Chronic Neck PainNCT05502406
Effectiveness of Manual Myofascial Release Versus Instrument Assisted Soft Tissue Mobilization (IASTM) in Patients With Chronic Neck Pain"
A study testing Instrument Assisted Soft tissue Mobilization and Manual Myofascial Release in people with Chronic Neck Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Neck pain has a global prevalence of 30%, being the fourth leading cause of disability among general population and is more prevalent among females than males, as per concluded by evidence. It is undoubtedly the need of time, to address its proper treatment and to hinder its recurrence amongst the general population. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Instrument Assisted Soft tissue Mobilization and Manual Myofascial Release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to Feb 2023
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Female participants belonging to the age group of 18 to 40 years
- Participants suffering from neck pain for more than 3months.
Who cannot join
- Recent history of Whiplash Injury.
- Recent traumatic history of head, cervical spine, shoulder girdle or fractures of the cervical spine or shoulder complex.
- History of Cervical Radiculopathy, spondylosis, spondylolisthesis, disc prolapse, any other systemic disease or vascular syndrome such as vertebro-basilar Insufficiency.
- Diagnosed Fibromyalgia, myopathy or myelopathy
- Sensory/Motor dysfunction owing to any neurological pathology in the mid or upper back.
Trial locations and contacts
1 site in 1 country.
About this study
Neck pain has a global prevalence of 30%, being the fourth leading cause of disability among general population and is more prevalent among females than males, as per concluded by evidence. It is undoubtedly the need of time, to address its proper treatment and to hinder its recurrence amongst the general population. The current physical therapy management of neck pain is more focused towards achieving the short term goals for the patient rather than addressing and amending the actual cause of its relapse. Manual Myofascial Release is one of the very effective treatment used to release soft tissue and fascial adhesions over the myofascia inorder to relieve chronic neck pain. The study aims to compare this manual treatment against Instrument Assisted soft tissue mobilization in order to determine which of the two provides improved outcome in terms of pain, neck disability and cervical Range of motion.
- Conditions
- Chronic Neck Pain
- Being tested
- Instrument Assisted Soft tissue Mobilization, Manual Myofascial Release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft tissue MobilizationProcedure or surgery
Using a C shaped IASTM tool gentle horizontal stroking at an angle of 45 degree will be given over the cervicodorsal fascia
Manual Myofascial ReleaseProcedure or surgery
Participants will receive myofascial release through velvet glove technique on upper trapezius and sternocleidomastoid muscle using four strokes in the following fashion:
- Begin superior to the clavicle with a loose fist and move the back of the hand over the upper trapezius, fastening the tissue and bringing it over the table.
- The next stroke addresses the curve of the neck, again hooking the tissue while moving the bak of your fist towards the table.
The last stroke goes over the entire cervical spine hooking over the sternocleidomastoid muscle bringing it into myofascial release. Stay away from the carotid pulse, and incase a pulse is felt, do not apply pressure and reposition your hand
| Study group | Role | What they receive |
|---|---|---|
| IASTM | Experimental | The participants of the respective group will receive myofascial release using a C shaped glider, by the help of gentle horizontal strokes the targeted soft tissue restrictions will be relieved over the cervicodorsal fascia Receives: Procedure: Instrument Assisted Soft tissue Mobilization |
| MMFR | Experimental | The participants of the respective group will recieve manual soft tissue release over the cervicodorsal fascia using velvet glove technique for a period of 5 to 7 mins inorder to set free any adhesion in the underlying myofascia Receives: Procedure: Manual Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain will be measured using numeric pain rating scale which is a 10 point scale characterising 0 as no pain and 10 as worst possible pain.
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 posted16 Aug 2022
- Study start1 Mar 2022
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- compare two treatment techniques the study type will be parallel experimental study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502406
- Sponsor's protocol ID
- FUI/CTR/2022/9
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Myofascial Release Versus Instrument Assisted Soft Tissue Mobilization (IASTM) in Patients With Chronic Neck Pain"
- ClinicalTrials.gov ID
- NCT05502406
- Acronym / sponsor ID
- FUI/CTR/2022/9
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 16 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.
Neck pain has a global prevalence of 30%, being the fourth leading cause of disability among general population and is more prevalent among females than males, as per concluded by evidence. It is undoubtedly the need of time, to address its proper treatment and to hinder its recurrence amongst the general population. The current physical therapy management of neck pain is more focused towards achieving the short term goals for the patient rather than addressing and amending the actual cause of its relapse. Manual Myofascial Release is one of the very effective treatment used to release soft tissue and fascial adhesions over the myofascia inorder to relieve chronic neck pain. The study aims to compare this manual treatment against Instrument Assisted soft tissue mobilization in order to determine which of the two provides improved outcome in terms of pain, neck disability and cervical Range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- compare two treatment techniques the study type will be parallel experimental study.
| Arm | Type | Receives |
|---|---|---|
| IASTM | Experimental | Procedure: Instrument Assisted Soft tissue MobilizationThe participants of the respective group will receive myofascial release using a C shaped glider, by the help of gentle horizontal strokes the targeted soft tissue restrictions will be relieved over the cervicodorsal fascia |
| MMFR | Experimental | Procedure: Manual Myofascial ReleaseThe participants of the respective group will recieve manual soft tissue release over the cervicodorsal fascia using velvet glove technique for a period of 5 to 7 mins inorder to set free any adhesion in the underlying myofascia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and Female participants belonging to the age group of 18 to 40 years
- Participants suffering from neck pain for more than 3months.
Key exclusion criteria (5 listed)
- Recent history of Whiplash Injury.
- Recent traumatic history of head, cervical spine, shoulder girdle or fractures of the cervical spine or shoulder complex.
- History of Cervical Radiculopathy, spondylosis, spondylolisthesis, disc prolapse, any other systemic disease or vascular syndrome such as vertebro-basilar Insufficiency.
- Diagnosed Fibromyalgia, myopathy or myelopathy
- Sensory/Motor dysfunction owing to any neurological pathology in the mid or upper back.
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 |
|---|---|---|
| Instrument Assisted Soft tissue MobilizationUsing a C shaped IASTM tool gentle horizontal stroking at an angle of 45 degree will be given over the cervicodorsal fascia | Procedure or surgery | IASTM |
| Manual Myofascial ReleaseParticipants will receive myofascial release through velvet glove technique on upper trapezius and sternocleidomastoid muscle using four strokes in the following fashion: * Begin superior to the clavicle with a loose fist and move the back of the hand over the upper trapezius, fastening the tissue and bringing it over the table. * The next stroke addresses the curve of the neck, again hooking the tissue while moving the bak of your fist towards the table. The last stroke goes over the entire cervical spine hooking over the sternocleidomastoid muscle bringing it into myofascial release. Stay away from the carotid pulse, and incase a pulse is felt, do not apply pressure and reposition your hand | Procedure or surgery | MMFR |
Primary outcome
Pain intensity
Time frame: 2 weeks
Pain will be measured using numeric pain rating scale which is a 10 point scale characterising 0 as no pain and 10 as worst possible pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft tissue Mobilization and Manual Myofascial Release in people with Chronic Neck Pain, run by Foundation University Islamabad 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 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 16 Aug 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?
Results are not available in the source record.
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?
Pain intensity (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 16 Aug 2022.