NCT02699294

Brief Summary

This randomised-controlled trial investigates whether a single intervention of manual pressure release combined with stretching exercise has an effect on muscle length, pain perception threshold, and respiratory function in subjects with latent myofascial trigger point in the pectoralis minor muscle or not. First quarter of the participants will receive a single intervention of manual pressure release combined with contract-relax PNF stretching exercise of pectoralis minor muscle, second quarter of the participants will receive a single intervention of manual pressure release combined with Z stretching exercise of pectoralis minor muscle while, only a single intervention of manual pressure release will be applied to third quarter of the participants and final quarter of them will not receive any intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

November 16, 2015

Last Update Submit

July 11, 2017

Conditions

Keywords

Pain ThresholdPectoralis MinorProprioceptive Neuromuscular Facilitation (PNF) StretchingPhysiotherapyRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Pectoralis minor index (PMI) to 24 hours follow-up

    The PMI will be calculated by dividing the resting muscle length measurement by the subject height in centimeters and multiplying by 100. The test-retest reliability for PMI measurement is 0.94 (95 % Confidence Interval (CI): 0.81-0.98).

    Baseline, immediately after intervention, and 24 hours follow-up

Secondary Outcomes (9)

  • Pectoralis minor length

    Baseline, immediately after intervention, and 24 hours follow-up

  • Pain pressure threshold of pectoralis minor muscle myofascial latent trigger point site

    Baseline, immediately after intervention, and 24 hours follow-up

  • Rounded shoulder posture measure

    Baseline, immediately after intervention, and 24 hours follow-up

  • The Forced Vital Capacity (FVC)

    Baseline and 24 hours follow-up

  • Forced Expiratory Volume in 1 second (FEV1)

    Baseline and 24 hours follow-up

  • +4 more secondary outcomes

Other Outcomes (3)

  • Visual Analogue Scale (VAS)

    Baseline

  • Disability arm shoulder hand questionnaire (DASH)

    Baseline

  • Short-Form 12

    Baseline

Study Arms (4)

Contract-relax PNF stretch

EXPERIMENTAL

A contract-relax PNF stretching techniques of the pectoralis minor muscle including latent trigger points will be applied by Group 1 after a single intervention of manual pressure release will be performed according to the techniques describe by Simons et al. (1999).

Other: Manual pressure releaseOther: Contract-relax PNF stretch

Z-stretch

EXPERIMENTAL

The Z- stretch of the pectoralis minor muscle including latent trigger points will be applied by Group 2 after a single intervention of manual pressure release will be performed according to the techniques describe by Simons et al. (1999).

Other: Manual pressure releaseOther: Z-stretch

Manual pressure release

EXPERIMENTAL

The single intervention of manual pressure release will be only applied to Group 3 according to the techniques describe by Simons et al. (1999).

Other: Manual pressure release

Control

NO INTERVENTION

This is a control group.

Interventions

Subjects will be positioned supine on a treatment plinth and will be encouraged to relax as much as possible before pressure is applied. A slow pressure to myofascial latent trigger point will be applied directly over the marked pectoralis minor muscle myofascial latent trigger point site until a moderate but tolerable pain value of 7 out of 10 (0= no pain, 10= severe pain) is reported. Constant pressure will be sustained for 90 seconds if the subjects report that the pain is decreased to a value of 3, the pressure will be increased to restore perceived pain to the value of 7. Then, tissue resistance (barrier) in pectoralis minor muscle will be controlled.

Contract-relax PNF stretchManual pressure releaseZ-stretch

Subjects will be in a sitting position with hands being clasped behind the head. The pectoralis minor muscle will be passively and slowly stretched until a strong but tolerable stretch discomfort intensity level of 4 out of 10 (0= no pain, 10= severe pain) is reported. Passive stretch will be sustained for 10 seconds followed by 6 seconds of maximal voluntary isometric contraction of the pectoralis minor muscle. Then, subjects will be instructed to relax for further 4 seconds. Subjects will maintain newly active stretched position of pectoralis minor muscle for 10 seconds with a strong but tolerable stretch discomfort intensity level of 4 out of 10. The procedure will be repeated four times with 30 seconds of rest between two successive trials.

Contract-relax PNF stretch

Subjects will be positioned supine with knee bent on a treatment plinth, and the legs will be rotated to the opposite direction of the arm to be stretched placing a stabilizing distal tension on the ribs. Then, the subjects will be slowly brought the arm in a circular motion overhead pausing at the points of tightness, maintaining close contact to the treatment table until a strong but tolerable stretch discomfort intensity level of 4 out of 10 (0= no pain, 10= severe pain) is reported. Self-stretch of pectoralis minor muscle, including myofascial latent trigger points will be sustained for 30 seconds. The procedure will be repeated four times with 30 seconds of rest between two successive trials.

Z-stretch

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects diagnosed with at least one latent myofascial trigger point in the pectoralis minor muscle

You may not qualify if:

  • Presence of active trigger points in the pectoralis minor muscle
  • Any orthopaedic problems pertaining to the spine-shoulder complex (e.g., fractures, arthrosis, listhesis, sprains, strains) within the last six months
  • Surgery on the spine-shoulder complex before the study
  • Neurological impairment in the upper extremities
  • Receiving the treatment for myofascial pain within the last three months
  • Receiving anti-inflammatory and pain relief medication in the past 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (12)

  • Trampas A, Kitsios A, Sykaras E, Symeonidis S, Lazarou L. Clinical massage and modified Proprioceptive Neuromuscular Facilitation stretching in males with latent myofascial trigger points. Phys Ther Sport. 2010 Aug;11(3):91-8. doi: 10.1016/j.ptsp.2010.02.003. Epub 2010 May 5.

    PMID: 20673857BACKGROUND
  • Borstad JD. Measurement of pectoralis minor muscle length: validation and clinical application. J Orthop Sports Phys Ther. 2008 Apr;38(4):169-74. doi: 10.2519/jospt.2008.2723. Epub 2007 Nov 21.

    PMID: 18434665BACKGROUND
  • Celik D, Mutlu EK. Clinical implication of latent myofascial trigger point. Curr Pain Headache Rep. 2013 Aug;17(8):353. doi: 10.1007/s11916-013-0353-8.

    PMID: 23801006BACKGROUND
  • Halbertsma JP, van Bolhuis AI, Goeken LN. Sport stretching: effect on passive muscle stiffness of short hamstrings. Arch Phys Med Rehabil. 1996 Jul;77(7):688-92. doi: 10.1016/s0003-9993(96)90009-x.

    PMID: 8669996BACKGROUND
  • Hanten WP, Olson SL, Butts NL, Nowicki AL. Effectiveness of a home program of ischemic pressure followed by sustained stretch for treatment of myofascial trigger points. Phys Ther. 2000 Oct;80(10):997-1003.

    PMID: 11002435BACKGROUND
  • Borstad JD, Ludewig PM. Comparison of three stretches for the pectoralis minor muscle. J Shoulder Elbow Surg. 2006 May-Jun;15(3):324-30. doi: 10.1016/j.jse.2005.08.011.

    PMID: 16679233BACKGROUND
  • Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.

    PMID: 22506152BACKGROUND
  • Lee JH, Cynn HS, Yoon TL, Ko CH, Choi WJ, Choi SA, Choi BS. The effect of scapular posterior tilt exercise, pectoralis minor stretching, and shoulder brace on scapular alignment and muscles activity in subjects with round-shoulder posture. J Electromyogr Kinesiol. 2015 Feb;25(1):107-14. doi: 10.1016/j.jelekin.2014.10.010. Epub 2014 Oct 28.

    PMID: 25467545BACKGROUND
  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PMID: 8628042BACKGROUND
  • Wong CK, Coleman D, diPersia V, Song J, Wright D. The effects of manual treatment on rounded-shoulder posture, and associated muscle strength. J Bodyw Mov Ther. 2010 Oct;14(4):326-33. doi: 10.1016/j.jbmt.2009.05.001. Epub 2009 Jun 26.

    PMID: 20850039BACKGROUND
  • Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.

    PMID: 6602967BACKGROUND
  • Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

    PMID: 8773720BACKGROUND

Related Links

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Tansu Birinci, PT

    Research Assistant

    PRINCIPAL INVESTIGATOR
  • Ebru Kaya Mutlu, PhD, PT

    Lecturer

    STUDY DIRECTOR
  • Rustem Mustafaoglu, MSc, PT

    Research Assistant

    PRINCIPAL INVESTIGATOR
  • Arzu Razak Ozdincler, Prof. Dr

    Professor

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 16, 2015

First Posted

March 4, 2016

Study Start

April 1, 2017

Primary Completion

May 16, 2017

Study Completion

July 11, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations