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.: PACTR202010523136337 Date of Approval: 12/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of trigger point therapy versus active release technique on females with piriformis syndrome
Official scientific title Effect of trigger point therapy versus active release technique on females with piriformis syndrome
Brief summary describing the background and objectives of the trial To compare between the effect of trigger point therapy and active release technique on pain ,ROM &lower extremity function on females with piriformis syndrome
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/10/2020
Actual trial start date 01/11/2020
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date 28/03/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 45
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
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 Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Active release technique Two times per week Six weeks Active release technique The trigger points are, thereafter, released using active release technique on the piriformis muscle and other muscles around the area having palpable trigger points in them. While the piriformis muscle in contracted state, the clinician then applied pressure on it, and the muscle will then stretched passively into extended state by the clinician. Subsequently, a short session of stretching exercises with a hold of five seconds and five repetitions each is conducted, followed by a short session of free-range exercises with three sets of 10 repetitions each. Afterward, a cold pack is placed on the treatment area for 15 minutes. The ART group will receive treatment twice per week for 20 minutes for 6 months. ( Kameda & Tanimae.,2019). 10 Active-Treatment of Control Group
Control Group Trigger point therapy Two times per week Six weeks Trigger point therapy: The therapist applies gentle, gradually increasing pressure on the MTrP until the finger encountered a definite increase in tissue resistance. At that point, the patient commonly would feel a certain degree of discomfort. The pressure was maintained until the therapist sensed relief of tension under the palpating finger or the patient experienced a considerable decline in pain. At that point, the therapist could repeat this procedure several times until pressure on the MTrP would provoke only a little discomfort without pain. This technique was combined with other manual techniques, such as deep stroking or strumming .The effectiveness of muscle-stretching exercises was enhanced by including short isometric contractions and relaxation (hold-relax). Patients were instructed to perform simple gentle static stretching and relaxation exercises at home several times during the day. All patients received ergonomic advice and instructions to assume and maintain good posture. . The duration of treatment will be 40 to 50 minutes to generate sweating twice per week for 6 months. For treatment to be effective, the specific trigger points or contracted portion of the muscle must be released. (Jayasingh & Thomson., 2017). 10 Active-Treatment of Control Group
Experimental Group Conventional physical therapy Two times per week 6 weeks Stretching to piriformis 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- The patients are females with age ranged from 30 to 45 years. (Jayasingh & Thomson., 2017). 2- The patients have a gluteal pain and a positive tests of pace abduction test and freiburg’s test. (Chavadi&Tamilnadu., 2019). 3- Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation.(Chavadi&Tamilnadu., 2019). 1) SLR tests negative. (2) Osteoporosis. (3) Spondylolisthesis. (4) history of vertebral fracture and spinal surgery. (5) systemic disorder. (6) stroke leprosy. (7) amputation . Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 45 Year(s) Female
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 10/09/2020 ethics committee of faculty of physical therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, dokki, giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome 3-goniometer to measure hip internal rotation After 6weeks of intervention
Primary Outcome Pain measure by VAS and function by lower extremity function scale 6weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Damietta specialized hospital El asar Damietta 34711 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aya ashraf zaghlol 91st Ras elbar damieeta 34737 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Damietta specialized hospital El harbe Damietta 34512 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr mariam omran grase Lebanon Cairo 11311 Egypt
Wadida Hassan El Sayed Cairo,Egypt Cairo 11311 Egypt
Ahmed hamdi azzam El manil Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aya Zaghlol Ayapt909@gmail.com 01001936082 93
City Postal code Country Position/Affiliation
Ras el bar 34737 Egypt Physical therapist
Role Name Email Phone Street address
Public Enquiries Aya Zaghlol Ayapt909@gmail.com 01001936092 Ras el bar st 93 nom22
City Postal code Country Position/Affiliation
Damietta 34511 Egypt Physical therapist
Role Name Email Phone Street address
Scientific Enquiries Wadida Hassan Dr.wadida.hassan@gmail.com +201001097571 Cairo egypt
City Postal code Country Position/Affiliation
Cairo 11511 Egypt Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes individual data will be available All of the individual data will be available after deidentification Statistical Analysis Plan,Study Protocol Data will be available available immediately after puplication no end date Any one who wishes to access data for any purpose
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