Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain (FUSTRA)
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|ClinicalTrials.gov Identifier: NCT02235207|
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : March 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain Low Back Pain, Recurrent||Behavioral: Neuromuscular exercise||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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 Start Date :||September 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
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
No Intervention: Control group
Participants are encouraged to continue there usual physical activity and exercise
- Change in the intensity of pain in the neck or/and low back [ Time Frame: Baseline, 12 months ]Visual analog scale (line 0-100) filled in electronically (Webrobol) for past 4 weeks assessed separately for neck and low back pain
- Change in the intensity of pain in the neck or/and low back [ Time Frame: Baselilne, 3 months ]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 [ Time Frame: Baselilne, 3 months ]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.
- Change in the quality of life [ Time Frame: Baseline, 12 months ]RAND 36 with six subscales
- Changes in objectively measured physical activity and sedentary behaviour [ Time Frame: Baseline, 12 months ]Accelerometer assessment for 7 days with simultaneous diary recordings on specific exercise
- Changes in fear avoidance beliefs [ Time Frame: Baseline, 12 months ]Fear Avoidance Questionnaire (FABQ) filled in electronically
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235207
|UKK Institute for Health Promotion Research|
|Tampere, Pirkanmaa, Finland, 33500|
|Principal Investigator:||Jaana H Suni, PhD||UKK Institute|