Trigger Point Pain, MyofascialNCT05971953
Muscle Energy Technique on Hamstring Muscle for Trigger Points of Muscle of Mastication
A study testing Muscle Energy Technique and Conventional PT in people with Trigger Point Pain, Myofascial and Temporomandibular Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial is to find the effect of muscle energy technique for trigger points of muscle of mastication for reducing pain , improving mouth opening and jaw functional limitations. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Trigger Point Pain, Myofascial, Temporomandibular Disorder
- What is being tested?
- Muscle Energy Technique and Conventional PT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2023to 28 Apr 2024
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 25 to 50 years..
- Diagnosis of trps using the diagnostic criteria:
- Presence of palpable taut band in a skeletal muscle.
- Presence of hypersensitive tendor spot in a taut band
- Spontaneous response of the typical referred pain pattern.
- A local twitch response provided by snapping palpation of taut band.
- Reproduction of the typical referred pain pattern of Trp in response to compression.
- Reduced mouth opening < 40nm
Who cannot join
- Diagnosis of fibromyalgia.
- History of whiplash injury
- History of any surgery in the cranio cervical region
- Having under gone any myofacial pain therapy
- No lower extremity or low back pathology.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Railway General Hospital
Rawalpindi, Punjab Province
KINZA ANWAR, MS-OMPT, +92-3239735427, kinza.anwar@riphah.edu.pk
Naureena Binte Sayed, MS-OMPT*
About this study
Official title: Effect of Muscle Energy Technique on Hamstring Muscle for the Trigger Points of Muscle of Mastication
The aim of this randomized controlled trial is to find the effect of muscle energy technique for trigger points of muscle of mastication for reducing pain , improving mouth opening and jaw functional limitations.
Read the detailed description
The primary muscles of mastication (chewing food) are the temporalis, medial pterygoid, lateral pterygoid, and masseter muscles. The masticatory muscles are divided into elevator and depressor groups. The collective term 'hamstrings' refers to four muscles- semimembranosus (SM), semitendinosus (ST), biceps femoris long head (BFlh) and biceps femoris short head (BFsh). The hamstring muscles are the major flexors of the knee and also aid hip extension. Trigger point is classically defined as a hyperirritable spot in the skeletal muscle that is associated with a hypersensitive palpable nodule in a taut band which is painful on compression and can give rise to characteristic referred pain, motor dysfunction, and autonomic phenomena. Latent trigger points located in the muscles can interfere with muscular movement patterns, cause cramps, and reduce muscle strength. Active MTrPs can be associated with a reduced range of motion through muscle dysfunction and muscle weakness, causing orefacial pain, MTrPs in the masticatory muscles may restrict active maximum mouth opening (MMO).
It is possible that stretching the hamstring muscles may activate the dorsal periaqueductal grey area of the midbrain [PAG], and activate descending inhibitory control pathways. It is known that descending projections from the PAG to the medulla have collateral branches that terminate in various areas including the upper cervical spinal cord. Convergence of the nociceptive afferents from the receptive fields of cervical roots C1-C3 and those of the trigeminal nerve, which include the masseter muscle, occurs in the nucleus caudalis. If hamstring muscle stretching is capable of activating the PAG, then decreased sensitivity should affect a greater number of muscles, including the remaining masticatory muscles.
Muscle energy technique (MET) is a manual technique developed by osteopaths that is now used in many different manual therapy professions. It is claimed to be effective for a variety of purposes, including lengthening a shortened or contractured muscle, strengthening muscles, as a lymphatic or venous pump to aid the drainage of fluid or blood, and increasing the range of motion (ROM) of a restricted joint. MET may influence pain mechanisms and promote hypoalgesia.
- Being tested
- Muscle Energy Technique, Conventional PT
- Keywords
- trigger points, muscles of mastication, hamstring
- Medical subject headings
- Myofascial Pain Syndromes, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy TechniqueOther
They would be receiving treatment as follow:
The patient is instructed to gently attempt to push down on the practitioner's shoulder with the leg against the practitioner's resistance( 75% of his and her available strength). After the relaxation, the muscle is lengthened more aggressively beyond the barrier and held for up to 15 seconds. Frequency: 10 reps for 4 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 20 mins
Conventional PTOther
They would be receiving conventional treatment as follow:
including hot pack for 10 mins ischemic compression for 60 seconds .Frequency: 5 reps with 60 sec hold for 4 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins
| Study group | Role | What they receive |
|---|---|---|
| Muscle Energy Technique | Active comparator | Muscle Energy Technique Receives: Other: Muscle Energy Technique |
| Conventional PT | Other | Hot pack Ischemic compression Receives: Other: Conventional PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale VAS
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
Measured: 2 weeks
Secondary outcomes (2)
Inch Tape
A measuring tape is a flexible tool used for measuring. It is marked in centimeters and inches.
