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Trigger Point Pain, MyofascialNCT04559906

Spray Stretch Technique Versus Sustain Pressure for Trapezius Triggers

A study testing Spray and Stretch technique (Ethyl chloride) and Sustain pressure release in people with Trigger Point Pain, Myofascial and Mechanical Neck Pain, run by Riphah International University at 1 site in Pakistan.

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

The aim of this research is to determine the effects of spray and stretch technique versus sustain pressure for the management of upper trapezius triggers. A randomized control trail is conducting at Khyber Teaching Hospital Peshawar and Northwest General Hospital and Research center Peshawar. The sample size is 54. Read more about this study

Who is it for?
Ages 20 to 35 years
What is being tested?
Spray and Stretch technique (Ethyl chloride) and Sustain pressure release
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 sitePakistan
Study dates
30 Sep 2020to 31 Mar 2021
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 20 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • At least one active myofascial trigger point in upper trapezius muscle.
  • Painful limitation of neck lateral flexion range to opposite side of affected muscle.

Who cannot join

  • Participants with pain pattern which is similar to pain of trigger point due to any other reason not related myofascial trigger points.
  • Any trauma to cervical spine (whiplash injury) or any cervical spine surgery.
  • Cervical myeloma, complex regional pain syndrome, thoracic outlet syndrome.
  • Cervical radiculopathy

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Northwest General hospital

    Peshawar, KPK, 25000

Other trials in Pakistan

About this study

Official title: Effects of Spray and Stretch Technique Versus Sustain Pressure for the Management of Upper Trapezius Triggers

The aim of this research is to determine the effects of spray and stretch technique versus sustain pressure for the management of upper trapezius triggers. A randomized control trail is conducting at Khyber Teaching Hospital Peshawar and Northwest General Hospital and Research center Peshawar. The sample size is 54. The Participants divide into two groups, 27 participants in Group A (receive the spray and stretch technique) and 27 in Group B (receive sustain pressure). The study duration is 6 months. Purposive non probability sampling technique applied. Only 20 to 35 years participants with upper trapezius trigger is including in this trial. Tools use in this study are visual analogue scale (VAS), Neck Disability Index (NDI), Hospital Anxiety and Depression Scale (HADS), Goniometer, Algometer and Manual muscle strength (MMT). Data analyzed through SPSS version 25.

Read the detailed description

Myofascial Trigger Point (MTrP) is a hyperirritable spot in the taut bands of the skeletal muscles' fascia which is palpable and tender, on direct compression can produce referred pain in its reference zone, local tenderness and elicit a local twitch response. MTrP can be identified as either active or latent. According to Simons et al. that active and latent trigger points are associated with tenderness, muscle dysfunction, muscle weakness and restricted muscle length. An active MTrP causes spontaneous pain complaint in surrounding tissue and generally in its pain reference zone while latent MTrP physically exist but doesn't associate with spontaneous pain complaint. However, by direct compression latent MTrP can cause local pain on the site of taut band. Myofascial trigger points (MTrP) are considered one of the most common cause of musculoskeletal pain. Active MTrP are considered to be more prevalent in upper fibers of trapezius muscle (45% in right upper trapezius and 25% in left upper trapezius and cause neck pain and shoulder discomfort. Predisposing Factors associated to MTrP can be either mechanical stress (such as overuse of muscles, repetitive strain injury, work related mechanical disorder, awkward posture and degenerative condition) or metabolic stress( such as hypo metabolic state and vitamin deficiency).According to integrated hypothesis presented by Simon, MTrP is believed to develop after a local injury either repetitive micro trauma or gross trauma to the muscle fibers. The diagnostic criteria of MTrP used by recent studies which is presented by Simons et al. is based on palpation of muscle. A well-trained clinician palpates the muscle to localize the active MTrP. During physical examination, a hyper sensitive spot within taut bands of muscle fibers, Palpation of recognized spot results in referred pain within reference zone, palpation of recognized spot elicits a jump sign (defensive movement), palpation may result in local twitch response defined as visible contraction of muscle. There are varieties of physiotherapy interventions for the management of MTrP which maybe invasive and non-invasive such as dry needling, anesthetic injections, spray and stretch, ischemic compression and muscle energy techniques. A very limited evidence found on effects of spray and stretch technique versus sustain pressure for the Management of upper trapezius trigger points with flaws in methodology design. To fill the gap, this study is formulated to determine the effects of spray and stretch technique vs sustain pressure for the management of upper trapezius MTrP. Study will find out most effective treatment for management of upper trapezius and would contribute to educate and treat the patient with most simple and effective treatment approach.

Literature review A systematic and evidence-based search of relevant literature were performed by utilizing PubMed and Google Scholar as search engines.

A study conducted in 2017 regarding spray and stretch technique versus progressive pressure release on treatment of myofascial pain trigger point reported that spray and stretch technique was more effective in increasing functional activities while progressive pressure release was more effective in decreasing pain

Another study in 2017 regarding Immediate effect of spray and stretch on trapezitis demonstrated that spray and stretch technique is effective in terms to increases range of motion and increase pain pressure threshold on acute trapezitis.

A study in 2017 found that the number of active MTrP was positively associated with the physical burden of headache and trait anxiety.

Study in 2013 concluded that Vapocoolant spray may be more effective than ice as an analgesic for IV insertion. Subjects were more satisfied with vapocoolant spray.

Another study in 2014 investigated that spray and stretch had a short-term (<6h) effect in reducing post needling soreness of a latent MTrP and Pressure pain threshold did not significantly change after spray and stretch.

Study in 2018 reported that ischemic compression and progressive sustained pressure both have significant effect on improving the pain of patients with chronic musculoskeletal pain pathologies.

