Trigger PointsNCT05249660
Instrument Assisted Soft Tissue Mobilization Versus Trigger Points Release on Upper Trapezius Trigger Points
A study testing Soft tissue release technique and Comparator: Instrument assisted soft tissue mobilization in people with Trigger Points, run by Riphah International University at 1 site in Pakistan.
Trial summary
Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 30 participants from Ganga Ram Hospital and Care medical centre will be selected and randomly allocated to two different groups i.e Group A and Group B. . Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Points
- What is being tested?
- Soft tissue release technique and Comparator: Instrument assisted soft tissue mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jan 2022to 13 Jul 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with neck pain in the upper trapezius muscle
- Tender nodule, constant pain, a jump sign during palpation will be included in this study
Who cannot join
- Patients with Whiplash injury
- History of neck/shoulder surgery
- Cervical Radiculopathy
- History of malignancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ganga Ram Hospital and Care medical centre
Lahore, Punjab Province, 54000
About this study
Official title: 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 will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 30 participants from Ganga Ram Hospital and Care medical centre will be selected and randomly allocated to two different groups i.e Group A and Group B. . Group A will be treated by trigger point release. Group B will be treated by Instrument assisted soft tissue release. NPRS, GONIOMETRY, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.
Read the 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.
- Conditions
- Trigger Points
- Being tested
- Soft tissue release technique, Comparator: Instrument assisted soft tissue mobilization
- Keywords
- Upper trapezius pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue release techniqueOther
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.
Comparator: Instrument assisted soft tissue mobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue release technique | Experimental | 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. Receives: Other: Soft tissue release technique |
| Instrument assisted soft tissue mobilization | Active comparator | 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. Receives: Other: Comparator: Instrument assisted soft tissue mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable
Measured: 6 weeks
Goniometry
Goniometer is used to measure the ranges of body joints.
Measured: 6 weeks
Neck disability index
Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform
Measured: 6 weks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start25 Jan 2022
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger PointsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249660
- Sponsor's protocol ID
- REC/RCR&AH/21/0129/TAUSEEF
- Status last verified
- Nov 2022
- First submitted
- 4 Feb 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05249660
- Acronym / sponsor ID
- REC/RCR&AH/21/0129/TAUSEEF
- Conditions
- Trigger Points
- Keywords
- Upper trapezius pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 30 participants from Ganga Ram Hospital and Care medical centre will be selected and randomly allocated to two different groups i.e Group A and Group B. . Group A will be treated by trigger point release. Group B will be treated by Instrument assisted soft tissue release. NPRS, GONIOMETRY, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft tissue release technique | Experimental | Other: Soft tissue release techniquePatient 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. |
| Instrument assisted soft tissue mobilization | Active comparator | Other: Comparator: Instrument assisted soft tissue mobilizationPatient 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with neck pain in the upper trapezius muscle
- Tender nodule, constant pain, a jump sign during palpation will be included in this study
Key exclusion criteria (4 listed)
- Patients with Whiplash injury
- History of neck/shoulder surgery
- Cervical Radiculopathy
- History of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft tissue release techniquePatient 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. | Other | Soft tissue release technique |
| Comparator: Instrument assisted soft tissue mobilizationPatient 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. | Other | Instrument assisted soft tissue mobilization |
Primary outcome
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
Goniometry
Time frame: 6 weeks
Goniometer is used to measure the ranges of body joints.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Trigger Points
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Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
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Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
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Comparison of Suboccipital Release and Muscle Energy Technique in Subjects With Mechanical Neck Pain and Forward Head Posture
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Not yet recruitingPhase 4
Botulinum Toxin Type A Versus Triamcinolone for Facial Myalgia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Sanaullah, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue release technique and Comparator: Instrument assisted soft tissue mobilization in people with Trigger Points, 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 28 Nov 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?
Numeric pain rating scale (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2022.