Newcastle Low Back Pain Intervention Study

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

1. whether FRED exercise reduces mechanical LBP ( low back pain);
2. whether FRED exercise improves functional and static balance in people with LBP;
3. whether FRED exercise has an effect on cross-sectional area (CSA) of relevant lumbo-pelvic muscles;
4. 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;
5. whether FRED exercise has an effect on TrA and internal oblique muscle thickness;
6. the rate of muscle physiology change in response to FRED exercise in people with LBP;
7. whether FRED exercise affects the analgesic intake, need for intervention and physical activity level of individuals with LBP;
8. whether FRED exercise affects wellbeing and every-day function in people with LBP;
9. 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)

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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