Transcutaneous Electrical Nerve Stimulation and Cervical Joint Manipulation on Pressure Pain Threshold
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 144
- Locations
- 4
- Primary Endpoint
- Pressure Pain Threshold of the posterior region of the forearm
Study Overview
Brief Summary
This study evaluates the hypoalgesic effect of the TENS application associated with joint manipulation of the cervical region in healthy individuals. One group had both active treatments, the other group received both placebo treatments, the third and fourth group received only one of the two treatments actively and the other placebo
Detailed Description
Transcutaneous Electrical Nerve Stimulation (TENS) and Cervical Joint Manipulation (CJM) are often used for pain treatment.
TENS also promotes analgesia by activating a descending pathway, which originates in the periaqueductal grey (PAG) and in the rostroventromedial medulla (RVM) to inhibit the excitability of nociceptive neurons in the dorsal horn of the spinal cord.
Joint manipulation generates a series of stimuli within the central nervous system through the activation of proprioceptors located in the joint capsule or muscles, stimulates the PAG, causing pain inhibition by activation of non-opioid descending inhibitory pathways
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The blinding will be assessed by examiner 2 (responsible for administering TENS) asking the participants which TENS intervention they think they received, with 3 options for the answer: "active," "placebo" or "don't know". The same questions will be asked by examiner 2 for CJM. Next, examiner 3 (responsible for administering CJM) will receive the blinding outcome and have 3 options for the answer: "active," "placebo" or "don't know". Examiner 1 will receive the blinding outcome will be asked: "Which group does the patient belong to: active TENS and CJM, active TENS and placebo CJM, placebo TENS and active CJM or placebo TENS and CJM" Their responses to these questions will be recorded and used to measure the adequacy of participants and examiners
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy subjects
- •no pain complaints from the last 90 days
Exclusion Criteria
- •previous spinal surgeries
- •spinal canal stenosis
- •vertebral fracture
- •spondylolisthesis
- •acute infections
- •hemorrhagic disorders
- •active tuberculosis
- •deep vein thrombosis
- •osteoporosis
- •diseases rheumatic
- •diseases metabolic
- •cardiorespiratory diseases
- •headache in the last seven days
- •changes in skin sensitivity
- •use of pacemaker
- •women in menstrual period
- •pregnant women
- •use of pain-killers in the last 48 hours
- •use of anti-inflammatory drugs in the last 48 hours
- •previous electrostimulation
- •previous cervical joint manipulation treatments
- •hypersensitivity to TENS application
- •aversion to cervical joint manipulation
- •positive test for vertebral artery.
Arms & Interventions
active TENS and CJM
The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes.
After application of TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust).
Intervention: Application of TENS (Device)
active TENS and CJM
The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes.
After application of TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust).
Intervention: CJM (Device)
placebos TENS and CJM
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value.
Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies[42-44]. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect
Intervention: Placebo CJM (Device)
placebos TENS and CJM
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value.
Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies[42-44]. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect
Intervention: Placebo TENS (Device)
placebo TENS and active CJM
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value.
After application of placebo TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation.
Intervention: CJM (Device)
placebo TENS and active CJM
The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value.
After application of placebo TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation.
Intervention: Placebo TENS (Device)
active TENS and placebo CJM
The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes.
After application of placebo TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation.
Intervention: Application of TENS (Device)
active TENS and placebo CJM
The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes.
After application of placebo TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation.
Intervention: Placebo CJM (Device)
Outcomes
Primary Outcomes
Pressure Pain Threshold of the posterior region of the forearm
Time Frame: 1 minute after the end of the intervention.
The examiner will use a Somedic Type II digital pressure algometer (Somedic Inc, Hörby, Sweden) on the posterior region of the forearm 10cm below the lateral epicondyle of the elbow towards the third finger, with the forearm maintained in pronation. Next, the pressure will be applied perpendicularly to the skin at a rate of 40kPa/s using a flat, 1cm2 circular probe covered with 1mm of rubber to avoid any skin pain from sharp metal edges. The average of the PPT scores (in kPa) will be recorded by the assessor.
Secondary Outcomes
- Pressure Pain Threshold of the tibialis anterior muscle(20 minutes after the end of the intervention)
- Pressure Pain Threshold of the posterior region of the forearm(20 minutes after the end of the intervention)
Investigators
Jonathan Daniel Telles
Principal Investigator
Universidade Federal de Sao Carlos