Effectiveness of Fustra-Exercise Program in Neck and Low Back Pain (FUSTRA)
Primary Purpose
Neck Pain, Low Back Pain, Recurrent
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Neuromuscular exercise
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring sedentary work, musculoskeletal pain, neuromuscular exercise, physical fitness, quality of life, work ability
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
Sites / Locations
- UKK Institute for Health Promotion Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Neuromuscular exercise
Control group
Arm Description
The exercise group will participate in Fustra20 Neck & Back neuromuscular exercise program.
Participants are encouraged to continue there usual physical activity and exercise
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT02235207
First Posted
September 5, 2014
Last Updated
March 10, 2016
Sponsor
UKK Institute
Collaborators
Fustra International Oy
1. Study Identification
Unique Protocol Identification Number
NCT02235207
Brief Title
Effectiveness of Fustra-Exercise Program in Neck and Low Back Pain
Acronym
FUSTRA
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UKK Institute
Collaborators
Fustra International Oy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Low Back Pain, Recurrent
Keywords
sedentary work, musculoskeletal pain, neuromuscular exercise, physical fitness, quality of life, work ability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuromuscular exercise
Arm Type
Experimental
Arm Description
The exercise group will participate in Fustra20 Neck & Back neuromuscular exercise program.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants are encouraged to continue there usual physical activity and exercise
Intervention Type
Behavioral
Intervention Name(s)
Neuromuscular exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the intensity of pain in the neck or/and low back
Description
Visual analog scale (line 0-100) filled in electronically (Webrobol) for past 4 weeks assessed separately for neck and low back pain
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in the intensity of pain in the neck or/and low back
Description
Visual analog scale (line 0-100) for past 4 weeks filled in electronically (Webrobol) assessed separately for neck and low back pain and
Time Frame
Baselilne, 3 months
Title
Change in musculoskeletal fitness index
Description
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.
Time Frame
Baselilne, 3 months
Other Pre-specified Outcome Measures:
Title
Change in the quality of life
Description
RAND 36 with six subscales
Time Frame
Baseline, 12 months
Title
Changes in objectively measured physical activity and sedentary behaviour
Description
Accelerometer assessment for 7 days with simultaneous diary recordings on specific exercise
Time Frame
Baseline, 12 months
Title
Changes in fear avoidance beliefs
Description
Fear Avoidance Questionnaire (FABQ) filled in electronically
Time Frame
Baseline, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaana H Suni, PhD
Organizational Affiliation
UKK Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UKK Institute for Health Promotion Research
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33500
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Fustra-Exercise Program in Neck and Low Back Pain
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