Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000596404
Ethics application status
Approved
Date submitted
19/05/2025
Date registered
10/06/2025
Date last updated
10/06/2025
Date data sharing statement initially provided
10/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Specific versus non-specific lumbar spine manipulation on clinical and physiological pain outcomes in chronic low back pain: A proof-of-concept trial
Scientific title
Specific versus non-specific lumbar spine manipulation on clinical and physiological pain outcomes in chronic low back pain: A proof-of-concept trial
Secondary ID [1] 314427 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 337443 0
Condition category
Condition code
Musculoskeletal 333814 333814 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333815 333815 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Specific lumbar spine high velocity thrust: Thrust applied to the specific symptomatic/stiff segment (i.e. L4-5) determined by the objective examination.

Arm 2: Non-specific lumbar spine high velocity thrust: Thrust applied to the whole lumbar spine i.e. L5-L1.

Arm 3: Sham lumbar spine high velocity thrust: Non-specific lumbar spine stretch with no thrust applied to the whole lumbar spine i.e. L5-L1. This is exactly the same as Arm 2 (Non-specific lumbar spine high velocity thrust) minus the thrust.

Each participant will receive four fully funded, face-to-face, physiotherapy sessions from weeks one to four, receiving either the specific high-velocity thrust, non-specific high-velocity thrust, and sham high-velocity thrust by the same treating physiotherapist. The initial session will be two-hours followed by three one-hour follow-up sessions over a four-week period. The frequency over this four week period will be at the discretion of the treating physiotherapist and the participant, mimicking normal clinical practice. The only criterion is that the participant receives four physiotherapy sessions over the four week period. The same therapist will perform all interventions for the same participant, but there will be multiple therapists involved in the trial. Notes will be written following each intervention session. Although not formally assessed, this will help monitor adherence. Appropriate training for each therapist will occur to ensure they are competent to perform the intervention and standardisation of assessment/treatment/data collection.

Interventions will be conducted through the School of Physiotherapy clinics, University of Otago and Consultancy House. Both being in Dunedin.

For standardization, the clinicians performing the interventions will receive a single, fac-to-face two-hour training session lead by the lead investigator (who currently teaches these manipulation techniques to undergraduate and postgraduate physiotherapy students) in how to perform the specific high-velocity thrust, non-specific high-velocity thrust, and sham high-velocity thrust applied in each arm of the trial. This training session will be held at least a month before commencement of the intervention.
Intervention code [1] 331034 0
Rehabilitation
Intervention code [2] 331035 0
Treatment: Other
Comparator / control treatment
Active control group.

The active control group is arm 3 of the trial.

Arm 3: Sham lumbar spine high velocity thrust: Non-specific lumbar spine stretch with no thrust applied to the whole lumbar spine i.e. L5-L1. This is exactly the same as Arm 2 (Non-specific lumbar spine high velocity thrust) minus the thrust.

Please refer to 'Description of the intervention(s) /exposure for more detail on the active control group.
Control group
Active

Outcomes
Primary outcome [1] 341521 0
Substance P concentration
Timepoint [1] 341521 0
Immediate: Saliva samples of substance P will be collected five-minutes prior to (baseline), and then five-minutes and 30-minutes following the initial intervention. The primary timepoint of the primary outcome will be substance P concentration 30-minutes following the intervention Short- and medium-term: Short- and medium-term outcome measurement will occur the night before the initial intervention (baseline), and then the night at four weeks (short term) and six weeks (medium term) following the initial intervention session (and subsequently following the full package of care (four intervention sessions in total)).
Secondary outcome [1] 447822 0
Pain intensity during lumbar spine movement
Timepoint [1] 447822 0
Immediate: Pain intensity during lumbar spine movement will be collected five-minutes prior to, and then five-minutes and 30-minutes following the initial intervention
Secondary outcome [2] 447823 0
Pain, Enjoyment of Life and General Activity Scale (PEG scale)
Timepoint [2] 447823 0
Short- and medium-term: Short- and medium-term outcome measurement will occur the night before the initial intervention (baseline), and then the night at four weeks (short term) and six weeks (medium term) following the initial intervention session (and subsequently following the full package of care (four intervention sessions in total)).
Secondary outcome [3] 447824 0
Oswestry disability index
Timepoint [3] 447824 0
Short- and medium-term: Short- and medium-term outcome measurement will occur the night before the initial intervention (baseline), and then the night at four weeks (short term) and six weeks (medium term) following the initial intervention session (and subsequently following the full package of care (four intervention sessions in total)).
Secondary outcome [4] 447827 0
Global rating of change scale
Timepoint [4] 447827 0
Short- and medium-term: Short- and medium-term outcome measurement will occur the night before the initial intervention (baseline), and then the night at four weeks (short term) and six weeks (medium term) following the initial intervention session (and subsequently following the full package of care (four intervention sessions in total)). Please note: Participants may have had their back pain for many years before starting this trial. Compared to when their back pain first started, there may have been some improvement/worsening of their symptoms. Hence the GROC scale will be used to get there current baseline at the start of the trial with whihc to compare any changes with.

