Neck PainNCT05860049
Adding Instrument Assisted Soft Tissue Mobilization to Core Stability Training in Chronic Mechanical Neck Pain
A study testing Conventional physiotherapy, Core stability and Instrument assisted soft tissue mobilization in people with Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose of the study was to investigate the effect of adding instrument assisted soft tissue mobilization to core stability training in treatment of chronic mechanical neck pain on pain level, cervical ROM, proprioception, muscle activity, H-reflex, and functions. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Conventional physiotherapy, Core stability and Instrument assisted soft tissue mobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2023to 30 Mar 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed as having chronic mechanical neck pain.
- Patient's age between 18-55 years old.
Who cannot join
- Subjects with any specific neck pathology as radiculopathy, rheumatoid arthritis and systemic diseases.
- sensory problems at mid or upper back.
- A history of head and upper trunk trauma or surgery.
- severe disorders of the cervical spine such as disk prolapse and cervical stenosis.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the study was to investigate the effect of adding instrument assisted soft tissue mobilization to core stability training in treatment of chronic mechanical neck pain on pain level, cervical ROM, proprioception, muscle activity, H-reflex, and functions.
Read the detailed description
Neck pain (NP) is a common musculoskeletal condition with a lifetime incidence rate between 22% and 70%.
Neck pain is commonly a recurrent condition with remissions and exacerbation that do not completely resolve. A history of previous injury to the neck (including whiplash, sports and work injuries etc.) increases the likelihood of chronic pain. As one ages, more chronic neck pain persists.
Mechanical neck pain is pain and/or stiffness in the neck or shoulder girdle region which was reproducible with neck movements.
Mechanical neck pain is the most common type found in neck-pain disorders. Studies have demonstrated altered behavior of the cervical muscles in mechanical neck-pain patients.
Mechanical neck pain produces mobility restriction, functional disability, decrease in muscle strength and decrease in health related quality of life.
Several treatment techniques and methods are used to rehabilitate pathologies of the cervical spine, including manual therapy, massage, stretching, soft-tissue techniques, and therapeutic exercise.
Manual therapy includes hands-on therapy techniques, such as soft tissue mobilization and massage techniques, as well as techniques using therapeutic equipment, such as stainless steel tools, that allow clinical therapists to identify and treat soft tissue dysfunctions.
Instrument-assisted soft tissue mobilization (IASTM) encompasses a broad range of techniques to treat soft tissue deficiencies. Tools used for IASTM produce micro-trauma to soft tissue for healing and restoring normal elasticity and function.
In recent years, Core stability training has become a popular fitness trend that has begun to be applied in rehabilitation programs and in sports medicine.
Core exercises have a positive effect on reducing lower back pain, improving upper extremities in breast cancer patients and lower extremities in patients with total hip and knee arthroplasty, as well as performance improvement for athletes. Core exercises are taken seriously in rehabilitation, medical care, and sports.
The core stability exercise program can be described as enhancing the ability to ensure a stable neutral spine position.
Statement of the problem Is there is effect of adding instrument assisted soft tissue mobilization to core stability in treatment of mechanical neck pain?
Purpose of the study:
Purpose of the study was to investigate effect of adding instrument assisted soft tissue mobilization to core stability in treatment of mechanical neck pain on pain level, cervical ROM, proprioception, muscle activity, H-reflex, and functions.
Significance of the study:
Study of Mohamed et al., (2020) investigated and compared the effects of instrument assisted soft tissue mobilization (IASTM) using m2t blade and trigger point release (TPR) in terms of neck lateral flexion and rotation range of motion on upper trapezius (UT) myofascial trigger points (MTrPs) in mechanical neck pain.
Both groups showed significant effects in improving range of motion. There was no significant difference in neck lateral flexion and rotation between the two groups.
The improvements in patients who received IASTM by M2t blade could be explained through loosening and removal of scar tissues and adhesions secondary to skin scraping which decreased soft tissue consistency and improved range of motion. It also induced vasodilation response and microvascular hemorrhage; so provided oxygen, nutrients and removed metabolic end products and inflammatory mediators which improved pain level and ppt.
Konstantinos et al., (2012) found that IASTM techniques combined with neuromuscular retraining exercises can significantly reduce pain and improve the corresponding function of patients with cervical pain compared to the application of the same exercises and a simple massage.
Rajalaxmi et al., (2020) analyzed the efficacy of multistep core stability exercise with and without conventional neck exercises in the treatment of chronic non-specific neck pain a Randomized Controlled Trial.
GROUP A received neck stability exercise and GROUP B received neck stability and core stability exercises. Both the groups received exercises for 45 min session per day for 6 days a week for 12 weeks. Pre and post-test measured using VAS, NDI, CCFT. Both the group received a hot pack for 10min as a common intervention.
