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Allied health professional treatments for chronic nonspecific low back pain

Allied health professional treatments for chronic nonspecific low back pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001298202
Enrollment
41
Registered
2018-08-01
Start date
2018-09-11
Completion date
2021-12-15
Last updated
2020-12-07

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

Conditions

None listed

Brief summary

Chronic nonspecific low back pain (CNLBP) has a significant impact on the health and well-being of individuals. The number of people with this condition is growing and the physical, mental, and financial costs are continuing to increase. People with CNLBP are more likely to experience changes to the way muscles in the hip and lower back area function. Foot orthoses have been shown to reduce pain and improve function in people with CNLBP. Additionally, foot orthotic devices have also been shown to alter the timing and intensity of muscle contractions in hip and lower back areas. This may be significant in the treatment of CNLBP as this condition is associated with dysfunction of muscles in these areas. The primary outcome measures will be change in pain and function from baseline to 12 (primary time point), 26, and 52 weeks. Secondary outcome measures include: gluteus medius muscle activity and transversus abdominis muscle thickness from baseline to 12 weeks, and physical activity over 12, 26, and 52 weeks. Number of hours per day and week that the prefabricated orthoses are worn over 12 weeks, as well as, adverse events over 52 weeks will be self-reported by participants.

Interventions

Participants will be fitted with full length prefabricated foot orthoses to wear in their usual shoes for 52 weeks. Participants will be encouraged at baseline to wear the orthoses as often as possible. Additionally, participants will also receive education about their low back pain in the form of the The Back Book. Participants will be instructed to read this booklet at home. These interventions will be administered to participants once at the beginning of the trial by a qualified podiatrist.

Participants will be fitted with full length prefabricated foot orthoses to wear in their usual shoes for 52 weeks. Participants will be encouraged at baseline to wear the orthoses as often as possible. Additionally, participants will also receive education about their low back pain in the form of the The Back Book. Participants will be instructed to read this booklet at home. These interventions will be administered to participants once at the beginning of the trial by a qualified podiatrist. Participants will receive these interventions in a clinical setting. Participants in this group will be given a diary so that they can record how many hours per day, over 12 weeks, they wear the prefabricated orthotic device. Intervention adhere after 12 weeks will not be monitored. At the 12 week follow-up, participants will be asked if they have read The Back Book.

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Participants must have a history of chronic nonspecific low back pain (CNLBP) of three months or greater as confirmed by a general practitioner. The CNLBP will need to be located between the ribs and buttock creases to be eligible. Additionally, participants are required to be proficient in English and report a score of 3 or greater for their CNLBP on the Numeric Pain Rating Scale to ensure a minimally clinically important change for this score can be measured.

Exclusion criteria

Participants will be excluded if they have non-mechanical low back pain (LBP) (e.g. spinal stenosis, spondylolisthesis, recent fractures, spinal surgery, tumours), specific LBP (e.g. herniated disc) acute or subacute LBP of any type, previous lower back surgery, neurological deficit, inflammatory joint disease, are pregnant or have previous (within the last 12 months) or current use of foot orthotic devices.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 25, 2026