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Trial registered on ANZCTR


Trial ID
ACTRN12612000304831
Ethics application status
Approved
Date submitted
15/03/2012
Date registered
16/03/2012
Date last updated
31/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
To investigate the effects of spinal manipulation for Achilles tendinopathy; a pilot study
Scientific title
To investigate the effects of spinal manipulation for Achilles tendinopathy; a pilot study
Secondary ID [1] 280139 0
Nil
Universal Trial Number (UTN)
U1111-1129-1365
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic Achilles tendinopathy 286065 0
Condition category
Condition code
Injuries and Accidents 286260 286260 0 0
Other injuries and accidents
Musculoskeletal 286262 286262 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a high velocity, low amplitude thrust manipulation, applied to the mid part of the spine (thoracic spine). It will take approximately 2 minutes to position the volunteer for this manipulation, and will take seconds to deliver the thrust. Volunteers will receive the manipulation during each physiotherapy appointment (i.e. twice weekly, for a total of 4 weeks).
The physiotherapy appointments will take about 20 minutes each, and during this time eccentric exercises will be monitored and modified as appropriate, and secondary outcome measures (blood pressure and pulse rate) will also be recorded.
Intervention code [1] 284473 0
Rehabilitation
Comparator / control treatment
The comparator group will receive eccentric exercises only. Eccentric exercises are a special type of exercise known to be beneficial for the rehabilitation of Achilles tendinopathy. For both groups, these exercises will be completed twice daily, for a total of four weeks. All participants will receive education and an information sheet, outlining how these exercises are to be preformed. The comparator group will attend for physiotherapy twice weekly, for four weeks. During these 20 minute appointments they will receive education on the exercise regime, and secondary outcome measures (blood pressure and pulse rate) will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 286725 0
The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A) score will be the primary outcome. This questionnaire is designed to assess Achilles tendinopathy severity.
Timepoint [1] 286725 0
Measures will be assessed before the initial intervention and after the final physiotherapy appointment, at the end of 4 weeks
Primary outcome [2] 286726 0
The numeric pain rating scale (NPRS) will be the other primary measure taken. The scale assesses the intensity of pain.
Timepoint [2] 286726 0
Measures will be assessed before the initial intervention and during each physiotherapy appointment, for 4 consecutive weeks. This outcome measure will also be taken after the final physiotherapy appointment, at the end of 4 weeks.
Secondary outcome [1] 296542 0
Blood pressure and pulse rate will be measured using an electronic blood pressure cuff.
Timepoint [1] 296542 0
Twice weekly for the first four weeks.

Eligibility
Key inclusion criteria
18-65 years old; diagnosis chronic AT by an advanced physiotherapist (i.e. post graduate practitioner); available twice weekly for a 20 minute physiotherapy appointment over 4 consecutive weeks.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to spinal manipulation such as osteoprosis, rheumatoid arthritis or the presence of cancer; bilateral tendinopathy involvement; Scheuermanns disease; neurological disease; pregnancy; inability to understand intervention or protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be recruited through an advertisement in the local paper. The lead investigator will assess volunteers against the inclusion and exclusion criteria. Concealed allocation will be carried out; volunteers will be asked to draw from 20 sealed opaque envelopes. The envelopes will contain the volunteers number and allocation group. The clinic receptionist will then organise the volunteer’s appointments for the following 4 weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4204 0
New Zealand
State/province [1] 4204 0
Dunedin

Funding & Sponsors
Funding source category [1] 284889 0
Self funded/Unfunded
Name [1] 284889 0
Address [1] 284889 0
Country [1] 284889 0
Primary sponsor type
Individual
Name
Laura Kingston
Address
School of Physiotherapy
University of Otago
PO Box 56
Dunedin
9045
Country
New Zealand
Secondary sponsor category [1] 283769 0
None
Name [1] 283769 0
Address [1] 283769 0
Country [1] 283769 0
New Zealand
Other collaborator category [1] 260621 0
Individual
Name [1] 260621 0
Dr. Steve Tumilty
Address [1] 260621 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin
9045
Country [1] 260621 0
New Zealand
Other collaborator category [2] 260622 0
Individual
Name [2] 260622 0
Dr. Leica Claydon
Address [2] 260622 0
School of Physiotheraoy
University of Otago
PO BOx 56
Dunedin
9045
Country [2] 260622 0
New Zealand
Other collaborator category [3] 276974 0
Individual
Name [3] 276974 0
Professor David Baxter
Address [3] 276974 0
School of Physiotherapy University of Otago PO Box 56 Dunedin 9045
Country [3] 276974 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286886 0
New Zealand Health and Disability Ethics Committee - Lower South Regional Ethics Committee
Ethics committee address [1] 286886 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 286886 0
New Zealand
Date submitted for ethics approval [1] 286886 0
24/04/2012
Approval date [1] 286886 0
21/06/2012
Ethics approval number [1] 286886 0

Summary
Brief summary
The goal of this trial is to assess if spinal manipulation, in addition to eccentric exercises, has an impact on the functional recovery of Achilles tendinopathy. The hypothesis is that both groups will improve after 4 weeks of eccentric exercises, and that the intervention group (receiving the spinal manipulation), will improve more than the group receiving eccentric exercises alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33925 0
Address 33925 0
Country 33925 0
Phone 33925 0
Fax 33925 0
Email 33925 0
Contact person for public queries
Name 17172 0
Laura Kingston
Address 17172 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 17172 0
New Zealand
Phone 17172 0
N/A
Fax 17172 0
Email 17172 0
kinla960@student.otago.acnz
Contact person for scientific queries
Name 8100 0
Laura Kingston
Address 8100 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 8100 0
New Zealand
Phone 8100 0
N/A
Fax 8100 0
Email 8100 0
kinla960@student.otago.ac.na