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.: PACTR201907782710996 Date of Approval: 11/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Combined Effects of Two Manual Therapy Techniques than the Individual Techniques alone in the Management of Lumbar Radiculopathy: A Randomized Controlled Trial
Official scientific title Combined Effects of Two Manual Therapy Techniques than the individual techniques alone in the Management of Lumbar Radiculopathy: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial LDHR has been managed using many treatment strategies including surgery, conservative care, and a combination of many therapies. In spite of the growing conservative treatment techniques, there are quite a large number of patients with disc herniation opting for surgery either due to lack of effective relief or due to risks of developing chronicity. However, while the surgical care is standardized, the non-surgical care is yet to be standardized [9]. In light of this, we conducted a study that aimed at providing more therapeutic options to ameliorate LDHR in which we hypothesized that a combination of PINS and SMWLM may yield better results than the individual techniques alone. In this current study we aimed at testing the proposed hypothesis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CMTT
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 15/07/2019
Actual trial start date 15/07/2019
Anticipated date of last follow up 10/08/2020
Actual Last follow-up date 10/08/2020
Anticipated target sample size (number of participants) 61
Actual target sample size (number of participants) 61
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 PINS 3 TIMES IN A WEEK 12 WEEKS This group will receive PROGRESSIVE INHIBITION OF NEUROMUSCULAR STRUCTURES (PINS) 20
Experimental Group SMWLM 3 TIMES IN A WEEK 12 WEEKS SPINAL MOBILIZATION WITH LEG MOVEMENT (SMWLM) 20
Control Group PINS plus SMWLM 3 TIMES IN A WEEK 12 WEEKS COMBINED PROGRESSIVE INHIBITION OF NEUROMUSCULAR STRUCTURES (PINS) AND SPINAL MOBILIZATION WITH LEG MOVEMENT (SMWLM) 21 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants with back and leg pains who were diagnosed with sub-acute LDHR will be included in the study. Sub-acute individuals will be selected because of the belief that acute LDHR may resolve spontaneously within few weeks of onset. The criteria for inclusion will be; patients with age range of 25-55 years having unilateral radiculopathy and pain in distribution of sciatic nerve. Pain will be accepted as evidence of L5 root compression when distributed to anterolateral aspect of calf and to dorsum of foot and as evidence to S1 root compression when distributed to posterior aspect of calf extending to the heel and lateral aspect of the foot. If pain did not extend below the ankle, at least one additional neurological sign will be demanded for the patient to be included. These signs are; painful passive knee flexion, weakness of resisted hip flexion and resisted knee extension and absence or sluggishness of knee jerk reflex for L2/L3 nerve roots, hypoesthesia in the dorsum of the foot, weakness of dorsiflexion of foot or first toe and impaired medial hamstring reflex for the L4/L5 nerve roots, hypoesthesia at the lateral aspect of the foot, weakness of the plantar flexion of the foot or first toe, impaired Achilles tendon reflex and painless weakness on resisted eversion for the L5/S1 verve roots, gluteal mass wasting and weakness on tip toeing on the affected leg for the S1/S2 verve roots. The exclusion criteria will be; subjects diagnosed with dementia or other cognitive impairment, subjects diagnosed with claudication, inflammatory or other specific disorders of spine such as ankylosing spondylitis, vertebral collapse, rheumatoid arthritis, stenosis, spondylolisthesis, osteoporosis, previous spinal surgery, a known pregnancy, bilateral radiculopathy, and presence of red flags (History of significant trauma, cancer, constitutional symptoms; fever, malaise, weight loss, recent infection, bladder and/or bowel dysfunction). 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 25/03/2019 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 IN THE BACK AND LEG AT BASELINE AND AFTER 6 WEEKS, AND AFTER 12 WEEKS, AT 6, 9, AND 12 MONTHS FOLLOW-UP
Secondary Outcome DISABILITY and SCIATICA BOTHERSOMENESS AT BASELINE AND AFTER 6 WEEKS, AND AFTER 12 WEEKS, AT 6, 9, AND 12 MONTHS FOLLOW-UP
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
Primary Sponsor MUSA SANI DANAZUMI MACHINA ROAD NGURU 630101 Nigeria Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
BASHIR KAKA MACHINA ROAD NGURU 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries YAKASAI ABDUSSALAM abdulpeace1@gmail.com +8037019137 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria MEDICAL REHABILITATION THERAPIST BOARD OF NIGERIA
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 BAYERO UNIVERSITY KANO
Role Name Email Phone Street address
Scientific Enquiries BASHIR BELLO abumuhibbat17@gmail.com +2348035537101 MACHINA ROAD, FMC NGURU
City Postal code Country Position/Affiliation
NGURU 630101 Nigeria BAYERO UNIVERSITY KANO
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants' pain levels, disability levels, sciatica frequency and bothersomeness Informed Consent Form,Statistical Analysis Plan,Study Protocol NOVEMBER, 2019 PUBLICATION
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://journals.lww.com/ajpmr/Abstract/9000/A_Comparison_between_the_Effect_of_Combined_Chain.97759.aspx 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