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Short and Medium-term Effects of Manual Therapy on Latent Myofascial Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier:
NCT01709357
First received: October 12, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Latent Myofascial Trigger Point of Upper Trapezius Muscle
Other: Muscle energy technique
Other: Passive stretching technique
Other: Ischemic compression technique
Other: Sham technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short and Medium-term Effects of Manual Therapy on Latent Myofascial Pain : a Comparative Study

Further study details as provided by Escola Superior de Tecnologia da Saúde do Porto:

Primary Outcome Measures:
  • Change from Baseline in Pressure pain threshold at 10 minutes after the intervention [ Time Frame: 10 minutes after the intervention ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in Cervical flexion at 10 minutes after the intervention [ Time Frame: 10 minutes after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical extension at 10 minutes after the intervention [ Time Frame: 10 minutes after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical rotation (homo-lateral of trigger point) at 10 minutes after the intervention [ Time Frame: 10 minutes after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical rotation (contra-lateral of trigger point) at 10 minutes after the intervention [ Time Frame: 10 minutes after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Pressure pain perception at 10 minutes after the intervention [ Time Frame: 10 minutes after the intervention ] [ Designated as safety issue: Yes ]
    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".

  • Change from Baseline in Cervical flexion at 24 hours after the intervention [ Time Frame: 24 hours after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical extension at 24 hours after the intervention [ Time Frame: 24 hours after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical rotation (homo-lateral of trigger point) at 24 hours after the intervention [ Time Frame: 24 hours after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical rotation (contra-lateral of trigger point) at 24 hours after the intervention [ Time Frame: 24 hours after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Pressure pain perception at 24 hours after the intervention [ Time Frame: 24 hours after the intervention ] [ Designated as safety issue: Yes ]
    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".

  • Change from Baseline in Cervical flexion at one week after the intervention [ Time Frame: one week after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical extension at one week after the intervention [ Time Frame: one week after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical rotation (homo-lateral of trigger point) at one week after the intervention [ Time Frame: one week after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Cervical rotation (contra-lateral of trigger point) at one week after the intervention [ Time Frame: one week after the intervention ] [ Designated as safety issue: Yes ]
    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.

  • Change from Baseline in Pressure pain perception at one week after the intervention [ Time Frame: one week after the intervention ] [ Designated as safety issue: Yes ]
    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".


Enrollment: 117
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Muscle energy technique

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.

Other: Muscle energy technique
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.
Experimental: Ischemic compression technique

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.

Other: Ischemic compression technique
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.
Experimental: Passive stretching technique

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.

Other: Passive stretching technique
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.
Sham Comparator: Sham technique

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.

Other: Sham technique
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.
No Intervention: No intervention group

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709357

Locations
Portugal
Escola Superior de Tecnologia da Saúde do Porto
Vila Nova de Gaia, Porto, Portugal, 4400-330
Sponsors and Collaborators
Escola Superior de Tecnologia da Saúde do Porto
Investigators
Principal Investigator: Natália MO Campelo Escola Superior de Tecnologia da Saúde do Porto
  More Information

Publications:
Responsible Party: Natália Maria Oliveira Campelo, Professor, Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier: NCT01709357     History of Changes
Other Study ID Numbers: NC-001
Study First Received: October 12, 2012
Last Updated: October 16, 2012
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Escola Superior de Tecnologia da Saúde do Porto:
manual therapy
trigger point
range of motion
pain threshold
pain perception

ClinicalTrials.gov processed this record on November 20, 2014