Chronic Neck PainNCT06468904
Efficacy of Cervical Stabilization Exercises on Hand Grip Strength in Chronic Myofascial Neck Pain
A study testing cervical stabilization exercises and integrated neuromuscular technique. in people with Chronic Neck Pain, run by Cairo University at 2 sites in Egypt.
Trial summary
The purpose of this study is to examine effect of cervical stabilization exercises on hand grip strength, key pinch strength, pain intensity, pain pressure threshold and hand function in chronic myofascial neck pain patients. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- cervical stabilization exercises and integrated neuromuscular technique.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2023to Aug 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chronic neck pain for more than 3 months.
- Active MTrPs in the UT muscle with a tender nodule.
- Constant neck pain, a jump sign during palpation of UT muscle.
- Referred pain.
- Symptoms of ipsilateral hand muscles weakness.
Who cannot join
- Signs of severe pathology such as malignancy of the cervical area.
- Fractures of the cervical spine.
- Cervical radiculopathy or myelopathy.
- Diabetes.
- Trauma, congenital anomalies and surgery around neck, shoulder and hand.
- Fibromyalgia or vascular syndromes such as vertebra-basilar insufficiency.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Completed
Cairo University
Giza, 11251
- Recruiting
Faculty of physical therapy
Giza, 11251
About this study
Official title: Efficacy of Cervical Stabilization Exercises on Hand Grip Strength, Pinch Strength, Pain Pressure Threshold in Patients With Chronic Myofascial Neck Pain
The purpose of this study is to examine effect of cervical stabilization exercises on hand grip strength, key pinch strength, pain intensity, pain pressure threshold and hand function in chronic myofascial neck pain patients.
Read the detailed description
Myofascial pain of the trapezius is considered one of the main causes of neck pain and characterized by deep, intense pain of the skeletal muscles and their fascia and by the presence of one or more MTrPs, Although MTrPs can be formed in any muscle or muscle group, previous studies concluded that the upper trapezius(UT) muscle is the most commonly affected muscle.
Considering the role of synergistic function of the UT muscle in scapula-humeral rhythm during shoulder movement, it is not surprising that MTrPs in UT muscle can result in shoulder dysfunction and disability. Muscle activity of proximal parts is necessary for activation of distal parts. In fact, the stable activity of distal parts needs controlling the proximal parts. Thus, the stability of shoulder girdle is required for activity of distal parts such as fingers, wrists and elbows. In addition, trigger points in the UT can affect grip strength, which depends on shoulder joint and scapular stability. Thus, UT muscle dysfunction can reduce grip strength.
However, little research has been carried out to determine the therapeutic effects of cervical stabilization exercises on chronic neck pain, and up till now, there is a gap in literature to explore efficacy of cervical stabilization exercises on chronic neck pain and hand grip strength. Therefore, this study aims to investigate whether cervical stabilization exercises has an effect on hand grip strength in chronic myofascial neck pain.
- Conditions
- Chronic Neck Pain
- Being tested
- cervical stabilization exercises and integrated neuromuscular technique.
- Keywords
- cervical stabilization, hand grip, myofascial neck pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical stabilization exercises and integrated neuromuscular technique.Procedure or surgery
Patients received cervical stabilization exercises and integrated neuromuscular inhibition technique. Cervical stabilization protocol included strengthening exercises of deep cervical flexors muscles which included chin tucks, isometric holds, ball squeeze, as well as deep cervical extensors muscles which included cranio-cervical flexion from neutral, upper cervical rotation and extension of cervical spine.
integrated technique includes ischemic compression, muscle energy technique and strain counter strain.
| Study group | Role | What they receive |
|---|---|---|
| cervical stabilization exercises and integrated neuromuscular inhibition technique | Experimental | patients received cervical stabilization exercises and integrated neuromuscular inhibition technique for 3 sessions / week for 4 weeks. Cervical stabilization included chin tucks, isometric holds, ball squeeze.
Integrated neuromuscular inhibition technique included:
1. ischemic compression: therapist applied an intermittent ischemic compression on upper trapezius trigger point by thumb for 90sec.
2. Strain counter-strain: therapist applied pressure at trigger point. patient's head was laterally flexed towards the affected side passively by one hand of the therapist. The other hand held the subject's forearm and moved the affected shoulder to 90degree of abduction and external rotation for 90 secs.
