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

NCT05680688 | Completed

• 1 other identifier: PAINMT1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (15)

• 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 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 3 days post-intervention

  At baseline and 3 days after the intervention

Study Arms (2)

Painful Manual Therapy

EXPERIMENTAL

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.

Other: Manual Therapy

Painless Manual Therapy

ACTIVE COMPARATOR

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.

Other: Manual Therapy

Interventions

Manual Therapy OTHER

* 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.

Painful Manual Therapy; Painless Manual Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Josue Fernandez Carnero: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28047, Spain

Location

Related Publications (4)

• 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.

  PMID: 29034802 BACKGROUND

• 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.

  PMID: 26788367 BACKGROUND

• 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.

  PMID: 141644 BACKGROUND

• 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.

  PMID: 13363246 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Josué Fernández Carnero, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 11, 2023
• Study Start: January 11, 2023
• Primary Completion: February 14, 2023
• Study Completion: February 21, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)