Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Funder refs: 2006-1162; 51-1010/06
Study information
Scientific title
The effect of neck coordination training on sensorimotor function, symptoms and self-rated health and functioning for non-specific neck-shoulder pain
Acronym
Study hypothesis
Main hypothesis:
Specific neck coordination training has a better short-term and long-term effect than strength training for the neck-shoulders-arms, and massage, on the primary outcomes of the sensorimotor functions (see Primary outcome measures).
Further hypotheses:
1. Specific neck coordination training has a better long-term effect than massage on the primary and secondary outcomes of the self-rated health, symptoms and functioning, (see Primary and Secondary outcome measures)
2. Specific neck coordination training as well as strength training for the neck-shoulders-arms have a better long-term effect than treatment as usual on the primary and secondary outcomes of the self-rated health, symptoms and functioning (see Primary and Secondary outcome measures)
3. Specific neck coordination training has a better long-term effect than massage, on the secondary outcomes of the sensorimotor functions (see Secondary outcome measures)
4. Specific neck coordination training as well as strength training for the neck-shoulders-arms have a better long-term effect than massage and treatment as usual on fear of movement and re-injury due to movement, assessed by the TAMPA Scale of Kinesiophobia.
Ethics approval
Regional Ethical Review Board in Uppsala, Sweden. Protocol was approved on 30/08/2007, complementary application approved on 25/06/2008 (ref: 2007/206)
Study design
Randomised, single-blind, single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic non-specific neck-shoulder pain
Intervention
One hundred forty participants with neck-shoulder pain and 40 participants without neck pain will be recruited into this study. The participants without neck pain will be involved in this trial only for the baseline assessments.
The participants with neck-shoulder pain will be randomly allocated to the following 4 treatment groups:
1. Neck coordination training ("index treatment"), 30 min treatment twice a week for 11 weeks
2. Strength training for neck, shoulder, arms ("best available treatment"), 30 min treatment twice a week for 11 weeks
3. Massage ("sham treatment" with respect to long-term effects), 30 min treatment twice a week for 11 weeks
4. No intervention (However, the participants are free to receive "standard treatment" from the national health service if they wish)
The group allocation will be concealed during data processing and analyses.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Sensorimotor functioning (Timepoints of assessment: 1 week before start of treatment; 1 week and 6 month after end of treatment):
1.1. Magnitude of fast and slow component of postural sway, calculated from force platform centre of pressure data
1.2. Arm movement precision, measured as end-point precision (variability in horizontal, depth and vertical directions) in a goal-directed arm movement task
2. Self-rated health, symptoms and functioning (Timepoints of assessment: 1 week before start of treatment; 1 week, 6 month, 1 year after end of treatment):
2.1. Nineteen selected questions addressing ability to perform all daily activity involving neck, shoulder, arm and hand from the DASH questionnaire
Secondary outcome measures
The following will be assessed at 1 week before start of treatment, 1 week and 6 month after end of treatment:
1. Sensorimotor functioning:
1.1. Jerkiness of cervical rotation, calculations based on the "minimum jerk" hypothesis
2. Self-rated health, symptoms and functioning:
2.1. Measurements covering the 4 core chronic pain outcome domains recommended by Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT):
a. Pain intensity, assessed by a 0 to 10 numeric rating scale (NRS), 0 = no pain, 10 = worst pain imaginable.
b. Physical functioning, assessed by the function index of the Profile Fitness Mapping questionnaire, (under publication), a neck specific questionnaire measuring self-rated functional limitations.
c. Emotional functioning, assessed by the Montgomery Åsberg Depression Rating Scale, a questionnaire which has shown high sensitivity to changes in depression.
d. Participant ratings of overall improvement, assessed by i) the Patient Global Impression of Change scale and ii) the Profile Fitness Mapping questionnaire - total score, neck-specific symptoms and functional limitations (under publication)
2.2. Fear of movement and re-injury due to movement, assessed by the TAMPA Scale of Kinesiophobia
Other outcome measures (these outcome measures will be used in exploratory analyses):
1. Sensorimotor functions:
1.1. Cervikal range of movement.
1.2. Peak velocity of cervical rotation.
1.3. Ankle, hip and neck kinematic coordination during quiet stance
1.4. Arm joint kinematic coordination during goal directed movements
2. Self-rated health, symptoms and functioning:
2.1. Pressure pain threshold, assessed with an algometer, for 3 neck-shoulder points: i) the suboccipital insertion of spinal extensor muscles ii) the trapezius muscle iii) the scapular insertion of the levator scapulae muscle.
2.2. Area of pain distribution, assessed by pain drawings
2.3. Severity of disability assessed by the Neck Disability Index
2.4. Upper extremity disability and symptoms assessed by the DASH questionnaire
2.5. General health and wellbeing, assessed by the 36-item Short Form Health Survey (SF-36)
2.6. Psychologic wellbeing, assessed by the Ryff's Psychological Well-Being scales
2.7. Pain patients' cognitive, behavioural, and affective responses to their condition, assessed by the Multidimensional Pain Inventory
Overall trial start date
01/03/2008
Overall trial end date
18/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Participants with neck-shoulder pain:
1. Women, age 25-65 years
2. Non-specific neck-shoulder pain with a duration of at least 3 months
3. Decreased physical functioning according to the Disability Arm Shoulder Hand (DASH) questionnaire (at least 9 normalised points on 19 selected questions addressing ability to perform all daily activity involving neck, shoulder and arm)
Baseline control group:
1. Women, age 25-65 years
2. Healthy volunteers without neck pain
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
180
Participant exclusion criteria
Participants with neck-shoulder pain:
1. Trauma to the head and neck associated with the onset or with any worsening of the symptoms
2. Conditions of rheumatic-, inflammatory- or neurological disease or fibromyalgia
3. Evidence of back-, neck- or shoulder surgery or fracture
4. Cervical rhizopathia
5. Signs of vestibular dysfunction
Baseline control group:
1. Trauma to the head, neck or shoulder that has caused considerable problems
2. Conditions of rheumatic-, inflammatory- or neurological disease or fibromyalgia
3. Evidence of back-, neck- or shoulder operation or fracture
Recruitment start date
01/03/2008
Recruitment end date
18/12/2008
Locations
Countries of recruitment
Sweden
Trial participating centre
Centre for Musculoskeletal Research
Gävle
SE-801 76
Sweden
Sponsor information
Organisation
Swedish Council for Working Life and Social Research (Sweden)
Sponsor details
Box 2220
Stockholm
SE-103 15
Sweden
+46 8 775 40 70
fas@fas.se
Sponsor type
Government
Website
Funders
Funder type
University/education
Funder name
Internal funding:
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Centre for Musculoskeletal Research, University of Gävle (Sweden)
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Department of Community Medicine and Rehabilitation, Physiotherapy, University of Umeå (Sweden)
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External funding:
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The Swedish Council for Working Life and Social Research (Registration number 2006-1162) (Sweden)
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Forskning & Framtid ("Research & Future") (Registration number 51-1010/06) (Sweden)
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Alfta Research Foundation (Sweden)
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Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary