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.: PACTR202004570377769 Date of Approval: 06/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The comparative effect of extracorporeal radial shockwave therapy and active release technique on active gluteus medius trigger points.
Official scientific title The comparative effect of extracorporeal radial shockwave therapy and active release technique on active gluteus medius trigger points.
Brief summary describing the background and objectives of the trial People with chronic non-specific lower back pain have been shown to have more gluteus medius weakness and more myofascial trigger points than healthy people. It is also suggested that gluteus medius weakness and myofascial trigger points are often the cause of lower back pain. Many soft tissue techniques are used in treatment of these myofascial trigger points. Extracorporeal shockwave therapy has been shown to be an effective technique in treatment of myofascial trigger points by means of desensitisation or hyper stimulation analgesia. Active release technique has been proposed to be one of the most popular techniques utilised in treating myofascial trigger points by manual therapists. The aim of this study is to explore the comparetive effectiveness of extracorporeal shockwave therapy and active release technique on active gluteus medius trigger point. A total of 30 participants between the ages of 18 - 40 years of age will be recruited for this study. All of which have to present with lower back pain and active gluteus medius trigger points. The participants will be randomly divided into two groups, each group consisting of 15 participants. Group 1 will receive extracorporeal radial shockwave therapy to the identified active gluteus medius trigger points and group 2 will receive active release technique to the identified active gluteus medius trigger point. Participant will receive a total of six treatments and a seventh consultation being a data collection consult with no treatment. Objective and subjective data will be collected on the first, fourth and seventh consultations. All participants will be screened on the first consultation with a history taking, physical exam and lumbar regional to determine the presence of active gluteus medius myofascial trigger points and to determine if they comply with the inclusion and exclusion criteria. Subjective data will be collected by use of a visual analogue pain scale and objective data will be collected using a handheld pressure Algometer. Possible outcomes of this study may determine the superior soft tissue technique in the form of extracorporeal radial shockwave therapy or active release technique in the treatment of active gluteus medius trigger points with the associated referred pain and lower back pain.
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: Devices
Anticipated trial start date 15/06/2020
Actual trial start date
Anticipated date of last follow up 15/09/2020
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 Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Extracorporeal shockwave therapy 1000 shocks at 3 bar between 15-30 Hz, twice a week 5-8mins Shcokwave head is held perpendicular and still over the identified myofascial trigger point within the gluteus medius muscle for the duration of the treatent. 15
Control Group Active release technique 2 times a week 5-8 mins Active release technique will be done by positioning the patient in lateral recumbent position with the affected side up - if treating the left gluteus medius, the patient will lie on their right side. The therapist the places a thumb contact on the identified active gluteus medius trigger point, applying a firm pressure from superior to inferior. The patient then actively flexes their thigh at the hip joint from neutral to full flexion, and ten back to neutral again while the therapist continues to apply pressure to the trigger point 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age 18 to 40 (participants over 18 years can give their own informed consent and up to 40 years to avoid early stage of degeneration). • Any gender. • Identified active gluteus medius trigger points. • Have a initial pain score of at leat 3/10 on the Visual Analogue Scale (VAS) • Any contra-indications to extracorporeal radial shockwave • Any contra-indictions to Active release technique • Patients that have taken part in any other treatment for lower back pain such as Chiropractic, Physiotherapy, Biokinetics treatment etc. • Patients that have taken any analgesic, muscle relaxants or non-steroidal anti-inflammatory drugs that could interfere with this study. • BMI of 30 or more (obese patient may have excessive adipose tissue over gluteus medius and could interfere with treatment as extracorporeal radial shockwave can only penetrates 3.9 cm.) • Patient presenting with a serious spinal or pathological disorder. Adult: 19 Year-44 Year 18 Year(s) 40 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 30/04/2020 University of johannesburg Health Science Ethic Comittee
Ethics Committee Address
Street address City Postal code Country
55 Beit st Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The aim of this study is to explore the comparative effectiveness of extracorporeal radial shockwave therapy and active release technique on active gluteus medius trigger points. 1st, 4th and 7th consultation
Secondary Outcome To establish a superior method of treating active gluteus medius triggerpoints. 1st, 4th and 7th consultation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Chiropractic clinic 55 Beit st Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg Health Science ethics comittee 55 Beit st Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Health Science ethics comittee 55 Beit st Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr. DM Landman 55 Beit st Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Irmarie Landman dmlandman@gmail.com +27844550303 55 Beit st
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa supervisor
Role Name Email Phone Street address
Principal Investigator Ruben Erasmus rubenera996@gmail.com +27833573853 35 Stafford
City Postal code Country Position/Affiliation
Johannesburg 2092 South Africa Researcher
Role Name Email Phone Street address
Public Enquiries Chris Yelverton chrisy@uj.ac.za +27114255161 55 Beit st
City Postal code Country Position/Affiliation
johannesburg 2028 South Africa HOD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data capturing sheet Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years Anyone can request it, but it must be requested from the Head of Department.
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