NCT02235207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

1.4 years

First QC Date

September 5, 2014

Last Update Submit

March 10, 2016

Conditions

Neck PainLow Back Pain, Recurrent

Keywords

sedentary workmusculoskeletal painneuromuscular exercisephysical fitnessquality of lifework ability

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, 12 months

Secondary Outcomes (2)

  • Change in the intensity of pain in the neck or/and low back

    Baselilne, 3 months

  • Change in musculoskeletal fitness index

    Baselilne, 3 months

Other Outcomes (3)

  • Change in the quality of life

    Baseline, 12 months

  • Changes in objectively measured physical activity and sedentary behaviour

    Baseline, 12 months

  • Changes in fear avoidance beliefs

    Baseline, 12 months

Study Arms (2)

Neuromuscular exercise

EXPERIMENTAL

The exercise group will participate in Fustra20 Neck \& Back neuromuscular exercise program.

Behavioral: Neuromuscular exercise

Control group

NO INTERVENTION

Participants are encouraged to continue there usual physical activity and exercise

Interventions

Neuromuscular exerciseBEHAVIORAL

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

Neuromuscular exercise

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKK Institute for Health Promotion Research

Tampere, Pirkanmaa, 33500, Finland

Location

MeSH Terms

Conditions

Neck PainLow Back PainMusculoskeletal Pain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jaana H Suni, PhD

    UKK Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research and develompment manager

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 9, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 11, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)