Trigger Point Pain, MyofascialNCT05497856
Comparison of Integrated Neuromuscular Inhibition Technique With Myofascial Release on Rhomboids Trigger Points
A study testing Integrated neuromuscular inhibition technique and Myofascial Release in people with Trigger Point Pain, Myofascial, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to compare the effect of integrated neuromuscular inhibition technique and myofascial release on pain, pain pressure threshold and shoulder disability in patients with rhomboid muscle. Randomized controlled trials will be done at Benazir Bhutto Hospital. The sample size is 32. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Integrated neuromuscular inhibition technique and Myofascial Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2022to 30 Sep 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Shoulder or mid back pain
- Presence of atleast one trigger points in rhomboids (diagnosed by the characteristics like hyperirritable spot in a taut band, twitch response and referral pain)
- Presence of Jump sign
Who cannot join
- • Any history of recent shoulder or Neck surgeries
- Fractures, Dislocations, Traumatic injuries, Adhesive capsulitis, Tendinitis, thoracic outlet syndrome, Advanced osteoporosis, Psychiatric Disorders
- Signs of cervical spinal cord compromise (e.g. diffuse sensory abnormality, diffuse weakness, hyperreflexia, or the presence of clonus
- Two or more signs of nerve root involvement (e.g. dermatomal sensation changes, myotomal weakness, or diminished/absent tendon jerk reflexes)
- A history of shoulder degenerative joint disease as per radiographs, endocrine disorders, and autoimmune conditions (e.g. rheumatoid arthritis, fibromyalgia etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Integrated Neuromuscular Inhibition Technique With the Myofascial Release on Pain and Stiffness in Rhomboids Trigger Points
The aim of this research is to compare the effect of integrated neuromuscular inhibition technique and myofascial release on pain, pain pressure threshold and shoulder disability in patients with rhomboid muscle. Randomized controlled trials will be done at Benazir Bhutto Hospital. The sample size is 32. The subjects will be divided in two groups, 16 subjects in integrated neuromuscular inhibition technique group and 16 in myofascial release group. Study duration will be of 6 months. Sampling technique applied will be non-probability purposive sampling technique. Only 25-45 years patients with shoulder/mid back pain and the presence of atleast one trigger point in rhomboid muscles will be included. Tools used in the study are algometer, shoulder pain and disability index (SPADI) and Numeric pain rating scale (NPRS). Data will be analyzed through SPSS 21.
Read the detailed description
: Trigger points (TrPs) are focal, discrete, and hyperirritable spots located in a taut band within a skeletal muscle. These are painful on compression and can produce referred pain, tenderness, autonomic nervous system symptoms, restricted range of motion and motor dysfunction. These trigger points are developed as a result of trauma, overuse, joint dysfunction, mechanical pressure overload, psychological distress, repetitive overhead activities, and postural stress. Shoulder imbalances can cause tightness of the Rhomboid muscles. The pathogenesis results from the overloading and injury of muscle tissue, leading to involuntary shortening of localized fibers.
However, there is dearth of literature showing the effects of INIT or MFR on trigger points of muscles like Trapezius, IT band, gluteus medius and piriformis etc. Rhomboids trigger points treatment has quiet limited evidence. The available studies focus on these trigger point release by electrotherapy or by muscle energy techniques.
Soft tissue manual mobilization like INIT can provide an effective mean to treat these trigger points as they have beneficial effects in other areas. This study focused on use of both manual techniques to find out their effects on pain, pain pressure threshold and shoulder disability of Rhomboid trigger points. Both manual techniques are easy to administer and require no equipment. INIT is proven to have beneficial effects on multiple muscles of body but its efficacy has not been tested on rhomboid so this study will also add to that and specifically in Pakistan there is no single study has been conducted to compare the effects of INIT and MFR in patients with Rhomboid Trigger Points. The results of this study therefore had therapeutic significance for determining whether the two approaches yield comparable results or whether one is more effective than the other. This would assist in laying the groundwork for more research and developing treatment regimens for the aforementioned population
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Integrated neuromuscular inhibition technique, Myofascial Release
- Keywords
- pain pressure threshold, algometer, SPADI
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated neuromuscular inhibition techniqueOther
Ischemic compression will be applied for 90 seconds followed by the SCS technique with a reduction in pain of at least 70%. it will be held for 20-30 sec followed by the Muscle energy technique in which the isometric contraction will be held for 7-10 sec and then the stretch will be held for 30 sec. This will be repeated 5 times per session with a 30-second rest interval in between each repetition Session will be held 3 times per week for 2 consecutive weeks
Myofascial ReleaseOther
Deep sustained pressure on the trigger points will be applied with thumb in 5-7/10 pain tolerance and maintained for 60 seconds and then will be released in a vertical direction followed by stretch of the rhomboid muscle held for 30 sec. This Sustained manual pressure will be applied for 3 times each followed by a stretch per session with a 30 sec rest interval in between .Session will be held 3 times per week for 2 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Integrated neuromuscular inhibition technique | Experimental | ischemic compression, strain counter strain, muscle energy techniques Receives: Other: Integrated neuromuscular inhibition technique |
| Myofascial Release | Active comparator | Deep sustained pressure on the trigger points Receives: Other: Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
it is a 11 point scale for pain measurements with 0 describing no pain and 10 describing max. pain. changes will be measure from baseline to 2nd week
Measured: 2nd week
Pain Pressure threshold
Pain pressure threshold is measured using algometer. The term algometer may imply pressure tolerance testing, the maximum amount of pressure one may endure. The point at which subjects first said they felt pain was called the Verbal Report of Pain (VRP). The point at which they said the pressure 'hurt a lot' was called the Pain Reaction Point (PRP). changes will be measured from baseline to 2nd week
Measured: 2nd week
Secondary outcomes (1)
shoulder pain and disability index (SPADI)
Shoulder disability will be measured using shoulder pain and disability index (SPADI). The shoulder pain and disability index (SPADI) is a self-report questionnaire developed to measure the pain and disability associated with shoulder pathology. The SPADI consists of 13 items in two subscales: pain (5 items) and disability (8 items). changes will be measured from baseline to 2nd week
Measured: 2nd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start10 Aug 2022
- Primary completion15 Sep 2022
- Study completion30 Sep 2022
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.
