Neck PainFUSTRANCT02235207
Effectiveness of Fustra-Exercise Program in Neck and Low Back Pain
A study testing Neuromuscular exercise in people with Neck Pain and Low Back Pain, Recurrent, run by UKK Institute at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Neck Pain, Low Back Pain, Recurrent
- What is being tested?
- Neuromuscular exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
UKK Institute for Health Promotion Research
Tampere, Pirkanmaa, 33500
About this study
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
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.
Read the 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.
- Conditions
- Neck Pain, Low Back Pain, Recurrent
- Being tested
- Neuromuscular exercise
- Keywords
- sedentary work, musculoskeletal pain, neuromuscular exercise, physical fitness, quality of life, work ability
- Medical subject headings
- Neck Pain, Low Back Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular exerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular exercise | Experimental | The exercise group will participate in Fustra20 Neck \& Back neuromuscular exercise program. Receives: Behavioral: Neuromuscular exercise |
| Control group | No intervention | Participants are encouraged to continue there usual physical activity and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12 months
Secondary outcomes (2)
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
Measured: 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.
Measured: Baselilne, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- UKK Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fustra International Oy
- Responsible party
- Principal investigator, Jaana Suni, UKK Institute
- Investigators
- Jaana H Suni, PhD, Principal investigator, UKK Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235207
- Sponsor's protocol ID
- R14030
- Acronym
- FUSTRA
- Status last verified
- Mar 2016
- First submitted
- 5 Sep 2014
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02235207
- Acronym / sponsor ID
- FUSTRA / R14030
- Conditions
- Neck Pain, Low Back Pain, Recurrent
- Keywords
- sedentary work, musculoskeletal pain, neuromuscular exercise, physical fitness, quality of life, work ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- UKK InstituteUniversity, hospital or other
- Collaborators
- Fustra International Oy
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular exercise | Experimental | Behavioral: Neuromuscular exerciseThe exercise group will participate in Fustra20 Neck \& Back neuromuscular exercise program. |
| Control group | No intervention | –Participants are encouraged to continue there usual physical activity and exercise |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular exerciseFustra20 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 | Behavioural | Neuromuscular exercise |
Primary outcome
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
2 secondary outcomes
Change in the intensity of pain in the neck or/and low back
Time frame: Baselilne, 3 months
Change in musculoskeletal fitness index
Time frame: Baselilne, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaana H Suni, PhD principal investigator
UKK Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular exercise in people with Neck Pain and Low Back Pain, Recurrent, run by UKK Institute at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the intensity of pain in the neck or/and low back (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.