3. Muscle energy technique: patient laterally flexed the neck to opposite side patient was moved the stabilized shoulder and ear towards each other. The contraction was maintained for 10 sec followed by 5 seconds of relaxation. The muscle was stretched for 30 secs. Receives: Procedure: cervical stabilization exercises and integrated neuromuscular technique. |
| Integrated neuromuscular inhibition technique | Active comparator | patients received integrated neuromuscular inhibition technique for 3 sessions / week for 4 weeks.it included Ischemic compression, Strain counter-strain and muscle energy technique.
1. ischemic compression. therapist applied an intermittent ischemic compression on upper trapezius trigger point by thumb for 90 sec.
2. Strain counter-strain: therapist applied pressure at trigger point. patient laterally flexed towards the affected side passively by one hand of the therapist. The other hand held the subject's forearm and moved the affected side shoulder passively to 90degree of abduction and external rotation for 90 secs.
3. Muscle energy technique: patient was asked to laterally flex the neck to opposite side. patient was requested to move the stabilized shoulder and ear towards each other. The contraction was maintained for 10 sec followed by 5 seconds of relaxation. The muscle was stretched for 30 secs. Receives: Procedure: cervical stabilization exercises and integrated neuromuscular technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome measure
hand grip strength was measured by hand held dynamometer.
Measured: up to four weeks
Secondary outcomes (4)
secondary outcome measures
pain pressure threshold was measured by pressure algometer.
Measured: up to four weeks
secondary outcome measure
hand function was measured by michigan quesstionaire.The Michigan Hand Outcomes Measure comprises 37 items with rating scale ranging 1 to 5. Every single domain was scored and converted to values that range from 0-100. A high score indicates better results, with the exception of pain in which a high score indicates a more intense pain.
Measured: up to four weeks
secondary outcome measure
pain intensity was measured by visual analogue scale.The level of pain on the VAS was recorded on a 10 cm line distinct at one end 'no pain' and marked at the other end 'the worst pain. Subjects were asked to state their pain level by placing a mark on this horizontal line
Measured: up to 4 weeks
secondary outcome measure
pinch strength was measured by pinch gauge
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 posted21 Jun 2024
- Study start1 Oct 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (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 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
- cervical stabilization exercises
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Alzahraa Mohamed Ali Ramadan, Cairo University
- Investigators
- soheir sh Rezkallah, PHD, Study director, professor of physaical therapyGhada Abd Elmoneim, PHD, Study director, assistant professor of physical therapyHaidy S Roshdy, PHD, Study director, lecturer of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468904
- Sponsor's protocol ID
- P.T.REC/012/004710
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cervical Stabilization Exercises on Hand Grip Strength, Pinch Strength, Pain Pressure Threshold in Patients With Chronic Myofascial Neck Pain
- ClinicalTrials.gov ID
- NCT06468904
- Acronym / sponsor ID
- P.T.REC/012/004710
- Conditions
- Chronic Neck Pain
- Keywords
- cervical stabilization, hand grip, myofascial neck pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 21 Jun 2024 (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 purpose of this study is to examine effect of cervical stabilization exercises on hand grip strength, key pinch strength, pain intensity, pain pressure threshold and hand function in chronic myofascial neck pain patients.
Detailed description
Myofascial pain of the trapezius is considered one of the main causes of neck pain and characterized by deep, intense pain of the skeletal muscles and their fascia and by the presence of one or more MTrPs, Although MTrPs can be formed in any muscle or muscle group, previous studies concluded that the upper trapezius(UT) muscle is the most commonly affected muscle.
Considering the role of synergistic function of the UT muscle in scapula-humeral rhythm during shoulder movement, it is not surprising that MTrPs in UT muscle can result in shoulder dysfunction and disability. Muscle activity of proximal parts is necessary for activation of distal parts. In fact, the stable activity of distal parts needs controlling the proximal parts. Thus, the stability of shoulder girdle is required for activity of distal parts such as fingers, wrists and elbows. In addition, trigger points in the UT can affect grip strength, which depends on shoulder joint and scapular stability. Thus, UT muscle dysfunction can reduce grip strength.
