid Use Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Group

Individuals in the process of maintenance therapy with opioid use disorder

Observational and anthropometric assesments

Intervention Type: OTHER

Plantar sensation, foot reaction time, head and trunk proprioceptions, posture, balance and gait assesments

Control Group

Healty people

Observational and anthropometric assesments

Intervention Type: OTHER

Plantar sensation, foot reaction time, head and trunk proprioceptions, posture, balance and gait assesments

Interventions

Observational and anthropometric assesments

Plantar sensation, foot reaction time, head and trunk proprioceptions, posture, balance and gait assesments

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Ilke Keser

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

İdil Esin ÜNLÜ, MSc, PT

Role: primary

idilesinyavuz@gmail.com

+905065156622

İlke Keser, Prof, PT

Role: backup

Other Identifiers

66442466-604.01.02

Identifier Type: -

Identifier Source: org_study_id