Non specific neck-shoulder pain, with evidence of impaired physical functioning in terms of self-rated neck disability and work capacity. Musculoskeletal Diseases Pain, not elsewhere classified
Conditions
Interventions
1. Intervention is planned to start 22/08/2011
2. Group allocation will be concealed during data processing and analyses
3. One hundred and five participants with neck-shoulder pain and 35 participant
Sponsors
The Swedish Council for Working Life and Social Research (Sweden)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Participants with neck-shoulder pain: 1. Women, age 20-65 years 2. Non-specific neck-shoulder pain with duration of at least six weeks 3. Decreased physical functioning, = 10 and = 68 (0-100) on the Neck Disability Index (NDI)4. Self-rated impaired capacity on the quality or quantity to work the preceding month due to neck problems (measured with two questions according to Martimo et al. 2009) Control group for baseline comparisons: 1. Women, age 20-65 years 2. Healthy volunteers without neck or back pain
Exclusion criteria
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 (self-ratings) 2. Cervical rhizopathy or vestibular dysfunction (according to specific diagnostic criteria) 3. Conditions of psychiatric, inflammatory, endocrinal, rheumatic, cancer, neurological or connective tissue disorders, stroke, heart infarct or type 1-diabetes (diagnosed by medical doctor) 4. Concurrent low back pain (defined according to pain drawing (Margolis et al. 1986) and a specific decision algorithm (Nyman et al. 2009) 5. Fibromyalgia/generalized pain according to the criteria of the American College of Rheumatology 6. Low treatment expectation or catastrophizing ?most? or ?all of the time? (5-point ordinal scale) 7. Anxiety or depression (assessed by the Hospital Anxiety and Depression Scale with cut off values of 10 for anxiety and 8 for depression (Lisspers et al. 1997) 8. Temporomandibular disorders (Criteria according to Storm and Wänman 2006) 9. Surgery the last 3 years in the neck, back or shoulder 10. Fracture in the neck or fracture the last 3 years in the shoulder or back 11. Luxation of a shoulder joint the last year 12. Severely restricted range of motion in cervical rotation (< 30° in any direction) or shoulder flexion (< 110°) Baseline control group: 1. Trauma that has caused considerable problems in the head, neck or shoulder 2. Conditions of psychiatric, inflammatory, endocrinal, rheumatic, cancer, neurological or connective tissue disorders, stroke, heart infarct or type 1-diabetes (diagnosed by medical doctor) 3. Evidence of back, neck or shoulder operation or fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Physical functioning, measured using the Neck Disability Index (NDI) 2. Average pain intensity last week, measured using the Numeric Rating Scale (NRS) (0 = no pain, 10 = worst imaginable pain) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General improvement, assessed by the Patient Global Impression of Change scale 2. Symptoms, measured by symptom index of the Profile Fitness Mapping neck questionnaire (ProFitMap-neck) (manuscript in preparation) 3. Capacity on the quality and quantity to work in the latest 6 weeks due to neck problems ([1 ? (quality/10) × (quantity/10)] × 100%) 4. Pain pressure threshold of m. trapezius, assessed with pressure algometer measurement Other outcome measures (for exploratory analyses): 1. Self-estimated improvement during treatment, for General improvement, ?much improved? or ?very much improved? on PGICS; for Pain intensity, no pain last week 2. Functional limitations and compound total score, assessed by the Profile Fitness Mapping neck questionnaire (ProFitMap-neck) 3. Cervical range of motion (active flexion-extension; active axial rotation; passive flexion-rotation) 4. Peak speed in cervical axial rotation 5. Cranio-cervical flexion endurance (50% of maximum voluntary contraction) 6. Lifting capacity, assessed by the cervical progressive isoinertial lifting evaluation test (C-PILE) 7. Physical activity, measured with LIV 2000 8. Health-related quality of life for clinical and economic appraisal, assessed by the EQ-5D (The EuroQol Group 1990) 9. Questions on reporting sick, and consumption of care 10. Quality of life - Mental health, assessed by the Mental component summary in the Short Form Health Survey (SF-36) 11. Quality of life ? Physical Health, assessed by the Physical component summary in the Short Form Health Survey (SF-36) 12. Area of pain distribution, assessed by pain drawings 13. Adverse events. Open ended questions, and Patient Global Impression of Change scale (PGICS) administered after 10, 20 and the last treatment session. ?Much worse? or ?Very much worse? on the PGICS is equalized with an adverse event. | — |
Countries
Sweden
Outcome results
None listed