Menu
Recruiting NCT07141069

Art Therapy for Adults With Chronic Low Back Pain

No phase Interventional Chronic Low Back Pain (CLBP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Art therapy combined with Exercise, Exercise.
Who it may be relevant to
Registry conditions: Chronic Low Back Pain (CLBP). Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Randomized Controlled Trial Exploring the Use of Supervised Group Art Therapy Among Individuals With Chronic Low Back Pain: Feasibility, Potential Efficacy, and Participant Experiences

Overview

This project aims to assess the feasibility and preliminary efficacy of a supervised group-based art intervention for adults with chronic low back pain (CLBP).

Detailed description

Chronic low back pain (CLBP) is a widespread and debilitating condition that affects millions globally, profoundly impacting individuals' physical, psychological, and social well-being. This pilot randomized controlled trial (RCT) aims to explore the feasibility and potential efficacy of a novel intervention that combines supervised group art therapy with exercise for adults suffering from CLBP.

The primary objective of this study is to assess participant recruitment, retention, and adherence while identifying any logistical challenges encountered during the implementation of the intervention. The investigators will gather preliminary data on its effectiveness by measuring changes in pain intensity, functional disability, psychological flexibility, and health-related quality of life (HRQoL).

In addition to quantitative measures, the investigators will conduct qualitative interviews and focus groups to explore participants' lived experiences, identifying facilitators and barriers to engagement. By integrating art therapy-an approach that promotes emotional expression and coping strategies-this study seeks to provide a holistic method for pain management, ultimately enhancing the HRQoL of individuals affected by CLBP.

The successful implementation of this pilot RCT may yield critical insights that can inform a larger-scale definitive RCT, paving the way for innovative, interdisciplinary strategies in chronic pain management and improving community health outcomes. This research not only aims to validate a new therapeutic approach but also aspires to create a supportive environment for individuals grappling with the challenges of CLBP.

Interventions

  • Other Art therapy combined with Exercise
    one hour of expressive art intervention followed by one hour of exercise training. The art therapy will be conducted in small groups of eight participants, facilitated by a part-time registered expressive art therapist. Each session begins with a 5-minute introduction and check-in, welcoming participants and inviting them to share their current status. This is followed by a 10-minute brief mindfulness exercise to help center participants and promote relaxation, setting the stage for the creative
  • Other Exercise
    each one-hour session in the exercise control group will involve progressive back and general reconditioning exercises, along with back care education to support self-management of LBP.

Primary outcome measures

  • Recruitment rate [Time frame: Baseline]
  • Retention Rate [Time frame: Immediately post intervention at 8-week]
  • Proportion of participants adhering to intervention [Time frame: Weekly from week 1 through 8]
  • Acceptability of the Intervention-satisfaction [Time frame: Weekly from week 1 through 8]
  • Acceptability of the Intervention-perceived burden [Time frame: Weekly from week 1 through 8]
  • Acceptability of the Intervention-willingness to continue [Time frame: Weekly from week 1 through 8]
  • Feasibility of Data Collection Procedures [Time frame: At 3-month post intervention]
  • Safety and Adverse Events [Time frame: Weekly from week 1 through 8]
Secondary outcome measures (6)
  • Global Impression of Change scale [Time frame: Immediately (at the 8-week timepoint) and at the 3-month follow-up post-intervention]
  • Numeric Pain Rating Scale (NPRS) [Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
  • Acceptance and Action Questionnaire II (AAQ-II) [Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
  • EQ-5D-5L [Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
  • Roland Morris Disability Index [Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
  • Depression, Anxiety, and Stress Scales (DASS) [Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]

Eligibility criteria

Inclusion criteria

  • aged 18 years to 59 years old
  • currently experiencing non-specific low back pain for at least three months
  • who have sought medical treatment for CLBP
  • can read and write in Traditional Chinese

Exclusion criteria

  • lumbar spinal stenosis
  • confirmed dementia
  • severe cognitive impairment
  • serious major medical or psychiatric disorders
  • currently receiving physiotherapy, cognitive therapy, or psychological treatments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 2 centers
  • Department of Rehabilitation Sciences, The Hong Kong Polytechnic University — Hong Kong
  • The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07141069 · HSEARS20250416004 · 1-WZBS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