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.: PACTR201911583499287 Date of Approval: 04/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Integrated Neuromuscular Inhibition Technique Compared with Positional Release Technique in the Management of Piriformis Syndrome: A Randomized Clinical Trial
Official scientific title Effects of Integrated Neuromuscular Inhibition Technique Compared with Positional Release Technique in the Management of Piriformis Syndrome: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Positional Release Technique (PRT) has been investigated as one of the effective manual therapy techniques for the management of piriformis syndrome [Ali et al., 2015]. This technique involves the identification of active Trigger Points (TrPs), followed by the application of ischemic compression (pressure) to produce a nociceptive response. The limb is then positioned in such a manner as to reduce the tension in the affected muscle and subsequently the painful TrP. When the position of ease reduction is attained, the stressed tissues are felt to be at their most relaxed position and a local reduction of tone is achieved.12 Chaitow (1996) described in a technique called integrated neuromuscular inhibition (INIT), that the combination of muscle energy technique (MET), and ischemic compression (PRT) may produce the most effective approach to trigger point management [19]. He also proposed that the benefit of the technique lies in its multifaceted approach which allows for the delivery of the techniques in a single coordinated manner. Although randomized clinical trials exist studying the effects of MET [Bose and Dusad, 2018] and PRT [Ali et al., 2015] in piriformis syndrome, there is lack of evidence regarding the integration of these techniques in individuals with this type of disorder. For this reason, additional research examining the effects of this technique is needed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INIT COMPARED WITH PRT
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 11/11/2019
Actual trial start date 11/11/2019
Anticipated date of last follow up 12/10/2020
Actual Last follow-up date 12/10/2020
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Integrated Neuromuscular Inhibition Technique 2 TIMES IN A WEEK FOR 8 WEEKS This group will receive Integrated Neuromuscular Inhibition Technique 24
Control Group Positional Release Technique 2 TIMES IN A WEEK FOR 8 WEEKS This group will receive Positional Release Technique 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Participants diagnosed with piriformis syndrome of any duration, 2) Age of 19 years and above 3) Who provide informed consent 1) Participants diagnosed with any condition, not piriformis syndrome, 2) Under 18 years of age 3) Who did not provide informed consent Adult: 19 Year-44 Year 19 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
Yes 07/03/2019 FEDERAL MEDICAL CENTER NGURU YOBE STATE NIGERIA
Ethics Committee Address
Street address City Postal code Country
MACHINA ROAD Nguru 630101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome PAIN, SCIATICA, FUNCTIONAL MOBILITY, QUALITY OF LIFE AT BASELINE AND AFTER 8 WEEKS
Secondary Outcome HIP ABDUCTION AND INTERNAL ROTATION AT BASELINE AND AFTER 8 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTER NGURU MACHINA ROAD NGURU 630101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MUSA SANI DANAZUMI MACHINA ROAD, FEDERAL MEDICAL CENTER, NGURU, YOBE STATE, NIGERIA NGURU 630101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor MUSA SANI DANAZUMI MACHINA ROAD NGURU 630101 Nigeria SELF SPONSORSHIP
COLLABORATORS
Name Street address City Postal code Country
SHEHU USMAN IBRAHIM MACHINA ROAD NGURU 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MUSA SANI DANAZUMI musadanazumisani@gmail.com +8145123496 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria ORTHOPEDIC AND SPORTS PHYSIOTHERAPIST
Role Name Email Phone Street address
Public Enquiries SHEHU USMAN IBRAHIM umanik28@gmail.com +8035307341 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria ORTHOPEDIC AND SPORTS PHYSIOTHERAPIST
Role Name Email Phone Street address
Scientific Enquiries ABDULSALAM MOHAMMED YAKASAI abdulpeace1@gmail.com +8037019137 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria NEUROPHYSIOTHERAPIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes RAW DATA IN A SPREAD SHEET Informed Consent Form,Statistical Analysis Plan,Study Protocol AFTER COMPLETION OF THE STUDY THROUGH PUBLICATION LINK
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.degruyter.com/document/doi/10.1515/jom-2020-0327/html 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