The Improvement of Physical Therapy Through Cognitive Techniques in Patients With Chronic Pain

Chronic Pain Clinical Trial

Official title:

The Improvement of Physical Therapy Through Cognitive Techniques in Patients With Chronic Pain in Physical, Mental, and Quality of Life - A Multidimensional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05351008
• Other study ID #: IntHellenicUniv
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2022
• Source: International Hellenic University
• Contact: Evgenia Trevlaki, PhD student
• Phone: +306987036438
• Email: jennytrevlaki[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research will provide a better understanding of the interaction of chronic neuropathic pain and its interaction with the mental state. In addition, he will compare the results of simple classical physiotherapy intervention with cognitive physiotherapy intervention in chronic neuropathic pain. Finally, it will highlight the usefulness of integrating elements of cognitive-behavioral therapy in physiotherapy intervention to achieve a comprehensive anthropocentric therapy.

Description:

In July 2020, the International Association for the Study of Pain (IASP) revised the definition of pain, according to which pain is an unpleasant aesthetic and emotional experience related to, or appears to be related to, real or potential tissue damage. Chronic pain is characterized by a long duration, exceeding 6 months. Chronic neuropathic pain is caused by damage or disease of the somatosensory nervous system.

Neuropathic pain is more severe than other types of pain and causes significant psychological weight, in contrast to pain from irritating the senses, and that it can cause more severe mental illness. There is therefore an interaction between chronic neuropathic pain and mental illness, especially depression in chronic pain and anxiety disorders in acute pain.

In recent years, cognitive physiotherapy intervention has been of particular interest, which has been shown to be effective in a wide range of chronic pain disorders, using different psychological techniques. Treatment argues that a person's beliefs, attitudes, and behaviors play a central role in determining the overall experience of pain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients, over 18 years old, in any distribution.

• Symptomatic with pain for greater than 3 months prior to surgery with a clinical diagnosis of SCI.

• DN4> 4

• Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact

Exclusion Criteria:

• Male and female patients younger than 18 years old

• History of psychogenic illness or manic episode

• Involvement with any other ongoing studies.

• History of other neuromuscular disorder

• Scheduled surgery until the end of the interventions

Related Conditions & MeSH terms

• Chronic Pain
• Cognitive Therapy
• Neuralgia
• Neuropathic Pain

Intervention

Other:
• Cognitive physical therapy
Cognitive therapy techniques, TENS, ultrasound, massage
• Physical therapy
TENS, ultrasound, massage, exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
International Hellenic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Short-form McGill Pain Questionnaire (SF-MPQ) is a pain rating index with 2 scales: Sensory subscale with 11 words, and Affective subscale with 4 words from the original MPQ. Minimum value 0, maximum value 5.	through study completion, an average of 2 year
Primary	Neck function	Neck Disability Index (NDI) is a 10 section, self-report questionnaire that evaluates cervical function and pain. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.; 0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation.	through study completion, an average of 2 years
Primary	Low back function	Roland-Morris Disability Questionnaire (RDQ), is a 24-item patient-reported outcome measure that inquiries about pain-related disability resulting from low back pain (LBP). The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 11, 18 or 24 (max. disability) depending on the questionnaire that is used.	through study completion, an average of 2 years
Primary	Anxiety	Generalised Anxiety Disorder Assessment (GAD-7) is a 7-item, self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD). A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD. Cut points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety on the GAD-7.	through study completion, an average of 2 years
Primary	Depression	Patient Health Questionnaire-9 (PHQ-9) is a 9-item, self-administered screening instrument for detecting MDD based on the DSM-IV diagnostic criteria. A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.	through study completion, an average of 2 years
Primary	Quality of Life as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.	WHO Quality of life - bref is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval, or alternatively, a 4-20 point interval.	through study completion, an average of 2 years