Newcastle Low Back Pain Intervention Study

N

Northumbria University

Status

Unknown

Conditions

Low Back Pain, Mechanical

Treatments

Device: Functional Re-adaptive Exercise Device

Study type

Interventional

Funder types

Other

Identifiers

NCT03062293
FRED2016

Details and patient eligibility

About

The aim of this study is to investigate if six-weeks of exercise intervention, 3 times per week on the Functional Re-adaptive Exercise Device (FRED) reduces non-specific mechanical low back pain in adults ages 18-60.

Full description

The aim of this study is to investigate whether an six-week FRED exercise intervention reduces low back pain (LBP) and improves a range of related outcomes. The objectives of this study are to examine whether FRED exercise reduces mechanical LBP ( low back pain); whether FRED exercise improves functional and static balance in people with LBP; whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles; whether FRED exercise has an effect on TrA (Transversus Abdominis), LM ( Lumbar Multifidus), lumbar Erector Spinae, External and Internal Oblique muscle activity and function in individuals with LBP; whether FRED exercise has an effect on TrA and internal oblique muscle thickness; the rate of muscle physiology change in response to FRED exercise in people with LBP; whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP; whether FRED exercise affects wellbeing and every-day function in people with LBP; the rate of change of level of pain, wellbeing and of function (incl. balance) in response to FRED exercise in people with LBP.

Enrollment

14 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Mechanical LBP for 8 weeks or longer
  • Score of < 15 on FABQ
  • Age 18-60
  • Commitment to taking part in the study for its full duration

Exclusion criteria

  • Presence of "red flags" - indicative of non-mechanical LBP
  • Score of > 15 on FABQ or other indicators of a likely poor response to a solely physical approach to treatment incl. seeking compensation for LBP
  • Exercise contraindicated as per Physical Activity Readiness Questionnaire
  • Inability to exercise safely on the FRED
  • Pregnancy
  • Surgery within the previous nine months
  • Difficulty to exercise safely in standing for 30 mins 3x/week
  • Cardio/respiratory disease
  • Neurological disorders
  • BMI > 28 where adipose tissue infringes on ultrasound imaging and intramuscular electrode placement

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Functional Re-adaptive Exercise Device
Experimental group
Description:
Single arm for within subject repeated measures design.
Treatment:
Device: Functional Re-adaptive Exercise Device

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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