On comparing the mean value of Group A \& Group B on VAS and NDI Group B (neck stability with core stability exercise) showed 3.5 and 33.4 post-test values which were more effective than Group A (neck stability exercise) 5. 3 and 45.2 at P≤ 0.001. On the Craniocervical flexion Group B had shown 29.5 greater mean value when compared to Group A 24.7 at P≥ 0.001.
Higher proportions of patients improved in group B compared to group A. Core stability exercise group demonstrated and benefited significant improvements in NDI, VAS, and CCFT scores.
Mohsen et al., (2019) showed that 12 sessions of neck, core, and combined stabilization training in the neck region could improve the tolerance and pain of the elderly with non-specific chronic neck pain.
This is the first study to investigate the effect of adding IASTM to core stability exercise in treatment of mechanical neck pain.
Delimitation
This study was delimited to:
- Subjects were divided randomly into two groups.
- Age of the subjects ranged from 18 and 55 with mechanical neck pain.
- Subjects were selected from outpatient clinic of Ismailia Medical Complex.
- Pain level was measured by VAS.
- Cervical range of motion and proprioception were measured using CROM.
- Functions were measured by Arabic version of Neck Disability Index.
- Muscle activity and H-reflex were measured by EMG. Basic Assumption
It was assumed that:
- All subjects would exert their best effort to be relaxed during testing procedures.
- All subjects would follow the researcher's instructions and advices.
- Psychological condition would be the same for all subjects.
Hypotheses:
- There would be no statistically significant effect of adding IASTM to core stability on pain level.
- There would be no statistically significant effect of adding IASTM to core stability on cervical ROM.
- There would be no statistically significant effect of adding IASTM to core stability on proprioception.
- There would be no statistically significant effect of adding IASTM to core stability on muscle activity.
- There would be no statistically significant effect of adding IASTM to core stability on H-reflex.
- There would be no statistically significant effect of adding IASTM to core stability on functions.
- Conditions
- Neck Pain
- Being tested
- Conventional physiotherapy, Core stability, Instrument assisted soft tissue mobilization
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyOther
All participants in both groups (A and B) received conventional physiotherapy program including infrared thermotherapy, transcutaneous electrical nerve stimulation, stretching exercises for for Upper Trapezius, Levator Scapulae, Sternocleidomastoid and Scalenes muscles, and active neck ROM exercises, 3 sessions per week, for 4 weeks.
Core stabilityOther
All participants in both groups (A and B) received core stability exercises in the form of bridging exercise, bridging exercise on a ball, plank, and side plank 3 sessions per week, for 4 weeks.
Instrument assisted soft tissue mobilizationDevice
Each participant in group (B) was seated in a comfortable position. The participant's forehead rested on his/her forearm on a table in front of him/her. A lubricant (Vaseline) was applied to the skin around the neck area prior to treatment, and the M2T blade (Figure 4) was cleaned with an alcohol pad. First, the M2T blade was used to find the exact areas of restriction in the RT upper trapezius. Then, the M2T blade was used at an angle of 45°, utilizing treatment planes 1, 2, and 3, to apply slow strokes along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion for approximately 3 minutes. This procedure was repeated twice a week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physiotherapy + Core stability | Active comparator | They received conventional physical therapy and core stability for 4 weeks. Receives: Other: Conventional physiotherapy; Other: Core stability |
| Conventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM) | Experimental | They received conventional physical therapy, core stability, and IASTM technique for 4 weeks. Receives: Other: Conventional physiotherapy; Other: Core stability; Device: Instrument assisted soft tissue mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
The pain level was measured by visual analogue scale.The VAS is a 100-mm horizontal line anchored by word descriptors at each end by ''no pain'' on the left and ''worst imaginable pain'' on the right. The minimum score means it is better.
Measured: 4 weeks
Cervical range of motion and proprioception
Cervical range of motion and proprioception were measured using CROM.
Measured: 4 weeks
Functions
Functions were measured by Arabic version of Neck Disability Index. It is consisting of 10 items with six choices (0-5), Each item is scored from zero (no disability) to five (total disability). Minimum score means it is better.
Measured: 4 weeks
Muscle activity
Muscle activity was measured by electromyography (EMG).
Measured: 4 weeks
H-reflex
H-reflex was measured by EMG.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start29 Aug 2023
- Primary completion29 Jan 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAGHDA MOHAMED HASSAN MAHMOUD, Cairo University
- Investigators
- Haytham El-Hafez, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860049
- Sponsor's protocol ID
- P.T.REC/012/003837
- Status last verified
- Aug 2024
- First submitted
- 28 Apr 2023
- Last updated
- 22 Aug 2024
- 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Instrument Assisted Soft Tissue Mobilization to Core Stability Training in Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05860049
- Acronym / sponsor ID
- P.T.REC/012/003837
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 16 May 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.
