Dance-therapy and Chronic Pain

Chronic Pain Clinical Trial

— ALGODANCE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05689944
• Other study ID #: 69HCL22_0361
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: December 2029

Study information

• Verified date: May 2023
• Source: Hospices Civils de Lyon
• Contact: Maud FROT, INSERM Researcher
• Phone: 04 72 35 78 88
• Email: maud.frot[@]univ-lyon1.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• Headache
• Reflex Sympathetic Dystrophy
• Tension-Type Headache

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Neuroscience Research Center of Lyon (CRNL)- INSERM U1028 - NEUROPAIN laboratory	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.