Back to resultsDance-therapy and Chronic Pain (ALGODANCE)
Primary Purpose
Chronic Pain, Complex Regional Pain Syndromes, Tension-Type Headache
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dance-therapy
Art-therapy
Yoga
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain focused on measuring Dance-therapy, Chronic pain, Complex Regional Pain Syndrome, Tension Type Headache, Adolescents
Eligibility Criteria
Inclusion Criteria: Patients aged 12 to 20 years, girls or boys, with either complex regional pain syndrome (CRPS) or chronic tension-type headache (CTTH). Diagnosis of CRPS or chronic CTTH made in a Pain Management Center Patients followed in a Pain Management Center (to ensure that patients entering the protocol have pain that is not relieved by conventional treatments) Patients who have given written consent for adults or whose parents have given consent for minors Patients who are affiliated with or benefit from a social security system. Exclusion Criteria: Patients with headaches other than CTTH Patients with other neurological or psychological disorders Patients with psychiatric illnesses Patients with chronic pain conditions other than CRPS or CTTH Patients with chronic infectious, metabolic, cancerous, autoimmune diseases. Patients whose motor limitations are not related to the diagnosis of CRPS or CTTH (e.g. cerebral palsy, spinal cord injury...) Non-communicating patients including deaf and hard of hearing patients Patients or parents who do not speak or read French Pregnant women Dance or yoga professionals (dance or yoga teachers or those studying to become teachers)
Sites / Locations
- Neuroscience Research Center of Lyon (CRNL)- INSERM U1028 - NEUROPAIN laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control group
Dance-therapy group
Art-therapy group
Yoga group
Arm Description
Patients in the control group will not participate in any art-therapy or yoga interventions. They will be asked to complete pain and sleep diaries, questionnaires and pain, fatigue and mood scales at the same times and for the same duration as the other groups.
Patients in the dance-therapy group will attend a weekly session of dance-therapy between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
Patients in the art-therapy group will attend a weekly session of art-therapy (drawings, collages…) between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
Patients in the yoga group will attend a weekly session of Vinyasa yoga between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
Outcomes
Primary Outcome Measures
Assesment of pain change
Daily self-assessment on visual numerical scale of pain intensity upon awakening, at bedtime, and on average during the day. Each item is scored 0-10 (0= no pain; 10 = maximal pain). Reporting of the times during the day and night when the patient feels pain and its intensity.
Secondary Outcome Measures
Kinesiophobia
Evaluation of the kinesiophobia index with the TAMPA scale: 13 items to be evaluated on a 4-point Likert-type scale between 1 (strongly disagree) and 4 (strongly agree). Scores between 13 and 52, a score of 30/52 being considered as a significant kinesiophobia.
Anxiety (adolescents)
Screen for Child Anxiety Related Disorders (SCARED). 41 items to be evaluated on a 3-point Likert-type scale between 0 ('not true' or 'almost never true') and 2 ('very true' or 'often true'). A score greater than or equal to 25 may indicate the presence of an anxiety disorder.
Anxiety (adults)
For adult patients: HAD scale. 14 items rated from 0 to 3. Seven items relate to anxiety and seven others to the depressive dimension. The highest scores correspond to the presence of a more severe symptomatology.
Pain catastrophizing
Pain catastrophizing scale (PCS). 13 items to be evaluated on a 5-point Likert-type scale between 0 (never) to 4 (always). Scores between 0 and 52. A total PCS score of 30 represents clinically relevant level of catastrophizing.
Fear of Pain (adolescents)
Fear of Pain Questionnaire (FOPQ). 24 items to be evaluated on a 5-point Likert-type scale between 0 (Strongly disagree) and 4 (Strongly agree). Scores between 24 and 96. A total score between 51 and 96 represents a high fear of pain
Fear of Pain (adults)
For adults patients: FABQ questionnaire. 16 items evaluated on a 7-point Likert scale between 0 (strongly disagree) and 4 (strongly agree). The first 5 items test fear and beliefs about pain in relation to physical activity and the second part of the questionnaire (12 items) tests fear and beliefs about pain in relation to work.
