Condition category
Musculoskeletal Diseases
Date applied
14/12/2009
Date assigned
04/01/2010
Last edited
04/01/2010
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

Prof Jan D Rompe

ORCID ID

Contact details

OrthoTrauma Evaluation Center
Mainz
55130
Germany

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

http://www.digest-ev.de

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

Publication citations

Additional files

Editorial Notes