Latent Myofascial Trigger Point of Upper Trapezius MuscleNCT01709357
Short and Medium-term Effects of Manual Therapy on Latent Myofascial Pain
A study testing Muscle energy technique, Passive stretching technique and Ischemic compression technique in people with Latent Myofascial Trigger Point of Upper Trapezius Muscle, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
The purpose of this study was to investigate the short and medium-term effects of three manual techniques on cervical range of motion and pressure pain sensitivity in subjects with mechanical stress, presenting latent trigger point of upper trapezius muscle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Myofascial Trigger Point of Upper Trapezius Muscle
- What is being tested?
- Muscle energy technique, Passive stretching technique and Ischemic compression technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2011to Mar 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteers with 18 or more years of age
- with a palpable latent trigger point in the fibbers of the upper trapezius muscle
- with an average time of computer work of at least 2h/day.
Who cannot join
- with a body mass index (BMI) equal or higher than 31 kg/cm2
- with bilateral latent triggers in the fibers of the upper trapezius muscle
- have done any pharmacological therapeutic during any of the 7 days before the study or anti-coagulant therapeutics
- have done any treatment at cervical region during the month before the study
- having cardio-respiratory, neurological, neuro-musculoskeletal, oncologic or systemic pathologies
- having cognitive deficits or psychologic/psychiatric disturbances
- be pregnant
- having a clinical history of cervical, high dorsal, shoulder or cranial surgery or trauma during the prior 12 months.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Tecnologia da Saúde do Porto
Vila Nova de Gaia, Porto District, 4400-330
About this study
Official title: Short and Medium-term Effects of Manual Therapy on Latent Myofascial Pain : a Comparative Study
The purpose of this study was to investigate the short and medium-term effects of three manual techniques on cervical range of motion and pressure pain sensitivity in subjects with mechanical stress, presenting latent trigger point of upper trapezius muscle.
Read the detailed description
Myofascial pain syndrome is a common non-articular musculoskeletal chronic pain which has not been yet fully understood. It is characterized by myofascial trigger point. This trigger point is clinically classified as active or latent. Some studies have demonstrated the potential relevance of latent trigger point. In fact, its presence may cause muscle activation pattern alterations, increase nociceptive sensitivity and cause sympathetic activity alterations. Nevertheless, the vast majority of individuals, even asymptomatic, have latent trigger point. High prevalence of myofascial trigger points subsists at cervical and scapular regions.
There is few data regarding myofascial trigger point physiopathology. Furthermore, a diversity of therapeutic interventions consisting of trigger point inactivation and interruption of the vicious cycle is suggested in literature. Nevertheless, the effectiveness of these different interventions in trigger points and the duration of the effects are not yet fully clarified.
- Being tested
- Muscle energy technique, Passive stretching technique, Ischemic compression technique, Sham technique
- Keywords
- manual therapy, trigger point, range of motion, pain threshold, pain perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle energy techniqueOther
The therapist, with one hand on the occipital bone and the other on the shoulder, performed passive side flexion, contralateral to the muscle, taking the subject's head until the end-feel. Then, subjects performed an isometric contraction of 25% of their maximum force, for 5 seconds, while the therapist offered manual resistance. Afterwards the subject was let to relax in this position for additional 5 seconds. Side flexion was now increased until a new end-feel point was reached. This sequence was repeated 3 times. At the end, the therapist passively guided the cervical segment to the neutral position.
Passive stretching techniqueOther
The therapist, with one hand on the occipital bone and the other on the shoulder, performed a contralateral side flexion of the muscle passively until the maximum obtainable amplitude was reached, while subjects were asked to breathe steadily. During the breathing phase the therapist increased the side flexion until the end of the obtainable amplitude, this position was maintained. This procedure was repeated during 30 seconds. Finally the therapist passively guided the cervical segment to the neutral position.
Ischemic compression techniqueOther
The therapist, with a pincer contact, applied gradual pressure on the latent trigger point of the upper trapezius muscle. Subjects had been previously asked to say when pain was "moderate but bearable", a pain value of 7 in a 1 to 1o scale of pain (in which 1 corresponds to "no pain" and 10 do "unbearable pain"). At this point, pressure was maintained until pain levels were reduced to level 3. The therapist increased once more the pressure until the level of pain was 7 again. This procedure was repeated during 90 seconds.
Sham techniqueOther
The therapist was seated at the head of the treatment table, and with one hand on the occipital bone and the other on the shoulder, without executing any movement, for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Muscle energy technique | Experimental | In each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured.
On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions.
Next, the therapist performed the muscle energy technique of the upper trapezius muscle.
Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. Receives: Other: Muscle energy technique |
| Ischemic compression technique | Experimental | In each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured.
On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions.
Next, the therapist performed ischemic compression technique on the latent trigger point.
Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. Receives: Other: Ischemic compression technique |
| Passive stretching technique | Experimental | In each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured.
On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions.
Next, the therapist performed the passive stretching of the upper trapezius muscle.
Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. Receives: Other: Passive stretching technique |
| Sham technique | Sham comparator | In each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured.
On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions.
Next, for the sham technique, the therapist only contacted with his hands the head and the shoulder of the subject, without executing any movement, for 30 seconds.
Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. Receives: Other: Sham technique |
| No intervention group | No intervention | In each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured. On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions. Next,the subject was lying for 30 seconds, without intervention. Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pressure pain threshold at 10 minutes after the intervention
To obtain the pressure pain threshold measurements, an electronic pressure algometer was used. With the subject seated, the evaluator placed the pointer on the trigger pint with an approximate angle of 90º and an increasing pressure of approximately 1 kg/cm²/s. Subjects were told to use the word "now" whenever the sensation of pressure was replaced by a sensation of pain. At this point, the evaluator removed the algometer and the equipment recorded the maximum applied pressure.
Measured: 10 minutes after the intervention
Change from Baseline in Pressure pain threshold at 24 hours after the intervention
To obtain the pressure pain threshold measurements, an electronic pressure algometer was used. With the subject seated, the evaluator placed the pointer on the trigger pint with an approximate angle of 90º and an increasing pressure of approximately 1 kg/cm²/s. Subjects were told to use the word "now" whenever the sensation of pressure was replaced by a sensation of pain. At this point, the evaluator removed the algometer and the equipment recorded the maximum applied pressure.
Measured: 24 hours after the intervention
Change from Baseline in Pressure pain threshold at one week after the intervention
To obtain the pressure pain threshold measurements, an electronic pressure algometer was used. With the subject seated, the evaluator placed the pointer on the trigger pint with an approximate angle of 90º and an increasing pressure of approximately 1 kg/cm²/s. Subjects were told to use the word "now" whenever the sensation of pressure was replaced by a sensation of pain. At this point, the evaluator removed the algometer and the equipment recorded the maximum applied pressure.
Measured: one week after the intervention
Secondary outcomes (21)
Change from Baseline in Cervical flexion at 10 minutes after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical flexion actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 10 minutes after the intervention
Change from Baseline in Cervical extension at 10 minutes after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical extension actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 10 minutes after the intervention
Change from Baseline in Cervical side flexion (homo-lateral of trigger point) at 10 minutes after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical side flexion (homo-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 10 minutes after the intervention
Change from Baseline in Cervical rotation (homo-lateral of trigger point) at 10 minutes after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical rotation (homo-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 10 minutes after the intervention
Change from Baseline in Cervical side flexion (contra-lateral of trigger point) at 10 minutes after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical side flexion (contra-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 10 minutes after the intervention
Change from Baseline in Cervical rotation (contra-lateral of trigger point) at 10 minutes after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical rotation (contra-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 10 minutes after the intervention
Change from Baseline in Pressure pain perception at 10 minutes after the intervention
For the determination of th pressure pain perception, with the subject seated, the evaluator placed the pointer on the point of upper trapezius muscle with an angle of 90º and an increasing pressure of 1 kg/cm²/s until the pressure reached 2,5 kg/cm² and it was maintained for 5 seconds. Then the subject would characterize the level of pain through a visual analog scale), which had a ruler with a numerical scale of 0 to 10, being 0 "no pain or discomfort" and 10 "worse pain ever felt".
Measured: 10 minutes after the intervention
Change from Baseline in Cervical flexion at 24 hours after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical flexion actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 24 hours after the intervention
Change from Baseline in Cervical extension at 24 hours after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical extension actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 24 hours after the intervention
Change from Baseline in Cervical side flexion (homo-lateral of trigger point) at 24 hours after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical side flexion (homo-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 24 hours after the intervention
Change from Baseline in Cervical rotation (homo-lateral of trigger point) at 24 hours after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical rotation (homo-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 24 hours after the intervention
Change from Baseline in Cervical side flexion (contra-lateral of trigger point) at 24 hours after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical side flexion (contra-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 24 hours after the intervention
Change from Baseline in Cervical rotation (contra-lateral of trigger point) at 24 hours after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical rotation (contra-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: 24 hours after the intervention
Change from Baseline in Pressure pain perception at 24 hours after the intervention
For the determination of th pressure pain perception, with the subject seated, the evaluator placed the pointer on the point of upper trapezius muscle with an angle of 90º and an increasing pressure of 1 kg/cm²/s until the pressure reached 2,5 kg/cm² and it was maintained for 5 seconds. Then the subject would characterize the level of pain through a visual analog scale), which had a ruler with a numerical scale of 0 to 10, being 0 "no pain or discomfort" and 10 "worse pain ever felt".
