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.: PACTR202007913630105 Date of Approval: 22/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Visceral manipulation on Non-specific neck dysfunction after dyspepsia
Official scientific title Effect of Visceral manipulation on Non-specific neck dysfunction after dyspepsia
Brief summary describing the background and objectives of the trial Most uncomplicated neck pain is insidiously and is generally multifactorial in origin associated with poor posture, anxiety, depression, neck strain, occupational activities, sporting injuries. Limited range of motion and a subjective feeling of stiffness may accompany with neck pain. Many patients with Non-specific neck dysfunction complain of gastrointestinal symptoms. Some are caused by NSAIDs, but many patients are not taking any medication. There is a direct or indirect relationship between the neck and the stomach, called the neck-stomach syndrome. Perhaps the clinical symptoms of neck pain include gastrointestinal disorders mediated through irritated sympathetic nerves objectives:1. To investigate the effect of using Visceral manipulation on pain, cervical range of motion and functional activities in patients with Non-specific neck dysfunction after dyspepsia. 2. To investigate the effect of adding Visceral manipulation to conventional physical therapy on pain, cervical range of motion and functional activities in patients with Non-specific neck dysfunction after dyspepsia 3. To compare the effect of using Visceral manipulation and conventional physical therapy on pain, cervical range of motion and functional activities inpatients with Non-specific neck dysfunction after dyspepsia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 15/08/2020
Actual trial start date
Anticipated date of last follow up 01/02/2021
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group visceral manipulation and conventional physical therapy program 3 times weekly 3 months visceral manipulation techniques and conventional physical therapy program(Hot backs, stretching and active strengthening exercises: Neck stabilizing exercises and Dynamic neck exercises). 20 Active-Treatment of Control Group
Experimental Group visceral manipulation techniques 2 times weekly 3 months visceral manipulation techniques 20
Experimental Group conventional physical therapy program 3 times weekly 3 months conventional physical therapy program(, stretching and active strengthening exercises: Neck stabilizing exercises and Dynamic neck exercises). 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Sixty patients with non-specific neck pain after dyspepsia Duration of non-specific neck pain complaining for more than 3 months Body mass index = 20: 25 Kg/m2.. Patients will be selected from referrals from internal medicine physicians. The patients who have signs of an acute infection, inflammation, or signs of serious disease as a tumor, bleeding in part of the body, a thrombosis, a perforated ulcer, enlarged lymph nodes, unexplained weight loss, aneurysm, or a heart condition will be excluded. Structural alterations or cervical abnormalities, history of cervical whip-lash type injury, surgery on the neck, shoulders, chest, or abdomen. Treatment for neck pain two weeks prior to the study. The use of analgesics, muscle relaxants, and psychotropic and anti-inflammatory drugs in the 5 days prior to intervention. Adult: 19 Year-44 Year 18 Year(s) 40 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 09/06/2019 Ethical committee of faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzayat street, Dokki,Giza cairo 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neck range of motion before and after treatment
Secondary Outcome Neck pain before and after treatment
Secondary Outcome Neck Proprioception before and after the treatment period
Secondary Outcome Neck disability index before and after the treatment period
Secondary Outcome cervical spine angle before and after the treatment period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
al olemy el gesh street meet ghamer Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Neveen abdel raoof 7th Ahmed elzayate street, been elsarayat Giza 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 atreet, Dokki, Giza cairo 12611 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Neveen abdel raoof mishmishg@yahoo.com 00201064615553 7 ahmed al zayat street, Dokki, Giza
City Postal code Country Position/Affiliation
Cairo Egypt professor of physical therapy
Role Name Email Phone Street address
Public Enquiries Nabil Abdel Aal nabil.mahmoud@cu.edu.eg 00201200133613 7 ahmed el zayat, dokki, Giza
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Rania Reda mishmishg@yahoo.com 00201273325285 7 ahmed el zayat street, dokki, Giza
City Postal code Country Position/Affiliation
cairo Egypt lecturer of physical therapy faculty
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the results of the study regarding the primary and secondary outcomes after the study completion. Study Protocol One year the criteria will be accessed by the publication of the trail in international journals.
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