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.: PACTR202402802373266 Date of Approval: 01/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of muscle energy technique and ischemic compression in the treatment of cervicogenic headaches: combination mode versus single mode
Official scientific title The effect of muscle energy technique and ischemic compression in the treatment of cervicogenic headaches: combination mode versus single mode
Brief summary describing the background and objectives of the trial Research Problem: While cervicogenic headache (CGH) is commonly associated with musculoskeletal disorders, it poses a challenge to health care workers as its aetiology has only recently been hypothesized (Barmherzig and Kingston 2019). Research has shown that MET and IC achieve tonus release (inhibition), target the restricted joints and muscle tension respectively (Shah and Shah 2015; Basak et al. 2018; Gilani, Obaid and Tariq 2018). There is an increasing amount of evidence-based research suggesting the use of conservative treatment options such as MET and IC for CGH (Kumar, Sneha and Sivajyothi 2015; Shah and Shah 2015; Basak et al. 2018; Gilani, Obaid and Tariq 2018; Kisilewicz et al. 2018; Abaspour et al. 2020; Gohil et al. 2020). A meta-analysis study further demonstrated that multimodal manual therapies were better in effectiveness than pharmacological drugs for reducing frequency of CGH (Fernández-De-Las-Peñas and Cuadrado 2016). However, there is lack of research in the effect of combination treatment with MET and IC in CGH. Thus, further investigation is required to investigate the effect of combination therapy (MET and IC) on CGH. Objectives 1. To determine the effectiveness of combining muscle energy technique with ischaemic compression in the treatment of cervicogenic headache in terms of subjective (disability and pain) and objective (PPT and CROM) findings. 2. To determine the effectiveness of muscle energy technique alone in the treatment of cervicogenic headache in terms of subjective and objective findings. 3. To determine the effectiveness of ischaemic compression alone in the treatment of cervicogenic headache in terms of subjective and objective findings. 4. To compare the three groups in terms of subjective and objective findings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NA
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical Therapy Interventions
Anticipated trial start date 10/07/2023
Actual trial start date 10/07/2023
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date 03/10/2023
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Completed
Publication URL No URL yet
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Muscle energy technique MET and Ischemic compression IC MET for 5-7 seconds, repeated three to five times IC for 30 to 60 seconds, repeated three times with 30-second intervals between repetitions. MET for 5-7 seconds. IC for 30 to 60 seconds. MET was performed to the side of restricted ROM and MFTP as described by the method stated by DeStefano (2017) and King, Docrat and Abdul-Rasheed (2022). MET was performed on posterior to anterior rotation fixations found during motion palpation related to the SCM muscle actions. The technique is applied in the same manner on both left and right posterior to anterior rotations. On completion of MET, IC was performed. The participant continued to lie supine with the involved side adequately exposed. The MFTP were determined and located by the practitioner's flat or pincer palpation as described by Simons et al. (1999). A mark with henna on the MFTP was performed during the regional examination so that the same MFTP can be found and measured upon consultation. The researcher administered the treatment after the MFTP was located as described by Simons et al. (1999). IC was applied by applying pressure with the therapist’s thumb and index fingers over the MFTP taut band, using sustained and constant pressure (Figure 3-3). IC was applied with a maximum tolerable level before reproducing patterns of headache. The pressure was applied for 30 to 60 seconds. When the patient reports a reduction of pain by over 50%, then the pressure was increased to the maximum tolerable level again (Jafari, Bahrpeyma and Togha 2017). This process was repeated three times with 30-second intervals between repetitions (Bukhari and Khan 2020). IC was discontinued if the headache pattern was reproduced, if the pain disappears, or if more than the 60s was passed since the initial IC (Togha et al. 2020). 15
Control Group Muscle Energy technique alone MET for 5-7 seconds, repeated three to five times MET for 5-7 seconds MET was performed to the side of restricted ROM and MFTP as described by the method stated by DeStefano (2017) and King, Docrat and Abdul-Rasheed (2022). MET was performed on posterior to anterior rotation fixations found during motion palpation related to the SCM muscle actions. The technique is applied in the same manner on both left and right posterior to anterior rotations. 15 Active-Treatment of Control Group