Being tested
Spray and Stretch technique (Ethyl chloride), Sustain pressure release
Keywords
Spray and Stretch technique, Progressive Pressure release technique, Active myofascial trigger points, Upper Trapezius Triggers
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.

  • Spray and Stretch technique (Ethyl chloride)Other

    Group A receive spray and stretch technique (Ethyl chloride) with conventional treatment.

    The upper trapezius muscle stretches on the basis of the Technique originally described by Simons. The subject is seated in a relaxed position on their homolateral hand for anchoring the distal end of the studied muscle. Initially, 3 to 5 parallel sweeps of ethyl chloride spray is applied covering the Upper trapezius muscle. Then, the muscle are positioned in a maximal but tolerable stretch and lengthened until the Physical Therapist felt the muscle tension barrier. This procedure repeated 2 or 3 times.

  • Sustain pressure releaseOther

    Group B receive sustain pressure release with conventional treatment. Progressive pressure release are considered in two stages. The initial step is to recognize and find the trigger in upper fiber of trapezius, utilizing trigger point palpation. Trigger point felt as firm and restricted hyperirritable knots with in gut of the muscle.

    The second step is to applying pressure release ranging from eight to twelve second for each pressure, then it increases gradually for maximum of twenty seconds. The total duration of pressure is five minutes or more until the discharge is felt by the fingers.

Study groups in NCT04559906
Study groupRoleWhat they receive
Group AExperimentalSpray and Stretch technique Conventional treatment Hot pack (10-15 min) Stretching (3 sets of 10 repetitions with 10 seconds hold) AROM exercises (3 sets of 10 repetition)
Receives: Other: Spray and Stretch technique (Ethyl chloride)
Group BActive comparatorSustain pressure release Conventional treatment Hot pack (10-15 min) Stretching (3 sets of 10 repetitions with 10 seconds hold) AROM exercises (3 sets of 10 repetition)
Receives: Other: Sustain pressure release

What is being measured

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

  1. Neck disability index

    Changes from base line Northwick disability index was developed first in Northwick Park hospital, England. It was designed to measure the neck pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100.

    Measured: 2 weeks

  2. Pressure Pain Threshold (PPT)

    Changes from the Baseline Pressure Pain Threshold (PPT) will taken with the help of Algometer

    Measured: 2 weeks

Secondary outcomes (3)
  1. Visual Analogue scale(VAS)

    Changes from base Line Visual Analogue scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain

    Measured: 2 weeks

  2. Range Of Motion of cervical

    Changes from the Baseline range of Motion of cervical spine will take with the Help of Goniometer

    Measured: 2 weeks

  3. The Hospital Anxiety and Depression Scale (HADS)

    HADS is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. The HADS is a fourteen-item scale. Seven of the items relate to anxiety and seven relate to depression.The "0-7" score indicates normal condition,"8-10" score indicates boarderline case and "11-21" score indicates the abnormal case.

    Measured: 2 weeks

Timeline

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

  1. First posted23 Sep 2020
  2. Study start30 Sep 2020
  3. Primary completion15 Mar 2021
  4. Study completion31 Mar 2021

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
Model description
Assignment
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559906
Sponsor's protocol ID
REC/00686 Uzair Ahmad
Status last verified
Apr 2022
First submitted
16 Sep 2020
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amin D. SPRAY STRETCH TECHNIQUE VERSUS PROGRESSIVE PRESSURE RELEASE ON TRATMENT OF MYOFACIAL PAIN TRIGGER POINT: RANDOMIZED CONTROLLED TRIAL. International Journal of Physiotherapy and Research. 2017;5:2101-7

  • Bulbuli D. Immediate Effect of Spray and Stretch Technique on Trapezits: An Experimental Study. Journal of Medical Science And clinical Research. 2017;05:20591-6

  • Palacios-Cena M, Castaldo M, Wang K, Catena A, Torelli P, Arendt-Nielsen L, Fernandez-de-Las-Penas C. Relationship of active trigger points with related disability and anxiety in people with tension-type headache. Medicine (Baltimore). 2017 Mar;96(13):e6548. doi: 10.1097/MD.0000000000006548.

    PubMed 28353618
  • Waterhouse MR, Liu DR, Wang VJ. Cryotherapeutic topical analgesics for pediatric intravenous catheter placement: ice versus vapocoolant spray. Pediatr Emerg Care. 2013 Jan;29(1):8-12. doi: 10.1097/PEC.0b013e31827b214b.

    PubMed 23283254
  • Martin-Pintado Zugasti A, Rodriguez-Fernandez AL, Garcia-Muro F, Lopez-Lopez A, Mayoral O, Mesa-Jimenez J, Fernandez-Carnero J. Effects of spray and stretch on postneedling soreness and sensitivity after dry needling of a latent myofascial trigger point. Arch Phys Med Rehabil. 2014 Oct;95(10):1925-1932.e1. doi: 10.1016/j.apmr.2014.05.021. Epub 2014 Jun 10.

    PubMed 24928191
  • Sharifullah M, Sajjad A, Mubeen A, Tariq I, Khan A, Darain H. COMPARISON OF SUSTAINED PRESSURE VS ISCHEMIC COMPRESSION ON TRIGGER POINTS IN CHRONIC MYOFACIAL PAIN MANAGEMENT. 2018

Questions about this trial

What is this clinical trial studying?

A study testing Spray and Stretch technique (Ethyl chloride) and Sustain pressure release in people with Trigger Point Pain, Myofascial and Mechanical Neck Pain, run by Riphah International University at 1 site in Pakistan.

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 2 inclusion and 4 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 15 Apr 2022. 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 Pakistan. 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?

Neck disability index (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT04559906, which also lists 6 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 15 Apr 2022.

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