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.: PACTR201903875689159 Date of Approval: 14/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study between a specific type of stretching called dynamic oscillatory stretching with isometric contraction versus chiropractic manipulative therapy of the lower back vs a combination of both on hamstring flexibility
Official scientific title Dynamic Osiillatory Stretching with Isometric Contraction versus Sacroiliac Joint Manipulation versus a Combination on Hamstring Flexibility
Brief summary describing the background and objectives of the trial Both Chiropractic manipulative therapy and Dynamic oscillatory stretching has very little research when focused on hamstring flexibility and a combination of both has no scientific research at all. Therefore the aim of this trial will be to firstly prove that dynamic oscillatory stretching is effective in treating tight muscles and secondly to prove that a combination of both therapies is the most effective way to treat such a common disorder as tight hamstrings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2019
Actual trial start date
Anticipated date of last follow up 31/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dynamic Oscillatory Stretching with Isometric Contraction 6 treatments 3 weeks Dynamic oscillatory stretching with isometric contraction will be carried out in the following manner: 1. The participant will be asked to lie in the supine position on the treatment bed. 2. The researcher will grasp the participant’s ankle of the one leg with their caudal hand and the participant’s knee of the same leg with the cephalad hand. 3. The researcher will elevate the participant’s leg, while the participant actively assists knee extension and hip flexion. The contralateral leg maintains firm contact with the treatment bed. The leg is elevated until the participant perceives the first sensation of stretch. 4. At this point, the researcher will place the participant’s foot on their shoulder and instruct the participant to activate the hamstring muscle by gently pushing down on the researcher’s shoulder. This will be held for 8 seconds. 5. The researcher will then elevate the participant’s leg higher until further stretch is perceived and the participant will be instructed to activate the hamstrings again. Step 5 is repeated one more time with the hamstring under further stretch. 6. At this point, the researcher will then apply a two second, slow passive stretch at the end range to further stretch the participant’s hamstrings. This is repeated three times. 10
Experimental Group Chiropractic manipulation of the sacroiliac joint 6 treatments 3 weeks Chiropractic manipulation of the sacroiliac joint will be carried out in the following manner: 1. The participant will be asked to lie on their uninvolved side with their upper leg bent and their lower leg straight and their arms folded over their chest on the treatment bed. 2. The researcher will stand square on to face the patient. The researcher’s cephalad hand will contact the participant’s shoulder while the caudal hand contacts the restricted sacroiliac joint, inferior and medial to the posterior superior iliac spine. 3. The forearm of the researcher’s caudal hand will contact the part of the participant’s ilium on the involved side. The researcher’s cephalad leg will remain on the ground and the caudal leg will contact thigh to thigh with the participant’s upper most bent leg. 4. A controlled rotary force will be applied using the researcher’s arm while the researcher also provides a thrust delivered by a body drop with a sudden impulse thrust manifested by collapsing both legs. 10
Experimental Group DOS with isometric contraction and chiropractic manipulation of the sacroiliac joint 6 treatments 3 weeks Dynamic oscillatory stretching with isometric contraction will be carried out in the following manner: As per 1st group Chiropractic manipulation of the sacroiliac joint will be carried out in the following manner: As per 2nd group 10
Control Group NO CONTROL 0 0 N/A 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following criteria must be met in order to partake in this study: • Female or male patients between the ages of 18 to 44 years old to rule out the effects of degeneration on lumbar spine range of motion that results with increasing age. • Decreased hamstring flexibility as determined by a passive straight leg raise below 70⁰. • The following diagnostic criteria indicating sacroiliac joint dysfunction: o At least three positive provocative orthopaedic tests specific to the sacroiliac joint: FABER, gaenslen’s, sacroiliac compression. o Sacroiliac Marching Test (motion palpation) in order to determine which sacroiliac joint is dysfunctional. If any of the following criteria are met, the participant cannot take part in this study: • Contraindicated for chiropractic manipulation of the sacroiliac joint. • Contraindicated for hamstring stretching. • Current or previous (up to eight weeks) hamstring strain as there will be pain and decreased range of motion on stretch. • Any hip pathology that would result in decreased hip flexion. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 44 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
No 14/03/2019 Faculty of Health Sciences Research Ethics Committee at the University of Johannesburg Doornfontein Campus
Ethics Committee Address
Street address City Postal code Country
55 Beit Street, Doornfontein, Johannesburg, 2094 Johannesburg 2094 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This study may determine if chiropractic manipulation of the sacroiliac joint, dynamic oscillatory stretching or a combination of the two, increase hamstring flexibility as well as which method is the most effective. Sessions 1, 4 and 7
Secondary Outcome This study could determine whether sacroiliac joint dysfunction is directly linked with decreased hamstring flexibility and vice versa Sessions 1, 4 and 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Doornfontein Chiropractic Clinic 55 Beit Street, Doornfontein, Johannesburg, 2094 Johannesburg 2094 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Supervisor Linked Bursary University of Johannesburg - 55 Beit Street, Doornfontein, Johannesburg, 2094 Johannesburg 2094 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Supervisor Linked Bursary 55 Beit Street, Doornfontein, Johannesburg, 2094 Johannesburg 2094 South Africa University
COLLABORATORS
Name Street address City Postal code Country
NA NA NA 2094 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kirsten Glover kirglover@gmail.com 0027736348646 7 Edens Garden, 240 Pine Ave, Ferndale, 2194
City Postal code Country Position/Affiliation
Johannesburg 2194 South Africa Masters student
Role Name Email Phone Street address
Public Enquiries Chris Yelverton chrisy@uj.ac.za 0027115596218 55 Beit Street, Doornfontein, Johannesburg, 2094
City Postal code Country Position/Affiliation
Johannesburg 2094 South Africa Head of Department
Role Name Email Phone Street address
Scientific Enquiries Chris Yelverton chrisy@uj.ac.za 0027115596218 55 Beit Street, Doornfontein, Johannesburg, 2094
City Postal code Country Position/Affiliation
Johannesburg 2094 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD is data captured is determined by the measurements taken to determine hamstring flexibility and any changes (using a goniometer measuring hip flexion in a straight leg raise as well as using the sit and reach test) and lumbar spine range of motion (using a digital inclinometer). These measurements are taken on session 1, 4 and 7 over a 3 week period. Statistical Analysis Plan Between requesting access to the IPD and reseiving the data, it should take a maximum of 5 working days. The IPD will be made available to the public but access will have to be requested from the University of Johannesburg's Head of Department of Chiropractic (Dr Chris Yelverton: chrisy@uj.ac.za). They would be required to state the reason for requesting the data and he will grant access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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