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Myofascial Trigger Point PainNCT02699294

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

A study testing Manual pressure release, Contract-relax PNF stretch and Z-stretch in people with Myofascial Trigger Point Pain, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Myofascial Trigger Point Pain
What is being tested?
Manual pressure release, Contract-relax PNF stretch and Z-stretch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2017to 11 Jul 2017
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 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Effectiveness of Two Different Stretching Exercises Combined With Pressure Release Technique on Latent Trigger Points in The Pectoralis Minor Muscle

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.

Read the 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.

Being tested
Manual pressure release, Contract-relax PNF stretch, Z-stretch
Keywords
Pain Threshold, Pectoralis Minor, Proprioceptive Neuromuscular Facilitation (PNF) Stretching, Physiotherapy, Rehabilitation
Medical subject headings
Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual pressure releaseOther

    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 stretchOther

    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.

  • Z-stretchOther

    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.

Study groups in NCT02699294
Study groupRoleWhat they receive
Contract-relax PNF stretchExperimentalA 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).
Receives: Other: Manual pressure release; Other: Contract-relax PNF stretch
Z-stretchExperimentalThe 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).
Receives: Other: Manual pressure release; Other: Z-stretch
Manual pressure releaseExperimentalThe single intervention of manual pressure release will be only applied to Group 3 according to the techniques describe by Simons et al. (1999).
Receives: Other: Manual pressure release
ControlNo interventionThis is a control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (9)

  1. 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.

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

  2. 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.

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

  3. 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

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

  4. The Forced Vital Capacity (FVC)

    The Forced Vital Capacity (FVC) (Liter (L) will be assessed by using a portable spirometer.

    Measured: Baseline and 24 hours follow-up

  5. Forced Expiratory Volume in 1 second (FEV1)

    Forced Expiratory Volume in 1 second (FEV1) (L) will be assessed by using a portable spirometer.

    Measured: Baseline and 24 hours follow-up

  6. The FEV1/FVC ratio

    The FEV1/FVC ratio (% of predicted normal) will be assessed by using a portable spirometer.

    Measured: Baseline and 24 hours follow-up

  7. Peak Expiratory Flow (PEF)

    Peak Expiratory Flow (PEF) (L/s) will be assessed by using a portable spirometer.

    Measured: Baseline and 24 hours follow-up

  8. Maximum Inspiratory Pressure (MIP)

    Maximum Inspiratory Pressure (MIP) will be assessed by using a hand-held respiratory pressure meter (cmH2O).

    Measured: Baseline and 24 hours follow-up

  9. Maximal Expiratory Pressure (MEP)

    Maximal Expiratory Pressure (MEP) will be assessed by using a hand-held respiratory pressure meter (cmH2O).

    Measured: Baseline and 24 hours follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study start1 Apr 2017
  3. Primary completion16 May 2017
  4. Study completion11 Jul 2017

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699294
Sponsor's protocol ID
34910702
Status last verified
Jul 2017
First submitted
16 Nov 2015
Last updated
13 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20673857

  • 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.

    PubMed 18434665

  • 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.

    PubMed 23801006

  • 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.

    PubMed 8669996

  • 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.

    PubMed 11002435

  • 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.

    PubMed 16679233

  • 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.

    PubMed 22506152

  • 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.

    PubMed 25467545

  • 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.

    PubMed 8628042

  • 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.

    PubMed 20850039

  • 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.

    PubMed 6602967

  • 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.

    PubMed 8773720

Questions about this trial

What is this clinical trial studying?

A study testing Manual pressure release, Contract-relax PNF stretch and Z-stretch in people with Myofascial Trigger Point Pain, run by Istanbul University at 1 site in Turkey (Türkiye).

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 1 inclusion and 6 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 13 Jul 2017. 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 Turkey (Türkiye). 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. 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 Pectoralis minor index (PMI) to 24 hours follow-up (time frame: Baseline, immediately after intervention, and 24 hours follow-up). 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 NCT02699294, which also lists 12 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 13 Jul 2017.

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