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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607647368246 Date of Registration: 23/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effects of thoracic mobilisation treatment techniques on the Autonomic Nervous System in patients with neck and/or upper back pain: A Randomised Controlled Trial.
Official scientific title The effects of thoracic mobilisation treatment techniques on the Autonomic Nervous System in patients with neck and/or upper back pain: A Randomised Controlled Trial.
Brief summary describing the background and objectives of the trial Neck pain and stress related disease have a significant impact on the global population. Stress is a known trigger for upregulating or exciting the pain centres in the brain and may add to the complexities of chronic neck pain. Prolonged exposure to stressors may contribute to chronic anxiety, hypertension and cardiovascular incidents. In acute or acute on chronic stressful exposures however, a more immediate intervention may be necessary in order to assist with pain control and moderate stress responses so that the patient is able to function appropriately. If thoracic mobilisations are able to moderate the ANS response in a significantly meaningful way for the patient (improved sense of well-being, decreased pain and increased ability to function), then it may be appropriate to use these techniques in clinical practice. 1.3.1. Objectives of the Study  To conduct a scoping review to map the evidence on manual therapy treatment techniques and the effects on the ANS.  To determine baseline measures in a patient population of neck and/or upper back pain of HRV (Heart Rate Variability), BPI (Brief Pain Inventory), NDI (Neck Disability Index), PHQ-4 (Patient Health Questionnaire 4) and SF-36 (Musculoskeletal Specific Quality of Life Questionnaire).  To determine the effects of thoracic mobilisations on HRV parameters of time-domain and frequency-domain in a patient population of neck and/or upper back pain as measured by the Card(X)plore ECG machine pre, during and post each intervention session.  To determine the three to six week post thoracic mobilisation intervention effects on a patient population of neck and/or upper back pain as measured by the BPI score, NDI score and PH-Q4 score.  To determine the 6 week post thoracic mobilisation intervention effect on a patient population of neck and/or upper back pain as measured by the SF-36 questionnaire administered at baseline and at 6 weeks after the last intervention session
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 01/06/2025
Actual trial start date 01/06/2025
Anticipated date of last follow up 01/08/2026
Actual Last follow-up date 01/01/2027
Anticipated target sample size (number of participants) 85
Actual target sample size (number of participants)
Recruitment status Active, not 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Specific set sequence of thoracic spinal mobilisation techniques Two interventions per week with a day in-between of no intervention. 12 minute intervention session The intervention group will receive two intervention sessions thoracic posterior-anterior mobilisations of T2 to T12 at a Grade III- mobilisation level (Maitland), 2 Hertz per minute for 4 minutes, followed by 4 mins of Grade III- rotatory butterfly mobilisations of the T5 – T8 level (one minute at each level) in a posterior-anterior, caudad-cephalad and lateral direction (Pentelka et al, 2012) (Jowsey and Perry, 2010) (Araujo et al, 2018). The T5 – T8 levels were selected for the ease of application in the prone position. Finally, 4 minutes of Grade III- transverse mobilisations will be applied to the T2 -T12 levels from a left to right and right to left direction (McGregor et al, 2014). Grade III- mobilisation amplitudes move the joint rhythmically in its available range whilst respecting pain but does not take the joint to end ranges (Maitland definition). These techniques, grades and thoracic spinal levels have been chosen to target input of the thoracic spinal ganglion, (Jowsey and Perry, 2010). 40
Control Group Ultrasound applied to the thoracic spine Two interventions applied during one week with one day in-between with no intervention. 12 minute intervention The control group will undergo two sessions of 12 minutes of therapeutic ultrasound (Zunke et al, 2020) from T2 to T12 and over the costovertebral joints of the corresponding levels. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients, male and female, age-range 18 – 75 years to encompass the normative data available on HRV (Dantas et al, 2017), experiencing acute (< 6 weeks), sub-acute (6 – 12 weeks) or chronic (> 12 weeks) (Hidalgo et al, 2018) neck or upper back pain will be asked to volunteer for the study via a REDcap questionnaire which will be distributed amongst private practices in Johannesburg, South Africa. Patients will be asked to disclose medication that they are taking and this will be noted as part of the study findings. They will also be asked to disclose any alcohol or smoking habits and these will also be noted as part of the study findings Patients will be excluded from the study if they have any of the following (Pessoa et al, 2020):  Cardiac history: severe heart failure (Dantas 2018)  Recent trauma with red flags and without x-rays or investigations  Existing fracture of the cervical spine, thoracic spine or ribs  Acute severe radiculopathy  Unusual first episode headaches/migraines not investigated  Severe unrelenting spinal pain, not investigated  Uncontrolled Hypertension  Uncontrolled Hyperthyroidism/Hyperthyroidism  High doses prolonged corticosteroid use  Current/recent pregnancy (< 4 months) (Dantas, 2018)  Osteoporosis (Rogan et al, 2019)  <18 years of age in order to eliminate concerns around informed consent from a minor 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 23/11/2023 Human Research Ethics Committee Medical University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Wits University, Medical Centre, 7 York Road, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Data will be obtained as pre and post intervention data using the Card(X)plore 5 lead ECG Holter device. Data will be interpreted by the device software program CardioVisions which will take raw data and convert it to usable conventional HRV parameters such as HRVt, RMSSD and SDNN used to assess sympathetic and parasympathetic activity. Blood pressure readings will also be taken. Data will be collected for 10minutes prior to the intervention and then for a further 10 minutes after the intervention.