- More trials run by Riphah International UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497856
- Sponsor's protocol ID
- RiphahIU Naqash Shabbir
- Status last verified
- Nov 2022
- First submitted
- 10 Aug 2022
- Last updated
- 9 Nov 2022
- 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Integrated Neuromuscular Inhibition Technique With the Myofascial Release on Pain and Stiffness in Rhomboids Trigger Points
- ClinicalTrials.gov ID
- NCT05497856
- Acronym / sponsor ID
- RiphahIU Naqash Shabbir
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- pain pressure threshold, algometer, SPADI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 11 Aug 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 this research is to compare the effect of integrated neuromuscular inhibition technique and myofascial release on pain, pain pressure threshold and shoulder disability in patients with rhomboid muscle. Randomized controlled trials will be done at Benazir Bhutto Hospital. The sample size is 32. The subjects will be divided in two groups, 16 subjects in integrated neuromuscular inhibition technique group and 16 in myofascial release group. Study duration will be of 6 months. Sampling technique applied will be non-probability purposive sampling technique. Only 25-45 years patients with shoulder/mid back pain and the presence of atleast one trigger point in rhomboid muscles will be included. Tools used in the study are algometer, shoulder pain and disability index (SPADI) and Numeric pain rating scale (NPRS). Data will be analyzed through SPSS 21.
Detailed description
: Trigger points (TrPs) are focal, discrete, and hyperirritable spots located in a taut band within a skeletal muscle. These are painful on compression and can produce referred pain, tenderness, autonomic nervous system symptoms, restricted range of motion and motor dysfunction. These trigger points are developed as a result of trauma, overuse, joint dysfunction, mechanical pressure overload, psychological distress, repetitive overhead activities, and postural stress. Shoulder imbalances can cause tightness of the Rhomboid muscles. The pathogenesis results from the overloading and injury of muscle tissue, leading to involuntary shortening of localized fibers.
However, there is dearth of literature showing the effects of INIT or MFR on trigger points of muscles like Trapezius, IT band, gluteus medius and piriformis etc. Rhomboids trigger points treatment has quiet limited evidence. The available studies focus on these trigger point release by electrotherapy or by muscle energy techniques.
Soft tissue manual mobilization like INIT can provide an effective mean to treat these trigger points as they have beneficial effects in other areas. This study focused on use of both manual techniques to find out their effects on pain, pain pressure threshold and shoulder disability of Rhomboid trigger points. Both manual techniques are easy to administer and require no equipment. INIT is proven to have beneficial effects on multiple muscles of body but its efficacy has not been tested on rhomboid so this study will also add to that and specifically in Pakistan there is no single study has been conducted to compare the effects of INIT and MFR in patients with Rhomboid Trigger Points. The results of this study therefore had therapeutic significance for determining whether the two approaches yield comparable results or whether one is more effective than the other. This would assist in laying the groundwork for more research and developing treatment regimens for the aforementioned population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated neuromuscular inhibition technique | Experimental | Other: Integrated neuromuscular inhibition techniqueischemic compression, strain counter strain, muscle energy techniques |
| Myofascial Release | Active comparator | Other: Myofascial ReleaseDeep sustained pressure on the trigger points |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Shoulder or mid back pain
Key exclusion criteria (5 listed)
- • Any history of recent shoulder or Neck surgeries
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 |
|---|---|---|
| Integrated neuromuscular inhibition techniqueIschemic compression will be applied for 90 seconds followed by the SCS technique with a reduction in pain of at least 70%. it will be held for 20-30 sec followed by the Muscle energy technique in which the isometric contraction will be held for 7-10 sec and then the stretch will be held for 30 sec. This will be repeated 5 times per session with a 30-second rest interval in between each repetition Session will be held 3 times per week for 2 consecutive weeks | Other | Integrated neuromuscular inhibition technique |
| Myofascial ReleaseDeep sustained pressure on the trigger points will be applied with thumb in 5-7/10 pain tolerance and maintained for 60 seconds and then will be released in a vertical direction followed by stretch of the rhomboid muscle held for 30 sec. This Sustained manual pressure will be applied for 3 times each followed by a stretch per session with a 30 sec rest interval in between .Session will be held 3 times per week for 2 consecutive weeks. | Other | Myofascial Release |
Primary outcome
NPRS
Time frame: 2nd week
it is a 11 point scale for pain measurements with 0 describing no pain and 10 describing max. pain. changes will be measure from baseline to 2nd week
Pain Pressure threshold
Time frame: 2nd week
Pain pressure threshold is measured using algometer. The term algometer may imply pressure tolerance testing, the maximum amount of pressure one may endure. The point at which subjects first said they felt pain was called the Verbal Report of Pain (VRP). The point at which they said the pressure 'hurt a lot' was called the Pain Reaction Point (PRP). changes will be measured from baseline to 2nd week
1 secondary outcome
shoulder pain and disability index (SPADI)
Time frame: 2nd week
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 9 Nov 2022.
- 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.
Aisha Razzaq, MSPT-OMPT 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 Integrated neuromuscular inhibition technique and Myofascial Release in people with Trigger Point Pain, Myofascial, 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 3 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: finished, as of the sponsor's last update on 9 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?
NPRS (time frame: 2nd week). The study lists 2 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 9 Nov 2022.