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.: PACTR201810520651000 Date of Registration: 09/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Progressive Inhibition of Neuromuscular Structures Compared with Spinal Mobilization with Leg Movement in Individuals with Lumbar Radiculopathy
Official scientific title Effects of Progressive Inhibition of Neuromuscular Structures Compared with Spinal Mobilization with Leg Movement in Individuals with Lumbar Radiculopathy
Brief summary describing the background and objectives of the trial The management for Lumbar disk herniation with radiculopathy (LDHR) have recently shifted from surgery to conservative management. However, lumbar surgery is definitive in which micro discectomy is used, there is still no definitive conservative management for LDHR. For this purpose, this study is designed to compare a technique that ameliorates radicular symptoms with a technique that relieves nerve compression.
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 To provide additional means of conservative mangement of LDHR.
Anticipated trial start date 09/10/2018
Actual trial start date 09/10/2018
Anticipated date of last follow up 04/12/2018
Actual Last follow-up date 04/12/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL https://doi.org/10.1016/j.jcm.2019.10.006
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 PINS GROUP Two times in a week 8 weeks progressive deactivation of MTrPs along Sciatic nerve continuum 20
Control Group SMWLM GROUP 2 TIMES IN A WEEK 8 WEEKS SPINAL MOBILISATION COUPLED WITH STRAIGHT LEG RAISING 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. patients with lumbar disk herniation with radiculopathy 2. Patients of age range 18-65 years 3. Patients with unilateral radiculopathy 1. Patients without radiculopathy 2. Patients with back surgery 3. patients with psychological problems Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 06/06/2018 FEDERAL MEDICAL CENTER NGURU
Ethics Committee Address
Street address City Postal code Country
MACHINA ROAD Yobe State 630101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, disability, sciatica and quality of life Baseline, after 4 weeks and after 8 weeks
Secondary Outcome GENERAL PERCEPTION OF CARE AT BASELINE, AT 4 WEEKS AND AT 8 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTER NGURU YOBE STATE MACHINA ROAD YOBE STATE 630101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FEDERAL MEDICAL CENTER NGURU MACHINA ROAD YOBE 630101 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Mubarak Abubakar Falke Machina road, Nguru town Yobe 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MUSA SANI DANAZUMI musadanazumisani@mail.com +2348145123496 Machina road, Nguru town
City Postal code Country Position/Affiliation
Yobe 630101 Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries SHEHU USMAN IBRAHIM usmanik28@gmail.com +2347030433882 Machina road, Nguru town
City Postal code Country Position/Affiliation
Yobe 630101 Nigeria Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries BASHIR BELLO nurubash@gmail.com +2348037019137 Machina road, Nguru town
City Postal code Country Position/Affiliation
Yobe 630101 Nigeria Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Published Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Published Published
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://doi.org/10.1016/j.jcm.2019.10.006 Yes 02/12/2020 25/12/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/12/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://doi.org/10.1016/j.jcm.2019.10.006
Changes to trial information