Upper Trapezius Trigger PointsNCT05415813
Effects of IC With and Without MET on Upper Trapezius Trigger Points
A study testing Ischemic Compression and Ischemic compression with Muscle Energy Technique in people with Upper Trapezius Trigger Points, run by University of Lahore at 1 site in Pakistan.
Trial summary
the aim of the study is to check the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Upper Trapezius Trigger Points
- What is being tested?
- Ischemic Compression and Ischemic compression with Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Aug 2021to 23 Jun 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender Aged 18 to 50 years (40)
- Participants with active myofascial trigger points in the upper trapezius diagnosed by a senior physiotherapist on the basis of Travel and Simon criteria will be randomly allocated into two clinical groups.
- Taut band having palpable nodule within upper trapezius muscle
- Pain produced in a specific pattern which is radiating in character when firm pressure is applied on trigger points
Who cannot join
- Trauma (whiplash injury)
- Injury to Cervical Spine
- Cervical Spine surgery
- Cervical Myelopathy and Radiculopathy
- Osteoporosis of the cervical spine
- Cervical myeloma
- Complex regional pain syndrome
- Patients with the H/O any Neurological, Rheumatology and other serious medical illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ischemic Compression With and Without Muscle Energy Technique on Pain, Range of Motion and Functional Disability in Patients With Trigger Points in Upper Trapezius; A Randomized Clinical Trial
the aim of the study is to check the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. In previous studies, Muscle Energy Technique and Ischemic Compression are compared with different conventional and combined therapy approaches, including most of the techniques used to treat Trigger Points in the upper trapezius. No study has evaluated the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. The outcome measures are a Numeric pain rating scale, universal goniometer and neck disability index questionnaire.
- Conditions
- Upper Trapezius Trigger Points
- Being tested
- Ischemic Compression, Ischemic compression with Muscle Energy Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic CompressionOther
It includes conventional Physical therapy, hot packs (75°C) for 20 minutes, and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold, and 10-second relaxation between two repetitions) as a baseline treatment. For the Ischemic compression, the patient will be in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position physiotherapist will apply gradually increasing pressure to the Trigger points until the subject perceived the first noticeable pain. At that moment, the pressure will be maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure will be increased until the discomfort appears again. This process will be maintained for 90 seconds.
Ischemic compression with Muscle Energy TechniqueOther
The Participants will receive all the treatments given to the active comparator group and they will also receive the Muscle Energy Technique treatment in supine position and the practitioner will stabilize the shoulder of the affected side with one hand, while the ear/mastoid area of the affected side will be held by the opposite hand. The head and neck were then bent towards the contralateral side, flexed, and ipsilaterally rotated. The subjects will then shrug the stabilized shoulder towards the ear at a sub-maximal pain-free effort (20% of the available strength). The isometric contraction will be held for 7-10s. This position will be maintained for 30 seconds and repeated three to five times per treatment session. Treatment sessions will be given on alternate days.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Compression | Active comparator | Ischemic Compression will be applied to the upper trapezius trigger points in patients recruited in group 1. Receives: Other: Ischemic Compression |
| Ischemic compression and Muscle Energy Technique | Experimental | ischemic compression along with muscle energy technique will be applied to the upper trapezius trigger points in patients allocated to group 2. Receives: Other: Ischemic compression with Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in pain on Numeric Pain Rating Scale at week 4
on a scale of 1 to 10, o means no pain while 10 means worst pain
Measured: Baseline and week 4
Change from Baseline in Goniometer readings at week 4
for flexion any value less than 90 degrees indicates limited range of motion, for extension any value less than 70 indicates limited range of motion, for lateral flexion values less than 20 and greater than 45 considered limited, for rotation value less than 90 is considered limited
Measured: Baseline and week 4
Change from baseline in Neck disability index questionnaire scores at week 4
on a scale of 0 to 50, 0 indicates no disability and 50 indicates completely disabled
Measured: Baseline and week 4
Secondary outcomes (3)
Pain on Numeric Pain Rating Scale at week 2
on a scale of 1 to 10, o means no pain while 10 means worst pain
Measured: week 2
Goniometer readings at week 2
Using goniometer, neck ranges of motion will be measured. for flexion any value less than 90 degrees indicates limited range of motion, for extension any value less than 70 indicates limited range of motion, for lateral flexion values less than 20 and greater than 45 considered limited, for rotation value less than 90 is considered limited
Measured: week 2
Neck disability index questionnaire scores at week 2
on a scale of 0 to 50, 0 indicates no disability and 50 indicates completely disabled
Measured: week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start17 Aug 2021
- Primary completion17 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Trapezius Trigger PointsStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syeda Khadija Kazmi, DPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415813
- Sponsor's protocol ID
- IRB-UOL-FAHS/890-II/2021
- Status last verified
- Apr 2023
- First submitted
- 8 Jun 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ischemic Compression With and Without Muscle Energy Technique on Pain, Range of Motion and Functional Disability in Patients With Trigger Points in Upper Trapezius; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05415813
- Acronym / sponsor ID
- IRB-UOL-FAHS/890-II/2021
- Conditions
- Upper Trapezius Trigger Points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 13 Jun 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.