Eligibility
Key inclusion criteria
All individuals aged between 18 and 65 with chronic low back pain (CLBP) will be included. CLBP is defined as pain every day for three months or pain for at least half the days in the last six months
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with any contraindications to lumbar spine manipulation (such as osteoporosis, fractures, active inflammatory or infectious disorders), red flags (such unremitting night pain or a non-mechanical presentation), neurological compromise (such as a radiculopathy), previous history of lumbar spine surgery, or current pregnancy will be excluded. Individuals with any precautions to lumbar spine manipulation (such as connective tissue disorders) or general medical conditions will be assessed on a case-by-case basis.

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)
Sealed opaque envelopes will be used for allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequences will be generated by the study biostatistician using R Software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation was performed using a linear mixed effect model with a random intercept approach, based on a simulation study (Molina-Ortega et al., 2014). Assuming both between-subject standard deviation and within-subject standard deviation of 18, a sample size of 16 per group is required to detect a 30pg/mg difference in immediate effect between the Specific and non-specific lumbar spine HVT arms, with power of 90% and a significance level of 5%. Assuming a drop out rate of 10%, 18 participants are required to be recruited per aim of the trial. Considering the funding we have available, we therefore will aim to recruit a maximum sample size of n = 45 with n = 18:18:9 (2:2:1 ratio) in each arm of the parallel-design, three-arm, proof-of-concept trial.

Linear mixed models with a random intercept will be used to assess whether changes in salivary substance P (SP) concentration differ between specific high-velocity thrust, non-specific high-velocity thrust, and sham high-velocity thrust interventions (Objective 1). Comparisons will be made across three time points: from baseline to assessment one (immediately after the initial treatment—immediate effect), from baseline to week 4 (short-term effect), and from baseline to week 6 (medium-term effect). The model will include time (treated as a categorical variable), intervention group, and the interaction between time and intervention as covariates.

The same modelling approach will be applied to evaluate differences between the three intervention groups in changes in secondary outcomes (objective 2), including the PEG scale (PEG), Oswestry Disability Index (ODI), and Global Rating of Change scale (GROC). Finally, we will describe the relationship between these outcome measures by examining patterns in their changes over time and the differences in those changes between intervention groups (objective 3).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2025
Actual
Date of last participant enrolment
Anticipated
12/12/2025
Actual
Date of last data collection
Anticipated
13/02/2026
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 27073 0
New Zealand
State/province [1] 27073 0
Otago

Funding & Sponsors
Funding source category [1] 318954 0
University
Name [1] 318954 0
University of Otago-Stanley Paris Fellowship
Country [1] 318954 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321482 0
None
Name [1] 321482 0
Address [1] 321482 0
Country [1] 321482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317565 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 317565 0
Ethics committee country [1] 317565 0
New Zealand
Date submitted for ethics approval [1] 317565 0
26/03/2025
Approval date [1] 317565 0
09/06/2025
Ethics approval number [1] 317565 0
2025 EXP 22488

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

Contacts
Principal investigator
Name 141442 0
Dr Gerard Farrell
Address 141442 0
School of Physiotherapy Clinics, University of Otago, 325 Great King Street, North Dunedin, Dunedin, 9016
Country 141442 0
New Zealand
Phone 141442 0
+64 3 479 7460
Fax 141442 0
Email 141442 0
[email protected]
Contact person for public queries
Name 141443 0
Gerard Farrell
Address 141443 0
School of Physiotherapy Clinics, University of Otago, 325 Great King Street, North Dunedin, Dunedin, 9016
Country 141443 0
New Zealand
Phone 141443 0
+64 3 479 7460
Fax 141443 0
Email 141443 0
[email protected]
Contact person for scientific queries
Name 141444 0
Gerard Farrell
Address 141444 0
School of Physiotherapy Clinics, University of Otago, 325 Great King Street, North Dunedin, Dunedin, 9016
Country 141444 0
New Zealand
Phone 141444 0
+64 3 479 7460
Fax 141444 0
Email 141444 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.