Condition category
Musculoskeletal Diseases
Date applied
21/07/2011
Date assigned
02/08/2011
Last edited
10/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Björklund

ORCID ID

Contact details

Centre for Musculoskeletal Research
University of Gävle
Gävle
SE-801 76
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009-1403

Study information

Scientific title

Rehabilitation of women with neck-shoulder pain: effects of individualized treatment and training, based on symptoms, clinical standardized tests and tests of functioning, on pain and physical functioning compared to either a non-individualized approach or treatment-as-usual

Acronym

Study hypothesis

1. Individualized rehabilitation has a better short, intermediate and long-term effect than either non-individualized rehabilitation or treatment-as-usual, on primary and secondary outcomes
2. Individualized and non-individualized rehabilitation has a better short, intermediate and long-term effect than treatment-as-usual, on primary and secondary outcomes
3. Which treatment model is the most cost-effective from the health economics perspective?
4. What impact do physical and psychosocial factors at the workplace have on long-term treatment outcomes?

Ethics approval

The Regional Ethical Review Board in Uppsala, Sweden, 23/03/2011, ref: 2011/081

Study design

Interventional single-centre single-assessor blinded randomized controlled clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Non specific neck-shoulder pain, with evidence of impaired physical functioning in terms of self-rated neck disability and work capacity.

Intervention

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 participants without neck pain will be recruited into this study
4. The participants without neck pain will be involved only for baseline comparisons
5. The participants with neck-shoulder pain will be randomly allocated to one of the following 3 groups:
5.1. Individualized treatment based on symptoms, standardized clinical tests and tests of functioning
5.2. Non-individualized treatment
5.3. No intervention (However, the participants are free to receive "standard treatment" from the National Health Service if they so wish)
6. Group 1 and 2 will receive 40 min treatment on 27 occasions during 11 weeks (2 treatments first week and 3 times the second week and so forth)
7. Treatment components included in the intervention target different functions and include craniocervical flexion exercises, postural correction and re-education, mobilization treatment according to manual therapy principles, strength training for the neck-shoulder and arm muscles, myofeedback supported training of a relaxed work technique and eye-neck-hand coordination training
8. Progression and context of the training will follow motor learning principles
9. The individualized treatment (group 1) will be tailored for each participant according to results of the baseline assessment
10. Traig in the individualized group will be adapted to each person’s activity limitations, obtained by the Problem Elicitation Technique
11. Participants in group 2, non-individualized treatment, will be given two treatment components taken at random from those that do not target the impaired functioning revealed at the baseline assessment for the specific participant

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

16/08/2011

Overall trial end date

15/02/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

160

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 (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

Recruitment start date

16/08/2011

Recruitment end date

15/02/2013

Locations

Countries of recruitment

Sweden

Trial participating centre

University of Gävle
Gävle
SE-801 76
Sweden

Sponsor information

Organisation

The Swedish Council for Working Life and Social Research (Sweden)

Sponsor details

Box 2220
Stockholm
SE-103 15
Sweden
+46 (0)8 775 40 70
fas@fas.se

Sponsor type

Research council

Website

http://www.fas.se/

Funders

Funder type

University/education

Funder name

Centre for Musculoskeletal Research, University of Gävle, Sweden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Umeå Universitet

Alternative name(s)

Umeå University

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Forskningsrådet för Arbetsliv och Socialvetenskap

Alternative name(s)

Swedish Council for Working Life and Social Research, FAS

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Sweden

Funder name

AFA Försäkring

Alternative name(s)

AFA Insurance Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Sweden

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22607546
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27716128

Publication citations

  1. Protocol

    Björklund M, Djupsjöbacka M, Svedmark A, Häger C, Effects of tailored neck-shoulder pain treatment based on a decision model guided by clinical assessments and standardized functional tests. A study protocol of a randomized controlled trial., BMC Musculoskelet Disord, 2012, 13, 75, doi: 10.1186/1471-2474-13-75.

Additional files

Editorial Notes

03/10/2016: Publication reference added.