the aim of the study is to check the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. In previous studies, Muscle Energy Technique and Ischemic Compression are compared with different conventional and combined therapy approaches, including most of the techniques used to treat Trigger Points in the upper trapezius. No study has evaluated the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. The outcome measures are a Numeric pain rating scale, universal goniometer and neck disability index questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Compression | Active comparator | Other: Ischemic CompressionIschemic Compression will be applied to the upper trapezius trigger points in patients recruited in group 1. |
| Ischemic compression and Muscle Energy Technique | Experimental | Other: Ischemic compression with Muscle Energy Techniqueischemic compression along with muscle energy technique will be applied to the upper trapezius trigger points in patients allocated to group 2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both gender Aged 18 to 50 years (40)
- Participants with active myofascial trigger points in the upper trapezius diagnosed by a senior physiotherapist on the basis of Travel and Simon criteria will be randomly allocated into two clinical groups.
- Taut band having palpable nodule within upper trapezius muscle
- Pain produced in a specific pattern which is radiating in character when firm pressure is applied on trigger points
Key exclusion criteria (8 listed)
- Trauma (whiplash injury)
- Injury to Cervical Spine
- Cervical Spine surgery
- Cervical Myelopathy and Radiculopathy
- Osteoporosis of the cervical spine
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 |
|---|---|---|
| Ischemic CompressionIt includes conventional Physical therapy, hot packs (75°C) for 20 minutes, and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold, and 10-second relaxation between two repetitions) as a baseline treatment. For the Ischemic compression, the patient will be in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position physiotherapist will apply gradually increasing pressure to the Trigger points until the subject perceived the first noticeable pain. At that moment, the pressure will be maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure will be increased until the discomfort appears again. This process will be maintained for 90 seconds. | Other | Ischemic Compression |
| Ischemic compression with Muscle Energy TechniqueThe Participants will receive all the treatments given to the active comparator group and they will also receive the Muscle Energy Technique treatment in supine position and the practitioner will stabilize the shoulder of the affected side with one hand, while the ear/mastoid area of the affected side will be held by the opposite hand. The head and neck were then bent towards the contralateral side, flexed, and ipsilaterally rotated. The subjects will then shrug the stabilized shoulder towards the ear at a sub-maximal pain-free effort (20% of the available strength). The isometric contraction will be held for 7-10s. This position will be maintained for 30 seconds and repeated three to five times per treatment session. Treatment sessions will be given on alternate days. | Other | Ischemic compression and Muscle Energy Technique |
Primary outcome
Change from Baseline in pain on Numeric Pain Rating Scale at week 4
Time frame: Baseline and week 4
on a scale of 1 to 10, o means no pain while 10 means worst pain
Change from Baseline in Goniometer readings at week 4
Time frame: Baseline and week 4
for flexion any value less than 90 degrees indicates limited range of motion, for extension any value less than 70 indicates limited range of motion, for lateral flexion values less than 20 and greater than 45 considered limited, for rotation value less than 90 is considered limited
Change from baseline in Neck disability index questionnaire scores at week 4
Time frame: Baseline and week 4
on a scale of 0 to 50, 0 indicates no disability and 50 indicates completely disabled
3 secondary outcomes
Pain on Numeric Pain Rating Scale at week 2
Time frame: week 2
Goniometer readings at week 2
Time frame: week 2
Neck disability index questionnaire scores at week 2
Time frame: week 2
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 7 Apr 2023.
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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.
Syeda Khadija Kazmi, DPT principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Compression and Ischemic compression with Muscle Energy Technique in people with Upper Trapezius Trigger Points, run by University of Lahore 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 4 inclusion and 8 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 7 Apr 2023. 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?
Change from Baseline in pain on Numeric Pain Rating Scale at week 4 (time frame: Baseline and week 4). 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 7 Apr 2023.