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Trial registered on ANZCTR


Registration number
ACTRN12616001267448
Ethics application status
Approved
Date submitted
6/09/2016
Date registered
9/09/2016
Date last updated
23/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
To investigate the immediate and short-term effects of a thoracic spinal manipulation in influencing hormonal levels and calf muscle blood flow in people with Achilles tendinopathy.
Scientific title
Efficacy of thoracic spinal manipulation in eliciting immediate and short term changes in salivary cortisol, salivary testosterone, T/C ratio, calf muscle and Achilles tendon blood flow in people with Achilles tendinopathy: A cross-over controlled trial.
Secondary ID [1] 290094 0
Nil
Universal Trial Number (UTN)
U1111-1187-2517
Trial acronym
TMAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinopathy 300183 0
Condition category
Condition code
Musculoskeletal 300067 300067 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300096 300096 0 0
Physiotherapy
Injuries and Accidents 300097 300097 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a thoracic spinal manipulation (SM) to the mid thoracic spine (T3-T6). Briefly, the procedure involves the application of high velocity low amplitude (HVLA) thrust which will take approximately 2-3 minutes (from positioning to delivery of thrust).
Depending on group allocation, participants will receive a SM during one of their two visits. The two visits are separated by a duration of one week.
The experiment will take place in an environmental chamber where temperature (24 degrees Celsius) and humidity (40%) will be kept constant.
The intervention will be performed by a manual therapist with more than 5 years of experience.
The whole procedure in the environmental chamber ranging from pre-intervention data collection to post-intervention (5 and 30 minutes) data collection will take approximately 45 minutes. Participants will then collect salivary samples at home 6 hours post-intervention.

Intervention code [1] 295831 0
Treatment: Other
Comparator / control treatment
Participants in the comparator group will receive sham intervention. This will involve manual contact and positioning of the participants similar to those in the intervention group, without the delivery of HVLA thrust.
Depending on group allocation, participants will receive a sham intervention during one of their two visits (separated by one week).
The participants in this group will also spend approximately 45 minutes for data collection.Participants will then collect salivary samples at home 6 hours post-intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 299536 0
Testosterone/Cortisol (T/C) ratio as measured by salivary cortisol and salivary testosterone levels.
Timepoint [1] 299536 0
Pre-intervention and at 5 minutes, 30 minutes and 6 hours post intervention.
Primary outcome [2] 299537 0
Oxygenated haemoglobin concentration (micromol/litre) of Calf muscle and Achilles tendon as measured by near infrared spectroscopy (NIRS).
Timepoint [2] 299537 0
Pre-intervention and at 5 minutes and 30 minutes post-intervention.
Secondary outcome [1] 327471 0
Heart rate variability (HRV) (low frequency/high frequency (LF/HF) ratio) as measured by an ECG.
Timepoint [1] 327471 0
Pre-intervention and at 5 minutes and 30 minutes post-intervention.

Eligibility
Key inclusion criteria
Aged 18 to 60; with a diagnosis of Achilles Tendinopathy based upon accepted diagnostic criteria by a physiotherapist or physician.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any contra-indications to SM such as rheumatoid arthritis; co-morbid musculoskeletal or serious conditions which may confound treatment or anticipated recovery such as cancer; any bone weakness or thoracic spine conditions such as osteoporosis and ankylosing spondylitis; steroid injections or surgery for the condition; The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A) score greater than 80.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on the findings from a pilot study and the cross-over design of the current study; a power calculation was performed (G power 3.0.1.0). A sample size of n = 30 is calculated to provide 80% power at the 5% level of significance.
A 2-way repeated measure ANOVA will be used to determine the effect of the interventions on all the outcome measures between the two groups

Recruitment
Recruitment status
Completed
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] 8192 0
New Zealand
State/province [1] 8192 0
Otago

Funding & Sponsors
Funding source category [1] 294464 0
Charities/Societies/Foundations
Name [1] 294464 0
New Zealand Manipulative Physiotherapists Association
Address [1] 294464 0
Level 2, Professional Building
39 Anzac Road
Browns Bay
Auckland: 0630
Country [1] 294464 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
School of Physiotherapy
University of Otago
PO Box 56
Dunedin: 9045
Country
New Zealand
Secondary sponsor category [1] 293329 0
Individual
Name [1] 293329 0
Kesava Kovanur Sampath
Address [1] 293329 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin: 9045
Country [1] 293329 0
New Zealand
Secondary sponsor category [2] 293336 0
Individual
Name [2] 293336 0
Dr. Ramakrishnan Mani
Address [2] 293336 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin:9045
Country [2] 293336 0
New Zealand
Secondary sponsor category [3] 293337 0
Individual
Name [3] 293337 0
Dr. Jim Cotter
Address [3] 293337 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin: 9045
Country [3] 293337 0
New Zealand
Secondary sponsor category [4] 293338 0
Individual
Name [4] 293338 0
Dr. Steve Tumilty
Address [4] 293338 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin: 9045
Country [4] 293338 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295894 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 295894 0
PO Box 56
Dunedin: 9054
New Zealand
Ethics committee country [1] 295894 0
New Zealand
Date submitted for ethics approval [1] 295894 0
20/07/2016
Approval date [1] 295894 0
29/08/2016
Ethics approval number [1] 295894 0
H16/088.

Summary
Brief summary
The goal of this trial is to determine whether there are immediate and short term changes in T/C ratio, calf and Achilles tendon blood flow following a thoracic spinal manipulation in people with Achilles tendinopathy. The hypothesis is that there will be changes in primary outcome measures of interest (T/C ratio and blood flow) which will be significantly different in the SM group compared to sham group. Findings from this trial will inform future larger RCTs planned in this area.
.
Trial website
http://www.otago.ac.nz/physio/research/ageing/otago625317.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68834 0
Mr Kesava Kovanur Sampath
Address 68834 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 68834 0
New Zealand
Phone 68834 0
+64 34797460
Fax 68834 0
Email 68834 0
kesava.kovanur-sampath@otago.ac.nz
Contact person for public queries
Name 68835 0
Mr Kesava Kovanur Sampath
Address 68835 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 68835 0
New Zealand
Phone 68835 0
+64 34797460
Fax 68835 0
Email 68835 0
kesava.kovanur-sampath@otago.ac.nz
Contact person for scientific queries
Name 68836 0
Mr Kesava Kovanur Sampath
Address 68836 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 68836 0
New Zealand
Phone 68836 0
+64 34797460
Fax 68836 0
Email 68836 0
kesava.kovanur-sampath@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary