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Trial registered on ANZCTR


Registration number
ACTRN12613000956707
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
28/08/2013
Date last updated
28/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of neurodynamic straight leg raise treatment duration on range of hip flexion and protective muscle activity, at first onset of pain.
Scientific title
Does passive straight leg raise neurodynamic treatment duration affect range of hip flexion or protective antagonistic muscle activity of semitendinosus, at first onset of pain, in healthy volunteers.
Secondary ID [1] 283039 0
Nil
Universal Trial Number (UTN)
U1111-1146-9410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurodynamic treatment duration 289874 0
- pain-free range of movement
289919 0
- protective antagonistic muscle activity 289934 0
Condition category
Condition code
Musculoskeletal 290235 290235 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290236 290236 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ankle was kept in plantargrade with an ankle-foot orthotic (AFO). The knee was held in full extension with the hips and pelvis unsupported. The leg was then raised in the passive straight leg raise (SLR) position until the first onset of pain (P1) was reached and, at this point, the hip was oscillated using a small amplitude at end of range (Grade IV+). Treatments lasted for either 3x1 or 3x2 minutes, with each oscillation standardized using a metronome (1.5Hz) and each set separated by 1-minute rest intervals. Participants were then required to attend the laboratory for a second session in order to receive the second experimental condition. Laboratory sessions were separated by at least 48 hours to control for carryover effects.
Intervention code [1] 287759 0
Rehabilitation
Intervention code [2] 287798 0
Treatment: Other
Comparator / control treatment
Group 1 (3x1 minutes) will be compared with Group 2 (3x2 minutes).
Control group
Dose comparison

Outcomes
Primary outcome [1] 290257 0
Between groups changes in range of hip flexion (measured with electro-goniometry) at first onset of pain (indicated by each participant squeezing a 'trigger').
Timepoint [1] 290257 0
Before and after each treatment.
Primary outcome [2] 290321 0
Between groups changes in electromyographic (EMG) magnitude of semitendinosus at first onset of pain.
Timepoint [2] 290321 0
Before and after each treatment.
Secondary outcome [1] 304217 0
Within groups changes in range of hip flexion (measured with electro-goniometry) at first onset of pain (indicated by each participant squeezing a 'trigger').
Timepoint [1] 304217 0
Before and after each treatment.
Secondary outcome [2] 304303 0
Within groups changes in EMG magnitude of semitendinosus at first onset of pain.
Timepoint [2] 304303 0
Before and after each treatment.

Eligibility
Key inclusion criteria
Able to maintain a supine position with a straight leg raise for 3x2 minutes.
Minimum age
18 Years
Maximum age
48 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Current or recent (<12 months) lower back or leg pain
- Inability to maintain a passive straight leg raise position
- Had positive neurological integrity test
- Had any red flags to manual therapy
- BMI > 28 kg/m^2
- Over 48 years old

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)
Participants were recruited via poster, email and word of mouth. Subjects were selected from sealed envelopes by a blinded researcher and assigned to experimental condition A or B, using computerized sequence generation. Participants received each intervention in a random order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were selected from sealed envelopes by a blinded researcher and assigned to experimental condition A or B.

Experimental condition A: Received 3x1 minutes on the first treatment session and 3x2 minutes on the second.

Experimental condition B: Received 3x2 minutes on the first treatment session and 3x1 minutes on the second.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Intra-class correlation coefficient was calculated to determine the examiner’s reliability in detecting range of hip flexion at first onset of pain. A two-way analysis of variance (ANOVA) was then used to test each hypothesis (correcting for violation of spherity using Greenhouse Geiser). A probability level of p = <0.05 was used to test for statistically significant differences. No power analysis was conducted. A comparable sample size was used in 'similar' studies.

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] 5317 0
United Kingdom
State/province [1] 5317 0
East Sussex

Funding & Sponsors
Funding source category [1] 287803 0
Self funded/Unfunded
Name [1] 287803 0
Address [1] 287803 0
Country [1] 287803 0
Primary sponsor type
University
Name
University of Brighton
Address
School of Health Professions
University of Brighton
Robert Dodd building
49 Darley Road
Eastbourne BN20 7UR
Country
United Kingdom
Secondary sponsor category [1] 286532 0
None
Name [1] 286532 0
None
Address [1] 286532 0
None
Country [1] 286532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289750 0
University of Brighton’s research ethics and governance committee
Ethics committee address [1] 289750 0
University of Brighton
Robert Dodd building
49 Darley Road
Eastbourne BN20 7UR
Ethics committee country [1] 289750 0
United Kingdom
Date submitted for ethics approval [1] 289750 0
16/08/2010
Approval date [1] 289750 0
04/10/2010
Ethics approval number [1] 289750 0

Summary
Brief summary
To compare the differences between 3x1 and 3x2 minutes of passive oscillating grade IV+ neurodynamic SLR treatment on measures of EMG magnitude of semitendinosus and range of hip flexion at first onset of pain.

The first hypothesis was that EMG magnitude of semimembranosus would be significantly reduced post-treatment, with a greater reduction in the 3x2 minutes group.

The second hypothesis was that range of hip flexion would be significantly increased post-treatment, with a greater increase in the 3x2 minutes group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42242 0
Mr Ryan Hanney
Address 42242 0
University of Brighton
Robert Dodd building
49 Darley Road
Eastbourne
BN20 7UR
Country 42242 0
United Kingdom
Phone 42242 0
447723743555
Fax 42242 0
Email 42242 0
ryanhanney@hotmail.co.uk
Contact person for public queries
Name 42243 0
Mr Ryan Hanney
Address 42243 0
University of Brighton
Robert Dodd building
49 Darley Road
Eastbourne
BN20 7UR
Country 42243 0
United Kingdom
Phone 42243 0
447723743555
Fax 42243 0
Email 42243 0
ryanhanney@hotmail.co.uk
Contact person for scientific queries
Name 42244 0
Mr Ryan Hanney
Address 42244 0
University of Brighton
Robert Dodd building
49 Darley Road
Eastbourne
BN20 7UR
Country 42244 0
United Kingdom
Phone 42244 0
447723743555
Fax 42244 0
Email 42244 0
ryanhanney@hotmail.co.uk

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