Neck PainNCT05680688
Effects of Painful Compared to Painless Manual Therapy on Pain Processing in University Students With Neck Pain
A study testing Manual Therapy in people with Neck Pain, run by Josue Fernandez Carnero at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effects of provoking pain with manual therapy on pain processing in university students with recurrent or chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2023to 21 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- University students
- Chronic neck pain (persistent pain > 3 months almost every day of the week) or recurrent neck pain (repeated episodes of neck pain starting > 3 months ago with pain-free periods)
- Non-specific neck pain (pain in the neck region that is not attributable to a known specific such as herniated disc, myelopathy, fractures, spinal stenosis, neoplasm etc. nor is it associated with traumatic causes such as whiplash)
- Mean NRS score the last week > 2/10 and presence of pain on the day of assesment and treatment
Who cannot join
- Signs of radiculopathy or neuropathic pain
- Neck surgeries
- Inflammatory rheumatic
- Neurological, cardiorespiratory, oncological or psychiatric disease
- Pregnancy
- Not being able to read Spanish in order to fill in the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conditioned Pain Modulation Effects of Manual Therapy in University Students With Recurrent or Chronic Neck Pain
The purpose of this study is to evaluate the effects of provoking pain with manual therapy on pain processing in university students with recurrent or chronic neck pain.
Read the detailed description
The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism generated by the pain that manual therapy techniques may elicit in the patient.
- Conditions
- Neck Pain
- Being tested
- Manual Therapy
- Keywords
- Manual Therapy, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
- Postero-anterior mobilizations: the physiotherapist will place his thumbs on the posterior surface of the spinous process of the vertebra previously assessed as the most painful to mobilise. The oscillations will be performed at the frequency of 1 oscillation per second and will be performed 3 series of 3 minutes, with a 1 minute rest interval.
- Pressure: The point of greatest pain shall be treated by maintained pressure in each of the following areas: right upper trapezius, left upper trapezius, right paravertebral musculature and left paravertebral musculature. Pressure shall be applied to each of the points for 1 minute.
- Massage: Pressure is applied to the muscles by sliding along the muscle belly. This will be done slowly to control the pain that is being provoked. 3 minutes will be carried out on each upper trapezius, sliding from the acromion to the occipital and another 3 minutes on the paravertebral musculature on each side, sliding from T1 to the occipital.
| Study group | Role | What they receive |
|---|---|---|
| Painful Manual Therapy | Experimental | Manual therapy treatment shall be carried out at a high intensity that causes pain to the patient. The aim is to provoke a medium intensity pain to the patient of 5/10 in the NRS. The physiotherapist will ask every 30 seconds the pain provoked by the treatment with the numeric rating scale (NRS) and the patient will give continuous feedback. Based on this, the physiotherapist will adapt the intensity of the treatment to provoke a medium intensity pain. Receives: Other: Manual Therapy |
| Painless Manual Therapy | Active comparator | Manual therapy treatment shall be performed at a low intensity that does not cause pain to the patient. The aim is for the patient to report a pain intensity of 0/10 in NRS throughout treatment. The physiotherapist will ask every 30 seconds the pain provoked by the treatment with NRS and the patient will give continuous feedback. Based on this, the physiotherapist will adapt the intensity of the treatment to be performed below the pain threshold. Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the tibialis anterior muscle (remote pain-free area) using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Measured: At baseline and immediately after the intervention
Change from Baseline in extensor carpi ulnaris PPT to immediate post-intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the extensor carpi ulnaris muscle (remote pain-free area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Measured: At baseline and immediately after the intervention
Change from Baseline in upper trapezius PPT to immediate post-intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the extensor upper trapezius muscle (symptomatic area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Measured: At baseline and immediately after the intervention
Change from Baseline in spinous process of C7 PPT to immediate post-intervention
PPT will be assessed over the spinous process of C7 (cervical innervated-related area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Measured: At baseline and immediately after the intervention
Secondary outcomes (15)
Change from Baseline in Pain Intensity by Numeric Rating Scale (NRS) to immediate post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and immediately after the intervention
Change from Baseline in Pain Intensity by NRS to 4 hours post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and 4 hours after the intervention
Change from Baseline in Pain Intensity by NRS to 1 day post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and 1 day after the intervention
Change from Baseline in Pain Intensity by NRS to 2 days post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and 2 days after the intervention
Change from Baseline in Pain Intensity by NRS to 3 days post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and 3 days after the intervention
Change from Baseline in Pain Intensity by NRS to 4 days post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and 4 days after the intervention
Change from Baseline in Pain Intensity by NRS to 5 days post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and 5 days after the intervention
Change from Baseline in Pain Intensity by NRS to 6 days post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and 6 days after the intervention
Change from Baseline in Pain Intensity by NRS to 7 days post-intervention
The NRS measures the pain intensity using a 11-point scale. Rank from 0 to 10, with the 0-end point labeled with "no pain" and the 10-end point labeled as "worst imaginable pain".
Measured: At baseline and 7 days after the intervention
Self-perceived improvement by Global Rating of Change (GROC scale) immediately after the intervention
The GROC assesses self-perceived improvement on a scale from -7 (a very great deal worse) to +7 (a very great deal better).
Measured: Immediately after the intervention
Self-perceived improvement by Global Rating of Change (GROC scale) 7 days after the intervention
The GROC assesses self-perceived improvement on a scale from -7 (a very great deal worse) to +7 (a very great deal better).
Measured: 7 days after the intervention
Change from Baseline in Parallel Conditioned Pain Modulation (CPM) to immediate post-intervention
To evaluate conditioned pain modulation (CPM), a handheld pressure algometer will be used as the test stimulus to evaluate the PPT at the nail bed of the thumb of the symptomatic side before and during application of a conditioning stimulus. Ischemic muscle pain will be used as the conditioning stimulus using a sphygmomanometer. The sphygmomanometer will be applied around the upper arm of the asymptomatic side, with its lower rim 3 cm proximal to the cubital fossa. The cuff was inflated to 260 mmHg and maintained until the subject perceived a 7/10 pain on the NRS. The CPM will be the result of the PPT during the conditioning stimulus minus the PPT before the conditioning stimulus.
Measured: At baseline and immediately after the intervention
Change from Baseline in Sequential Conditioned Pain Modulation (CPM) to immediate post-intervention
To evaluate conditioned pain modulation (CPM), a handheld pressure algometer (Model FPX, Wagner instruments, Greenwich, CT, USA) will be used as the test stimulus to evaluate the PPT at the nail bed of the thumb of the symptomatic side before and 1 minute after application of a conditioning stimulus. Ischemic muscle pain will be used as the conditioning stimulus using a sphygmomanometer. The sphygmomanometer will be applied around the upper arm of the asymptomatic side, with its lower rim 3 cm proximal to the cubital fossa. The cuff was inflated to 260 mmHg and maintained until the subject perceived a 7/10 pain on the NRS. The CPM will be the result of the PPT after the conditioning stimulus minus the PPT before the conditioning stimulus.
Measured: At baseline and immediately after the intervention
Change from Baseline in Termporal Summation of Pain (TSP) to immediate post-intervention
TSP will be elicited with 10 applications of the algometer (Model FPX, Wagner instruments, Greenwich, CT, USA) at the individual PPT intensity perceived at the nail bed of the thumb of the asymptomatic side. For each pulse, the pressure will be increased at a rate of approximately 2 kg/second to the previously determined PPT intensity. Pulses will be presented with an interstimulus interval of 1 second because this has previously been shown to be optimal for inducing TSP with pressure pain. Before application of the first pressure pulse, subjects were instructed to manually rate the pain intensity of the first and 10th pulse with a NRS. The TSP will be calculated as the difference between the pain intensity of the tenth stimulus minus the first stimulus.
Measured: At baseline and immediately after the intervention
Change from Baseline in Cold Pain Intensity to immediate post-intervention
Cold pain intensity will be evaluated with the subject resting on a chair with the ice application test. Testing will be conducted on the anterior skin of the right forearm.
For the ice application test, the ice pack will be held on the skin for 10 s. After 10 s of ice application, subjects will be instructed to rate the intensity of pain on NRS. The procedure will be repeated three times to obtain a mean value, with a 60 s rest period between measures to avoid summation of pain.