Incidence of art therapy on quality of life (adolescents)
-VSP-A scale for adolescents. 40 items to be evaluated on a 5-point Likert-type scale between 0 (always) and 100 (never). This scale explores 6 areas (psychological well-being, energy/vitality, leisure activities, friendships, relationships with parents, school life). The scores are averaged and then transformed to obtain a rating between 0% and 100%. A total score below 50% is considered to reflect a low quality of life.
Incidence of art therapy on quality of life (adults)
-The McGill Quality of Life Questionnaire-revised version (MQOL-R) for the adults. 14 items to be evaluated on a 11-point Likert-type scale between 0 (not at all) and 10 (extremely). These items form 4 subscales (physical, psychological, existential, and social). The total MQOL-R score is the average of the scores on the 4 subscales.
Body satisfaction and global self-perception
QSCPGS questionnaire. 20 items. The QSCPGS is divided into two parts. Each part consists of a series of 10 items. The first set is designed to define how the individual perceives his or her body and the second seeks to highlight the feelings of himself in a more global way. Each item is composed of a positive term (good health, pure, calm. . .) and its opposite (bad health, impure, nervous. . .); these two expressions are opposed by a series of numbers from 1 to 5 presented in mirror and separated in their center by the 0; the 1 corresponds to the answer "very little" and 5: "very strong".
Incidence of art therapy on sleep quality
Daily measurement of sleep quality, wake quality and average day energy (5-point Likert-type scale between 'very good' and 'very bad'). Filling out a sleep diary with the daily bedtime and wake-up times for one week.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05689944
Brief Title
Dance-therapy and Chronic Pain
Acronym
ALGODANCE
Official Title
Effect of Dance-therapy on Chronic Adolescent Pain Patients - a Randomized Controlled Trial Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
December 2029 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain, when it becomes chronic, can be a threat to patients and it is very common to observe a fear of pain and a fear of movement (kinesiophobia). Avoidance of movement due to fear of pain can lead to a deterioration of body image. Non-medicinal therapies are essential to correct this fear and movement avoidance behavior, to decrease "catastrophic" judgments and thus anxiety. The use of art-therapy in the accompaniment of patients with pain has shown, in particular, decreases in the intensity of pain, the level of anxiety, an improvement in stress, mood and overall psychological state. However, according to the current literature, it appears that 1) this technique is rarely used in children or adolescents, for whom non-medicinal therapies are fundamental, and 2) in the case of chronic pain, the form of art used is very rarely related to the body (most often painting, drawing, music...).
In this project, investigators propose to set up and test the potential benefit of art-therapy sessions related to the body, namely dance-therapy, in adolescents and young adults suffering from chronic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Complex Regional Pain Syndromes, Tension-Type Headache
Keywords
Dance-therapy, Chronic pain, Complex Regional Pain Syndrome, Tension Type Headache, Adolescents
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group will not participate in any art-therapy or yoga interventions. They will be asked to complete pain and sleep diaries, questionnaires and pain, fatigue and mood scales at the same times and for the same duration as the other groups.
Arm Title
Dance-therapy group
Arm Type
Experimental
Arm Description
Patients in the dance-therapy group will attend a weekly session of dance-therapy between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
Arm Title
Art-therapy group
Arm Type
Experimental
Arm Description
Patients in the art-therapy group will attend a weekly session of art-therapy (drawings, collages…) between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
Arm Title
Yoga group
Arm Type
Experimental
Arm Description
Patients in the yoga group will attend a weekly session of Vinyasa yoga between weeks 1 and 15 of the protocol (15 sessions). They will be asked to complete daily pain and sleep diaries at weeks W0, W5, W16, W20 and W28 as well as questionnaires (kinesiophobia, anxiety, catastrophizing, fear of pain, quality of life, body image/self-perception). They will also be asked to assess their pain, fatigue and mood levels at the end of each week between W1 and W15.
Intervention Type
Behavioral
Intervention Name(s)
Dance-therapy
Intervention Description
This session will take place once a week between weeks 1 and 15 of the protocol.
