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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Sponsored by
Josue Fernandez Carnero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Manual Therapy, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Painful Manual Therapy

Painless Manual Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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".
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".
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".
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".
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".
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".
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".
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".
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".
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).
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).
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.
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.
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.
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.

Full Information

First Posted
December 27, 2022
Last Updated
June 29, 2023
Sponsor
Josue Fernandez Carnero
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1. Study Identification

Unique Protocol Identification Number
NCT05680688
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
February 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josue Fernandez Carnero

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Manual Therapy, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Painful Manual Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Painless Manual Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Tibialis Anterior Pressure Pain Threshold (PPT) to immediate post-intervention
Description
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.
Time Frame
At baseline and immediately after the intervention
Title
Change from Baseline in extensor carpi ulnaris PPT to immediate post-intervention
Description
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.
Time Frame
At baseline and immediately after the intervention
Title
Change from Baseline in upper trapezius PPT to immediate post-intervention
Description
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.
Time Frame
At baseline and immediately after the intervention
Title
Change from Baseline in spinous process of C7 PPT to immediate post-intervention
Description
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.
Time Frame
At baseline and immediately after the intervention
Secondary Outcome Measure Information:
Title
Change from Baseline in Pain Intensity by Numeric Rating Scale (NRS) to immediate post-intervention
Description
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".
Time Frame
At baseline and immediately after the intervention
Title
Change from Baseline in Pain Intensity by NRS to 4 hours post-intervention
Description
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".
Time Frame
At baseline and 4 hours after the intervention
Title
Change from Baseline in Pain Intensity by NRS to 1 day post-intervention
Description
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".
Time Frame
At baseline and 1 day after the intervention
Title
Change from Baseline in Pain Intensity by NRS to 2 days post-intervention
Description
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".
Time Frame
At baseline and 2 days after the intervention
Title
Change from Baseline in Pain Intensity by NRS to 3 days post-intervention
Description
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".
Time Frame
At baseline and 3 days after the intervention
Title
Change from Baseline in Pain Intensity by NRS to 4 days post-intervention
Description
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".
Time Frame
At baseline and 4 days after the intervention
Title
Change from Baseline in Pain Intensity by NRS to 5 days post-intervention
Description
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".
Time Frame
At baseline and 5 days after the intervention
Title
Change from Baseline in Pain Intensity by NRS to 6 days post-intervention
Description
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".
Time Frame
At baseline and 6 days after the intervention
Title
Change from Baseline in Pain Intensity by NRS to 7 days post-intervention
Description
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".
Time Frame
At baseline and 7 days after the intervention
Title
Self-perceived improvement by Global Rating of Change (GROC scale) immediately after the intervention
Description
The GROC assesses self-perceived improvement on a scale from -7 (a very great deal worse) to +7 (a very great deal better).
Time Frame
Immediately after the intervention
Title
Self-perceived improvement by Global Rating of Change (GROC scale) 7 days after the intervention
Description
The GROC assesses self-perceived improvement on a scale from -7 (a very great deal worse) to +7 (a very great deal better).
Time Frame
7 days after the intervention
Title
Change from Baseline in Parallel Conditioned Pain Modulation (CPM) to immediate post-intervention
Description
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.
Time Frame
At baseline and immediately after the intervention
Title
Change from Baseline in Sequential Conditioned Pain Modulation (CPM) to immediate post-intervention
Description
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.
Time Frame
At baseline and immediately after the intervention
Title
Change from Baseline in Termporal Summation of Pain (TSP) to immediate post-intervention
Description
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.
Time Frame
At baseline and immediately after the intervention
Title
Change from Baseline in Cold Pain Intensity to immediate post-intervention
Description
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.
Time Frame
At baseline and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josué Fernández Carnero, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28047
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29034802
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.
Results Reference
background
PubMed Identifier
26788367
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.
Results Reference
background
PubMed Identifier
141644
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.
Results Reference
background
PubMed Identifier
13363246
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.
Results Reference
background

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

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