Primary Outcome Brief Pain Inventory Questionnaire (BPI) This questionnaire was initially specific for monitoring pain in cancer patients; however studies have validated the questionnaire for non-cancer patients, particularly those with arthritis. This questionnaire is sensitive to changes in severity of pain and severity of conditions over time (Keller et al, 2004). It also measures the degree to which pain interferes with common dimensions of feeling and function. Questionnaire will be administered the day prior to the initial intervention, then 3 weeks post the initial intervention, and then a further 6 weeks after the initial intervention.
Primary Outcome PH-Q4 Questionnaire: The four-item patient health questionnaire for anxiety and depression This brief four-point questionnaire has been validated as a reliable screening questionnaire for anxiety and depression in the general population with a high sensitivity (83% - 86%) and specificity (83% - 90%) for the cut-off score of 3 or above. Questionnaire will be administered the day prior to the initial intervention, then 3 weeks post the initial intervention, and then a further 6 weeks after the initial intervention.
Primary Outcome Neck Disability Index Questionnaire (NDI) This is reliable and validated tool for assessing subjective neck pain and its impact on function at a particular point in time. Responsiveness is reported as the minimum detectable change (MDC), defined as a change in a patient’s score that is greater than measurement error. Responsiveness is also reported as the minimum clinically important difference (MCID) or the smallest change perceived to be beneficial by the patient, and therefore would likely bring about a change in patient management Questionnaire will be administered the day prior to the initial intervention, then 3 weeks post the initial intervention, and then a further 6 weeks after the initial intervention.
Primary Outcome SF-36: Musculoskeletal Specific Quality of Life Questionnaire The SF-36 is a generic health-related quality of life (QoL) questionnaire which produces 8 domain scores including social functioning, emotional role limitations, mental health and general health perceptions. Each domain is scored from 0 – 100 with higher scores indicating better health. It is widely used across a range of conditions (Jha et al, 2018). It also has a single item providing indication of perceived change in health (RAND Corporation). Questionnaire will be administered the day prior to the initial intervention, then 3 weeks post the initial intervention, and then a further 6 weeks after the initial intervention.
Secondary Outcome Stress Incident Diary Diary data is an acceptable form of self-reporting stress triggers (Vives-Mestres et al, 2021). Subjects will be required to complete a daily stress diary at the same time two times a day over the one week of HRV data collection and intervention period. Collecting data points two times per day may assist in showing a correlation between stressful events and changes in data values. Two diary entries per day over 7 consecutive days starting from the day after the initial intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
In Balance Physiotherapy and Pilates 345 Jan Smuts Avenue Johannesburg 2196 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Danielle Grobicki 32 Gleneagles Road Johannesburg 2196 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Danielle Grobicki Researcher 32 Gleneagles Road Johannesburg 2196 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Danielle Grobicki danielle@inbalancephysio.co.za +27737091938 32 Gleneagles Road
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Researcher
Role Name Email Phone Street address
Public Enquiries Vaneshveri Naidoo Vaneshveri.Naidoo@wits.ac.za +27117173702 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Corlia Brandt corlia.brandt@wits.ac.za +27117172014 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Link to published journal articles will be included at the completion of the trial. Informed Consent Form,Study Protocol From completion date of study for a period of 2 years. Access will depend on the criteria as described by the Journals that publish the results.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available 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