Dance-therapy and Chronic Pain (ALGODANCE)

Effect of Dance-therapy on Chronic Adolescent Pain Patients - a Randomized Controlled Trial Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Complex Regional Pain Syndromes; Tension-Type Headache
• Intervention / Treatment: Behavioral: Dance-therapy; Behavioral: Art-therapy; Behavioral: Yoga

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maud FROT, INSERM Researcher; Phone Number: +33 04 72 35 78 88; Email: maud.frot@univ-lyon1.fr
• Study Contact Backup: Name: Caroline PERCHET, research engineer; Phone Number: +33 04 72 35 78 88; Email: caroline.perchet@univ-lyon1.fr

Study Locations

• France
  • Bron, France, 69677
    • Neuroscience Research Center of Lyon (CRNL)- INSERM U1028 - NEUROPAIN laboratory
    • Contact: Maud FROT, INSERM Researcher; Phone Number: +33 04 72 35 78 88; Email: maud.frot@univ-lyon1.fr
    • Contact: Caroline PERCHET, research engineer; Phone Number: +33 04 72 35 78 88; Email: caroline.perchet@univ-lyon1.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Experimental: Dance-therapy group; 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.	Behavioral: Dance-therapy; 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.
Experimental: Art-therapy group; 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.	Behavioral: Art-therapy; 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.
Experimental: Yoga group; 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.	Behavioral: Yoga; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 0, 5, 16, 20 and 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Inclusion, weeks 5, 16, 20, 28.
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.	Inclusion, weeks 5, 16, 20, 28.
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.	Inclusion, weeks 5, 16, 20, 28.
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.	Inclusion, weeks 5, 16, 20, 28.
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".	Inclusion, weeks 5, 16, 20, 28.
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.	Weeks 0, 5, 16, 20 and 28.
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.	Inclusion, weeks 5, 16, 20, 28
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.	Inclusion, weeks 5, 16, 20, 28
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	Inclusion, weeks 5, 16, 20, 28.
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.	Inclusion, weeks 5, 16, 20, 28.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2029
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Chronic pain; Complex Regional Pain Syndrome; Tension Type Headache; Dance-therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Chronic Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Headache; Tension-Type Headache
• Other Study ID Numbers: 69HCL22_0361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No