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.: PACTR201910688942182 Date of Approval: 15/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Effect of Passive Release Technique vs Cervical Manipulation in the Treatment of Chronic Mechanical Neck Pain
Official scientific title Comparative Effect of Passive Release Technique vs Cervical Manipulation in the Treatment of Chronic Mechanical Neck Pain
Brief summary describing the background and objectives of the trial Chronic mechanical neck pain can be defined as pain perceived anywhere in the posterior region of the cervical spine which is present for three months or more, arising from structures within the neck such as facet joints or musculature. Chronic mechanical neck pain can negatively affect an individuals’ sleep patterns, occupational or recreational activities of their daily life as well as decrease their overall well-being. The 6-month prevalence of neck pain for the adult population is averaged at 29.8%. Costs to the worker, employer and society associated with work-related neck pain are known to be considerable and are escalating. The objectives of this study is to explore the additive effect of passive release technique of the upper trapezius muscle combined with chiropractic manipulation of the cervical spine and if they are as effective as each other in the treatment for the relief of symptoms caused by chronic mechanical neck pain. Chiropractic manipulation and passive release have been shown to be effective in the treatment of mechanical neck pain but no research has been done comparing the two.
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 Treatment: Other
Anticipated trial start date 04/02/2020
Actual trial start date
Anticipated date of last follow up 01/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Passive release technique 6 treatments. 3 week period Passive release technique, also known as positional release therapy or strain-counterstrain is a form of manual therapy that utilises tender muscle points and positioning of the body and tissues in a position of comfort (POC) that resolves pain and dysfunction. 10
Experimental Group Chiropractic manipulation 6 Treatments 3 week period Chiropractic manipulation can be defined as a low-amplitude, high-velocity thrust in which the normal physiological range of motion of the vertebral segment is surpassed without exceeding the boundaries of anatomic integrity 10
Experimental Group Passive Release and chiropractic manipulation 6 treatments 3 week period Chiropractic manipulation can be defined as a low-amplitude, high-velocity thrust in which the normal physiological range of motion of the vertebral segment is surpassed without exceeding the boundaries of anatomic integrity. Passive release technique, also known as positional release therapy or strain-counterstrain is a form of manual therapy that utilises tender muscle points and positioning of the body and tissues in a position of comfort (POC) that resolves pain and dysfunction. 10
Control Group not applicable not applicable not applicable not applicable 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male or female participants between the ages of 18 and 40 years old to exclude any degenerative diseases that will alter the study results.Present with signs and symptoms of chronic mechanical neck pain including pain perceived anywhere in the posterior region of the cervical spine which is present for three months or more.Presence of an active trigger point in the trapezius muscle, which may cause local or referred pain in the neck.At least one cervical spine anterior rotary restriction with a decreased range of motion of the facet joint determined by using motion palpation. Participants who present with any contra-indications to chiropractic manipulation of the cervical spine and passive release technique as determined by history taking, physical examination and cervical spine regional examination. Participants who present with any pre-existing conditions or a history of trauma to the cervical spine. Participants who are already receiving treatment to the cervical spine or active myofascial trigger points of the trapezius muscle.Participants taking any analgesic or anti-inflammatory medication which will alter the results of the study. 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 12/11/2019 University of Johannesburg Health Science Ethics Committee
Ethics Committee Address
Street address City Postal code Country
55 Beit street Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Possible outcomes to this study could show an additive effect of passive release technique of the upper trapezius muscle with chiropractic manipulation of the cervical spine in the treatment for the relief of symptoms caused by chronic mechanical neck pain. first, fourth and seventh consultations
Secondary Outcome if both treatments are as effective as each other in the treatment for the relief of symptoms caused by chronic mechanical neck pain. first, fourth and seventh consultations
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
university of johannesburg doornfontein campus 55 Beit street Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg Health Science Ethics Committee 55 Beit street Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Health Science Ethics Committee 55 Beit street Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Caroline Hay 55 Beit street Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Caroline Hay carolineh@uj.ac.za +27823490925 55 Beit street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Supervisor
Role Name Email Phone Street address
Principal Investigator Tristan Schut Tristan.kodee@gmail.com +2723374922 15 franz koenig place, Benmore gardens
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Researcher
Role Name Email Phone Street address
Public Enquiries Chri Yelverton chrisy@uj.ac.za +27115596646 55 Beit street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Head of department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data capturing sheet. Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years. Anyone can request it but must be requested from the head of department (HOD)
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