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.: PACTR202108743278313 Date of Approval: 25/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long-term Effects of Integrated Neuromuscular Inhibition Technique Compared with Positional Release Technique Or Therapeutic Exercises for Individuals with Piriformis Syndrome: A Randomized Controlled Trial
Official scientific title Long-term Effects of Integrated Neuromuscular Inhibition Technique Compared with Positional Release Technique Or Stretching Exercises for Individuals with Piriformis Syndrome: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial A previous study has indicated that Integrated Neuromuscular Inhibition Technique (INIT) and Positional Release Technique (PRT) are effective in the management of Piriformis Syndrome, however, that study reported data for intermediate-term follow-up and no control group was used to determine the effects of the techniques in isolation. For this reason, this study would like to examine the Long-term Effects of the Integrated Neuromuscular Inhibition Technique Compared with the Positional Release Technique Or Stretching Exercises for Individuals with Piriformis Syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) INIT compared with PRT or SEs
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 06/09/2021
Actual trial start date 06/09/2021
Anticipated date of last follow up 06/09/2022
Actual Last follow-up date 06/09/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
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 INIT twice a week for 8 weeks Integrated Neuromuscular Inhibition Technique 20
Experimental Group PRT twice a week for 8 weeks Positional Release Technique 20
Control Group SEs twice a week for 8 weeks Stretching Exercises 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male and female participants aged 19 years and older with leg or buttock pain diagnosed as having a chronic (3 months or longer) PS without any spinal pathology or involvement will be eligible for enrollment in the study. The diagnostic criteria included: (1) unilateral buttock pain and radiculopathy due to spasms of the piriformis muscle or sciatic nerve compression; (2) buttock pain aggravated when sitting; (3) external tenderness near the greater sciatic notch and pain with any maneuver (e.g., pain with passive internal rotation of the hip [Freiberg sign]; provocation of sciatic symptoms by lifting and holding the affected leg 4 inches off the table when the participant lies on the unaffected leg (Beatty test); and reproduction of sciatic symptoms using a flexion, adduction, and internal rotation (FAIR) test performed with the patient in a lateral recumbent position with the affected side up, the hip flexed to an angle of 60°, the knee flexed to an angle of 60°–90° while stabilizing the hip, and the examiner internally rotating and adducting the hip by applying downward pressure to the knee) that increased piriformis muscle tension; and (4) limited straight leg raising ability. Participants with the following will be excluded: (1) psychiatric conditions that would have made it difficult to provide consent, as assessed by one author (M.S.D.) using Mini-Mental State Examinations; (2) any pathology or recent injury around the hip, sacroiliac joint, or lumbar spine; (3) limb length discrepancy; (4) recent buttock trauma and bladder/bowel dysfunction; or (5) deep gluteal syndrome (entrapment of sciatic nerve in the deep gluteal space) or extrapelvic compression of the sciatic nerve or sacral plexus including sciatic neuritis due to gamelli-obturator internus syndrome, compression of the pudendal nerves or increased mechanical stress on the innominate bones, compression of the fibular branch of the sciatic nerve, ischiogluteal/ischiofemoral bursitis or impingement, upper hamstrings tendinitis, or referred pain from gastrointestinal or pelvic causes (including colon cancer, endometriosis, and interstitial cystitis). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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
No 23/08/2021 Federal Medical Centre Nguru
Ethics Committee Address
Street address City Postal code Country
02 Machina Road Nguru 630101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, Functional mobility, Sciatica bothersomeness AT BASELINE, 8 weeks OF INTERVENTION, 6 and 12 MONTHS OF FOLLOW-UP
Secondary Outcome Quality of life, Hip abduction, Hip internal rotation AT BASELINE, 8 weeks OF INTERVENTION, 6 and 12 MONTHS OF FOLLOW-UP
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Nguru 02 Machina Road Nguru 630101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Musa Sani Danazumi 02 Machina Road Nguru 630101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Musa Sani Danazumi 02 Machina Road Nguru 630101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Abdulsalam Mohammed Yakasai 02 Machina Road Nguru 630101 Nigeria
Shehu Usman Ibrahim 02 Machina Road Nguru 630101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Musa Sani Danazumi musadanazumisani@gmail.com +23409028439699 02 machina Road
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries Shehu Usman Ibrahim usmanik28@gmail.com +23409028439699 02 machina Road
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Abdulsalam Mohammed Yakasai abdulpeace1@gmail.com +23409028439699 02 machina Road
City Postal code Country Position/Affiliation
Nguru 630101 Nigeria Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial, after deidentification including data that underlie the results (text, tables, figures, and appendices) will be reported in this study. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol September 2023 Publication
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