However, little research has been carried out to determine the therapeutic effects of cervical stabilization exercises on chronic neck pain, and up till now, there is a gap in literature to explore efficacy of cervical stabilization exercises on chronic neck pain and hand grip strength. Therefore, this study aims to investigate whether cervical stabilization exercises has an effect on hand grip strength in chronic myofascial neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- cervical stabilization exercises
| Arm | Type | Receives |
|---|---|---|
| cervical stabilization exercises and integrated neuromuscular inhibition technique | Experimental | Procedure: cervical stabilization exercises and integrated neuromuscular technique.patients received cervical stabilization exercises and integrated neuromuscular inhibition technique for 3 sessions / week for 4 weeks. Cervical stabilization included chin tucks, isometric holds, ball squeeze. Integrated neuromuscular inhibition technique included: 1. ischemic compression: therapist applied an intermittent ischemic compression on upper trapezius trigger point by thumb for 90sec. 2. Strain counter-strain: therapist applied pressure at trigger point. patient's head was laterally flexed towards the affected side passively by one hand of the therapist. The other hand held the subject's forearm and moved the affected shoulder to 90degree of abduction and external rotation for 90 secs. 3. Muscle energy technique: patient laterally flexed the neck to opposite side patient was moved the stabilized shoulder and ear towards each other. The contraction was maintained for 10 sec followed by 5 seconds of relaxation. The muscle was stretched for 30 secs. |
| Integrated neuromuscular inhibition technique | Active comparator | Procedure: cervical stabilization exercises and integrated neuromuscular technique.patients received integrated neuromuscular inhibition technique for 3 sessions / week for 4 weeks.it included Ischemic compression, Strain counter-strain and muscle energy technique. 1. ischemic compression. therapist applied an intermittent ischemic compression on upper trapezius trigger point by thumb for 90 sec. 2. Strain counter-strain: therapist applied pressure at trigger point. patient laterally flexed towards the affected side passively by one hand of the therapist. The other hand held the subject's forearm and moved the affected side shoulder passively to 90degree of abduction and external rotation for 90 secs. 3. Muscle energy technique: patient was asked to laterally flex the neck to opposite side. patient was requested to move the stabilized shoulder and ear towards each other. The contraction was maintained for 10 sec followed by 5 seconds of relaxation. The muscle was stretched for 30 secs. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chronic neck pain for more than 3 months.
- Active MTrPs in the UT muscle with a tender nodule.
- Constant neck pain, a jump sign during palpation of UT muscle.
- Referred pain.
- Symptoms of ipsilateral hand muscles weakness.
Key exclusion criteria (7 listed)
- Signs of severe pathology such as malignancy of the cervical area.
- Fractures of the cervical spine.
- Cervical radiculopathy or myelopathy.
- Diabetes.
- Trauma, congenital anomalies and surgery around neck, shoulder and hand.
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 |
|---|---|---|
| cervical stabilization exercises and integrated neuromuscular technique.Patients received cervical stabilization exercises and integrated neuromuscular inhibition technique. Cervical stabilization protocol included strengthening exercises of deep cervical flexors muscles which included chin tucks, isometric holds, ball squeeze, as well as deep cervical extensors muscles which included cranio-cervical flexion from neutral, upper cervical rotation and extension of cervical spine. integrated technique includes ischemic compression, muscle energy technique and strain counter strain. | Procedure or surgery | Integrated neuromuscular inhibition technique, cervical stabilization exercises and integrated neuromuscular inhibition technique |
Primary outcome
primary outcome measure
Time frame: up to four weeks
hand grip strength was measured by hand held dynamometer.
4 secondary outcomes
secondary outcome measures
Time frame: up to four weeks
secondary outcome measure
Time frame: up to four weeks
secondary outcome measure
Time frame: up to 4 weeks
secondary outcome measure
Time frame: up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- 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.
soheir sh Rezkallah, PHD study director
professor of physaical therapy
Ghada Abd Elmoneim, PHD study director
assistant professor of physical therapy
Haidy S Roshdy, PHD study director
lecturer of physical therapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical stabilization exercises and integrated neuromuscular technique. in people with Chronic Neck Pain, run by Cairo University at 2 sites 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 5 inclusion and 7 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Alzahraa M Ali, Master (01028371924, fatmaalzahraa@pt.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome measure (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 26 Jun 2024.