Neck PainNCT05265468
Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain
A study testing Jones Group (Strain Counterstrain), Lewit Group and Chaitow Group in people with Neck Pain and Trigger Point Pain, Myofascial, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Trigger Point Pain, Myofascial
- What is being tested?
- Jones Group (Strain Counterstrain), Lewit Group and Chaitow Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2022to 19 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- persistent neck pain or headache for more than 3 days
- presence of active trigger point in upper trapezius
Who cannot join
- Participants who present dizziness, vertigo and/or symptoms aggravated by the movement and/or positioning of the neck;
- who present infection or febrile state at the time of performing the test;
- with anxiety and/or extreme emotional tension;
- who are undergoing pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain. A Randomized Clinical Trial
Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy. Based on these factors, the objective of the study is to determine the effect of the combined therapy of the Jones, Chaitow, Lewit technique and pain-free positioning in participants with the presence of an active upper trapezius trigger point.
Read the detailed description
The treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 3 experimental groups and a placebo group, of no-pain positioning. In addition to basic indices and scales of cervical pain and functionality, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when it comes to representing reliable results in differences between techniques.
- Conditions
- Neck Pain, Trigger Point Pain, Myofascial
- Being tested
- Jones Group (Strain Counterstrain), Lewit Group, Chaitow Group, Placebo Group
- Keywords
- Physiotherapy, Rehabilitation, Treatment, Active Trigger Point
- Medical subject headings
- Neck Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jones Group (Strain Counterstrain)Other
No pain positioning technique with diaphragmatic breathing
Lewit GroupOther
Isometric muscular exercise acompained with stretching technique
Chaitow GroupOther
Isometric muscular exercise acompained with stretching technique and diaphragmatic breathing
Placebo GroupOther
No pain positioning of participants
| Study group | Role | What they receive |
|---|---|---|
| Jones Group (Strain Counterstrain) | Experimental | Jones Group consist in 90 seconds in a ralease positioning of no pain in muscle acortation Receives: Other: Jones Group (Strain Counterstrain) |
| Lewit Group | Active comparator | Lewit Group consist in a maximum of four minutes of muscular contraction acompaind by stretching techniques Receives: Other: Lewit Group |
| Chaitow Group | Active comparator | Chaitow Group consist in a maximum of four minutes of muscular contraction acompaind by stretching techniques and deep diaphragmatic respiration Receives: Other: Chaitow Group |
| Placebo Group | Placebo comparator | Placebo Group only have to mantain no pain positioning for 3 minutes Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Self-completed neck questionnaire wich consists in 10 sections. Each one of them (cervical pain intensity, personal care, lifting weights, reading, headache, ability to concentrate, ability to work, driving, sleep and leisure activities) offers 6 possible answers that represent 6 progressive levels of functional capacity, and is scored from 0 to 5. The total score is expressed in percentage terms with respect to the maximum possible
Measured: 10 minutes
Pain intensity
Measured with Numeric Rating Scale wich consist in measure pain intensity with a score of 0-10
Measured: 10 minutes
Pression algometer
Measures pressure pain thresholds
Measured: 10 minutes
Secondary outcomes (2)
Cervical Test
Measured with Baiobit Software. The range of movement will be measured in grades as per: flexion/extension; right/left rotation; and right/left inclination
Measured: 10 minutes
Proprioceptive Test
Measured with Baiobit Software o'clock test in a high/medium/low levels wich consist in a velocity and accuracy evaluation of combined cervical movements in the o'clock game test.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start14 Mar 2022
- Primary completion14 Mar 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Martínez Fuentes, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265468
- Sponsor's protocol ID
- CE112103
- Status last verified
- May 2022
- First submitted
- 20 Jan 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05265468
- Acronym / sponsor ID
- CE112103
- Conditions
- Neck Pain, Trigger Point Pain, Myofascial
- Keywords
- Physiotherapy, Rehabilitation, Treatment, Active Trigger Point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. The scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy. Based on these factors, the objective of the study is to determine the effect of the combined therapy of the Jones, Chaitow, Lewit technique and pain-free positioning in participants with the presence of an active upper trapezius trigger point.
Detailed description
The treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 3 experimental groups and a placebo group, of no-pain positioning. In addition to basic indices and scales of cervical pain and functionality, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when it comes to representing reliable results in differences between techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Jones Group (Strain Counterstrain) | Experimental | Other: Jones Group (Strain Counterstrain)Jones Group consist in 90 seconds in a ralease positioning of no pain in muscle acortation |
| Lewit Group | Active comparator | Other: Lewit GroupLewit Group consist in a maximum of four minutes of muscular contraction acompaind by stretching techniques |
| Chaitow Group | Active comparator | Other: Chaitow GroupChaitow Group consist in a maximum of four minutes of muscular contraction acompaind by stretching techniques and deep diaphragmatic respiration |
| Placebo Group | Placebo comparator | Other: Placebo GroupPlacebo Group only have to mantain no pain positioning for 3 minutes |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- persistent neck pain or headache for more than 3 days
- presence of active trigger point in upper trapezius
Key exclusion criteria (4 listed)
- Participants who present dizziness, vertigo and/or symptoms aggravated by the movement and/or positioning of the neck;
- who present infection or febrile state at the time of performing the test;
- with anxiety and/or extreme emotional tension;
- who are undergoing pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jones Group (Strain Counterstrain)No pain positioning technique with diaphragmatic breathing | Other | Jones Group (Strain Counterstrain) |
| Lewit GroupIsometric muscular exercise acompained with stretching technique | Other | Lewit Group |
| Chaitow GroupIsometric muscular exercise acompained with stretching technique and diaphragmatic breathing | Other | Chaitow Group |
| Placebo GroupNo pain positioning of participants | Other | Placebo Group |
Primary outcome
Neck Disability Index
Time frame: 10 minutes
Self-completed neck questionnaire wich consists in 10 sections. Each one of them (cervical pain intensity, personal care, lifting weights, reading, headache, ability to concentrate, ability to work, driving, sleep and leisure activities) offers 6 possible answers that represent 6 progressive levels of functional capacity, and is scored from 0 to 5. The total score is expressed in percentage terms with respect to the maximum possible
Pain intensity
Time frame: 10 minutes
Measured with Numeric Rating Scale wich consist in measure pain intensity with a score of 0-10
Pression algometer
Time frame: 10 minutes
Measures pressure pain thresholds
2 secondary outcomes
Cervical Test
Time frame: 10 minutes
Proprioceptive Test
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jones Group (Strain Counterstrain), Lewit Group and Chaitow Group in people with Neck Pain and Trigger Point Pain, Myofascial, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.