5 mn of welcome and presentation of the upcoming session
5 mn of self-evaluation of the pain as well as of the thymia and the fatigue before the beginning of the session (Visual numerical scales: VNS)
15 mn of body warm-up with taught contemporary dance exercises
15 mn of creative research based on dance improvisation on a given theme
15 mn of sharing for the elaboration of a choreography
At the end of the session, 5mn of self-evaluation of the pain, the thymia, the fatigue and the level of appreciation of the session (VNS).
After the session, the patient will be asked to think about the next session if he/she wishes (e.g. think of a choreography, remember what was done etc. ....) in order to encourage the commitment to care. These sessions will be based on contemporary dance and dance improvisation techniques.
Intervention Type
Behavioral
Intervention Name(s)
Art-therapy
Intervention Description
This session will take place once a week between weeks 1 and 15 of the protocol.
5 mn of welcome and presentation of the upcoming session
5 mn of self-evaluation of the pain as well as of the thymia and the fatigue before the beginning of the session (Visual numerical scales: VNS)
10 mn of discovery of a new technique (acrylic painting or collage).
35 mn of practice in a project fixed beforehand
At the end of the session, 5mn of self-evaluation of the pain, the thymia, the fatigue and the level of appreciation of the session (VNS).
After the session, the patient will be asked to think about the next session (e.g. collecting plants for collage....) in order to encourage commitment to the treatment. The sessions will be based on acrylic painting or collage techniques.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
This session will take place once a week between weeks 1 and 15 of the protocol.
5 mn welcome
5 mn of self-evaluation of the pain as well as of the thymia and the fatigue before the beginning of the session (Visual numerical scales: VNS)
50 mn of Vinyasa type yoga (warm-up, breathing, balance, strength and flexibility, relaxation)
5 mn of closing of the session
At the end of the session, 5mn of self-evaluation of the pain thanks, the thymia, the fatigue and the level of appreciation of the session (VNS).
These sessions engage the body without entering into a therapy protocol turned towards art as in the two previous interventions.
Primary Outcome Measure Information:
Title
Assesment of pain change
Description
Daily self-assessment on visual numerical scale of pain intensity upon awakening, at bedtime, and on average during the day. Each item is scored 0-10 (0= no pain; 10 = maximal pain). Reporting of the times during the day and night when the patient feels pain and its intensity.
Time Frame
Weeks 0, 5, 16, 20 and 28.
Secondary Outcome Measure Information:
Title
Kinesiophobia
Description
Evaluation of the kinesiophobia index with the TAMPA scale: 13 items to be evaluated on a 4-point Likert-type scale between 1 (strongly disagree) and 4 (strongly agree). Scores between 13 and 52, a score of 30/52 being considered as a significant kinesiophobia.
Time Frame
Inclusion, weeks 5, 16, 20, 28.
Title
Anxiety (adolescents)
Description
Screen for Child Anxiety Related Disorders (SCARED). 41 items to be evaluated on a 3-point Likert-type scale between 0 ('not true' or 'almost never true') and 2 ('very true' or 'often true'). A score greater than or equal to 25 may indicate the presence of an anxiety disorder.
Time Frame
Inclusion, weeks 5, 16, 20, 28
Title
Anxiety (adults)
Description
For adult patients: HAD scale. 14 items rated from 0 to 3. Seven items relate to anxiety and seven others to the depressive dimension. The highest scores correspond to the presence of a more severe symptomatology.
Time Frame
Inclusion, weeks 5, 16, 20, 28
Title
Pain catastrophizing
Description
Pain catastrophizing scale (PCS). 13 items to be evaluated on a 5-point Likert-type scale between 0 (never) to 4 (always). Scores between 0 and 52. A total PCS score of 30 represents clinically relevant level of catastrophizing.
Time Frame
Inclusion, weeks 5, 16, 20, 28.
Title
Fear of Pain (adolescents)
Description
Fear of Pain Questionnaire (FOPQ). 24 items to be evaluated on a 5-point Likert-type scale between 0 (Strongly disagree) and 4 (Strongly agree). Scores between 24 and 96. A total score between 51 and 96 represents a high fear of pain
Time Frame
Inclusion, weeks 5, 16, 20, 28.
