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.: PACTR201904920882014 Date of Approval: 01/04/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Spinal manipulation versus cervical stretching and strengthening in the treatment of tension-type headaches with forward head posture: a randomized clinical trial
Official scientific title Spinal manipulation versus cervical stretching and strengthening in the treatment of tension-type headaches with forward head posture: a randomized clinical trial
Brief summary describing the background and objectives of the trial This study aimed to determine which treatment (spinal manipulation, soft tissue protocol or a combination there of) is more effective in treatment of tension-type headaches in individuals with a forward head posture.
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 Education /Training
Anticipated trial start date 01/09/2015
Actual trial start date
Anticipated date of last follow up 01/11/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
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 Spinal Manipulation Two treatments twice a week for three weeks. The consult where the participant received the the treatment lasted for about 15 minutes. The participant is taken into the treatment room. Measurements were taken on the 1st, 4th and 7th visits. Treatment was only administered on the 1st to 6th visits. Participants were motion palpated to find cervical restrictions, following this they received chiropractic manipulations to those restrictions. 10
Experimental Group Soft tissue group Two treatments, twice w eek for three weeks Each consult was about 15 minutes. For this group, participants received a cervical stretching and strengthening (neck stretches) protocol to follow, these were done with the participant in the consult times on the 1st ti 6th visits. 10
Experimental Group Combination group Two treatments twice a week for three weeks Consults for this group were about 20 minutes. In this group, participants received a combination of the other two treatment interventions - spinal manipulation and the cervical stretching and strengthening protocol. 10
Control Group Control group This study did not have a control group as our Ethics committee does not allow us the use of control groups. This study did not have a control group as our Ethics committee does not allow us the use of control groups. This study did not have a control group as our Ethics committee does not allow us the use of control groups. 0 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
In order to be included into the study, participants needed to comply with the following criteria: • Symptomatic males and females who have a forward head posture. Patients are considered to have a forward head posture when their head and cervical spine leans anteriorly to the plumb line that passes the lateral malleolus in sagittal view.9 • Participants between the ages of 18 and 50 years. These are the individuals who are most susceptible to developing a forward head posture due to continual studying positions, work positions and sleeping positions.10 Participants had to be suffering from tension-type headaches. The diagnostic criteria for tension-type headaches, according to the International Headache Society are:11 A) At least 10 previous headache episodes fulfilling criteria B through D. B) Headaches lasting anywhere from 30 minutes to seven days. C) At least two of the following characteristics: - A pressing or tightening (non-pulsating) quality around the head; - Mild to moderate intensity; - Bilateral location; and - No aggravation from walking stairs or similar routine activities. D) Absence of the following: - Nausea or vomiting; and - Phonophobia and photophobia; one may be present but not both. Participants were excluded if they presented with the following: • Any known congenital anomalies that can result in a forward head posture e.g. wedge vertebrae. • Contraindication to cervical spine manipulative therapy. • History of cervical spine surgery. • Participants demonstrating a forward head posture but are asymptomatic for headaches. • Red flags of headaches Adult: 19 Year-44 Year 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 02/02/2014 REC University of Johannesburg
Ethics Committee Address
Street address City Postal code Country
55 Beit Street, Doornfontien, 2028 Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of this study was to compare the effectiveness of two different treatment approaches on the same condition. It was found that all three groups showed a clinical improvement but that spinal manipulations was more effective with pain relief and the soft tissue protocol was more effective with correcting posture. 1st, 4th and 7th consultations
Secondary Outcome A secondary outcome was to determine if a combination of the two would have an additive effect, this was found not to be the case. 1st, 4th and 7th consults
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Chiropractic clinic on Doornfontein campus 55 Beit Street, Doornfontein Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg 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 55 Beit Street, Doornfontein Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Anesu Kuhudzai 20 Chiselhurst Drive, Auckland Park Johannesburg 2092 South Africa
Fatima Ismail 55 Beit Street, Doornfontein Johannesburg 2092 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Christopher Yelverton chrisy@uj.ac.za 0115596546 55 Beit Street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Head of Department
Role Name Email Phone Street address
Scientific Enquiries Christopher Yelverton chrisy@uj.ac.za 0115596546 55 Beit street, Doornfontein
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Supervisor
Role Name Email Phone Street address
Principal Investigator Patrick Newman patricknewman55@gmail.com +27795224034 34 4th Avenue. Melville, 2092
City Postal code Country Position/Affiliation
Johannesburg 2092 South Africa At the time of study Masters student and currently a private Chiropractor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results available on request from HOD Informed Consent Form,Study Protocol 5 years after completion Anyone can request data from the HOD, the Hod will grant permission to access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.uj.ac.za Yes Intra-group analysis for the NDI, pressure algometer and the CVA found statistically significant post-treatment differences in all treatment groups (p < 0.001). The spinal manipulation group showed the greatest percentage improvement regarding the subjective data NDI (49.54%) and pressure algometer (133.80%). The soft tissue group showed the greatest percentage improvement regarding the objective CVA (24.93%). There was no statistical evidence of an additive effect of when the two treatment approaches were used simultaneously 30/08/2015 27/03/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks www.uj.ac.za
Changes to trial information