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

Sponsor
International Hellenic University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05351008
Collaborator
(none)
100
2
24

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive physical therapy
  • Other: Physical therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two arms, parallel-design, assessor-blinded randomized controlled trialTwo arms, parallel-design, assessor-blinded randomized controlled trial
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive Physical Therapy group

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

Other: Cognitive physical therapy
Cognitive therapy techniques, TENS, ultrasound, massage

Active Comparator: Physical therapy group

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

Other: Physical therapy
TENS, ultrasound, massage, exercise

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [through study completion, an average of 2 year]

    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.

  2. Neck function [through study completion, an average of 2 years]

    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.

  3. Low back function [through study completion, an average of 2 years]

    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.

  4. Anxiety [through study completion, an average of 2 years]

    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.

  5. Depression [through study completion, an average of 2 years]

    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.

  6. 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. [through study completion, an average of 2 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • International Hellenic University

Investigators

  • Study Chair: Alexandra-Hristara Papadopoulou, Professor, International Hellenic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Evgenia Trevlaki, Principal Investigator, International Hellenic University
ClinicalTrials.gov Identifier:
NCT05351008
Other Study ID Numbers:
  • IntHellenicUniv
First Posted:
Apr 28, 2022
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022