Non-specific Chronic Mechanical Neck PainIASTMNCT04702100
Instrument-assisted Soft Tissue Mobilization Versus Integrated on Mechanical Neck Pain
A study testing instrument assisted soft tissue mobilization, integrated neuromuscular inhibition technique and conventional therapy in people with Non-specific Chronic Mechanical Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is to investigate the efficacy of instrumented assisted soft tissue mobilization versus integrated neuromuscular inhibition technique on mechanical non-specific neck pain Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Non-specific Chronic Mechanical Neck Pain
- What is being tested?
- instrument assisted soft tissue mobilization, integrated neuromuscular inhibition technique and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Mar 2021
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed as non-specific neck pain with upper trapezius active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
- body mass index from 18 to 25 kg/m2
- their ages from 18-35
Who cannot join
- if they had trigger point injections within the past 6 months
- history of neck or upper back surgery, trauma or fracture
- history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
- cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Instrument-assisted Soft Tissue Mobilization Versus Integrated Neuromuscular Inhibition Technique on Mechanical Non-specific Neck Pain
the aim of this study is to investigate the efficacy of instrumented assisted soft tissue mobilization versus integrated neuromuscular inhibition technique on mechanical non-specific neck pain
Read the detailed description
Mechanical neck pain is a prevalent condition in various populations. Neck pain occurrence is affected by several factors, involving environmental, psychological, and social aspects. Neck pain represents the fourth major disorder responsible for a person's year lived with disability and ranked eleventh as disability-adjusted life years of a person. The neck pain incidence ranges from 10.4 to 23.3% in 1-year time, while the range of prevalence was 0.4 to 86.8%. It has a high prevalence among computer users, office workers, and females, especially females aged 35 to 49 years old. Myofascial trigger point (MTrP) might play an important role in the formation of mechanical neck pain and is known as a hyperirritable spot in skeletal muscle that is accompanied with a hypersensitive palpable nodule in a taut band. IASTM and integrated play an important role in the treatment of mechanical neck pain.this trial has three groups; one will receive IASTM+ conventional, the second will receive integrated + conventional and the third will receive conventional treatment for four week
- Being tested
- instrument assisted soft tissue mobilization, integrated neuromuscular inhibition technique, conventional therapy
- Keywords
- instrument-assisted soft tissue mobilization, integrated neuromuscular inhibition technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instrument assisted soft tissue mobilizationOther
the patients will receive instrument-assisted soft tissue mobilization:The subject was seated in a relaxed sitting position. M2T blade was used to find specific areas of restriction on RT upper trapezius. Then treatment plane 1 - 2 and 3 were used.The lubricant (Vaseline) was applied to the skin around the neck area prior to treatment and the tool was cleaned with an alcohol preparation pad. Then by using M2T blade with angle 45, we were giving long slow strokes without causing any discomfort or pain over muscle starting from its insertion up to its origin approximately for 2 to 3 min repeated two times.
integrated neuromuscular inhibition techniqueOther
will receive integrated neuromuscular inhibition technique: from supine lying position.we the patients will perform ischemic compression at trigger points then positional release technique and finally muscle energy technique.
