Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201608001732180 Date of Approval: 01/08/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dynamic oscillatory stretch improves hamstring flexibility and perceived pain in asymptomatic young adults: A randomised trial
Official scientific title Dynamic oscillatory stretching efficacy on hamstring extensibility and pain tolerance: a randomised controlled trial.
Brief summary describing the background and objectives of the trial Background: While passive stretch, proprioceptive neuromuscular facilitation (PNF) and joint mobilization techniques are well documented to have positive effects on range of motion (ROM), there is no information on the effect of dynamic oscillatory stretching (DOS), a technique that combines these three modalities on ROM and pain tolerance. Purpose: To determine if dynamic oscillatory stretching (DOS) improves hamstring flexibility and pain tolerance to a greater degree than static stretching (SS) and a placebo intervention in asymptomatic participants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal conditions,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/02/2011
Actual trial start date 17/02/2012
Anticipated date of last follow up 15/03/2012
Actual Last follow-up date 26/03/2012
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL Preparing for publication
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised The study was a randomised control trial with unblinded treatment and blinded outcome assessment. Random number sequencing was generated using the Research Randomizer computer programme (Urbaniak GC et al, 2013). Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Static stretch 60 seconds 60 seconds, once off The main investigator passively raised the leg to the point of first sensation of pain, waited 15 seconds until the participant could tolerate more stretching and then added a further stretch to achieve a new ¿tolerance point¿. 20 Dose Comparison
Experimental Group Dynamic oscillatory stretch 60 seconds 60 seconds, once off The main investigator passively raised the leg to the point of ¿the first sensation of pain¿. The participant assisted the stretch by contracting his/her knee extensors and hip flexor muscles. A two-second, slow passive stretch at the end of the range was applied to assist in further extending the stretch. The agonist contraction was maintained throughout the stretch. This procedure was repeate 20 Dose Comparison
Control Group Placebo Control group Once 1 minute Ultrasound to the dorsal aspect of the dominant foot 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy, young asymptomatic physiotherapy students from a local University with a straight leg raise test equal or less than 90 degrees. Participants were excluded if they had a previous history of lower-extremity and/or back pathology, and/or direct injury to the hamstring muscles in the previous six months; if they were suffering from a neurological disorder; if they were participating in a regular stretching regimen of the hamstring muscles group; or if they attended regular yoga classes. 21 Year(s) 23 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/11/2010 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
7 York Road Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The SLR ROM measurement position was the same as the starting positon of each stretching protocol. examiner passively raised the leg to the point where the participant could not tolerate the pain or the end of SLR ROM; the ROM was read off the inclinometer. This measurement was performed prior to, immediately after and 1 hour following each intervention. Baseline pre intervention Immediately post intervention One hour post intervention
Secondary Outcome Perception of pain during end range of SLR was determined via the use of a horizontal 10 cm visual analogue scale (VAS) with anchor points of 0 (no pain) and 10 (pain as bad as it could possibly be). Participants were requested to mark the intensity of the perceived pain on the scale (VAS) using a pencil. Baseline pre intervention Immediately post intervention One hour post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy Department, University of Witwatersrand 7 York Road Parktown 2193 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
No funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor No sponsoring University
COLLABORATORS
Name Street address City Postal code Country
Univeristy of Witwatersrand, Physiotherapy Department 7 York Road Parktown 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Arie Michaeli ari@clinisol.co.za 0827411644 32 Boundary Road
City Postal code Country Position/Affiliation
Johannesburg 2192 South Africa Clinical Physiotherapist
Role Name Email Phone Street address
Public Enquiries Aimee Stewart aimee.stewart@wits.ac.za 0117173702 7 York Road
City Postal code Country Position/Affiliation
Johannesburg 2192 South Africa Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Arie Michaeli ari@clinisol.co.za 0827411644 32 Boundary Road
City Postal code Country Position/Affiliation
Johannesburg 2192 South Africa Clinical Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information