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Does subgroup classification by movement patterns of chronic low back pain patients result in differing effects of a device based progressive strength and movement exercise rehabilitation ( 24 sessions), on measures of strength and range of movement in the spinal musculature and daily function and disability.

Effect of subgroup classification by movement patterns of chronic low back pain patients on strength, range of motion, pain, and disability following a device-based strength and movement exercise rehabilitation program

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000207819
Enrollment
175
Registered
2021-02-26
Start date
2024-05-15
Completion date
2025-10-06
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to examine whether subgroup classification of chronic low back pain patients results in differing effects from a device based isolated, targeted and progressive resistance strength rehabilitation programme (24 Sessions) on respective measures of spinal strength, range of motion and pain and disability. The sustainability of the results will be examined in a 12 month followup. It is hypothesized that all groups will respond positively to the device based rehabilitation as the specific nature of the exercise addresses the underlying weak spinal musculature as a major factor in all patients with chronic low back pain.

Interventions

The intervention will provide two, 40 minute Device based exercise rehabilitation sessions per week over a 12-week period. All the device based exercise sessions will be supervised by physiotherapists and exercise physiologists who are experienced in prescribing and delivering device based strengthening and movement rehabilitation exercises to people with chronic low back pain. The first 5 sessions will be a one on one with the Exercise Therapist and all subsequent sessions will be on a small g

The intervention will provide two, 40 minute Device based exercise rehabilitation sessions per week over a 12-week period. All the device based exercise sessions will be supervised by physiotherapists and exercise physiologists who are experienced in prescribing and delivering device based strengthening and movement rehabilitation exercises to people with chronic low back pain. The first 5 sessions will be a one on one with the Exercise Therapist and all subsequent sessions will be on a small group basis of one to 5 participants supervised by the Exercise Therapist. A description of the specific device based rehabilitation exercise follows: Device Based Isolated, Targeted and Progressive Resistance Strengthening and Movement: Six specific Exercise Devices will be used in this study. The Devices and the inbuilt software [David Health Solutions Company, Finland] are designed to produce a strengthening training effect by isolating the spinal musculature and provide safe, progressive resistance exercise and permit range of motion (ROM) in flexion, extension, lateral flexion and rotation in the lumbar/thoracic and cervical spine. These exercise devices are registered with Therapeutic Goods Administration (TGA), Department of Health as "Medical Exercise Rehabilitation Devices with measuring Function" . The Device based strengthening and movement intervention training (24 sessions ,2 per week for 12 weeks) will have four distinct phases over the intervention: Coordination phase Adaptation phase Strengthening phase Normalization phase Regardless of the Classification Pattern every patient will go through the same stages of progression, in the same order, however the timing and magnitude of each stage are very individual. Using the strength and ROM data collected by each device during the initial assessment the training will commenced at 30% of the initial maximal pain free range of movement and at 25% of the maximal Isometric strength measured on assessment . Strength resistance starting point (Kg) is based off the individual initial isometric maximal torque Newton Meters where 1kg weight resistance equates to 0.98NM of torque. Each device is fitted with a computer screen providing the patient with movement speed and ROM feedback, guidance and motivation to produce a quality consistent movements . The devices record performance indicators like the compliance graphs speed of movement and ROM) which indicates the patient's ability to co ordinate the specific concentric, eccentric and isometric muscle contractions of the spinal musculature. Using the Exercise Device terminal, feedback, guidance and motivation will provide for the patients to complete one set of 20 controlled contractions (concentric, Isometric and eccentric) lasting 4.5seconds per repetition. Once Coordination is established ROM is progressed to above 50% ,the speed is adjusted to 6.0 seconds per repetition. under the guidance of the Exercise Therapist (Exercise Physiologist or Physiotherapist) the training/ rehabilitation program will be progressed to meet the following resistance levels for each phase: Orientation phase 2/5, Adaption phase 3/5, exercise phase 4/5 and optimisation phase 4/5 based on initial evaluation test.

Sponsors

getback Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

i) aged over 18 years; ii) report recurrent low back pain with or without pain radiating into the lower limbs for at least six weeks iii) demonstrate moderate disability on the Oswestry Disability Index (i.e., 28% or less).

Exclusion criteria

(1) diagnosed as having a tumour, infection, or inflammatory disease affecting the spine; (2) recent spinal or lower-limb surgery; (3) had spinal fractures or structural deformities such as spondylolisthesis and spondylolysis; (4) contraindications to exercise therapy (e.g., uncontrolled hypertension, previous myocardial infarction, cerebrovascular disease, peripheral vascular disease, respiratory disorders); (5) signs of nerve root compromise, defined as decreased tendon reflexes, sensory loss, and motor deficits; (6) receiving medications other than analgesics and non steroidal anti-inflammatory drugs. (7) Oswestry Disability score exceeding 30. (8) Patient with a Movement Classification 'Leg Dominant always constant pain (Red Flag Sciatica)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026