NCT05689944

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
43mo left

Started May 2023

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
May 2023Dec 2029

First Submitted

Initial submission to the registry

December 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

6.6 years

First QC Date

December 1, 2022

Last Update Submit

May 4, 2023

Conditions

Keywords

Dance-therapyChronic painComplex Regional Pain SyndromeTension Type HeadacheAdolescents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Kinesiophobia

    Inclusion, weeks 5, 16, 20, 28.

  • Anxiety (adolescents)

    Inclusion, weeks 5, 16, 20, 28

  • Anxiety (adults)

    Inclusion, weeks 5, 16, 20, 28

  • Pain catastrophizing

    Inclusion, weeks 5, 16, 20, 28.

  • Fear of Pain (adolescents)

    Inclusion, weeks 5, 16, 20, 28.

  • +5 more secondary outcomes

Study Arms (4)

Control group

NO INTERVENTION

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.

Dance-therapy group

EXPERIMENTAL

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

Art-therapy group

EXPERIMENTAL

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

Yoga group

EXPERIMENTAL

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

Interventions

Dance-therapyBEHAVIORAL

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.

Dance-therapy group
Art-therapyBEHAVIORAL

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.

Art-therapy group
YogaBEHAVIORAL

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.

Yoga group

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuroscience Research Center of Lyon (CRNL)- INSERM U1028 - NEUROPAIN laboratory

Bron, 69677, France

Location

MeSH Terms

Conditions

Chronic PainComplex Regional Pain SyndromesTension-Type Headache

Interventions

Dance TherapyArt TherapyYoga

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CareExercise Movement TechniquesPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesSpiritual Therapies

Central Study Contacts

Maud FROT, INSERM Researcher

CONTACT

Caroline PERCHET, research engineer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

January 19, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations