This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
Fustra International Oy
Information provided by (Responsible Party):
Jaana Suni, UKK Institute
ClinicalTrials.gov Identifier:
NCT02235207
First received: September 5, 2014
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Neck Pain Low Back Pain, Recurrent Behavioral: Neuromuscular exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jaana Suni, UKK Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Enrollment: 175
Study Start Date: September 2014
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02235207

Locations
Finland
UKK Institute for Health Promotion Research
Tampere, Pirkanmaa, Finland, 33500
Sponsors and Collaborators
UKK Institute
Fustra International Oy
Investigators
Principal Investigator: Jaana H Suni, PhD UKK Institute
  More Information

Responsible Party: Jaana Suni, Research and develompment manager, UKK Institute
ClinicalTrials.gov Identifier: NCT02235207     History of Changes
Other Study ID Numbers: R14030
Study First Received: September 5, 2014
Last Updated: March 10, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jaana Suni, UKK Institute:
sedentary work
musculoskeletal pain
neuromuscular exercise
physical fitness
quality of life
work ability

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2017