Title
Fear of Pain (adults)
Description
For adults patients: FABQ questionnaire. 16 items evaluated on a 7-point Likert scale between 0 (strongly disagree) and 4 (strongly agree). The first 5 items test fear and beliefs about pain in relation to physical activity and the second part of the questionnaire (12 items) tests fear and beliefs about pain in relation to work.
Time Frame
Inclusion, weeks 5, 16, 20, 28.
Title
Incidence of art therapy on quality of life (adolescents)
Description
-VSP-A scale for adolescents. 40 items to be evaluated on a 5-point Likert-type scale between 0 (always) and 100 (never). This scale explores 6 areas (psychological well-being, energy/vitality, leisure activities, friendships, relationships with parents, school life). The scores are averaged and then transformed to obtain a rating between 0% and 100%. A total score below 50% is considered to reflect a low quality of life.
Time Frame
Inclusion, weeks 5, 16, 20, 28.
Title
Incidence of art therapy on quality of life (adults)
Description
-The McGill Quality of Life Questionnaire-revised version (MQOL-R) for the adults. 14 items to be evaluated on a 11-point Likert-type scale between 0 (not at all) and 10 (extremely). These items form 4 subscales (physical, psychological, existential, and social). The total MQOL-R score is the average of the scores on the 4 subscales.
Time Frame
Inclusion, weeks 5, 16, 20, 28.
Title
Body satisfaction and global self-perception
Description
QSCPGS questionnaire. 20 items. The QSCPGS is divided into two parts. Each part consists of a series of 10 items. The first set is designed to define how the individual perceives his or her body and the second seeks to highlight the feelings of himself in a more global way. Each item is composed of a positive term (good health, pure, calm. . .) and its opposite (bad health, impure, nervous. . .); these two expressions are opposed by a series of numbers from 1 to 5 presented in mirror and separated in their center by the 0; the 1 corresponds to the answer "very little" and 5: "very strong".
Time Frame
Inclusion, weeks 5, 16, 20, 28.
Title
Incidence of art therapy on sleep quality
Description
Daily measurement of sleep quality, wake quality and average day energy (5-point Likert-type scale between 'very good' and 'very bad'). Filling out a sleep diary with the daily bedtime and wake-up times for one week.
Time Frame
Weeks 0, 5, 16, 20 and 28.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 12 to 20 years, girls or boys, with either complex regional pain syndrome (CRPS) or chronic tension-type headache (CTTH).
Diagnosis of CRPS or chronic CTTH made in a Pain Management Center
Patients followed in a Pain Management Center (to ensure that patients entering the protocol have pain that is not relieved by conventional treatments)
Patients who have given written consent for adults or whose parents have given consent for minors
Patients who are affiliated with or benefit from a social security system.
Exclusion Criteria:
Patients with headaches other than CTTH
Patients with other neurological or psychological disorders
Patients with psychiatric illnesses
Patients with chronic pain conditions other than CRPS or CTTH
Patients with chronic infectious, metabolic, cancerous, autoimmune diseases.
Patients whose motor limitations are not related to the diagnosis of CRPS or CTTH (e.g. cerebral palsy, spinal cord injury...)
Non-communicating patients including deaf and hard of hearing patients
Patients or parents who do not speak or read French
Pregnant women
Dance or yoga professionals (dance or yoga teachers or those studying to become teachers)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maud FROT, INSERM Researcher
Phone
04 72 35 78 88
Ext
+33
Email
maud.frot@univ-lyon1.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline PERCHET, research engineer
Phone
04 72 35 78 88
Ext
+33
Email
caroline.perchet@univ-lyon1.fr
Facility Information:
Facility Name
Neuroscience Research Center of Lyon (CRNL)- INSERM U1028 - NEUROPAIN laboratory
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maud FROT, INSERM Researcher
Phone
04 72 35 78 88
Ext
+33
Email
maud.frot@univ-lyon1.fr
First Name & Middle Initial & Last Name & Degree
Caroline PERCHET, research engineer
Phone
04 72 35 78 88
Ext
+33
Email
caroline.perchet@univ-lyon1.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dance-therapy and Chronic Pain
We'll reach out to this number within 24 hrs