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RESTORE - Individualised movement rehabilitation and movement sensor biofeedback for chronic, disabling low back pain

RESTORE - The effect of individualised movement rehabilitation and movement sensor biofeedback on pain-related physical activity limitation and quality-adjusted life years in people with chronic, disabling low back pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001396213
Acronym
RESTORE (Individualised movement rehabilitation and movement sensor biofeedback for chronic, disabli
Enrollment
492
Registered
2018-08-20
Start date
2018-10-23
Completion date
2020-08-03
Last updated
2021-01-05

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 main aim of this RCT is to compare the clinical effectiveness and cost-effectiveness of individualised Cognitive Functional Therapy delivered with movement sensor biofeedback versus without movement sensor biofeedback, and also compared with usual care for patients with persistent, disabling LBP.

Interventions

Arm 1: Cognitive Functional Therapy alone CFT is a physiotherapist-led individualised behavioural intervention for people with disabling musculoskeletal pain. Based on screening questionnaires and an extensive examination (interview and physical examination), the following unhelpful responses to pain are identified and targeted: cognitive (i.e. negative beliefs), emotional (i.e. pain related fear and distress) and behavioural (i.e. protective muscle guarding, movement, activity avoidance and poo

Arm 1: Cognitive Functional Therapy alone CFT is a physiotherapist-led individualised behavioural intervention for people with disabling musculoskeletal pain. Based on screening questionnaires and an extensive examination (interview and physical examination), the following unhelpful responses to pain are identified and targeted: cognitive (i.e. negative beliefs), emotional (i.e. pain related fear and distress) and behavioural (i.e. protective muscle guarding, movement, activity avoidance and poor sleep habits) responses. This targeting includes: 1. personalised biopsychosocial pain education; 2. graduated exposure to previously avoided and/or provocative movements and activities with pain control in order to re-engage people with valued activities; and 3. lifestyle change targeting physical activity, sleep habits, stress management. Arm 2: CFT plus movement sensor biofeedback Movement sensors enable clinicians to precisely measure movement patterns, postures, back muscle activity and their relationship to pain, both in the clinical setting and during patients’ normal activities of work, rest and play. Via biofeedback, movement sensors can help patients develop an awareness of how they move and the postures they use during activities of daily living, where changes to habituated movement are most important. In this study we will use the ViMove2 clinical movement sensor system (dorsaVi P/L, Melbourne, Australia) Both CFT treatment groups (arm 1 and arm 2) will have the same treatment frequency of up to 7 treatment sessions over 12 weeks plus a ‘booster’ session at 6 months (initial consultation 60 minutes, otherwise 30-40 minutes). In these treatment groups only, the movement sensors will be placed on the lower back region, with kinematic sensors at the thoracolumbar junction and upper sacrum, and EMG sensors paraspinally at approximately L3. Clinicians will use the ViMove2 app (Apple app store) to access the data using a version that has been modified for this study. The sensors will be worn during each treatment session and for the rest of that day. Patients in the CFT plus movement sensor biofeedback will use a modified version of the myViMove app (Apple app store) to receive biofeedback, which is so intuitive it requires little instruction. At each treatment session, adherence to the program will be assessed by the physiotherapist and barriers to program adherence will be discussed in a collaborative manner. Participants will self-rate program adherence at 2, 6 and 12 weeks using a 0-10 scale specifically created for this study. Physiotherapist intervention training These treatment approaches will be delivered by specially trained physiotherapists in private physiotherapy clinics in Perth and Sydney. That treating physiotherapist training, to the point of competency, will consist of up to 100 hours of workshop participation and direct clinical mentoring, supported by a treatment manual, videos, an e-book and private Facebook discussion groups. The treatment and eBook manual are unpublished training materials specifically designed for the physiotherapists delivering the active interventions.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

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

Inclusion criteria

Participants need to meet all of the following: 1. Adult people with current low back pain that has an episode duration of more than 3 months. 2. Presented to a primary care clinician at least 6 weeks prior for this episode of low back pain. 3. Average low back pain intensity of 4 or more when rated on a 0-10 Numerical Pain Rating Scale. 4. At least moderate pain-related interference with normal work or daily activities (measured by item 8 of the Short Form 36 questionnaire).

Exclusion criteria

If a person has any of the following: (1) Any medical conditions that prevents them from being physically active (as prescribed by their doctor). (2) A serious spinal pathology (e.g. fracture, infection, cancer). (3) Is currently pregnant or has given birth within 3 months. (4) Inadequate English for the study’s questionnaires and instructions. (5) A skin allergy to hypoallergenic band-aide or tape adhesives.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026