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The Effect Of Stretching Exercise on Pectoralis Minor Myofascial Latent Trigger Points

Primary Purpose

Myofascial Trigger Point Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual pressure release
Contract-relax PNF stretch
Z-stretch
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring Pain Threshold, Pectoralis Minor, Proprioceptive Neuromuscular Facilitation (PNF) Stretching, Physiotherapy, Rehabilitation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Contract-relax PNF stretch

Z-stretch

Manual pressure release

Control

Arm Description

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).

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).

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

This is a control group.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pectoralis minor length
The resting length of the pectoralis minor can be validly measured using palpable landmarks and can be reliably measured with a caliper or a cloth tape measure. These landmarks are (1) the inferomedial aspect of the coracoid process and (2) the caudal edge of the fourth rib at the sternum. The distance in centimeters between these bony reference points will be measured with using a tape measure.
Pain pressure threshold of pectoralis minor muscle myofascial latent trigger point site
Digital pressure algometry showed high intra-rater reliability for pressure pain threshold measurements which might be a useful parameter in assessing the effects of treatment for musculoskeletal pain and myofascial pain syndrome.
Rounded shoulder posture measure
There is no significant difference between the concurrent validity of the supine rounded shoulder posture measure an a seated assessment of scapular posture. Rounded shoulder posture will be measured from the acromion to the wall behind the subject to determine the amount of forward displacement with using a levelled metric ruler
The Forced Vital Capacity (FVC)
The Forced Vital Capacity (FVC) (Liter (L) will be assessed by using a portable spirometer.
Forced Expiratory Volume in 1 second (FEV1)
Forced Expiratory Volume in 1 second (FEV1) (L) will be assessed by using a portable spirometer.
The FEV1/FVC ratio
The FEV1/FVC ratio (% of predicted normal) will be assessed by using a portable spirometer.
Peak Expiratory Flow (PEF)
Peak Expiratory Flow (PEF) (L/s) will be assessed by using a portable spirometer.
Maximum Inspiratory Pressure (MIP)
Maximum Inspiratory Pressure (MIP) will be assessed by using a hand-held respiratory pressure meter (cmH2O).
Maximal Expiratory Pressure (MEP)
Maximal Expiratory Pressure (MEP) will be assessed by using a hand-held respiratory pressure meter (cmH2O).