Measured: 24 hours after the intervention
Change from Baseline in Cervical flexion at one week after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical flexion actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: one week after the intervention
Change from Baseline in Cervical extension at one week after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical extension actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: one week after the intervention
Change from Baseline in Cervical side flexion (homo-lateral of trigger point) at one week after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical side flexion (homo-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: one week after the intervention
Change from Baseline in Cervical rotation (homo-lateral of trigger point) at one week after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical rotation (homo-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: one week after the intervention
Change from Baseline in Cervical side flexion (contra-lateral of trigger point) at one week after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical side flexion (contra-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: one week after the intervention
Change from Baseline in Cervical rotation (contra-lateral of trigger point) at one week after the intervention
A cervical range of motion instrument was used to measure the cervical ranges of motion. Each subject performed cervical rotation (contra-lateral of trigger point)actively until the maximum available amplitude three times, and the evaluator read the values on the inclinometer on the plane of the performed movement.
Measured: one week after the intervention
Change from Baseline in Pressure pain perception at one week after the intervention
For the determination of th pressure pain perception, with the subject seated, the evaluator placed the pointer on the point of upper trapezius muscle with an angle of 90º and an increasing pressure of 1 kg/cm²/s until the pressure reached 2,5 kg/cm² and it was maintained for 5 seconds. Then the subject would characterize the level of pain through a visual analog scale), which had a ruler with a numerical scale of 0 to 10, being 0 "no pain or discomfort" and 10 "worse pain ever felt".
Measured: one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Latent Myofascial Trigger Point of Upper Trapezius MuscleStudies 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
- Participant, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, Principal investigator, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709357
- Sponsor's protocol ID
- NC-001
- Status last verified
- Oct 2012
- First submitted
- 12 Oct 2012
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Simons DG. New views of myofascial trigger points: etiology and diagnosis. Arch Phys Med Rehabil. 2008 Jan;89(1):157-9. doi: 10.1016/j.apmr.2007.11.016.
PubMed 18164347Fernandez-de-Las-Penas C, Simons D, Cuadrado ML, Pareja J. The role of myofascial trigger points in musculoskeletal pain syndromes of the head and neck. Curr Pain Headache Rep. 2007 Oct;11(5):365-72. doi: 10.1007/s11916-007-0219-z.
PubMed 17894927Simons DG. Review of enigmatic MTrPs as a common cause of enigmatic musculoskeletal pain and dysfunction. J Electromyogr Kinesiol. 2004 Feb;14(1):95-107. doi: 10.1016/j.jelekin.2003.09.018.
PubMed 14759755Ge HY, Arendt-Nielsen L. Latent myofascial trigger points. Curr Pain Headache Rep. 2011 Oct;15(5):386-92. doi: 10.1007/s11916-011-0210-6.
PubMed 21559783
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Medium-term Effects of Manual Therapy on Latent Myofascial Pain : a Comparative Study
- ClinicalTrials.gov ID
- NCT01709357
- Acronym / sponsor ID
- NC-001
- Keywords
- manual therapy, trigger point, range of motion, pain threshold, pain perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Oct 2012 (estimated)
- 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.
The purpose of this study was to investigate the short and medium-term effects of three manual techniques on cervical range of motion and pressure pain sensitivity in subjects with mechanical stress, presenting latent trigger point of upper trapezius muscle.
Detailed description
Myofascial pain syndrome is a common non-articular musculoskeletal chronic pain which has not been yet fully understood. It is characterized by myofascial trigger point. This trigger point is clinically classified as active or latent. Some studies have demonstrated the potential relevance of latent trigger point. In fact, its presence may cause muscle activation pattern alterations, increase nociceptive sensitivity and cause sympathetic activity alterations. Nevertheless, the vast majority of individuals, even asymptomatic, have latent trigger point. High prevalence of myofascial trigger points subsists at cervical and scapular regions.
