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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001263381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
25/04/2026
Date registered
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20/10/2026
Date last updated
Help: Date last updated
20/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
20/10/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Comparing functional exercise and progressive strength training, both combined with pain science education, on pain intensity in people with chronic neck and/or low back pain
Scientific title
Effects of functional exercise versus progressive strength training, both combined with pain science education, on pain intensity in adults with chronic neck and/or low back pain: a randomised controlled trial
Additional trial identifiers [1] 317109 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Chronic neck pain 341655 0
Chronic low back pain 343009 0
Condition category
Condition code
Musculoskeletal 337746 337746 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 337747 337747 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Brief name:
Pain neuroscience education combined with therapeutic exercise

Intervention group: Functional exercise with a playful and graded exposure approach
Participants will receive a structured group-based physiotherapy programme combining pain neuroscience education (PNE) with functional therapeutic exercise. The intervention will be delivered by a physiotherapist with clinical experience in musculoskeletal pain in a primary care setting.

The programme will consist of 12 face-to-face sessions over 6 weeks (2 sessions per week), each lasting approximately 90 minutes. During the first 6 sessions, approximately 50 minutes per session will be dedicated to pain neuroscience education, covering neurophysiology of pain, central sensitisation, biopsychosocial factors, reconceptualisation of pain, and promotion of safe movement.

The exercise component will be based on functional movements from daily life and delivered in a group format. It will include graded exposure to feared or avoided movements (e.g., sit-to-stand transitions, trunk rotation, changes in position) with progressive increase in complexity and movement variability.

Playful and task-oriented activities (e.g., use of balls, group-based games, coordinated tasks) will be incorporated to promote implicit motor learning, reduce fear of movement, and shift attention away from pain. Exercises will be individualised and progressively adapted based on participant tolerance and performance.

Each session will include a warm-up phase, a central functional exercise block (approximately 50–60 minutes), and a cool-down phase with stretching, breathing, and relaxation exercises.
Intervention code [1] 333869 0
Rehabilitation
Intervention code [2] 333870 0
Behaviour
Intervention code [3] 333871 0
Lifestyle
Description of the comparator or control
Control group: Progressive strength training programme
Participants will receive the same pain neuroscience education programme as described above, combined with a structured progressive resistance training programme.

The exercise intervention will follow general recommendations from the American College of Sports Medicine for adult populations, adapted to individuals with chronic neck and/or low back pain.

The programme will consist of 12 face-to-face sessions over 6 weeks (2 sessions per week), each lasting approximately 90 minutes. During the first 6 sessions, exercise intensity will be low to moderate and focused on learning movement techniques, body awareness, and activation of core and stabilising musculature.

From session 7 onwards, exercise intensity will progressively increase. The central exercise block (approximately 50–60 minutes) will include multi-joint resistance exercises such as squats, lunges, push-ups (modified if needed), planks, and pulling and pushing movements, typically performed in a range of 8–15 repetitions per set.

The programme will follow principles of progressive overload, with adjustments in intensity, volume, and complexity based on individual capacity and tolerance.

Each session will include a warm-up phase, a central strength training block, and a cool-down phase with stretching, breathing, and relaxation exercises.
Control group
Active

