Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Treatment of neck disorders with exercises, acupuncture or shockwave therapy: a randomised controlled trial
Acronym
Study hypothesis
Null hypothesis:
A general neck exercise program, acupuncture and shockwave therapy produce equivalent outcomes at 4 months from baseline.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/03/2010
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
350
Participant 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
Recruitment start date
01/03/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Germany, Luxembourg
Trial participating centre
OrthoTrauma Evaluation Center
Mainz
55130
Germany
Sponsor information
Organisation
German and International Society for Extracorporeal Shock Wave Therapy (DIGEST) (Germany)
Sponsor details
Kurfürstendamm 61
Berlin
10707
Germany
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
German and International Society for Extracorporeal Shock Wave Therapy (Deutsche und Internationale Gesellschaft für Extrakorporale Stoßwellentherapie [DIGEST]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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