There is few data regarding myofascial trigger point physiopathology. Furthermore, a diversity of therapeutic interventions consisting of trigger point inactivation and interruption of the vicious cycle is suggested in literature. Nevertheless, the effectiveness of these different interventions in trigger points and the duration of the effects are not yet fully clarified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Muscle energy technique | Experimental | Other: Muscle energy techniqueIn each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured. On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions. Next, the therapist performed the muscle energy technique of the upper trapezius muscle. Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. |
| Ischemic compression technique | Experimental | Other: Ischemic compression techniqueIn each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured. On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions. Next, the therapist performed ischemic compression technique on the latent trigger point. Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. |
| Passive stretching technique | Experimental | Other: Passive stretching techniqueIn each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured. On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions. Next, the therapist performed the passive stretching of the upper trapezius muscle. Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. |
| Sham technique | Sham comparator | Other: Sham techniqueIn each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured. On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions. Next, for the sham technique, the therapist only contacted with his hands the head and the shoulder of the subject, without executing any movement, for 30 seconds. Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. |
| No intervention group | No intervention | –In each volunteer, the therapist identified the latent trigger point on the upper trapezius. A questionnaire about general information was performed. And the maximum homolateral side flexion of the trigger point was measured. On the following week, the blind assessor performed the pre-intervention measurements of pressure pain threshold, pressure pain perception and cervical range of motions. Next,the subject was lying for 30 seconds, without intervention. Then, all measurements, before described, were repeated, by the assessor, after 10 minutes, 24 hours and one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- volunteers with 18 or more years of age
- with a palpable latent trigger point in the fibbers of the upper trapezius muscle
- with an average time of computer work of at least 2h/day.
Key exclusion criteria (8 listed)
- with a body mass index (BMI) equal or higher than 31 kg/cm2
- with bilateral latent triggers in the fibers of the upper trapezius muscle
- have done any pharmacological therapeutic during any of the 7 days before the study or anti-coagulant therapeutics
- have done any treatment at cervical region during the month before the study
- having cardio-respiratory, neurological, neuro-musculoskeletal, oncologic or systemic pathologies
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 |
|---|---|---|
| Muscle energy techniqueThe therapist, with one hand on the occipital bone and the other on the shoulder, performed passive side flexion, contralateral to the muscle, taking the subject's head until the end-feel. Then, subjects performed an isometric contraction of 25% of their maximum force, for 5 seconds, while the therapist offered manual resistance. Afterwards the subject was let to relax in this position for additional 5 seconds. Side flexion was now increased until a new end-feel point was reached. This sequence was repeated 3 times. At the end, the therapist passively guided the cervical segment to the neutral position. | Other | Muscle energy technique |
| Passive stretching techniqueThe therapist, with one hand on the occipital bone and the other on the shoulder, performed a contralateral side flexion of the muscle passively until the maximum obtainable amplitude was reached, while subjects were asked to breathe steadily. During the breathing phase the therapist increased the side flexion until the end of the obtainable amplitude, this position was maintained. This procedure was repeated during 30 seconds. Finally the therapist passively guided the cervical segment to the neutral position. | Other | Passive stretching technique |
| Ischemic compression techniqueThe therapist, with a pincer contact, applied gradual pressure on the latent trigger point of the upper trapezius muscle. Subjects had been previously asked to say when pain was "moderate but bearable", a pain value of 7 in a 1 to 1o scale of pain (in which 1 corresponds to "no pain" and 10 do "unbearable pain"). At this point, pressure was maintained until pain levels were reduced to level 3. The therapist increased once more the pressure until the level of pain was 7 again. This procedure was repeated during 90 seconds. | Other | Ischemic compression technique |
| Sham techniqueThe therapist was seated at the head of the treatment table, and with one hand on the occipital bone and the other on the shoulder, without executing any movement, for 30 seconds. | Other | Sham technique |
Primary outcome
Change from Baseline in Pressure pain threshold at 10 minutes after the intervention
Time frame: 10 minutes after the intervention
To obtain the pressure pain threshold measurements, an electronic pressure algometer was used. With the subject seated, the evaluator placed the pointer on the trigger pint with an approximate angle of 90º and an increasing pressure of approximately 1 kg/cm²/s. Subjects were told to use the word "now" whenever the sensation of pressure was replaced by a sensation of pain. At this point, the evaluator removed the algometer and the equipment recorded the maximum applied pressure.
Change from Baseline in Pressure pain threshold at 24 hours after the intervention
Time frame: 24 hours after the intervention
To obtain the pressure pain threshold measurements, an electronic pressure algometer was used. With the subject seated, the evaluator placed the pointer on the trigger pint with an approximate angle of 90º and an increasing pressure of approximately 1 kg/cm²/s. Subjects were told to use the word "now" whenever the sensation of pressure was replaced by a sensation of pain. At this point, the evaluator removed the algometer and the equipment recorded the maximum applied pressure.
