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

Primary Purpose

Chronic Pain, Neuropathic Pain, Cognitive Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive physical therapy
Physical therapy
Sponsored by
International Hellenic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cognitive Physical Therapy group

    Physical therapy group

    Arm Description

    The group will receive 4 months 3 times per week of cognitive physical therapy.

    The group will receive 4 months 3 times per week of physical therapy.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2022
    Last Updated
    April 27, 2022
    Sponsor
    International Hellenic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05351008
    Brief Title
    The Improvement of Physical Therapy Through Cognitive Techniques in Patients With Chronic Pain
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    International Hellenic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain, Neuropathic Pain, Cognitive Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two arms, parallel-design, assessor-blinded randomized controlled trial
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Physical Therapy group
    Arm Type
    Experimental
    Arm Description
    The group will receive 4 months 3 times per week of cognitive physical therapy.
    Arm Title
    Physical therapy group
    Arm Type
    Active Comparator
    Arm Description
    The group will receive 4 months 3 times per week of physical therapy.
    Intervention Type
    Other
    Intervention Name(s)
    Cognitive physical therapy
    Intervention Description
    Cognitive therapy techniques, TENS, ultrasound, massage
    Intervention Type
    Other
    Intervention Name(s)
    Physical therapy
    Intervention Description
    TENS, ultrasound, massage, exercise
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    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.
    Time Frame
    through study completion, an average of 2 year
    Title
    Neck function
    Description
    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.
    Time Frame
    through study completion, an average of 2 years
    Title
    Low back function
    Description
    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.
    Time Frame
    through study completion, an average of 2 years
    Title
    Anxiety
    Description
    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.
    Time Frame
    through study completion, an average of 2 years
    Title
    Depression
    Description
    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.
    Time Frame
    through study completion, an average of 2 years
    Title
    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.
    Description
    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.
    Time Frame
    through study completion, an average of 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Evgenia Trevlaki, PhD student
    Phone
    +306987036438
    Email
    jennytrevlaki@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandra-Hristara Papadopoulou, Professor
    Organizational Affiliation
    International Hellenic University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Risk of bias To control for expectation bias, participants were told that the study was being performed to compare two interventions for CLBP, and that based on current knowledge, it was not known which intervention was superior. Randomization and masking Simple randomization was used. Sealed opaque envelopes were sent by the research team to each site. Allocation was picked by each participant from a sealed opaque envelope, given by the consulting physiotherapist, after eligibility for the study was established, to ensure concealed allocation. The envelope contained only two pieces of paper. Participants were asked to pick one piece of paper from the envelope. One piece of paper had the letter 'C' for CFT and the other, letter 'T' for traditional physical therapy. Participants and physiotherapists could obviously not be masked to randomization because the physiotherapists were administering the active intervention.

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

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