Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000143628
Ethics application status
Approved
Date submitted
24/01/2014
Date registered
5/02/2014
Date last updated
5/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of two cervical manipulation techniques in patients with restricted neck movement and neck pain.
Scientific title
A comparison of two non-thrust mobilization techniques applied to the C7 segment in patients with restricted and painful cervical rotation: A Quasi-randomized controlled trial
Secondary ID [1] 283976 0
Nil known
Universal Trial Number (UTN)
U1111-1152-5205
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck Pain 291003 0
restricted neck movement 291030 0
Condition category
Condition code
Musculoskeletal 291349 291349 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291369 291369 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comparison of two different low velocity cervical (neck) stretching (mobilization) techniques
Participants will receive one or the other stretching technique. A coin toss will determine which technique will be applied to the first participant, then the technique will be alternated.

Both techniques rotate the C7 motion segment first to the left and then to the right. In essence the first technique applies a stretching force to both the left and right side joints of the C7 vertebrae and the second technique stretches the joints on just one side of the C7 vertebrae.
Once the participant receives the stretch once that will end their participation in the study.

A single PT, myself, will administer both stretching techniques.

quasi-randomised controlled trial

Single administration of once for left rotation and once for right. 10 second stretch applied three times
Intervention code [1] 288664 0
Treatment: Other
Intervention code [2] 288681 0
Rehabilitation
Comparator / control treatment
Two different but standard treatments that are commonly applied are being compared.
Technique applied by the clinicians hands to the patients C7 vertebrae.
Both techniques are applied 3 times for 10 seconds to assist restricted left rotation and then to assist right rotation. One technique stretches joints on both sides of the C7 vertebrae and the other one just one side
Control group
Active

Outcomes
Primary outcome [1] 291344 0
Improvement in neck motion as measured by the cervical range of motion device (CROM)
Timepoint [1] 291344 0
Immediate effect study right after the application of the stretching technique.
Secondary outcome [1] 306561 0
Nil
Timepoint [1] 306561 0
Nil

Eligibility
Key inclusion criteria
Patients with limited neck rotation (movement to the left and right) and pain experienced at the end of this movement
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cervical instability and or symptomatic disc herniation at the C7 motion segments

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2012
Actual
4/01/2012
Date of last participant enrolment
Anticipated
23/05/2012
Actual
23/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5773 0
United States of America
State/province [1] 5773 0
Michigan

Funding & Sponsors
Funding source category [1] 288605 0
Self funded/Unfunded
Name [1] 288605 0
None
Country [1] 288605 0
Primary sponsor type
Individual
Name
Doug Creighton
Address
Doug Creighton
3172 Human Health Building
Rochester Michigan 48309
Country
United States of America
Secondary sponsor category [1] 287315 0
None
Name [1] 287315 0
Nil
Address [1] 287315 0
Nil
Country [1] 287315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290467 0
Oakland University IRB
Ethics committee address [1] 290467 0
Oakland University
Rochester Michigan
49309
Ethics committee country [1] 290467 0
United States of America
Date submitted for ethics approval [1] 290467 0
13/09/2011
Approval date [1] 290467 0
09/11/2011
Ethics approval number [1] 290467 0
4573

Summary
Brief summary
A comparison of two different cervical (neck) stretching (mobilization) treatment techniques.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45838 0
A/Prof Douglas Creighton
Address 45838 0
Oakland University
Associate Professor
3077 Human Health Building
Rochester Michigan 48309
Country 45838 0
United States of America
Phone 45838 0
+1 248 364 8696
Fax 45838 0
+1 248 364 8660
Email 45838 0
[email protected]
Contact person for public queries
Name 45839 0
A/Prof Doug Creighton
Address 45839 0
Oakland University
Associate Professor
3077 Human Health Building
Rochester Michigan 48309
Country 45839 0
United States of America
Phone 45839 0
+1 248 364-8696
Fax 45839 0
+1 248 364 8660
Email 45839 0
[email protected]
Contact person for scientific queries
Name 45840 0
A/Prof Doug Creighton
Address 45840 0
Oakland University
Associate Professor
3077 Human Health Building
Rochester Michigan 48309
Country 45840 0
United States of America
Phone 45840 0
+1 248 364-8696
Fax 45840 0
+1 248 364-8660
Email 45840 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.