Manual therapy vs tactile sensory training in patients with neck pain
| ISRCTN | ISRCTN37282752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37282752 |
| EudraCT/CTIS number | Nil Known |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | University of Patras 7922/26022019 |
- Submission date
- 24/03/2021
- Registration date
- 26/04/2021
- Last edited
- 10/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Neck pain is a major musculoskeletal condition with a great impact on people's lives worldwide in modern society. It is reported that more than 60% of the population will suffer from it at least once over the course of their lifetime.
Neck pain is managed by a plethora of treatment options, mostly delivered in primary care settings, including non-pharmacological treatments( self-management advise and pain education, exercise therapy, manual therapy and psychosocial interventions)complementary treatments (i.e. acupuncture), pharmacological therapies and more rarely surgical options in severe cases.
Recently greater attention has been given to factors, like patients’ beliefs and expectations placebo effect and pain education which provide input into the nervous system, as well as activate the brain to modulate pain experience.
The purpose of the present study was to investigate the outcomes of neck pain treatment and compare the immediate effects of manual therapy versus localization training by the tactile stimulus on pain intensity and mobility of the neck, after a single treatment session.
Who can participate?
Eligible patients had to present with neck pain for at least 1 week prior to their recruitment in the trial
Patients were excluded if they could not read or understand spoken /written Greek, were under the age 18 and over 65, had undergone spinal surgery in the area of focus, had any skin condition preventing them from receiving tactile stimuli, had any contraindications to manual therapy (vertebral arteries insufficiency, spinal instability, steroid medication use, malignancy) present any symptoms related to neurological conditions altering sensation (i.e. peripheral neuropathy, multiple sclerosis, diabetes), had a diagnosis of radiculopathy with high irritability. All participants were required to completed and pass, a health questionnaire
What does the study involve?
Volunteer adults suffering from neck pain and meeting the inclusion criteria were asked to complete a consent form prior to the commencement and participants were reminded at this point that they were free to withdraw from the study at any point.
Then the assessor assessed the level of pain and neck mobility of the participants using the equipment before and right after the one session treatment which is painless and its duration is less than 5 minutes.
The participants were randomly assigned into either the tactile sensory stimulation group or the manual therapy group, with mobilizations.
What are the possible benefits and risks of participating?
The possible benefits after your participation in the current trial are the decrease in the level of pain and the improvement of cervical spine mobility. But even if there is no immediate benefit from this one single treatment session you would have contributed to further investigate the aspects and treatment of neck pain.
If the participant meets the inclusion criteria to the experimental procedure there are no risks from the application of the therapeutic techniques as the interventions are painless and safe.
Where is the study run from?
The study was run by the University of Patras, Department of Physiotherapy and took place in Aigion Campus (Greece)
When is the study starting and how long is it expected to run for?
