Clinical trial NCT02235207: Effectiveness of Fustra-Exercise Program in Neck and Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Low Back Pain, Recurrent
Keywords: sedentary work
musculoskeletal pain
neuromuscular exercise
physical fitness
quality of life
work ability
Lead sponsor: UKK Institute
Sponsor class: OTHER
Collaborators: name: Fustra International Oy
First posted: 2014-09-09
Enrollment: 175
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the intensity of pain in the neck or/and low back
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in the intensity of pain in the neck or/and low back
timeFrame: Baselilne, 3 months
measure: Change in musculoskeletal fitness index
timeFrame: Baselilne, 3 months
Other outcomes:
measure: Change in the quality of life
timeFrame: Baseline, 12 months
measure: Changes in objectively measured physical activity and sedentary behaviour
timeFrame: Baseline, 12 months
measure: Changes in fear avoidance beliefs
timeFrame: Baseline, 12 months
Locations:
city: Tampere
country: Finland
facility: UKK Institute for Health Promotion Research
state: Pirkanmaa
Study officials:
affiliation: UKK Institute
name: Jaana H Suni, PhD
role: PRINCIPAL_INVESTIGATOR
References: