NCT01709357

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

6 months

First QC Date

October 12, 2012

Last Update Submit

October 16, 2012

Conditions

Keywords

manual therapytrigger pointrange of motionpain thresholdpain perception

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    one week after the intervention

Secondary Outcomes (21)

  • Change from Baseline in Cervical flexion at 10 minutes after the intervention

    10 minutes after the intervention

  • Change from Baseline in Cervical extension at 10 minutes after the intervention

    10 minutes after the intervention

  • Change from Baseline in Cervical side flexion (homo-lateral of trigger point) at 10 minutes after the intervention

    10 minutes after the intervention

  • Change from Baseline in Cervical rotation (homo-lateral of trigger point) at 10 minutes after the intervention

    10 minutes after the intervention

  • Change from Baseline in Cervical side flexion (contra-lateral of trigger point) at 10 minutes after the intervention

    10 minutes after the intervention

  • +16 more secondary outcomes

Study Arms (5)

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.

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.

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.

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.

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.

Interventions

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.

Muscle energy 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.

Passive stretching 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.

Ischemic compression 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.

Sham technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Tecnologia da Saúde do Porto

Vila Nova de Gaia, Porto District, 4400-330, Portugal

Location

Related Publications (4)

  • 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.

    PMID: 18164347BACKGROUND
  • Fernandez-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.

    PMID: 17894927BACKGROUND
  • Simons 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.

    PMID: 14759755BACKGROUND
  • Ge 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.

    PMID: 21559783BACKGROUND

Study Officials

  • Natália MO Campelo

    Escola Superior de Tecnologia da Saúde do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 12, 2012

First Posted

October 18, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations