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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202607647368246

Enrollment

Registered

2026-07-23

Start date

2025-06-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases

Interventions

Specific set sequence of thoracic spinal mobilisation techniques

Ultrasound applied to the thoracic spine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients, male and female, age-range 18 – 75 years to encompass the normative data available on HRV (Dantas et al, 2017), experiencing acute ( 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.;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. ;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. ;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;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 domai	—

Measure

Time frame

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.;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. ;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. ;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;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 domai

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

South Africa

Contacts

Public ContactVaneshveri Naidoo

Supervisor

Vaneshveri.Naidoo@wits.ac.za+27117173702

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026