Control Group Ischemic compression IC IC for 30–60 seconds, repeated three times with 30-second intervals between repetitions. IC for 30–60 seconds. IC was performed. The participant continued to lie supine with the involved side adequately exposed. The MFTP were determined and located by the practitioner's flat or pincer palpation as described by Simons et al. (1999). A mark with henna on the MFTP was performed during the regional examination so that the same MFTP can be found and measured upon consultation. The researcher administered the treatment after the MFTP was located as described by Simons et al. (1999). IC was applied by applying pressure with the therapist’s thumb and index fingers over the MFTP taut band, using sustained and constant pressure (Figure 3-3). IC was applied with a maximum tolerable level before reproducing patterns of headache. The pressure was applied for 30 to 60 seconds. When the patient reports a reduction of pain by over 50%, then the pressure was increased to the maximum tolerable level again (Jafari, Bahrpeyma and Togha 2017). This process was repeated three times with 30-second intervals between repetitions (Bukhari and Khan 2020). IC was discontinued if the headache pattern was reproduced, if the pain disappears, or if more than the 60s was passed since the initial IC (Togha et al. 2020). 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Participants must be between the ages of 18 and 55 years (verified by identification) as individuals in between those years are more likely to suffer from MPS (Simons et al. 1999; Barbero et al. 2019; Li et al. 2020). These statistics would support the current age group limits set for this study. The mean age for the CGH condition is 42.9 years, but it varies from 20 to 60 (Park et al. 2021). • It is preferable that participants are conversant and literate in English. • Participants were only accepted once they have read and signed the Informed Consent form and had undergone a complete case history and physical examination. • Participants must meet a minimum of three diagnostic criteria listed below to qualify for the research study (Sjaastad and Fredriksen 2000). These criteria were evaluated on the participant by the researcher and clinician on duty. o Unilateral headache with no side shift o Aggravation of headache by sustained awkward head position, neck movement or external pressure on the occipital area or upper cervical area on the symptomatic side. o Decreased range of motion or spinal facet restriction in the cervical spine. o Ipsilateral non-radicular head, neck, or shoulder pain. The International Headache Society criteria for the diagnostic test for CGH was not used in this study because it needed to use a diagnostic nerve block and was impractical for the setting of this study. • Participants that do not sign the informed consent form (Appendix C) or refuse to undergo case history and physical examination. • Participants that are unable to commit to the full study duration. • Participants that have any contra-indications to MET including hypermobility, the fragility of tissue, myositis, and tumours (Chaitow and Crenshaw, 2006; Fernández-de-las-Peñas, Cleland and Huijbregts, 2011). • Participant who has taken any medication or received any other treatment in the 24 hours prior to the initial consultation and duration of the study. • Participants with neck or shoulder pain caused by reasons other than CGH. This was determined during the first consultation. • Participants receiving any other cervical manipulative treatment for the CGH. Adult: 19 Year-44 Year 18 Year(s) 55 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 26/06/2023 Institutional Research Ethics Committee Research and Postgraduate Support Directorate
Ethics Committee Address
Street address City Postal code Country
2nd Floor, Berwyn Court Gate 1, Steve Biko Campus, Durban University of Technology Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measurement would be the pain pressure threshold. Outcome measured before intervention and immediately after intervention and a few days after primary intervention.
Secondary Outcome cervical range of motion measurement Outcome measured before intervention and immediately after intervention and a few days after primary intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chiropractic Day Clinic 11 Ritson Rd, Musgrave, Berea, 4001, South Africa Berea 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Family 113 Jan Smuts Avenue, Winston Park Gillitts 3610 South Africa
DUT Internal Grant 51 Steve Biko Rd, Musgrave, Berea, 4001 Durban 4001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NA N/A NA N/A South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Keseri Padayachy 3 Eagle Road Malvern Durban 4093 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ching Tung Chen devinchen980210@gmail.com +27849271014 113 Jan Smuts Avenue, Winston Park
City Postal code Country Position/Affiliation
Gillitts 3610 South Africa Myself
Role Name Email Phone Street address
Public Enquiries Linda Twiggs lindat@dut.ac.za +27313732512 11 Ritson Rd, Musgrave
City Postal code Country Position/Affiliation
Berea 4001 South Africa Clinic Administration Officer
Role Name Email Phone Street address
Scientific Enquiries Keseri Padayachy keserip@dut.ac.za +27843716438 11 Ritson Rd, Musgrave
City Postal code Country Position/Affiliation
Berea 4001 South Africa Main Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD Sharing Statement. The data for the results belongs to the university, and the data is on the DUT library and website. All data submitted to DUT will be accessible to the public through the university's DUT portal and DUT Open Scholar. Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years Accessed only by the supervisor and ethics committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A Yes 16/01/2024 16/01/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/01/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks NA
Changes to trial information