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
About this trial
This is an interventional treatment trial for Chronic Pain
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
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
NCT ID
NCT05351008
First Posted
April 7, 2022
Last Updated
April 27, 2022
Sponsor
International Hellenic University
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.
Learn more about this trial
The Improvement of Physical Therapy Through Cognitive Techniques in Patients With Chronic Pain
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