conventional therapyOther
the patients will receive hot back for 10 minutes, active range of motion exercise, chin tuck, stretches
| Study group | Role | What they receive |
|---|---|---|
| instrument assisted soft tissue mobilization | Experimental | the patients will receive instrument-assisted soft tissue mobilization+conventional therapy three times per week for four week Receives: Other: instrument assisted soft tissue mobilization; Other: conventional therapy |
| integrated neuromuscular inhibition technique | Experimental | the patients will receive integrated neuromuscular inhibition technique+ conventional therapy. three times a week for four week Receives: Other: integrated neuromuscular inhibition technique; Other: conventional therapy |
| conventional therapy | Active comparator | the patients will receive conventional therapy three times a week for four week Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
Measured: up to four weeks
Secondary outcomes (3)
neck disability
will be measured by Arabic neck disability index
Measured: up to four weeks
muscle amplitude in the form of normalized root mean square (RMS)
muscle amplitude will be measured by surface electromyography for upper trapezius
Measured: up to four weeks
muscle fatigue in the form of median frequency
muscle fatigue will be measured by surface electromyography for upper trapezius
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jan 2021
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Chronic Mechanical Neck PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- instrument assisted soft tissue mobilization and integrated neuromuscular inhibition technique
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702100
- Sponsor's protocol ID
- p.t.REC/012/003038
- Acronym
- IASTM
- Status last verified
- Jun 2022
- First submitted
- 6 Jan 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrument-assisted Soft Tissue Mobilization Versus Integrated Neuromuscular Inhibition Technique on Mechanical Non-specific Neck Pain
- ClinicalTrials.gov ID
- NCT04702100
- Acronym / sponsor ID
- IASTM / p.t.REC/012/003038
- Keywords
- instrument-assisted soft tissue mobilization, integrated neuromuscular inhibition technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 8 Jan 2021 (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 study is to investigate the efficacy of instrumented assisted soft tissue mobilization versus integrated neuromuscular inhibition technique on mechanical non-specific neck pain
Detailed description
Mechanical neck pain is a prevalent condition in various populations. Neck pain occurrence is affected by several factors, involving environmental, psychological, and social aspects. Neck pain represents the fourth major disorder responsible for a person's year lived with disability and ranked eleventh as disability-adjusted life years of a person. The neck pain incidence ranges from 10.4 to 23.3% in 1-year time, while the range of prevalence was 0.4 to 86.8%. It has a high prevalence among computer users, office workers, and females, especially females aged 35 to 49 years old. Myofascial trigger point (MTrP) might play an important role in the formation of mechanical neck pain and is known as a hyperirritable spot in skeletal muscle that is accompanied with a hypersensitive palpable nodule in a taut band. IASTM and integrated play an important role in the treatment of mechanical neck pain.this trial has three groups; one will receive IASTM+ conventional, the second will receive integrated + conventional and the third will receive conventional treatment for four week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- instrument assisted soft tissue mobilization and integrated neuromuscular inhibition technique
| Arm | Type | Receives |
|---|---|---|
| instrument assisted soft tissue mobilization | Experimental | Other: instrument assisted soft tissue mobilization, Other: conventional therapythe patients will receive instrument-assisted soft tissue mobilization+conventional therapy three times per week for four week |
| integrated neuromuscular inhibition technique | Experimental | Other: integrated neuromuscular inhibition technique, Other: conventional therapythe patients will receive integrated neuromuscular inhibition technique+ conventional therapy. three times a week for four week |
| conventional therapy | Active comparator | Other: conventional therapythe patients will receive conventional therapy three times a week for four week |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnosed as non-specific neck pain with upper trapezius active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
- body mass index from 18 to 25 kg/m2
- their ages from 18-35
Key exclusion criteria (4 listed)
- if they had trigger point injections within the past 6 months
- history of neck or upper back surgery, trauma or fracture
- history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
- cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
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 mobilizationthe patients will receive instrument-assisted soft tissue mobilization:The subject was seated in a relaxed sitting position. M2T blade was used to find specific areas of restriction on RT upper trapezius. Then treatment plane 1 - 2 and 3 were used.The lubricant (Vaseline) was applied to the skin around the neck area prior to treatment and the tool was cleaned with an alcohol preparation pad. Then by using M2T blade with angle 45, we were giving long slow strokes without causing any discomfort or pain over muscle starting from its insertion up to its origin approximately for 2 to 3 min repeated two times. | Other | instrument assisted soft tissue mobilization |
| integrated neuromuscular inhibition techniquewill receive integrated neuromuscular inhibition technique: from supine lying position.we the patients will perform ischemic compression at trigger points then positional release technique and finally muscle energy technique. | Other | integrated neuromuscular inhibition technique |
| conventional therapythe patients will receive hot back for 10 minutes, active range of motion exercise, chin tuck, stretches | Other | conventional therapy, instrument assisted soft tissue mobilization, integrated neuromuscular inhibition technique |
Primary outcome
pain intensity
Time frame: up to four weeks
The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
3 secondary outcomes
neck disability
Time frame: up to four weeks
muscle amplitude in the form of normalized root mean square (RMS)
Time frame: up to four weeks
muscle fatigue in the form of median frequency
Time frame: up to four weeks
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 23 Jun 2022.
Related trials for Non-specific Chronic Mechanical Neck Pain
Not yet recruiting
Comparing Between Mulligan Technique and Active Release Technique in Treatment of Chronic Mechanical Neck Pain
Chronic Non-specific Neck Pain
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, integrated neuromuscular inhibition technique and conventional therapy in people with Non-specific Chronic Mechanical Neck Pain, run by Cairo University at 1 site in Egypt.
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 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 23 Jun 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 Egypt. 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?
pain intensity (time frame: up to four 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 23 Jun 2022.