Effectiveness of a general neck exercise program, of acupuncture or of repetitive low-energy shockwave therapy for chronic neck disorders
| ISRCTN | ISRCTN99496264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99496264 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/12/2009
- Registration date
- 04/01/2010
- Last edited
- 04/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jan D Rompe
Scientific
Scientific
OrthoTrauma Evaluation Center
Mainz
55130
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Treatment of neck disorders with exercises, acupuncture or shockwave therapy: a randomised controlled trial |
| Study objectives | Null hypothesis: A general neck exercise program, acupuncture and shockwave therapy produce equivalent outcomes at 4 months from baseline. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neck disorders |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/03/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 350 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Germany
- Luxembourg
Study participating centre
OrthoTrauma Evaluation Center
Mainz
55130
Germany
55130
Germany
Sponsor information
German and International Society for Extracorporeal Shock Wave Therapy (DIGEST) (Germany)
Research organisation
Research organisation
Kurfürstendamm 61
Berlin
10707
Germany
| Website | http://www.digest-ev.de |
|---|
Funders
Funder type
Research organisation
German and International Society for Extracorporeal Shock Wave Therapy (Deutsche und Internationale Gesellschaft für Extrakorporale Stoßwellentherapie [DIGEST]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
