Expressive Art Therapy for Elder Adults With Chronic Low Back Pain

NCT07141082 | Recruiting

• 2 other identifiers: HSEARS20250416004-011-WZBS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research project aims to assess the feasibility of expressive art therapy for elderly adults with chronic low back pain and to evaluate the preliminary efficacy of combining art therapy with exercise intervention. Additionally, the study will investigate facilitators and barriers to participation. A mixed-methods approach will be employed, including a quantitative questionnaire and qualitative semi-structured focus group discussions. The questionnaire will examine physical, functional, and psychological changes potentially influenced by art therapy, while the focus groups will provide in-depth insights into participants' experiences and perceptions of the combined intervention.

Conditions

Chronic Low Back Pain

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 of participants

  The proportion of participants who complete the full study protocol.

  Through study completion, an average of 8 weeks

• 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 of participants

  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 post-intervention and at the 3-month follow-up post-intervention

• Numeric Pain Rating Scale (NPRS)

  Baseline, immediately post-intervention, and 3 month follow up post-intervention

• Acceptance and Action Questionnaire II (AAQ-II)

  Baseline, immediately post-intervention, and 3 month follow up post-intervention

• EQ-5D-5L

  Baseline, immediately post-intervention, and 3 month follow up post-intervention

• Roland Morris Disability Index (RMDQ)

  Baseline, immediately post-intervention, and 3 month follow up post-intervention

Study Arms (2)

Experimental: Expressive art therapy

EXPERIMENTAL

One hour of expressive art therapy followed by exercise session.

Other: Exercise

Control Group: Exercise

ACTIVE COMPARATOR

The control group will be a one-hour session that includes progressive back strengthening and general reconditioning exercises, complemented by education on back care to support self-management of low back pain.

Other: Art therapy combined with Exercise

Interventions

Art therapy combined with Exercise OTHER

The intervention program consists of one hour of expressive art intervention followed by one hour of exercise training. Art therapy sessions 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 encouraging them to share their current status. This is followed by a 10-minute mindfulness exercise designed to center participants and promote relaxation, preparing them for the creative activities ahead. The core of each session features a 20-minute art-making process focused on specific themes that guide participants in exploring their pain and personal narratives.

Control Group: Exercise

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.

Experimental: Expressive art therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 60 years and above
• 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
• MoCA-5 of 18 or above

You may not qualify if:

• malignant pain
• 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 (1)

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

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 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 cluster randomization, allocating them into two groups: the expressive art therapy plus exercises group or the exercise-only group. 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 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)