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.: PACTR202006473495513 Date of Approval: 04/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The comparative effect of dry needling versus ultrasound therapy in the treatment of active rhomboid trigger points.
Official scientific title The comparative effect of dry needling versus ultrasound therapy in the treatment of active rhomboid trigger points.
Brief summary describing the background and objectives of the trial Myofascial pain affects about 85% of the population and is common presentation of musculoskeletal pain. Ultrasound has been a widely accepted non-invasive therapy for managing musculoskeletal conditions, however the evidence on the effects of ultrasound on myofascial trigger points are still controversial, and due to these conflicting evidences, the effects of ultrasound on pain relief and physical improvement will be evaluated. Dry needling is a modern treatment designed to ease muscular pain. The needles are inserted into trigger points also termed hard or knotted muscles which help to release the knot, relieve muscle pain or spasms. The aim of this study is to explore the comparative effect of dry needling versus ultrasound therapy in the treatment of active rhomboid trigger points.
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 30/03/2020
Actual trial start date
Anticipated date of last follow up 20/04/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound Therapy Twice a week 3 week period Therapeutic ultrasound machine produces sound waves that are transmitted to the affected tissue by a handheld probe using conductive gel. A single treatment is usually 3- 5 minutes depending on the size of the area. A conductive gel is applied over the skin surface to allow better transmission of the ultrasound waves. During the treatment the therapeutic ultrasound probe is slowly moved over the area in small circular motions. Ultrasound has thermal and non-thermal effects that occur concurrently, the thermal effect is created by the oscillation of the molecules, which in-turn creates heat and the non-thermal effects are produced by the creation of acoustic pressure waves, this plays a role in the relief of pain, inflammation, muscular spams, and contributes to accelerated healing in areas where the heat is generated in deep and superficial tissues. 15
Experimental Group Dry Needling Twice a week 3 weeks Dry Needling is a form of treatment in which a fine solid filiform needle is inserted into the myofascial trigger point of the muscles commonly termed a knotted or hard muscle, the needle remains in the skin for a short period of time, inducing intramuscular stimulation, and helps to release the knot and relive any local and referred pain, spams, increases joint range of motion and normalizes the chemical environment of myofascial trigger points 15
Control Group not applicable not applicable not applicable not applicable 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants are either male or female aged between 18-50 years old –reason for a minimum age of 18 so that parental consent is avoided, and participants can sign their own consent forms, and the maximum age of 50 is to avoid degenerative changes that may be present. Participants presenting with active rhomboid trigger point pain Rhomboid Trigger point diagnosis according to the following criteria: Presence of hyperirritable palpable nodule within a taut band of muscle. Spot tenderness over the palpable nodule With a pain referral along the vertebral border of scapula between the scapula and Paraspinal muscles. It may spread upwards to the spinous portion of the scapula and pain patterns resemble that of the levator scapulae muscle but without the neck component and without restriction to neck rotation. Participants with any contraindication to ultrasound therapy obtained on case history and physical examination Participants with any contraindications to dry needling obtained on case history and physical examination Participants receiving any other form of treatment such as physiotherapy, other chiropractic treatment or any medication, such as muscle relaxants, analgesics or anti-inflammatories that will interfere with the study. Adult: 19 Year-44 Year 18 Year(s) 50 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 10/03/2020 University of Johannesburg Health Science Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
55 Beit Street Jonannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Possible outcomes of this study will determine whether dry needling of the rhomboids or ultrasound of the rhomboids is the more effective treatment, or whether the same results are yielded. first, fourth and seventh consultations
Secondary Outcome If same results are yielded as effective treatments, due to the rhomboids being closely situated to the lungs, this will help give alternatives of a different treatment approach for patients who are afraid of needles, or have contraindications to either of the two treatment methods. This may be beneficial to the profession in establishing an effective treatment protocol for trigger points. first, fourth and seventh visit.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Of Johannesburg 55 Beit Street Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University Of Johannesburg Health Science Chiropractic department 55 Beit Street Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Health Science Chiroparctic Department 55 Beit Street Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr M Moodley University of Johannesburg Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Malany Moodley mmoodley@uj.ac.za +27837757997 55 Beit Street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Supervisor
Role Name Email Phone Street address
Principal Investigator Meera Daya mdaya1603@gmail.com +27843651081 84 California Street Crosby
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 +21115596646 55 Beit Street
City Postal code Country Position/Affiliation
Johannesburg South Africa Head of Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data capturing sheet Informed Consent Form 5 years Anyone can request it but must request it from 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