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Sensor-Based Intervention to Enhance Movement Control of the Spine in Low Back Pain

Sensor-Based Intervention to Enhance Movement Control of the Spine in Low Back Pain - SensI MoveS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50809
Enrollment
60
Registered
2021-05-14
Start date
2021-06-14
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

Chronic low back pain Long lasting pain in the lower back

Interventions

Both interventions will be offered over a course of eight weeks (week 2 - 9 of the study), each week consisting of: - Two supervised therapy sessions of 20-30 minutes - Provided by experienced ther

Sponsors

Militair Revalidatie Centrum 'Aardenburg'
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Between 20 and 60 years of age - Experienced low back pain on a daily basis over the last 3 months, with or without accompanying leg pain above the knee.

Exclusion criteria

Exclusion criteria: - Any condition (other than chronic low-back pain) that might interfere with motor control of the trunk. - A recent surgical intervention on the spinal column, proven serious pathology of the spine* and related structures (canal and/or foramen stenosis, spondylolysis, spondylolisthesis, osteoid osteoma), infections, recent fractures or psychiatric disorders. - Signs of neurological compression, e.g., loss of sensory or motor functions in the legs and/or pelvis and/or radiating pain in the lower leg and/or foot. - The use of drugs that influence the reaction time (In the Netherlands, drugs with a yellow sticker on the box that reads (translated): "This medication may influence your reactions. Use with caution when driving a car or operating dangerous machinery."). - A Body Mass Index of 30 (kg/m2) or more as this could hamper the planned movement control intervention as a result of movement artefacts. - Implanted electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic infusion pumps, and implanted stimulators.

Design outcomes

Primary

MeasureTime frame
Trunk movement control Average tracking error of three trunk-controlled tracking tasks on a laptop (one flexion-extension, one lateral flexion, one rotation) at the beginning and end of the intervention, reported in as average tracking error (degrees).

Secondary

MeasureTime frame
Trunk movement control Results from clinical movement control tests of the low back. Cycle-to-cycle variability of trunk rotations (degrees) during gait at low (2 km/h), comfortable (subject specific) and high (6 km/h) gait speed. Cycle-to-cycle variability of trunk flexion during a repetitive bending task while standing. Cycle-to-cycle variability of trunk rotation during a repetitive standing rotation task. Therapy adherence Number of individual therapy sessions present and reported reason for missing a session (not scheduled / therapist absent / patient absent). Dutch version of the Exercise Adherence Rating Scale for the prescribed homework exercises. Disability Two questionnaires will be used. (1) The Dutch version of the Oswestry Disability Index 2.1a. (2) The Dutch version of the Roland Morris Disability Questionnaire. * Pain intensity A numeric rating scale (0-10) for current, week-average, and week-maximum pain intensity of the low back. Fear Avoidance Beliefs The Dutch version of the Fear Avoidance Beliefs Questionnaire. Health related quality of life. The scales *physical functioning*, *mental health*, *general health* and *pain* from the Dutch version of the RAND-36.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)