Outcomes
Primary outcome [1] 345197 0
Pain intensity
Timepoint [1] 345197 0
Baseline, immediately post-intervention at 6 weeks (primary timepoint), and follow-up at 3 months and 12 months
Secondary outcome [1] 460913 0
Pain self-efficacy
Timepoint [1] 460913 0
Baseline and immediately post-intervention at 6 weeks
Secondary outcome [2] 460914 0
Neck-related disability
Timepoint [2] 460914 0
Baseline, immediately post-intervention at 6 weeks, and follow-up at 3 months and 12 months
Secondary outcome [3] 460915 0
Kinesiophobia
Timepoint [3] 460915 0
Baseline and immediately post-intervention at 6 weeks
Secondary outcome [4] 460916 0
Pain catastrophising
Timepoint [4] 460916 0
Baseline and immediately post-intervention at 6 weeks
Secondary outcome [5] 460917 0
Perceived global change
Timepoint [5] 460917 0
Immediately post-intervention at 6 weeks
Secondary outcome [6] 460918 0
Type of pain-related medication used
Timepoint [6] 460918 0
Baseline, immediately post-intervention (6 weeks), 3-month follow-up, and 12-month follow-up.
Secondary outcome [7] 460919 0
Physical activity level
Timepoint [7] 460919 0
Baseline and follow-up at 3 months and 12 months
Secondary outcome [8] 460920 0
Type of physical exercise performed
Timepoint [8] 460920 0
Baseline and follow-up at 3 months and 12 months
Secondary outcome [9] 460921 0
Health-related self-perceived health
Timepoint [9] 460921 0
Baseline and immediately post-intervention at 6 weeks
Secondary outcome [10] 460922 0
Sleep quality
Timepoint [10] 460922 0
Baseline and immediately post-intervention at 6 weeks
Secondary outcome [11] 460923 0
Pain extent
Timepoint [11] 460923 0
Baseline and immediately post-intervention at 6 weeks.
Secondary outcome [12] 465481 0
Low back-related disability
Timepoint [12] 465481 0
Baseline, immediately post-intervention at 6 weeks, and follow-up at 3 months and 12 months
Secondary outcome [13] 465482 0
Pain-related medication consumption during the previous week
Timepoint [13] 465482 0
Baseline, immediately post-intervention (6 weeks), 3-month follow-up, and 12-month follow-up.
Secondary outcome [14] 465483 0
Self-perceived reduction in pain medication use
Timepoint [14] 465483 0
Immediately post-intervention (6 weeks), 3-month follow-up, and 12-month follow-up.
Secondary outcome [15] 465484 0
Total weekly duration of physical exercise
Timepoint [15] 465484 0
Baseline, 3-month follow-up, and 12-month follow-up.
Secondary outcome [16] 465485 0
Change in type of physical exercise performed
Timepoint [16] 465485 0
3-month and 12-month follow-up.
Secondary outcome [17] 465486 0
Self-perceived increase in physical exercise intensity
Timepoint [17] 465486 0
3-month and 12-month follow-up.

Eligibility
Key inclusion criteria
Adults aged 18 years or older with chronic neck and/or low back pain lasting more than 3 months, with average pain intensity of at least 3 out of 10 on the Visual Analogue Scale. Participants must be able to attend group-based education and exercise sessions and provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Medical diagnosis of a specific or structural cause of pain (e.g., fractures, symptomatic radiculopathy)
Neurological or neurodegenerative conditions that may interfere with the intervention (e.g., multiple sclerosis, Parkinson’s disease, acquired brain injury)
Recent spinal surgery or other major surgery within the last 6 months
Active oncological processes
Cognitive impairment or severe mental health disorders that may limit participation
Medical contraindications to physical exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved using two sealed opaque envelopes, one containing "Functional exercise" and the other "Progressive strength training". Participants will be allocated to treatment groups according to their availability. After all participants in a treatment group have completed the baseline assessment, one envelope will be randomly selected to determine the intervention delivered to that group. Baseline assessors will remain blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sealed opaque envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2026
Date of last participant enrolment
Anticipated
12/03/2027
Actual
Date of last data collection
Anticipated
28/04/2028
Actual
Sample size
Target
169
Accrual to date
32
Final
Recruitment outside Australia
Country [1] 28052 0
Spain
State/province [1] 28052 0
Vizcaya

Funding & Sponsors
Funding source category [1] 321692 0
University
Name [1] 321692 0
University of the Basque Country (UPV/EHU)
Country [1] 321692 0
Spain
Primary sponsor type
University
Name
University of the Basque Country (UPV/EHU)
Address
Country
Spain
Secondary sponsor category [1] 324522 0
Hospital
Name [1] 324522 0
Osakidetza – Basque Health Service
Address [1] 324522 0
Country [1] 324522 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320229 0
Research Ethics Committee for Medicines of the Basque Country (CEIm Euskadi)
Ethics committee address [1] 320229 0
Ethics committee country [1] 320229 0
Spain
Date submitted for ethics approval [1] 320229 0
12/11/2025
Approval date [1] 320229 0
25/02/2026
Ethics approval number [1] 320229 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149826 0
Ms Ainara Zamacola Garcia
Address 149826 0
Trapagarán Centro de Salud (Osakidetza), C/San Jose, s/n. Postcode: 48510, Trapagaran (Bizkaia)
Country 149826 0
Spain
Phone 149826 0
+34661068158
Fax 149826 0
Email 149826 0
[email protected]
Contact person for public queries
Name 149827 0
Ainara Zamacola Garcia
Address 149827 0
Trapagarán Centro de Salud (Osakidetza), C/San Jose, s/n. Postcode: 48510, Trapagaran (Bizkaia)
Country 149827 0
Spain
Phone 149827 0
+34661068158
Fax 149827 0
Email 149827 0
[email protected]
Contact person for scientific queries
Name 149828 0
Ainara Zamacola Garcia
Address 149828 0
Trapagarán Centro de Salud (Osakidetza), C/San Jose, s/n. Postcode: 48510, Trapagaran (Bizkaia)
Country 149828 0
Spain
Phone 149828 0
+34661068158
Fax 149828 0
Email 149828 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.