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.: PACTR201811844846658 Date of Approval: 08/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Combined Effect of Extracorporeal Shockwave Therapy and Integrated Neuromuscular Inhibition Technique on Myofascial Trigger Points of Upper Trapezius
Official scientific title The Combined Effect of Extracorporeal Shockwave Therapy and Integrated Neuromuscular Inhibition Technique on Myofascial Trigger Points of Upper Trapezius
Brief summary describing the background and objectives of the trial The upper trapezius (UT) muscle runs between the cervical and thoracic spines and upper medial border of the scapula. The UT has an important role in optimizing scapular elevation and upward rotation control during shoulder abduction. However, overuse of the UT muscle during shoulder movements can interfere with scapular alignment and the movement pattern can lead to specific errors in choosing an appropriate movement strategy. Myofascial trigger points (MTrPs) are the main sources of musculoskeletal pain in about 30-85% of patients, and these knots have detrimental effects on patient's social activities and quality of life. The extracorporeal shock wave therapy (ESWT) is a non-invasive treatment which has recently come into use for musculoskeletal disorders. In patients with non-specific neck pain (NS-NP) integrated neuromuscular inhibition technique to the treatment of MTrPs has proven to be more beneficial in relieving pain, reducing stiffness, and improving functional ability. So the purpose of the study is to measure the combined effect of extracorporeal shockwave therapy and integrated neuromuscular inhibition technique on myofascial trigger points of upper trapezius. A pilot study will be conducted to calculate sample size. The subjects of both genders with age ranging from 18 to 30 will be allocated randomly into three equal groups A,B and C. Outcome measures will include: Pressure Pain Threshold(PPT)will be measured by electronic algometer, Pain intensity will be measured by Visual analogue scale(VAS), Sympathetic skin response(SSR) and Neuromuscular junction response(NMJR) will be measured by electromyography instrument. The assessment will be done before and after treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UT MTrPs ESWT INIT NSNP PPT VAS SSR NMJR
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2018
Actual trial start date
Anticipated date of last follow up 01/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A One session per week four weeks will receive ESWT on upper trapezius 20 Active-Treatment of Control Group
Control Group Group B three sessions per week four weeks will receive INIT on upper trapezius 20 Active-Treatment of Control Group
Experimental Group Group C three sessions per week four weeks will receive ESWT and INIT on upper trapezius 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age range of 18-30 years. 2. Male and female 3. Subjects have pain at least 3 on VAS and 2.5kg/cm2 on algometer 4. Presence of palpable taut band in the skeletal muscle. 5. Presence of a hypersensitive tender spot in the taut band. 6. Local twitch response provoked by the snapping palpation of the taut band. 7. Reproduction of the typical referred pain pattern of the MTrPs in response to compression. 8. Spontaneous presence of the typical referred pain pattern and/ or the patient's recognition of the referred pain as familiar. 9. Trigger point 1, 2 will be examined if both trigger points will be involved, the most tender trigger point will be used. If the subject has a bilateral neck pain, both upper trapezius muscles will be treated 1. History of neck or shoulder surgery, 2. moderate to severe cervical, thoracic and shoulder degenerative pathology, 3. History of neck or shoulder trauma, 4. Systemic disorder, 5. Spinal deformities, 6. Cervical radiculopathy, 7. And fibromyalgia syndrome Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 30 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 04/11/2018 Faculty of Physical Therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El- Zayat Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain pressure threshold pre and post treatment
Primary Outcome Pain intensity pre and post treatment
Secondary Outcome Sympathetic skin response pre and post treatment
Secondary Outcome Neuromuscular junction response pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Beni Suef university East Nile New Beni Suef 62517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dina Al Amir Birum El Tonsy New Beni Suef 62517 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo university 7 Ahmed El- Zayat Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina Al Amir dinaalamir@yahoo.com 01229370053 Birum El Tonsy
City Postal code Country Position/Affiliation
New Beni Suef 62517 Egypt Assistant lecturer at faculty of physical therapy Beni Suef University
Role Name Email Phone Street address
Public Enquiries Ragia Mohamed ragiamohamed@yahoo.com 01222404923 7 Ahmed El- Zayat
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Yasser Aneis yasseraneis@pt.cu.edu 01011228823 7 Ahmed El- Zayat
City Postal code Country Position/Affiliation
Giza 12613 Egypt Assistant Professor of Basic Science Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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