Full Information

First Posted
November 16, 2015
Last Updated
July 11, 2017
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT02699294
Brief Title
The Effect Of Stretching Exercise on Pectoralis Minor Myofascial Latent Trigger Points
Official Title
Comparison of Effectiveness of Two Different Stretching Exercises Combined With Pressure Release Technique on Latent Trigger Points in The Pectoralis Minor Muscle
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
July 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Myofascial trigger points are hyperirritable points located within a taut band of skeletal muscle or fascia, which cause referred pain, local tenderness and autonomic changes when compressed. They are classified as either active myofascial trigger points (ATrPs) or latent myofascial trigger points (LTrPs). ATrPs can be inactivated by different treatment strategies; however, they never fully disappear but rather convert to the latent form. Therefore, the diagnosis and treatment of LTrPs is important. Invasive and noninvasive techniques are available for management of LTrPs. Invasive techniques include trigger point injections and dry needling whereas noninvasive techniques include manual therapy techniques and electrotherapy modalities. Manual therapy techniques for the treatment of myofascial trigger points include joint manipulation, strain/counterstrain, ischemic compression and pressure, massage therapy, myofascial release therapy, muscle energy techniques, point pressure release and transverse friction massage. Additionally, recent studies showed that the myofascial trigger point therapy combined with stretching exercise may be an effective for decreasing the pain level. However, there is insufficient evidence to determine what type stretching exercise is most effective and its immediate effects on muscle length in people with LTrPs. Therefore, the aim of this randomised-controlled trial is to investigate the effect on muscle length, pain perception threshold, and respiratory function after a single intervention of manual pressure release combined with stretching exercise on LTrPs in the pectoralis minor muscle. The sample size and power calculations is performed with the sample size calculator (InStat). The calculations is based on a standard deviation of 0.5 points, the minimal clinically important difference (MCID) for Pectoralis Minor Index of 0.89 points, an alpha level of 0.05, a β level of 5%, and a desired power of 95%. These parameters generate a sample size of at least 9 participants for each group. Total of 40 subjects will be recruited into the study in order to allow for a loss to follow-up. Potential participants will be invited through the posting of flyers at Istanbul University, Turkey. Flyer recruitment method will be used in this trial because it is the most effective, yielding the highest number of enrolments. All participants will be completed an informed consent form that described the purpose and procedures of testing. prior to participating in the study. Forty participants fitting the inclusion criteria will be randomly assigned to one of four parallel groups (ratio 1:1:1:1). For allocation of the participants, "Randomization.com" which is an online, randomisation web service will be used (http://www.randomization.com/). Simple randomisation procedures (computerized random numbers) will be done and sequentially numbered index cards with the random assignment will be prepared by an investigator with no clinical involvement in the study. The index cards will be folded and placed in sealed opaque envelopes. Then, the blind investigator will open each envelope and allocate the participants to group according to selected index card. The interventions will be performed by the same physiotherapist at a university research clinic, and assessments and data collection will be made by another therapist. Whereas interventionist will be aware of the allocated arm, patients and outcome assessor will be kept blind to allocation. The data will be evaluated using the Statistical Package for the Social Sciences 21.0 program for Windows and by analyzing descriptive statistics (frequency, mean and standard deviation). Kolmogorov-Smirnov Test will be used to assess the distribution of data. The one-way analysis of variance (ANOVA) for repeated measures with the Bonferroni post hoc test will used to determine whether differences in the mean scores of outcome measure among three time points (baseline, immediate after and 24 hours later) between study groups. In this study, p values less than 0.05 will be regarded as statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain
Keywords
Pain Threshold, Pectoralis Minor, Proprioceptive Neuromuscular Facilitation (PNF) Stretching, Physiotherapy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contract-relax PNF stretch
Arm Type
Experimental
Arm Description
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).
Arm Title
Z-stretch
Arm Type
Experimental
Arm Description
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).
Arm Title
Manual pressure release
Arm Type
Experimental
Arm Description
The single intervention of manual pressure release will be only applied to Group 3 according to the techniques describe by Simons et al. (1999).
Arm Title
Control
Arm Type
No Intervention
Arm Description
This is a control group.
Intervention Type
Other
Intervention Name(s)
Manual pressure release
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Contract-relax PNF stretch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Z-stretch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Pectoralis minor index (PMI) to 24 hours follow-up
Description
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).
Time Frame
Baseline, immediately after intervention, and 24 hours follow-up
Secondary Outcome Measure Information:
Title
Pectoralis minor length
Description
The resting length of the pectoralis minor can be validly measured using palpable landmarks and can be reliably measured with a caliper or a cloth tape measure. These landmarks are (1) the inferomedial aspect of the coracoid process and (2) the caudal edge of the fourth rib at the sternum. The distance in centimeters between these bony reference points will be measured with using a tape measure.
Time Frame
Baseline, immediately after intervention, and 24 hours follow-up
Title
Pain pressure threshold of pectoralis minor muscle myofascial latent trigger point site
Description
Digital pressure algometry showed high intra-rater reliability for pressure pain threshold measurements which might be a useful parameter in assessing the effects of treatment for musculoskeletal pain and myofascial pain syndrome.
Time Frame
Baseline, immediately after intervention, and 24 hours follow-up
Title
Rounded shoulder posture measure
Description
There is no significant difference between the concurrent validity of the supine rounded shoulder posture measure an a seated assessment of scapular posture. Rounded shoulder posture will be measured from the acromion to the wall behind the subject to determine the amount of forward displacement with using a levelled metric ruler
Time Frame
Baseline, immediately after intervention, and 24 hours follow-up
Title
The Forced Vital Capacity (FVC)
Description
The Forced Vital Capacity (FVC) (Liter (L) will be assessed by using a portable spirometer.
Time Frame
Baseline and 24 hours follow-up
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Forced Expiratory Volume in 1 second (FEV1) (L) will be assessed by using a portable spirometer.
Time Frame
Baseline and 24 hours follow-up
Title
The FEV1/FVC ratio
Description
The FEV1/FVC ratio (% of predicted normal) will be assessed by using a portable spirometer.
Time Frame
Baseline and 24 hours follow-up
Title
Peak Expiratory Flow (PEF)
Description
Peak Expiratory Flow (PEF) (L/s) will be assessed by using a portable spirometer.
Time Frame
Baseline and 24 hours follow-up
Title
Maximum Inspiratory Pressure (MIP)
Description
Maximum Inspiratory Pressure (MIP) will be assessed by using a hand-held respiratory pressure meter (cmH2O).
Time Frame
Baseline and 24 hours follow-up
Title
Maximal Expiratory Pressure (MEP)
Description
Maximal Expiratory Pressure (MEP) will be assessed by using a hand-held respiratory pressure meter (cmH2O).
Time Frame
Baseline and 24 hours follow-up
Other Pre-specified Outcome Measures:
Title
Visual Analogue Scale (VAS)
Description
The VAS is used for which a patient is asked to indicate his/her perceived pain during the rest and activity times. Respondents will mark the location on the 10-centimeter (cm) line corresponding to the amount of pain they experienced.
Time Frame
Baseline
Title
Disability arm shoulder hand questionnaire (DASH)
Description
The DASH questionnaire is a region-specific, self-report scale to evaluate health status of upper extremity disabilities.
Time Frame
Baseline
Title
Short-Form 12
Description
The Short-Form 12 questionnaire is an instrument for evaluating health and quality of life perception.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed with at least one latent myofascial trigger point in the pectoralis minor muscle Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tansu Birinci, PT
Organizational Affiliation
Research Assistant
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ebru Kaya Mutlu, PhD, PT
Organizational Affiliation
Lecturer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rustem Mustafaoglu, MSc, PT
Organizational Affiliation
Research Assistant
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arzu Razak Ozdincler, Prof. Dr
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20673857
Citation
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Results Reference
background
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18434665
Citation
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.
Results Reference
background
PubMed Identifier
23801006
Citation
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.
Results Reference
background
PubMed Identifier
8669996
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
16679233
Citation
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.
Results Reference
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PubMed Identifier
22506152
Citation
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.
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PubMed Identifier
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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.
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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.
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Citation
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.
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Results Reference
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Links:
URL
https://books.google.com.tr/books?id=63OYdoNBNC8C&redir_esc=y
Description
Simons et al., 1999

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The Effect Of Stretching Exercise on Pectoralis Minor Myofascial Latent Trigger Points

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