Measured: At baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start11 Jan 2023
- Primary completion14 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josue Fernandez Carnero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Josué Fernández Carnero, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680688
- Sponsor's protocol ID
- PAINMT1
- Status last verified
- Jun 2023
- First submitted
- 27 Dec 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bialosky JE, Beneciuk JM, Bishop MD, Coronado RA, Penza CW, Simon CB, George SZ. Unraveling the Mechanisms of Manual Therapy: Modeling an Approach. J Orthop Sports Phys Ther. 2018 Jan;48(1):8-18. doi: 10.2519/jospt.2018.7476. Epub 2017 Oct 15.
PubMed 29034802Vigotsky AD, Bruhns RP. The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review. Pain Res Treat. 2015;2015:292805. doi: 10.1155/2015/292805. Epub 2015 Dec 16.
PubMed 26788367Melzack R. Prolonged relief of pain by brief, intense transcutaneous somatic stimulation. Pain. 1975 Dec;1(4):357-373. doi: 10.1016/0304-3959(75)90073-1.
PubMed 141644WAND-TETLEY JI. Historical methods of counter-irritation. Ann Phys Med. 1956 Jul;3(3):90-9. doi: 10.1093/rheumatology/iii.3.90. No abstract available.
PubMed 13363246
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioned Pain Modulation Effects of Manual Therapy in University Students With Recurrent or Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05680688
- Acronym / sponsor ID
- PAINMT1
- Conditions
- Neck Pain
- Keywords
- Manual Therapy, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Josue Fernandez CarneroUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of provoking pain with manual therapy on pain processing in university students with recurrent or chronic neck pain.
Detailed description
The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. Almost all types of MT elicit a neurophysiological response that is associated with the descending pain modulation circuit. But it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism generated by the pain that manual therapy techniques may elicit in the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painful Manual Therapy | Experimental | Other: Manual TherapyManual therapy treatment shall be carried out at a high intensity that causes pain to the patient. The aim is to provoke a medium intensity pain to the patient of 5/10 in the NRS. The physiotherapist will ask every 30 seconds the pain provoked by the treatment with the numeric rating scale (NRS) and the patient will give continuous feedback. Based on this, the physiotherapist will adapt the intensity of the treatment to provoke a medium intensity pain. |
| Painless Manual Therapy | Active comparator | Other: Manual TherapyManual therapy treatment shall be performed at a low intensity that does not cause pain to the patient. The aim is for the patient to report a pain intensity of 0/10 in NRS throughout treatment. The physiotherapist will ask every 30 seconds the pain provoked by the treatment with NRS and the patient will give continuous feedback. Based on this, the physiotherapist will adapt the intensity of the treatment to be performed below the pain threshold. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- University students
- Chronic neck pain (persistent pain > 3 months almost every day of the week) or recurrent neck pain (repeated episodes of neck pain starting > 3 months ago with pain-free periods)
- Non-specific neck pain (pain in the neck region that is not attributable to a known specific such as herniated disc, myelopathy, fractures, spinal stenosis, neoplasm etc. nor is it associated with traumatic causes such as whiplash)
- Mean NRS score the last week > 2/10 and presence of pain on the day of assesment and treatment
Key exclusion criteria (6 listed)
- Signs of radiculopathy or neuropathic pain
- Neck surgeries
- Inflammatory rheumatic
- Neurological, cardiorespiratory, oncological or psychiatric disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy* Postero-anterior mobilizations: the physiotherapist will place his thumbs on the posterior surface of the spinous process of the vertebra previously assessed as the most painful to mobilise. The oscillations will be performed at the frequency of 1 oscillation per second and will be performed 3 series of 3 minutes, with a 1 minute rest interval. * Pressure: The point of greatest pain shall be treated by maintained pressure in each of the following areas: right upper trapezius, left upper trapezius, right paravertebral musculature and left paravertebral musculature. Pressure shall be applied to each of the points for 1 minute. * Massage: Pressure is applied to the muscles by sliding along the muscle belly. This will be done slowly to control the pain that is being provoked. 3 minutes will be carried out on each upper trapezius, sliding from the acromion to the occipital and another 3 minutes on the paravertebral musculature on each side, sliding from T1 to the occipital. | Other | Painful Manual Therapy, Painless Manual Therapy |
