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.: PACTR202006794610830 Date of Registration: 09/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Muscle Energy Technique versus Static Stretch on Forward Head Posture in Mechanical Neck Pain
Official scientific title Muscle Energy Technique versus Static Stretch on Craniovertebral Angle, Visual Analogue Scale, Neck Disability Index, Cervical Range of Motion in Forward Head Posture
Brief summary describing the background and objectives of the trial Neck pain is one of the most common musculoskeletal disorders in the general population. Neck pain was correlated to forward head posture.A variety of therapeutic exercises designed to mitigate the symptoms of FHP have been examined. The majority suggests that weakened postural muscles should be strengthened and shortened muscles should be lengthened.Muscle Energy Technique (MET) is effective for lengthening of shortened or contractured muscle, strengthening of muscles, increase the range of motion. MET was used to correct FHP in patients with chronic neck pain. Resting head posture in sitting (a method to assess FHP) was improved in the group receiving MET in addition to deep cervical flexors exercise (Sakshi et al., 2014). Neglecting muscles that are more involved in FHP (e.g. scalene, levator scapulae and sternocledomastoid) is a shortening in that study as MET was applied only to suboccipitalis, upper trapezius and pectoralis major. Also MET was compared to exercise of deep flexor muscles only, neglecting the effect of stretching exercise in restoring ROM and normalizing the postural deficits.So the effect of MET on FHP correction needs further investigation. The current study will be conducted to investigate the effect of MET on FHP, pain, disability and cervical ROM and the effect of static stretch on FHP, pain, disability and cervical ROM and to compare the effects of both techniques.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FHP MET
Disease(s) or condition(s) being studied mechanical neck pain, forward head posture
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 17/12/2018
Actual trial start date 17/01/2019
Anticipated date of last follow up 04/06/2020
Actual Last follow-up date 04/06/2020
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status 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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group muscle energy technique, hot packs, postural education 3 times per week 4 weeks MET for upper trapezius, levator scapulae, suboccipitalis, scalene, sternocleidomastiod and pectoralis major muscles. 15 Active-Treatment of Control Group
Experimental Group stretching and strengthening exercise, hot packs and postural education. 3 times per week 4 weeks stretching exercise for upper trapezius, levator scapulae, suboccipitalis, scalene, sternocleidomastiod and pectoralis major muscles and strengthening exercises for deep cervical flexor and scapular retractor muscles. 15
Control Group hot packs, postural education 3 times per week 4 weeks Hot packs applied to the neck for 15 min 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants of both genders aged 18 to 50 years old. The participants are subacute or chronic mechanical neck pain. craniovertebral angle of < 49. signs of serious pathology (e.g., malignancy, inflammatory disorder, infection) history of cervical spine surgery history of trauma or fractures in cervical spine signs of cervical radiculopathy or myelopathy spondylotic changes vascular syndromes such as basilar insufficiency Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 06/05/2018 ethical commitee of faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmed el- zayat street giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome craniovertebral angle baseline after treatment 4 weeks follow up
Secondary Outcome visual analogue scale baseline after treatment 4 weeks follow up
Secondary Outcome neck disability index baseline after treatment 4 weeks follow up
Secondary Outcome cervical range of motion baseline after treatment 4 weeks follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out-patient clinic, faculty of physical therapy ahmed el-zayat street dokki, Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof Maher Elkeblawy 7th alzayyat street giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy 7 ahmed elzayyat dokki, Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
haidy samir roshdy 7 ahmed elzayyat dokki, Giza Egypt
soheir samaan 7 ahmed elzayyat dokki, Giza Egypt
Maher el-Keblawy 7 ahmed elzayyat dokki, Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator maher elkeblawy maher_ma2014@yahoo.com 01149609702 7 ahmed elzayat
City Postal code Country Position/Affiliation
dokki, Giza Egypt profeesor
Role Name Email Phone Street address
Public Enquiries soheir samaan Soheirsamaan@yahoo.com 01149609702 7 ahmed elzayat
City Postal code Country Position/Affiliation
dokki, Giza Egypt assisstant professor
Role Name Email Phone Street address
Scientific Enquiries soheir samaan Soheirsamaan@yahoo.com 01149609702 7 ahmed elzayat
City Postal code Country Position/Affiliation
dokki, Giza Egypt assisstant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of 1-craniovertebral angle 2-pain intensity 3- neck function 4- a cervical range of motion Study Protocol after one year the criteria will be accessed by the publication of the trial in the international journal
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