Skip to content

Effects of Painful Compared to Painless Manual Therapy on Pain Processing in University Students With Neck Pain

Conditioned Pain Modulation Effects of Manual Therapy in University Students With Recurrent or Chronic Neck Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05680688
Enrollment
38
Registered
2023-01-11
Start date
2023-01-11
Completion date
2023-02-21
Last updated
2023-07-03

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

Conditions

Neck Pain

Keywords

Manual Therapy, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Neck Pain

Brief 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.

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.

Interventions

OTHERManual 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.

Sponsors

Josue Fernandez Carnero
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-interventionAt baseline and immediately after the interventionPPTs 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-interventionAt baseline and immediately after the interventionPPTs 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-interventionAt baseline and immediately after the interventionPPTs 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-interventionAt baseline and immediately after the interventionPPT 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.

Secondary

MeasureTime frameDescription
Self-perceived improvement by Global Rating of Change (GROC scale) 7 days after the intervention7 days after the interventionThe GROC assesses self-perceived improvement on a scale from -7 (a very great deal worse) to +7 (a very great deal better).
Change from Baseline in Pain Intensity by NRS to 6 days post-interventionAt baseline and 6 days after the interventionThe 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.
Change from Baseline in Pain Intensity by NRS to 7 days post-interventionAt baseline and 7 days after the interventionThe 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.
Self-perceived improvement by Global Rating of Change (GROC scale) immediately after the interventionImmediately after the interventionThe GROC assesses self-perceived improvement on a scale from -7 (a very great deal worse) to +7 (a very great deal better).
Change from Baseline in Pain Intensity by Numeric Rating Scale (NRS) to immediate post-interventionAt baseline and immediately after the interventionThe 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.
Change from Baseline in Pain Intensity by NRS to 4 hours post-interventionAt baseline and 4 hours after the interventionThe 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.
Change from Baseline in Pain Intensity by NRS to 1 day post-interventionAt baseline and 1 day after the interventionThe 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.
Change from Baseline in Pain Intensity by NRS to 2 days post-interventionAt baseline and 2 days after the interventionThe 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.
Change from Baseline in Pain Intensity by NRS to 3 days post-interventionAt baseline and 3 days after the interventionThe 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.
Change from Baseline in Pain Intensity by NRS to 4 days post-interventionAt baseline and 4 days after the interventionThe 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.
Change from Baseline in Pain Intensity by NRS to 5 days post-interventionAt baseline and 5 days after the interventionThe 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.
Change from Baseline in Parallel Conditioned Pain Modulation (CPM) to immediate post-interventionAt baseline and immediately after the interventionTo 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.
Change from Baseline in Sequential Conditioned Pain Modulation (CPM) to immediate post-interventionAt baseline and immediately after the interventionTo 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.
Change from Baseline in Termporal Summation of Pain (TSP) to immediate post-interventionAt baseline and immediately after the interventionTSP 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.
Change from Baseline in Cold Pain Intensity to immediate post-interventionAt baseline and immediately after the interventionCold 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026