Effectiveness of a telephone-based weight management program in overweight or obese patients with lower back pain waiting for orthopedic consultation.

Not Applicable

Completed

• Conditions: ow back pain; Overweight and obesity; Low back pain; Musculoskeletal - Other muscular and skeletal disorders; Diet and Nutrition - Obesity

• Registration Number: ACTRN12615000478516
• Lead Sponsor: Hunter New England Population Health, Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

*Primary complaint of pain in the lower back area (i.e. between the 12th rib and buttock crease) with or without leg pain
*Pain duration of longer than 3 months since the onset of pain
*Average back pain intensity of 3 or greater out of 10 over the past week on a numerical rating scale of 0 to 10
*Moderate level of interference in activities of daily living (adaptation of item 8 on SF36)
*Aged 18 years or over
*Classified as overweight or obese with a self-reported body mass index (BMI) between 27 or greater and less than 40
*Have access to and can use a telephone

Exclusion Criteria

*A known or suspected serious pathology as the underlying cause of back pain (e.g. fracture, cancer, infection)
*A previous history of obesity surgery
*Currently participating in any prescribed, medically supervised or commercial weight loss program
*Back surgery in the last six months or planned surgery in the next 6 months
*Unable to comply with the study protocol, adapt meals or exercise, due to non-independent living arrangements
*Any medical or physical impairment apart from back pain precluding safe participation in exercise such as uncontrolled hypertension, or morbid obesity (BMI>40)
*Cannot speak and read English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Intensity measured as the average lower back pain over the past week using a numerical rating scale of 0 to 10, where 0 is no pain and 10 is the worst possible pain[Baseline and at 2, 6, 10, 14, 18, 22 and 26 weeks after randomisation. ]

Secondary Outcome Measures

Name	Time	Method
Disability and function assessed using the Roland Morris Disability Questionnaire[Baseline and at 6 and 26 weeks after randomisation];Patient quality of life assessed using the SF-12.v2[Baseline and at 6 and 26 weeks after randomisation];Diet assessed using the Food Frequency Questionnaire[Baseline and at 6 and 26 weeks after randomisation];Physical activity assessed using the Active Australia Survey[Baseline and at 6 and 26 weeks after randomisation];Weight (kg) assessed by a trained research assistant using a portable digital scale measured to the nearest 0.1kg [26 weeks after randomisation ]