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11 February 2012
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| [ Print-friendly version ] |
| Effectiveness of a general neck exercise program, of acupuncture or of repetitive low-energy shockwave therapy for chronic neck disorders |
| ISRCTN | ISRCTN99496264 |
| ClinicalTrials.gov identifier | |
| Public title | Effectiveness of a general neck exercise program, of acupuncture or of repetitive low-energy shockwave therapy for chronic neck disorders |
| Scientific title | Treatment of neck disorders with exercises, acupuncture or shockwave therapy: a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
Null hypothesis:
A general neck exercise program, acupuncture and shockwave therapy produce equivalent outcomes at 4 months from baseline. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany, Luxembourg |
| Disease/condition/study domain | Neck disorders |
| Participants - inclusion criteria |
1. Aged 18 years and older, either sex
2. Neck pain symptoms for longer than 3 months 3. Referred to therapy with a new episode of neck pain by their general practitioner (GP). Non-specific neck pain is defined as pain and/or stiffness in the cervical spine, with or without unilateral arm pain, after the exclusion of red flags. |
| Participants - exclusion criteria |
1. Weight loss
2. Fever 3. Progressive neurological signs including bilateral arm pain 4. Evidence of muscle weakness or disturbance in normal sensation 5. History of malignancy, inflammatory arthritis, polymyalgia rheumatica, osteoporosis, or gross structural or neurologic abnormality affecting the neck 6. Contraindications to the study treatments (e.g., patients taking anticoagulants) 7. Any injury awaiting a compensation claim (e.g., deceleration or industrial injury) 8. Pregnancy |
| Anticipated start date | 01/03/2010 |
| Anticipated end date | 31/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 350 |
| Interventions |
General neck exercise program:
Posture correction techniques and active range of movement exercises are delivered. The active range of movement exercises prescribed are at the therapist's discretion, but can include flexion, extension, side flexion, and rotation. Posture correction will be taught in the context of functional and work activities. Total duration of treatment: 4 weeks Total duration of follow-up: 15 months from baseline Acupuncture: We use single-use, sterile, silver-handle, prepacked needles without guide tubes. We base point selection on individualised western acupuncture techniques by using a list of points previously reported as being effective in neck pain. The specific points for each individual are defined at each treatment session, depending on the patient's pain distribution and palpation of the neck and thorax to determine ah-shi points, or local tender points, for acupuncture. At least 1 distal point is used. Total duration of treatment: 4 weeks Total duration of follow-up: 15 months from baseline Shockwave therapy: Painful muscles are identified and tender points are treated with low-energy shockwave therapy (EFD = 0.1 mJ/mm^2, 2000 shocks per muscle, 3 sessions 1 - 2 weeks apart). Total duration of treatment: 4 weeks Total duration of follow-up: 15 months from baseline |
| Primary outcome measure(s) |
1. Neck pain on a 100 mm visual analogue scale
2. Disability assessed with the 100 point neck disability index Measured at 2 months, 4 months and 15 months from baseline. |
| Secondary outcome measure(s) |
Treatment satisfaction, assessed on a five point scale: 1 = very satisfied, 2 = satisfied, 3 = equivocal, 4 = unsatisfied, and 5 = very unsatisfied; Scores of 1 and 2 are classified as "satisfied" and scores of 4 and 5 as "unsatisfied.
Measured at 2 months, 4 months and 15 months from baseline. |
| Sources of funding | German and International Society for Extracorporeal Shock Wave Therapy (Deutsche und Internationale Gesellschaft für Extrakorporale Stoßwellentherapie [DIGEST]) (Germany) |
| Trial website | |
| Publications | |
| Contact name | Prof Jan D Rompe |
| Address | OrthoTrauma Evaluation Center |
| City/town | Mainz |
| Zip/Postcode | 55130 |
| Country | Germany |
| Sponsor | German and International Society for Extracorporeal Shock Wave Therapy (DIGEST) (Germany) |
| Address | Kurfürstendamm 61 |
| City/town | Berlin |
| Zip/Postcode | 10707 |
| Country | Germany |
| Sponsor website: | http://www.digest-ev.de |
| Date applied | 14/12/2009 |
| Last edited | 04/01/2010 |
| Date ISRCTN assigned | 04/01/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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