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.: PACTR201910917924976 Date of Approval: 11/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Chiropractic Manipulation and Ankle Flossing on Ankle Range of Motion in Patients with Chronic Ankle Inversion Injury.
Official scientific title The Effect of Chiropractic Manipulation and Ankle Flossing on Ankle Rage of Motion in Patients with Chronic Ankle Inversion Injury.
Brief summary describing the background and objectives of the trial Joint Flossing is an increasingly popular mobilisation technique that results in partial vascular occlusion and tissue compression, allowing re-perfusion of blood to the tissue. Limited research regarding the effectiveness of floss bands exists, with a lack of evidence regarding the comparison of joint flossing to chiropractic manipulative therapy or the effect achieved when these two techniques are used in combination. The aim of this study is to compare the effect of chiropractic manipulation of the ankle and ankle joint flossing on ankle range of motion in patients with a chronic ankle inversion injury.
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 15/01/2020
Actual trial start date
Anticipated date of last follow up 05/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chiropractic manipulation of the ankle joint Mortise separation manipulation A total of seven consultations will be required. One chiropractic ankle manipulation in the form of a mortise separation manipulation will be administered on the first to sixth consultation. Ankle dorsiflexion and plantar flexion range of motion measurements will be recorded on the first, fourth and seventh consultations. A total of seven consultations will be required over a three week period. One chiropractic ankle manipulation in the form of a mortise separation manipulation will be administered on the first to sixth consultations. Ankle dorsiflexion and plantar flexion range of motion measurements will be recorded on the first, fourth and seventh consultation. Chiropractic manipulation of the ankle through the use of a mortise separation manipulation. The patient lies supine, the patient's ankle is dorsiflexed,internally rotated and everted, a caudal thrust is then applied. 10
Experimental Group Ankle Joint Flossing The patient will receive a total of seven consultations. The patient will receive ankle joint flossing for two minutes on the first to sixth consultations. Ankle dorsiflexion and plantar flexion range of motion measurements will be recorded on the first, fourth and seventh consultations. The patient will receive a total of seven consultations over a three week period. The patient will receive ankle joint flossing for two minutes on the first to sixth consultations. Ankle dorsiflexion and plantar flexion range of motion measurements will be recorded on the first, fourth and seventh consultations. Ankle joint flossing, a floss band is applied to the ankle in a figure 8, beginning at the lateral malleolus, continue to wrap around the Achilles tendon, then towards the distal head of the 5th metatarsal, around the plantar aspect of the foot and back to the lateral malleolus. The patient then dosiflexes and plantar flexes the ankle for twenty repetitions over two minutes. 10
Control Group Chiropractic manipulation of the ankle and ankle joint flossing The patient will be required to have a total of seven consultations. Chiropractic ankle manipulation and ankle joint flossing for two minutes will be administered at the first to sixth consultation. Dorsiflexion and Plantar flexion range of motion will be tested on the first, fourth and seventh consultation. The patient will be required to have a total of seven consultations over a three week period. The patient will receive a chiropractic ankle manipulation and ankle joint flossing for two minutes during the first six consultations. Dorsiflexion and Plantar flexion range of motion will be tested on the first, fourth and seventh consultations. Chiropractic manipulation through the use of a mortise separation manipulation, the patient lies supine, the ankle is dorsiflexed, internally rotated and everted and a caudal thrust is applied. Ankle joint flossing, a floss band is applied to the ankle in a figure 8, beginning at the lateral malleolus, continue to wrap around the Achilles tendon, then towards the distal head of the 5th metatarsal, around the plantar aspect of the foot and back to the lateral malleolus. The patient then dosiflexes and plantar flexes the ankle for twenty repetitions over two minutes. 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male and female participants between the age of 18 and 45 years. The presence of chronic ankle inversion injury. Participants with any contraindications to manipulative therapy. Participants with any contraindications to tissue flossing. Participants with any lower limb injuries, other than chronic ankle inversion injury, that would affect lower limb range of motion. Participants that have had any previous major injury or trauma, other than chronic ankle inversion injury, that would affect lower limb range of motion. Participants participating in any other research study involving the ankle. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 19/09/2019 University of Johannesburg Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Sherwell street between Saratoga and Beit Street Johannesburg 2006 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome An increase in ankle range of motion - plantarflexion and dorsiflexion, measured through the use of a handheld manual goniometer. An average of three measurements will be recorded. on the first, fourth and seventh consultation
Secondary Outcome Increased ankle dosiflexion measured through the use of a weight bearing lunge test on the first, fourth and seventh consultation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Sherwell street between Saratoga and Beit Street. Johannesburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg Sherwell Street between Saratoga and Beit Street Johannesburg South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Sherwell street between Beit street and Saratoga street Johannesburg South Africa University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashleigh McCallum ashleighmccallum1@gmail.com +27729810611 Sherwell street between Beit street and Saratoga street
City Postal code Country Position/Affiliation
Johannesburg South Africa Student
Role Name Email Phone Street address
Public Enquiries Ashleigh McCallum ashleighmccallum1@gmail.com +27729810611 Sherwell street between Beit street and Saratoga street
City Postal code Country Position/Affiliation
Johannesburg South Africa Student
Role Name Email Phone Street address
Scientific Enquiries Ashleigh McCallum ashleighmccallum1@gmail.com +27729810611 Sherwell street between Beit street and Saratoga street
City Postal code Country Position/Affiliation
Johannesburg South Africa Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Analytic Code,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Anyone who wishes to access the data, for any purpose, will have access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be confirmed Yes 21/08/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information