February 2019 to December 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Eleftheria Thomaidou, elethom@gmail.com
2. Dr Evdokia Billis, billis@upatras.gr
Contact information
Scientific
Department of Physiotherapy
School of Health Rehabilitation Science
University of Patras
Psaron 6
Myrtia
Aigion
25100
Greece
 ORCID ID |
0000-0003-1319-9269 |
|---|---|
| Phone | +30 6976246965 |
| elethom@gmail.com |
Scientific
Department of Physiotherapy
School of Health Rehabilitation Science
University of Patras
Psaron 6
Myrtia
Aigion
25100
Greece
| ORCID ID |
0000-0002-5828-809X |
|---|---|
| Phone | +30 26910 22058 |
| billis@upatras.gr |
Study information
| Study design | Single-blind interventional randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN37282752_PIS.pdf |
| Scientific title | Manual therapy vs localization (tactile sensory training) in patients with neck pain: a randomized clinical trial |
| Study objectives | 1. There is a significant difference in the interventional effect between manual therapy and localization group (Group Factor) 2. There is a significant difference in pain levels and cervical range of motion between pre and post-intervention to cervicothoracic spine (Time Factor) |
| Ethics approval(s) | Approved 01/04/2019, TEI Western Greece University of Patras Bioethics Committee (University Campus 26504 Rio Achaia, Greece; +30 2610 996683; rectorate@upatras.gr), ref:12144 |
| Health condition(s) or problem(s) studied | Neck pain |
| Intervention | Thirty eligible volunteers, with neck pain, consented and were randomly allocated to a Manual Therapy or to a motionless, localization (tactile sensory training) group. A single three-minute treatment session was delivered to each group’s cervico-thoracic area by two therapists (one for each group). Localization involved tactile sensory stimulation, applied randomly in one out of a nine-block grid. Subjects were asked to identify the number of the square being touched. Manual therapy involved three-minute anteroposterior glides and SNAG techniques, applied to hypo-mobile levels. Pre- and post-intervention pain intensity, using a pressure pain threshold (PPT) algometer and numeric pain rate scale (NPRS), was assessed. Neck ROM was recorded with a bubble inclinometer. Randmoization Randomized number table designed by an online software (www.randomizer.org) in a private room in the Clinical Rehabilitation lab. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Self-reported neck and thoracic pain intensity was evaluated using 0-10 Numeric Pain Scale (NPRS) pre and immediately post-treatment 2. Pain Pressure Threshold (PPT) measured through an algometer pre and immediately post-treatment 3. The range of motion of the cervical spine was measured through a bubble inclinometer pre and immediately post-treatment |
| Secondary outcome measures | 1. Neck Disability was measured using Neck Disability Index (questionnaire) only at baseline 2. Anxiety and Depression was measured using the Hospital Anxiety and Depression Scale (HADS) only at baseline 3. Patient's improvement or deterioration over time, was measured using the Global Rating of Change Scale (GRoC)only at baseline |
| Overall study start date | 26/02/2019 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | A sample of 30 patients with neck pain, who met the inclusion criteria were randomly assigned into 2 equal groups(n=15) |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Participants should suffer from neck pain for at least 1 week 2. Participants must be between the ages of 18-65, including both males and females 3. Participants able to understand spoken and written Greek 4. Participants must be able to give informed consent 5. No previous adverse effects to manual therapy |
| Key exclusion criteria | 1. Trauma/surgery to the CxTx in past 2. Skin allergies/ irritation/ dermatological conditions (dermatitis, eczema) 3. Neurological disorders such as altered sensation, peripheral neuropathy, multiple sclerosis 4. Vertebral arteries insufficiency 5. Steroid medication use 6. Spinal instability 7. High irritability 8. Radiculopathy 9. Malignant neoplasm 10. Cervical myelopathy 11. Those who answered YES to any of the questions in the health screening questionnaire, suggesting having contraindication on treatment |
| Date of first enrolment | 01/11/2019 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- Greece
Study participating centre
School of Health Rehabilitation Science
University of Patras
Psaron 6, Myrtia
Aigion
25100
Greece
Sponsor information
University/education
Department of Physiotherapy
School of Health Rehabilitation Sciences
University of Patras
Psaron 6
Aigion
25100
Greece
| Phone | +30 2691061150 |
|---|---|
| physiosecr@upatras.gr | |
| Website | http://www.upatras.gr/ |
"ROR" |
https://ror.org/017wvtq80 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/05/2021 | No | Yes | ||
| Protocol file | 04/05/2021 | No | No | ||
| Thesis results | 01/05/2020 | 13/01/2022 | No | No | |
| Results article | 11/05/2023 | 10/05/2024 | Yes | No |
Additional files
- ISRCTN37282752_PROTOCOL_no_date.pdf
- uploaded 04/05/2021
- ISRCTN37282752_PIS.pdf
- uploaded 04/05/2021
Editorial Notes
10/05/2024: Publication reference added.
13/01/2022: Thesis added to trial outputs.
07/04/2021: Trial's existence confirmed by TEI Western Greece University of Patras Bioethics Committee
