Clinical trial NCT05680688: Effects of Painful Compared to Painless Manual Therapy on Pain Processing in University Students With Neck Pain
Official title: Conditioned Pain Modulation Effects of Manual Therapy in University Students With Recurrent or Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Manual Therapy
Physiotherapy
Physical Therapy
Conditioned Pain Modulation
Neck Pain
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from Baseline in extensor carpi ulnaris PPT to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from Baseline in upper trapezius PPT to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from Baseline in spinous process of C7 PPT to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
Secondary outcomes:
measure: Change from Baseline in Pain Intensity by Numeric Rating Scale (NRS) to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from Baseline in Pain Intensity by NRS to 4 hours post-intervention
timeFrame: At baseline and 4 hours after the intervention
measure: Change from Baseline in Pain Intensity by NRS to 1 day post-intervention
timeFrame: At baseline and 1 day after the intervention
measure: Change from Baseline in Pain Intensity by NRS to 2 days post-intervention
timeFrame: At baseline and 2 days after the intervention
measure: Change from Baseline in Pain Intensity by NRS to 3 days post-intervention
timeFrame: At baseline and 3 days after the intervention
measure: Change from Baseline in Pain Intensity by NRS to 4 days post-intervention
timeFrame: At baseline and 4 days after the intervention
measure: Change from Baseline in Pain Intensity by NRS to 5 days post-intervention
timeFrame: At baseline and 5 days after the intervention
measure: Change from Baseline in Pain Intensity by NRS to 6 days post-intervention
timeFrame: At baseline and 6 days after the intervention
measure: Change from Baseline in Pain Intensity by NRS to 7 days post-intervention
timeFrame: At baseline and 7 days after the intervention
measure: Self-perceived improvement by Global Rating of Change (GROC scale) immediately after the intervention
timeFrame: Immediately after the intervention
measure: Self-perceived improvement by Global Rating of Change (GROC scale) 7 days after the intervention
timeFrame: 7 days after the intervention
measure: Change from Baseline in Parallel Conditioned Pain Modulation (CPM) to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from Baseline in Sequential Conditioned Pain Modulation (CPM) to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from Baseline in Termporal Summation of Pain (TSP) to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
measure: Change from Baseline in Cold Pain Intensity to immediate post-intervention
timeFrame: At baseline and immediately after the intervention
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josué Fernández Carnero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vigotsky 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.
citation: Melzack 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.
citation: WAND-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.