Measured: 2 weeks
Jaw Functional Limitation Scale
The JFLS-20 is an organ-specific instrument comprising 3 constructs for assessing functional status of the masticatory system; the 3 scales exhibit properties that are ideal for both research and patient evaluation in patient groups with a range of functional limitations of the jaw.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start30 Aug 2023
- Primary completion10 Mar 2024 (estimated)
- Study completion28 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Point Pain, MyofascialStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KINZA ANWAR, MS-OMPT, Principal investigator, RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971953
- Sponsor's protocol ID
- REC/01649Naureena Binte Sayed
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Energy Technique on Hamstring Muscle for the Trigger Points of Muscle of Mastication
- ClinicalTrials.gov ID
- NCT05971953
- Acronym / sponsor ID
- REC/01649Naureena Binte Sayed
- Keywords
- trigger points, muscles of mastication, hamstring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 28 Apr 2024 (estimated)
- First posted
- 2 Aug 2023 (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 this randomized controlled trial is to find the effect of muscle energy technique for trigger points of muscle of mastication for reducing pain , improving mouth opening and jaw functional limitations.
Detailed description
The primary muscles of mastication (chewing food) are the temporalis, medial pterygoid, lateral pterygoid, and masseter muscles. The masticatory muscles are divided into elevator and depressor groups. The collective term 'hamstrings' refers to four muscles- semimembranosus (SM), semitendinosus (ST), biceps femoris long head (BFlh) and biceps femoris short head (BFsh). The hamstring muscles are the major flexors of the knee and also aid hip extension. Trigger point is classically defined as a hyperirritable spot in the skeletal muscle that is associated with a hypersensitive palpable nodule in a taut band which is painful on compression and can give rise to characteristic referred pain, motor dysfunction, and autonomic phenomena. Latent trigger points located in the muscles can interfere with muscular movement patterns, cause cramps, and reduce muscle strength. Active MTrPs can be associated with a reduced range of motion through muscle dysfunction and muscle weakness, causing orefacial pain, MTrPs in the masticatory muscles may restrict active maximum mouth opening (MMO).
It is possible that stretching the hamstring muscles may activate the dorsal periaqueductal grey area of the midbrain [PAG], and activate descending inhibitory control pathways. It is known that descending projections from the PAG to the medulla have collateral branches that terminate in various areas including the upper cervical spinal cord. Convergence of the nociceptive afferents from the receptive fields of cervical roots C1-C3 and those of the trigeminal nerve, which include the masseter muscle, occurs in the nucleus caudalis. If hamstring muscle stretching is capable of activating the PAG, then decreased sensitivity should affect a greater number of muscles, including the remaining masticatory muscles.
Muscle energy technique (MET) is a manual technique developed by osteopaths that is now used in many different manual therapy professions. It is claimed to be effective for a variety of purposes, including lengthening a shortened or contractured muscle, strengthening muscles, as a lymphatic or venous pump to aid the drainage of fluid or blood, and increasing the range of motion (ROM) of a restricted joint. MET may influence pain mechanisms and promote hypoalgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Technique | Active comparator | Other: Muscle Energy TechniqueMuscle Energy Technique |
| Conventional PT | Other | Other: Conventional PTHot pack Ischemic compression |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age group 25 to 50 years..
- Diagnosis of trps using the diagnostic criteria:
- Reduced mouth opening < 40nm
Key exclusion criteria (5 listed)
- Diagnosis of fibromyalgia.
- History of whiplash injury
- History of any surgery in the cranio cervical region
- Having under gone any myofacial pain therapy
- No lower extremity or low back pathology.
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 |
|---|---|---|
| Muscle Energy TechniqueThey would be receiving treatment as follow: The patient is instructed to gently attempt to push down on the practitioner's shoulder with the leg against the practitioner's resistance( 75% of his and her available strength). After the relaxation, the muscle is lengthened more aggressively beyond the barrier and held for up to 15 seconds. Frequency: 10 reps for 4 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 20 mins | Other | Muscle Energy Technique |
| Conventional PTThey would be receiving conventional treatment as follow: including hot pack for 10 mins ischemic compression for 60 seconds .Frequency: 5 reps with 60 sec hold for 4 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins | Other | Conventional PT |
Primary outcome
Visual Analog Scale VAS
Time frame: 2 weeks
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
2 secondary outcomes
Inch Tape
Time frame: 2 weeks
Jaw Functional Limitation Scale
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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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.
KINZA ANWAR, MS-OMPT principal investigator
RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technique and Conventional PT in people with Trigger Point Pain, Myofascial and Temporomandibular Disorder, 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KINZA ANWAR, MS-OMPT (+92-3239735427, kinza.anwar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale VAS (time frame: 2 weeks). 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 5 Sep 2023.