Purpose of the study was to investigate the effect of adding instrument assisted soft tissue mobilization to core stability training in treatment of chronic mechanical neck pain on pain level, cervical ROM, proprioception, muscle activity, H-reflex, and functions.
Detailed description
Neck pain (NP) is a common musculoskeletal condition with a lifetime incidence rate between 22% and 70%.
Neck pain is commonly a recurrent condition with remissions and exacerbation that do not completely resolve. A history of previous injury to the neck (including whiplash, sports and work injuries etc.) increases the likelihood of chronic pain. As one ages, more chronic neck pain persists.
Mechanical neck pain is pain and/or stiffness in the neck or shoulder girdle region which was reproducible with neck movements.
Mechanical neck pain is the most common type found in neck-pain disorders. Studies have demonstrated altered behavior of the cervical muscles in mechanical neck-pain patients.
Mechanical neck pain produces mobility restriction, functional disability, decrease in muscle strength and decrease in health related quality of life.
Several treatment techniques and methods are used to rehabilitate pathologies of the cervical spine, including manual therapy, massage, stretching, soft-tissue techniques, and therapeutic exercise.
Manual therapy includes hands-on therapy techniques, such as soft tissue mobilization and massage techniques, as well as techniques using therapeutic equipment, such as stainless steel tools, that allow clinical therapists to identify and treat soft tissue dysfunctions.
Instrument-assisted soft tissue mobilization (IASTM) encompasses a broad range of techniques to treat soft tissue deficiencies. Tools used for IASTM produce micro-trauma to soft tissue for healing and restoring normal elasticity and function.
In recent years, Core stability training has become a popular fitness trend that has begun to be applied in rehabilitation programs and in sports medicine.
Core exercises have a positive effect on reducing lower back pain, improving upper extremities in breast cancer patients and lower extremities in patients with total hip and knee arthroplasty, as well as performance improvement for athletes. Core exercises are taken seriously in rehabilitation, medical care, and sports.
The core stability exercise program can be described as enhancing the ability to ensure a stable neutral spine position.
Statement of the problem Is there is effect of adding instrument assisted soft tissue mobilization to core stability in treatment of mechanical neck pain?
Purpose of the study:
Purpose of the study was to investigate effect of adding instrument assisted soft tissue mobilization to core stability in treatment of mechanical neck pain on pain level, cervical ROM, proprioception, muscle activity, H-reflex, and functions.
Significance of the study:
Study of Mohamed et al., (2020) investigated and compared the effects of instrument assisted soft tissue mobilization (IASTM) using m2t blade and trigger point release (TPR) in terms of neck lateral flexion and rotation range of motion on upper trapezius (UT) myofascial trigger points (MTrPs) in mechanical neck pain.
Both groups showed significant effects in improving range of motion. There was no significant difference in neck lateral flexion and rotation between the two groups.
The improvements in patients who received IASTM by M2t blade could be explained through loosening and removal of scar tissues and adhesions secondary to skin scraping which decreased soft tissue consistency and improved range of motion. It also induced vasodilation response and microvascular hemorrhage; so provided oxygen, nutrients and removed metabolic end products and inflammatory mediators which improved pain level and ppt.
Konstantinos et al., (2012) found that IASTM techniques combined with neuromuscular retraining exercises can significantly reduce pain and improve the corresponding function of patients with cervical pain compared to the application of the same exercises and a simple massage.
Rajalaxmi et al., (2020) analyzed the efficacy of multistep core stability exercise with and without conventional neck exercises in the treatment of chronic non-specific neck pain a Randomized Controlled Trial.
GROUP A received neck stability exercise and GROUP B received neck stability and core stability exercises. Both the groups received exercises for 45 min session per day for 6 days a week for 12 weeks. Pre and post-test measured using VAS, NDI, CCFT. Both the group received a hot pack for 10min as a common intervention.
On comparing the mean value of Group A \& Group B on VAS and NDI Group B (neck stability with core stability exercise) showed 3.5 and 33.4 post-test values which were more effective than Group A (neck stability exercise) 5. 3 and 45.2 at P≤ 0.001. On the Craniocervical flexion Group B had shown 29.5 greater mean value when compared to Group A 24.7 at P≥ 0.001.
Higher proportions of patients improved in group B compared to group A. Core stability exercise group demonstrated and benefited significant improvements in NDI, VAS, and CCFT scores.