Change from Baseline in Pressure pain threshold at one week after the intervention
Time frame: one week after the intervention
To obtain the pressure pain threshold measurements, an electronic pressure algometer was used. With the subject seated, the evaluator placed the pointer on the trigger pint with an approximate angle of 90º and an increasing pressure of approximately 1 kg/cm²/s. Subjects were told to use the word "now" whenever the sensation of pressure was replaced by a sensation of pain. At this point, the evaluator removed the algometer and the equipment recorded the maximum applied pressure.
21 secondary outcomes
Change from Baseline in Cervical flexion at 10 minutes after the intervention
Time frame: 10 minutes after the intervention
Change from Baseline in Cervical extension at 10 minutes after the intervention
Time frame: 10 minutes after the intervention
Change from Baseline in Cervical side flexion (homo-lateral of trigger point) at 10 minutes after the intervention
Time frame: 10 minutes after the intervention
Change from Baseline in Cervical rotation (homo-lateral of trigger point) at 10 minutes after the intervention
Time frame: 10 minutes after the intervention
Change from Baseline in Cervical side flexion (contra-lateral of trigger point) at 10 minutes after the intervention
Time frame: 10 minutes after the intervention
Change from Baseline in Cervical rotation (contra-lateral of trigger point) at 10 minutes after the intervention
Time frame: 10 minutes after the intervention
Change from Baseline in Pressure pain perception at 10 minutes after the intervention
Time frame: 10 minutes after the intervention
Change from Baseline in Cervical flexion at 24 hours after the intervention
Time frame: 24 hours after the intervention
Change from Baseline in Cervical extension at 24 hours after the intervention
Time frame: 24 hours after the intervention
Change from Baseline in Cervical side flexion (homo-lateral of trigger point) at 24 hours after the intervention
Time frame: 24 hours after the intervention
Change from Baseline in Cervical rotation (homo-lateral of trigger point) at 24 hours after the intervention
Time frame: 24 hours after the intervention
Change from Baseline in Cervical side flexion (contra-lateral of trigger point) at 24 hours after the intervention
Time frame: 24 hours after the intervention
Change from Baseline in Cervical rotation (contra-lateral of trigger point) at 24 hours after the intervention
Time frame: 24 hours after the intervention
Change from Baseline in Pressure pain perception at 24 hours after the intervention
Time frame: 24 hours after the intervention
Change from Baseline in Cervical flexion at one week after the intervention
Time frame: one week after the intervention
Change from Baseline in Cervical extension at one week after the intervention
Time frame: one week after the intervention
Change from Baseline in Cervical side flexion (homo-lateral of trigger point) at one week after the intervention
Time frame: one week after the intervention
Change from Baseline in Cervical rotation (homo-lateral of trigger point) at one week after the intervention
Time frame: one week after the intervention
Change from Baseline in Cervical side flexion (contra-lateral of trigger point) at one week after the intervention
Time frame: one week after the intervention
Change from Baseline in Cervical rotation (contra-lateral of trigger point) at one week after the intervention
Time frame: one week after the intervention
Change from Baseline in Pressure pain perception at one week after the intervention
Time frame: one week after the intervention
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 18 Oct 2012.
- Background: PubMed 18164347Simons DG. New views of myofascial trigger points: etiology and diagnosis. Arch Phys Med Rehabil. 2008 Jan;89(1):157-9. doi: 10.1016/j.apmr.2007.11.016.
- Background: PubMed 17894927Fernandez-de-Las-Penas C, Simons D, Cuadrado ML, Pareja J. The role of myofascial trigger points in musculoskeletal pain syndromes of the head and neck. Curr Pain Headache Rep. 2007 Oct;11(5):365-72. doi: 10.1007/s11916-007-0219-z.
- Background: PubMed 14759755Simons DG. Review of enigmatic MTrPs as a common cause of enigmatic musculoskeletal pain and dysfunction. J Electromyogr Kinesiol. 2004 Feb;14(1):95-107. doi: 10.1016/j.jelekin.2003.09.018.
- Background: PubMed 21559783Ge HY, Arendt-Nielsen L. Latent myofascial trigger points. Curr Pain Headache Rep. 2011 Oct;15(5):386-92. doi: 10.1007/s11916-011-0210-6.
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.
Natália MO Campelo principal investigator
Escola Superior de Tecnologia da Saúde do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle energy technique, Passive stretching technique and Ischemic compression technique in people with Latent Myofascial Trigger Point of Upper Trapezius Muscle, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 3 inclusion and 8 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 18 Oct 2012. 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 Portugal. 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?
Change from Baseline in Pressure pain threshold at 10 minutes after the intervention (time frame: 10 minutes after the intervention). 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?
On the ClinicalTrials.gov record for NCT01709357, which also lists 4 linked publications.
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 18 Oct 2012.