Art Therapy for Adults With Chronic Low Back Pain

NCT07141069 | Recruiting

• 2 other identifiers: HSEARS202504160041-WZBS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Chronic Low Back Pain (CLBP)

Keywords

art therapy; expressive art; chronic low back pain; musculoskeletal diseases; physiotherapy practice; physical therapists; physiotherapists

Outcome Measures

Primary Outcomes (8)

• Recruitment rate

  The proportion of eligible participants who agree to enrol in the study.

  Baseline

• Retention Rate

  The proportion of participants who complete the full study protocol.

  Immediately post intervention at 8-week

• Proportion of participants adhering to intervention

  Intervention adherence will be assessed by the proportion of participants who attended at least 80% of the scheduled group sessions out of the total number randomized. Reasons for non-adherence will be explored through qualitative interviews with participants who did not meet the attendance threshold or discontinued the program prematurely.

  Weekly from week 1 through 8

• Acceptability of the Intervention-satisfaction

  Participants will rate their satisfaction with the program on a scale from 0 (not satisfied) to 10 (very satisfied).

  Weekly from week 1 through 8

• Acceptability of the Intervention-perceived burden

  Participants will rate the perceived burden of the intervention on a scale from 0 (not demanding) to 10 (very demanding).

  Weekly from week 1 through 8

• Acceptability of the Intervention-willingness to continue

  Participants will rate their willingness to continue with the program on a scale from 0 (not willing to continue) to 10 (very willing to continue).

  Weekly from week 1 through 8

• Feasibility of Data Collection Procedures

  This outcome measure will evaluate the feasibility and acceptability of the data collection methods used in the study, including completion rates for outcome assessments. Feasibility Metrics: Completion Rates for Outcome Assessments: The number of completed assessments will be divided by the total number of scheduled assessments to calculate the completion rate.

  At 3-month post intervention

• Safety and Adverse Events

  This outcome measure will document any adverse events or safety concerns that arise during the study, including: Undesirable medical occurrences or problems that a participant experiences during or after the intervention, lasting more than 2 days and/or causing the participant to seek additional treatment. These adverse events will be categorized into: Serious Related Adverse Events Non-Serious Adverse Events Safety Metrics: Number and type of adverse events Proportion of participants who report serious related adverse events Proportion of participants who report non-serious adverse events

  Weekly from week 1 through 8

Secondary Outcomes (6)

• Global Impression of Change scale

  Immediately (at the 8-week timepoint) and at the 3-month follow-up post-intervention

• Numeric Pain Rating Scale (NPRS)

  Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention

• Acceptance and Action Questionnaire II (AAQ-II)

  Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention

• EQ-5D-5L

  Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention

• Roland Morris Disability Index

  Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention

Study Arms (2)

Expressive art therapy group

EXPERIMENTAL

One hour of expressive art intervention, followed by exercise training.

Other: Art therapy combined with Exercise

Exercise group

ACTIVE COMPARATOR

The control group will participate in one hour of exercises focused on progressive back strengthening and general reconditioning, supplemented with education on back care to promote self-management of low back pain

Other: Exercise

Interventions

Art therapy combined with Exercise OTHER

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 activities that follow. The core of each session consists of a 20-minute art-making process centered around specific themes that guide participants in exploring their pain and personal narratives.

Expressive art therapy group

Exercise OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 0000, Hong Kong

RECRUITING

The Hong Kong Polytechnic University

Hong Kong, Kowloon, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Fadi MQ Al Zoubi, PhD

CONTACT

852-2766-6705; fadi.alzoubi@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Eligible participants will be randomized using computer-generated numbers placed in sealed, opaque envelopes, allocating them into two groups: the expressive art therapy plus exercises group or the exercise-only group on a 1:1 basis. A research assistant not involved in the study will manage allocation. Randomization will stratify participants based on sex and functional level to ensure balanced representation in both groups.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 26, 2025
• Study Start: August 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)