Mohsen et al., (2019) showed that 12 sessions of neck, core, and combined stabilization training in the neck region could improve the tolerance and pain of the elderly with non-specific chronic neck pain.
This is the first study to investigate the effect of adding IASTM to core stability exercise in treatment of mechanical neck pain.
Delimitation
This study was delimited to:
- Subjects were divided randomly into two groups.
- Age of the subjects ranged from 18 and 55 with mechanical neck pain.
- Subjects were selected from outpatient clinic of Ismailia Medical Complex.
- Pain level was measured by VAS.
- Cervical range of motion and proprioception were measured using CROM.
- Functions were measured by Arabic version of Neck Disability Index.
- Muscle activity and H-reflex were measured by EMG. Basic Assumption
It was assumed that:
- All subjects would exert their best effort to be relaxed during testing procedures.
- All subjects would follow the researcher's instructions and advices.
- Psychological condition would be the same for all subjects.
Hypotheses:
- There would be no statistically significant effect of adding IASTM to core stability on pain level.
- There would be no statistically significant effect of adding IASTM to core stability on cervical ROM.
- There would be no statistically significant effect of adding IASTM to core stability on proprioception.
- There would be no statistically significant effect of adding IASTM to core stability on muscle activity.
- There would be no statistically significant effect of adding IASTM to core stability on H-reflex.
- There would be no statistically significant effect of adding IASTM to core stability on functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physiotherapy + Core stability | Active comparator | Other: Conventional physiotherapy, Other: Core stabilityThey received conventional physical therapy and core stability for 4 weeks. |
| Conventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM) | Experimental | Other: Conventional physiotherapy, Other: Core stability, Device: Instrument assisted soft tissue mobilizationThey received conventional physical therapy, core stability, and IASTM technique for 4 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed as having chronic mechanical neck pain.
- Patient's age between 18-55 years old.
Key exclusion criteria (4 listed)
- Subjects with any specific neck pathology as radiculopathy, rheumatoid arthritis and systemic diseases.
- sensory problems at mid or upper back.
- A history of head and upper trunk trauma or surgery.
- severe disorders of the cervical spine such as disk prolapse and cervical stenosis.
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 |
|---|---|---|
| Conventional physiotherapyAll participants in both groups (A and B) received conventional physiotherapy program including infrared thermotherapy, transcutaneous electrical nerve stimulation, stretching exercises for for Upper Trapezius, Levator Scapulae, Sternocleidomastoid and Scalenes muscles, and active neck ROM exercises, 3 sessions per week, for 4 weeks. | Other | Conventional physiotherapy + Core stability, Conventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM) |
| Core stabilityAll participants in both groups (A and B) received core stability exercises in the form of bridging exercise, bridging exercise on a ball, plank, and side plank 3 sessions per week, for 4 weeks. | Other | Conventional physiotherapy + Core stability, Conventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM) |
| Instrument assisted soft tissue mobilizationEach participant in group (B) was seated in a comfortable position. The participant's forehead rested on his/her forearm on a table in front of him/her. A lubricant (Vaseline) was applied to the skin around the neck area prior to treatment, and the M2T blade (Figure 4) was cleaned with an alcohol pad. First, the M2T blade was used to find the exact areas of restriction in the RT upper trapezius. Then, the M2T blade was used at an angle of 45°, utilizing treatment planes 1, 2, and 3, to apply slow strokes along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion for approximately 3 minutes. This procedure was repeated twice a week, for 4 weeks. | Device | Conventional physiotherapy + Core stability + Instrument assisted soft tissue mobilization (IASTM) |
Primary outcome
Pain level
Time frame: 4 weeks
The pain level was measured by visual analogue scale.The VAS is a 100-mm horizontal line anchored by word descriptors at each end by ''no pain'' on the left and ''worst imaginable pain'' on the right. The minimum score means it is better.
Cervical range of motion and proprioception
Time frame: 4 weeks
Cervical range of motion and proprioception were measured using CROM.
Functions
Time frame: 4 weeks
Functions were measured by Arabic version of Neck Disability Index. It is consisting of 10 items with six choices (0-5), Each item is scored from zero (no disability) to five (total disability). Minimum score means it is better.
Muscle activity
Time frame: 4 weeks
Muscle activity was measured by electromyography (EMG).
H-reflex
Time frame: 4 weeks
H-reflex was measured by EMG.
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 22 Aug 2024.
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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.
Haytham El-Hafez, PhD study chair
Professor, Cairo 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 Conventional physiotherapy, Core stability and Instrument assisted soft tissue mobilization in people with 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 2 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 22 Aug 2024. 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 level (time frame: 4 weeks). The study lists 5 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 22 Aug 2024.