- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05249660
Instrument Assisted Soft Tissue Mobilization Versus Trigger Points Release on Upper Trapezius Trigger Points
Effect of Instrument Assisted Soft Tissue Mobilization Versus Trigger Points Release on Pain; Mobility and Function of Upper Trapezius Trigger Points in Chronic Neck Pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Trigger point is defined as a hyperirritable palpable nodule contained in the skeletal muscle fibers. The palpable nodule, also named taut band, is described as a limited number of fibers with an increased stiffness. Trp causes the muscles to week and stiff, leading to reduction in range of movement. MTrP can produce local and referred pain, either on manual compression or spontaneously.
Instrument-assisted soft tissue mobilization (IASTM) is the use of hard tools to manipulate soft tissue and was derived from the Cyriax1 cross-friction massage. It has recently emerged as a popular alternative to traditional manual therapy techniques. Modern-day IASTM instruments vary in material (e.g. stainless steel, plastic) and design and are used to improve a variety of musculoskeletal conditions and associated outcomes.
Manual technique that uses direct vertical pressure to the TP, is a well-established treatment method used to resolve the TP-related pain syndrome. This directed pressure is managed according to the therapist's perception of the tissue resistance of the treated soft tissue or according to the pain perceived by the patient based on a pain scale. Manual therapy is a commonly used treatment for MPS as it has been considered one of the most effective techniques for the inactivation of MTrPs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54000
- Ganga Ram Hospital and Care medical centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with neck pain in the upper trapezius muscle
- Tender nodule, constant pain, a jump sign during palpation will be included in this study
Exclusion Criteria:
- Patients with Whiplash injury
- History of neck/shoulder surgery
- Cervical Radiculopathy
- History of malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Soft tissue release technique
Patient sat on a chair.
The therapist stood behind the participant and held one hand over head as the support, with the thumb of the other hand scan to detect the painful area of the latent TP of the upper trapezius muscle along the fibers.
Then, pressure was applied by the thumb and the participant was asked to simultaneously actively change the muscle from shorted position to elongated state (ipsilateral side flexion of the cervical to the opposite side).
This technique was repeated 3-5 times per session, and each repetition was maintained for 40-60 s till release is felt, with a 15-second rest interval.
Three times passive stretching of the upper trapezius muscle was also performed for 45 s for each side.
|
Patient sat on a chair.
The therapist stood behind the participant and held one hand over head as the support, with the thumb of the other hand scan to detect the painful area of the latent TP of the upper trapezius muscle along the fibers.
Then, pressure was applied by the thumb and the participant was asked to simultaneously actively change the muscle from shorted position to elongated state (ipsilateral side flexion of the cervical to the opposite side).
This technique was repeated 3-5 times per session, and each repetition was maintained for 40-60 s till release is felt, with a 15-second rest interval.
Three times passive stretching of the upper trapezius muscle was also performed for 45 s for each side.
|
Active Comparator: Instrument assisted soft tissue mobilization
Patient lied prone; the treatment was applied for approximately 20-seconds in a direction parallel to the muscle fibers with the instrument at a 45º angle.
Followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45º angle for an additional 20-second, resulting in a total treatment time of approximately 40 s.
This technique was applied 3-5 times per session with 20 s rest between each time.
Three times passive stretching of the upper trapezius muscle was also performed for 45 s for each side.
|
Patient lied prone; the treatment was applied for approximately 20-seconds in a direction parallel to the muscle fibers with the instrument at a 45º angle.
Followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45º angle for an additional 20-second, resulting in a total treatment time of approximately 40 s.
This technique was applied 3-5 times per session with 20 s rest between each time.
Three times passive stretching of the upper trapezius muscle was also performed for 45 s for each side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale
Time Frame: 6 weeks
|
Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
|
6 weeks
|
Goniometry
Time Frame: 6 weeks
|
Goniometer is used to measure the ranges of body joints.
|
6 weeks
|
Neck disability index
Time Frame: 6 weks
|
Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform
|
6 weks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR&AH/21/0129/TAUSEEF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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