Neck Pain Clinical Trial
Official title:
Conditioned Pain Modulation Effects of Manual Therapy in University Students With Recurrent or Chronic Neck Pain
Verified date | June 2023 |
Source | Universidad Rey Juan Carlos |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | February 21, 2023 |
Est. primary completion date | February 14, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Rey Juan Carlos | Alcorcón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Josue Fernandez Carnero |
Spain,
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. — View 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. — View 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. Erratum In: Pain Res Treat. 2017;2017:1535473. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At baseline and immediately after the intervention | |
Primary | 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. | At baseline and immediately after the intervention | |
Primary | 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. | At baseline and immediately after the intervention | |
Primary | 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. | At baseline and immediately after the intervention | |
Secondary | 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". | At baseline and immediately after the intervention | |
Secondary | 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". | At baseline and 4 hours after the intervention | |
Secondary | 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". | At baseline and 1 day after the intervention | |
Secondary | 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". | At baseline and 2 days after the intervention | |
Secondary | 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". | At baseline and 3 days after the intervention | |
Secondary | 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". | At baseline and 4 days after the intervention | |
Secondary | 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". | At baseline and 5 days after the intervention | |
Secondary | 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". | At baseline and 6 days after the intervention | |
Secondary | 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". | At baseline and 7 days after the intervention | |
Secondary | 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). | Immediately after the intervention | |
Secondary | 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). | 7 days after the intervention | |
Secondary | 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. | At baseline and immediately after the intervention | |
Secondary | 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. | At baseline and immediately after the intervention | |
Secondary | 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. | At baseline and immediately after the intervention | |
Secondary | 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. |
At baseline and immediately after the intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05293847 -
Postural Based Telerehabilitation in Mechanic Neck Pain
|
N/A | |
Completed |
NCT04060004 -
The Effects of Dry Needling on the Superficial Neck Musculature
|
N/A | |
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Active, not recruiting |
NCT05870371 -
The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain
|
N/A | |
Completed |
NCT06049316 -
Scapular Stabilization vs Functional Exercises on Chronic Neck Pain
|
N/A | |
Recruiting |
NCT05944354 -
Wearable Spine Health System for Military Readiness
|
||
Completed |
NCT02882061 -
Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain
|
N/A | |
Completed |
NCT02731014 -
Dry Needling for Patients With Neck Pain
|
N/A | |
Completed |
NCT02904668 -
Self-management Program in Chronic Neck Pain
|
N/A | |
Completed |
NCT03147508 -
Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.
|
||
Completed |
NCT02638987 -
EMG Activity Before, During and After Dry Needling
|
N/A | |
Active, not recruiting |
NCT02843269 -
Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Completed |
NCT02245425 -
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
|
N/A | |
Completed |
NCT02225873 -
The Effectiveness of Exercises Protocol in Management of Neck Pain
|
N/A | |
Completed |
NCT02235207 -
Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain
|
N/A | |
Completed |
NCT02190890 -
Dry Needling Dosage in the Treatment of Myofascial Neck Pain
|
N/A | |
Completed |
NCT02051478 -
Thoracic Manipulation and Mobilization for Neck Pain
|
N/A | |
Completed |
NCT01938209 -
A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain
|
N/A | |
Completed |
NCT01233180 -
Effects of Gua Sha and Thermotherapy on Chronic Neck Pain
|
N/A |