Primary outcome
Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-intervention
Time frame: At baseline and immediately after the intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the tibialis anterior muscle (remote pain-free area) using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from Baseline in extensor carpi ulnaris PPT to immediate post-intervention
Time frame: At baseline and immediately after the intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the extensor carpi ulnaris muscle (remote pain-free area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from Baseline in upper trapezius PPT to immediate post-intervention
Time frame: At baseline and immediately after the intervention
PPTs will be assessed bilaterally (the mean between both sides will be used for analysis) over the extensor upper trapezius muscle (symptomatic area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from Baseline in spinous process of C7 PPT to immediate post-intervention
Time frame: At baseline and immediately after the intervention
PPT will be assessed over the spinous process of C7 (cervical innervated-related area) using a digital algometer (Model FPX, Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say "stop" when the pressure sensation becomes painful. The average of two trials will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
15 secondary outcomes
Change from Baseline in Pain Intensity by Numeric Rating Scale (NRS) to immediate post-intervention
Time frame: At baseline and immediately after the intervention
Change from Baseline in Pain Intensity by NRS to 4 hours post-intervention
Time frame: At baseline and 4 hours after the intervention
Change from Baseline in Pain Intensity by NRS to 1 day post-intervention
Time frame: At baseline and 1 day after the intervention
Change from Baseline in Pain Intensity by NRS to 2 days post-intervention
Time frame: At baseline and 2 days after the intervention
Change from Baseline in Pain Intensity by NRS to 3 days post-intervention
Time frame: At baseline and 3 days after the intervention
Change from Baseline in Pain Intensity by NRS to 4 days post-intervention
Time frame: At baseline and 4 days after the intervention
Change from Baseline in Pain Intensity by NRS to 5 days post-intervention
Time frame: At baseline and 5 days after the intervention
Change from Baseline in Pain Intensity by NRS to 6 days post-intervention
Time frame: At baseline and 6 days after the intervention
Change from Baseline in Pain Intensity by NRS to 7 days post-intervention
Time frame: At baseline and 7 days after the intervention
Self-perceived improvement by Global Rating of Change (GROC scale) immediately after the intervention
Time frame: Immediately after the intervention
Self-perceived improvement by Global Rating of Change (GROC scale) 7 days after the intervention
Time frame: 7 days after the intervention
Change from Baseline in Parallel Conditioned Pain Modulation (CPM) to immediate post-intervention
Time frame: At baseline and immediately after the intervention
Change from Baseline in Sequential Conditioned Pain Modulation (CPM) to immediate post-intervention
Time frame: At baseline and immediately after the intervention
Change from Baseline in Termporal Summation of Pain (TSP) to immediate post-intervention
Time frame: At baseline and immediately after the intervention
Change from Baseline in Cold Pain Intensity to immediate post-intervention
Time frame: At baseline and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 29034802Bialosky JE, Beneciuk JM, Bishop MD, Coronado RA, Penza CW, Simon CB, George SZ. Unraveling the Mechanisms of Manual Therapy: Modeling an Approach. J Orthop Sports Phys Ther. 2018 Jan;48(1):8-18. doi: 10.2519/jospt.2018.7476. Epub 2017 Oct 15.
- Background: PubMed 26788367Vigotsky AD, Bruhns RP. The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review. Pain Res Treat. 2015;2015:292805. doi: 10.1155/2015/292805. Epub 2015 Dec 16.
- Background: PubMed 141644Melzack R. Prolonged relief of pain by brief, intense transcutaneous somatic stimulation. Pain. 1975 Dec;1(4):357-373. doi: 10.1016/0304-3959(75)90073-1.
- Background: PubMed 13363246WAND-TETLEY JI. Historical methods of counter-irritation. Ann Phys Med. 1956 Jul;3(3):90-9. doi: 10.1093/rheumatology/iii.3.90. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josué Fernández Carnero, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy in people with Neck Pain, run by Josue Fernandez Carnero at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-intervention (time frame: At baseline and immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680688, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.