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Spray Stretch Technique Versus Sustain Pressure for Trapezius Triggers

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ClinicalTrials.gov Identifier: NCT04559906
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Trigger Point Pain, Myofascial Mechanical Neck Pain Combination Product: Spray and Stretch technique (Ethyl chloride) Other: Sustain pressure release Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Spray and Stretch Technique Versus Sustain Pressure for the Management of Upper Trapezius Triggers
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Spray 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)
Combination Product: Spray and Stretch technique (Ethyl chloride)

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.


Active Comparator: Group B
Sustain 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)
Other: Sustain pressure release

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.





Primary Outcome Measures :
  1. Neck disability index [ Time Frame: 2 weeks ]
    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.

  2. Pressure Pain Threshold (PPT) [ Time Frame: 2 weeks ]
    Changes from the Baseline Pressure Pain Threshold (PPT) will taken with the help of Algometer


Secondary Outcome Measures :
  1. Visual Analogue scale(VAS) [ Time Frame: 2 weeks ]
    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

  2. Range Of Motion of cervical [ Time Frame: 2 weeks ]
    Changes from the Baseline range of Motion of cervical spine will take with the Help of Goniometer

  3. The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 2 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559906


Contacts
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Contact: Imran Amjad, PHD 03324390125 imran.amjad@riphah.edu.pk

Locations
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Pakistan
Northwest General hospital Recruiting
Peshawar, KPK, Pakistan, 25000
Contact: Saira Waqqar, PHD*    03336176884    saira.waqar@riphah.edu.pk   
Principal Investigator: Uzair Ahmad, MSOMPT*         
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Dr Saira Waqqar, PP-DPT,MHPE Riphah International University
Publications:
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04559906    
Other Study ID Numbers: REC/00686 Uzair Ahmad
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Riphah International University:
Spray and Stretch technique
Progressive Pressure release technique
Active myofascial trigger points
Upper Trapezius Triggers
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Neck Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Ethyl Chloride
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents