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Clinical Trials/NCT05680688
NCT05680688
Completed
Not Applicable

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

Josue Fernandez Carnero1 site in 1 country38 target enrollmentJanuary 11, 2023
ConditionsNeck Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neck Pain
Sponsor
Josue Fernandez Carnero
Enrollment
38
Locations
1
Primary Endpoint
Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-intervention
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 11, 2023
End Date
February 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Josue Fernandez Carnero
Responsible Party
Sponsor Investigator
Principal Investigator

Josue Fernandez Carnero

Professor

Universidad Rey Juan Carlos

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change from Baseline in Pain Intensity by Numeric Rating Scale (NRS) to immediate post-intervention(At baseline and immediately after the intervention)
  • Change from Baseline in Pain Intensity by NRS to 4 hours post-intervention(At baseline and 4 hours after the intervention)
  • Change from Baseline in Pain Intensity by NRS to 5 days post-intervention(At baseline and 5 days after the intervention)
  • Change from Baseline in Pain Intensity by NRS to 6 days post-intervention(At baseline and 6 days after the intervention)
  • Change from Baseline in Pain Intensity by NRS to 3 days post-intervention(At baseline and 3 days after the intervention)
  • Change from Baseline in Pain Intensity by NRS to 4 days post-intervention(At baseline and 4 days after the intervention)
  • Change from Baseline in Pain Intensity by NRS to 1 day post-intervention(At baseline and 1 day after the intervention)
  • Change from Baseline in Pain Intensity by NRS to 2 days post-intervention(At baseline and 2 days after the intervention)
  • Change from Baseline in Pain Intensity by NRS to 7 days post-intervention(At baseline and 7 days after the intervention)
  • Self-perceived improvement by Global Rating of Change (GROC scale) immediately after the intervention(Immediately after the intervention)
  • Self-perceived improvement by Global Rating of Change (GROC scale) 7 days after the intervention(7 days after the intervention)
  • Change from Baseline in Parallel Conditioned Pain Modulation (CPM) to immediate post-intervention(At baseline and immediately after the intervention)
  • Change from Baseline in Sequential Conditioned Pain Modulation (CPM) to immediate post-intervention(At baseline and immediately after the intervention)
  • Change from Baseline in Termporal Summation of Pain (TSP) to immediate post-intervention(At baseline and immediately after the intervention)
  • Change from Baseline in Cold Pain Intensity to immediate post-intervention(At baseline and immediately after the intervention)

Study Sites (1)

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