Effectiveness of Fustra-Exercise Program in Neck and Low Back Pain (FUSTRA)

Effectiveness of Fustra-Exercise Program on Pain, Physical Fitness and Quality of Life in Female and Male Office Workers Suffering From Recurrent Neck and Low Back Pain - a Randomized Controlled Trial

The purpose of the study is to investigate the effectiveness of Fustra® exercise program in relieving recurrent pain in the neck or/and back, and thus improve quality of life in female and male office workers. The hypothesis is that neuromuscular exercise will improve control of posture and movement, neck shoulder and trunk flexibility, trunk muscular endurance and leg strength, and thus decrease intensity of pain by 30% compared to non-exercise group. In addition, financial feasibility of the exercise program and effects of training on quality of life and perceived work ability are studied.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Low Back Pain, Recurrent
• Intervention / Treatment: Behavioral: Neuromuscular exercise

Detailed Description

Neck and low back pain (LBP) are the two major reasons for visiting a physician and they cause significant sickness absence from work. Neuromuscular exercise of at least moderate intensity is the only mode of therapeutic exercise, which has been shown to be effective in relieving pain and disability in recurrent or chronic neck and LBP.

This study examines the effects of a standardized exercise program Fustra20 Neck & Back applied individually by educated exercise leaders in about 30 private sports clubs located in different parts of Finland. The target is to have 5-6 participants in each club. Recruitment began with advertisements in two national level newspapers. Interested individuals were asked to contact UKK Institute (UKKI) by phone or e-mail. In addition, the website of UKKI and the sports clubs are used to reach people more locally. Structured telephone interview is conducted to screen the eligible participants. Two researchers select the participants according to eligibility criteria.

Accepted participants are invited to the study by personal e-mail including the detailed announcement of the study and approval papers to be signed in. The tester of each sport club, responsible for conducting the fitness measurements (baseline, 3 months, 12 months) will receive text message from UKKI including names and phone numbers of accepted study participants. After that UKKI sends similar type of text message to each Fustra exercise leaders including only those participants that were randomly allocated to exercise group.

The exercise group will participate in individually guided, graded exercise twice a week for 20 times. Each session lasts one hour. Fustra exercise leaders have a personal diary for each participant, where they make notes on compliance and contents of each exercise session. After 20 sessions participants are encouraged to continue exercising at home with a help of an individual home exercise plan including diary of compliance.

Participants allocated to control group are asked to continue their usual physical activity and exercise habits. After the final measurements at 12-month they have a possibility to participate to Fustra20 Neck & Back exercise for five times.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33500
      • UKK institute for Health Promotion Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 30-50 years
• sedentary "office" worker sitting at least 6 hours per day
• rating of neck pain or low back pain in the past four weeks is at least 3 in 10 point scale (1-10)
• number of pain episodes (neck/back) in the past year is at least 2

Exclusion Criteria:

• chronic pain (neck/back) defined as continuous pain over 1 year
• serious former neck injury (fracture, surgery, whiplash, protruded disc)
• serious former back injury (fracture, surgery, protruded disc)
• engaged in neuromuscular exercise 3 times a week or more
• engaged in competitive sports
• pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular exercise; The exercise group will participate in Fustra20 Neck & Back neuromuscular exercise program.	Behavioral: Neuromuscular exercise; Fustra20 Neck & Back is individually guided, graded neuromuscular exercise program which is conducted twice a week for 20 times. Each session lasts one hour. After 20 sessions participants are encouraged to continue exercising at home with a help of an individual home exercise plan including diary of compliance. The main targets are to; improve movement control in different posture and movements of the neck and back; improve flexibility with active functional movements; improve pelvic, spine and shoulder-neck stability using co-contraction of several muscle groups, and thus enhancing gross movement of the whole kinetic chain; improve muscular endurance of shoulder neck area, trunk, pelvis and lower extremities
No Intervention: Control group; Participants are encouraged to continue there usual physical activity and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the intensity of pain in the neck or/and low back	Visual analog scale (line 0-100) filled in electronically (Webrobol) for past 4 weeks assessed separately for neck and low back pain	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the intensity of pain in the neck or/and low back	Visual analog scale (line 0-100) for past 4 weeks filled in electronically (Webrobol) assessed separately for neck and low back pain and	Baselilne, 3 months
Change in musculoskeletal fitness index	Fitness index is computed based on age and sex specific norm-reference values of 5 standardized tests assessing balance, shoulder neck mobility, trunk flexibility, ability to stabilize trunk and lower extremity endurance strength.	Baselilne, 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the quality of life	RAND 36 with six subscales	Baseline, 12 months
Changes in objectively measured physical activity and sedentary behaviour	Accelerometer assessment for 7 days with simultaneous diary recordings on specific exercise	Baseline, 12 months
Changes in fear avoidance beliefs	Fear Avoidance Questionnaire (FABQ) filled in electronically	Baseline, 12 months

Collaborators and Investigators

• Sponsor: UKK Institute
• Collaborators: Fustra International Oy
• Investigators: Principal Investigator: Jaana H Suni, PhD, UKK Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; physical fitness; musculoskeletal pain; neuromuscular exercise; work ability; sedentary work
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Neck Pain
• Other Study ID Numbers: R14030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No