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The STONE-Trial (STOckholm NEck Trial): The effect of massage and/or physical exercise on sub-acute or long lasting neck pain

The effect of massage and/or physical exercise on sub-acute or long lasting neck pain: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN01453590
Enrollment
600
Registered
2014-07-03
Start date
2014-08-15
Completion date
Unknown
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Specific Neck pain Musculoskeletal Diseases

Interventions

Participants are randomised to 4 treatment arms: 1. Massage: Up to six treatment sessions within six weeks, with massage therapy (first effleurage and then deeper techniques) applied t

Sponsors

Scandinavian College of Naprapathic Manual Medicine (Naprapathögskolan) (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years 2. Ongoing neck pain (including whiplash associated pain WAD and neck pain with headache and/or radiating findings in the upper limbs) of sub-acute (30-90 days duration) or long lasting (>90days duration) duration with pain intensity of at least 2 on a numerical rating scale (0-10), as an average the preceding 4 weeks and at present. The neck pain shall be such that it is disturbing daily activities at work and/ or leisure 3. Participants are required to have a mobile phone and access to internet

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Inability to understand Swedish 3. Manual therapy or physical therapy for the neck pain in the preceding months 4. Problems with the skin that makes it difficult to give massage in the area 5. Have or have had cancer 6. Too mild symptoms 7. Surgery in the painful area 8. Acute prolapsed disc 9. Spondylolisthesis, stenosis 10. Red flags (older than 55 when the pain debut for the first time, recent trauma in the area, constant pain or pain getting worse in the night, cancer in the past or at present, consumption steroids now or recently, drug abuser, HIV)

Design outcomes

Primary

MeasureTime frame
The outcomes will be measured by web-based self-report questionnaires 7, 12, 26 and 52 weeks after inclusion in the trial. Up to three reminders will be sent out, and a personal phone call if necessary aiming to reach a high participating rate. The primary outcomes will be pain and disability, measured by a slightly modified Chronic Pain Questionnaire (4 weeks recall period instead of 6 months) with 6 items on a numerical 11-point rating scale and 1 item on the number of disability days of pain and disability. Three items rates pain (the current pain, the worst pain experienced during the preceding 4 weeks, and an average of the pain during the preceding 4 weeks). A pain score will be constructed from the mean of these 3 items. Three items rates disability and concerned to what degree pain 'interfered with your daily activities', 'changed your ability to take part in recreational, social, and family activities', and 'changed your ability to work (including housework)' in the past 4 weeks. The disability score will be the mean of these 3 items. On the basis of these scores, 2 dichotomized outcomes will be defined based on what is considered to correspond to a clinical important improvement when the baseline and the follow-up value is compared.

Secondary

MeasureTime frame
Global improvement, health (EQ-5D), satisfaction with care, sick leave, drug consumption, health care utilization 2. Adverse events within 24 hours post treatment will be measured at each return visit (duration and severity), with a questionnaire used in one of our previous trials 3. Patients will be followed with automated text messages (SMSes) every week to survey the course of neck pain over one year. They will receive two questions every week: 3.1. How would you rate your neck pain intensity, on average, the previous week? Please answer with a number between 0 and 10, where 0 is 'No pain' and 10 is 'Worst imaginable pain' 3.2. How much has your neck pain in average hindered your ability to work or perform other daily activities during the last week? Answer by selecting a number on a scale from 0-10, where 0 is 'Not at all' and 10 is 'Impossible to perform these activities'

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026