Neck PainNCT06485921
Comparison of Two Treatments on Nonspecific Neck Pain
A study testing Ischemic compression, Instrument assisted soft tissue mobilization Group and Exercise and workplace modifications in people with Neck Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate the impact of Ischemic Compression (IC) and Instrument Assisted Soft Tissue Mobilization (IASTM) on pain, functionality, cervical range of motion, pressure pain threshold, and quality of life in patients suffering from nonspecific neck pain. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Ischemic compression, Instrument assisted soft tissue mobilization Group and Exercise and workplace modifications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having nonspecific neck pain and at least 3 myofascial trigger points in the back and neck muscles,
- Pain duration exceeding 3 months,
- Working with a computer for at least 20 hours per week for at least 1 year,
- Pain intensity rated as at least 3 on the Visual Analog Scale (VAS),
- Age between 18 and 50 years
Who cannot join
- Use of anti-inflammatory, analgesic, anticoagulant, muscle relaxant, or antidepressant medications at the start of the study or within 1 week prior to the study,
- History of cervical spine surgery or trauma,
- Neck pain, including inflammatory rheumatic diseases,
- Malignancy or structural deformity,
- Coagulation disorders,
- Presence of cervical radiculopathy or myelopathy,
- Individuals who have undergone any physical therapy and rehabilitation interventions to the neck and back regions in the last three months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences, Istanbul University-Cerrahpasa
Istanbul, Büyükçekmece, 34
About this study
Official title: Comparison of the Effectiveness of Ischemic Compression and Instrument Assisted Soft Tissue Mobilization on Pain and Function in Patients With Nonspecific Neck Pain
The purpose of this study was to evaluate the impact of Ischemic Compression (IC) and Instrument Assisted Soft Tissue Mobilization (IASTM) on pain, functionality, cervical range of motion, pressure pain threshold, and quality of life in patients suffering from nonspecific neck pain.
Read the detailed description
Chronic nonspecific neck pain affects approximately 67% of the global population at least once in their lifetime. This type of neck pain, which is not linked to any specific cause or disease but often associated with the musculoskeletal system, can result from muscle strain or spasms in the neck. It causes functional limitations and decreases quality of life for those affected. Individuals frequently turn to healthcare services and pain-relieving medications in their efforts to manage this discomfort. Chronic nonspecific neck pain is recognized as a significant public health challenge due to its considerable socioeconomic impact. Several studies have indicated that myofascial trigger points in the neck region are associated with nonspecific neck pain and that myofascial trigger point therapy can reduce pain. Therefore, the role of myofascial trigger point therapy in the treatment of nonspecific neck pain has been emphasized in studies.
- Conditions
- Neck Pain
- Being tested
- Ischemic compression, Instrument assisted soft tissue mobilization Group, Exercise and workplace modifications
- Keywords
- Neck pain, Trigger point, Exercise, Physical therapy, Manual therapy
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic compressionOther
Participants will received a total of 12 treatment sessions over 6 weeks, with 2 sessions per week.
Instrument assisted soft tissue mobilization GroupOther
Participants will received a total of 12 treatment sessions over 6 weeks, with 2 sessions per week.
Exercise and workplace modificationsOther
Participants will receive stretching and strengthening exercises for neck and scapular stabilizer muscles as a 6-week home program.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic compression GROUP | Active comparator | This group will receive 90 seconds of ischemic compression on myofascial trigger points in the trapezius, levator scapulae, supraspinatus, infraspinatus, and splenius cervicis, along with exercises and suggestions for workplace modifications. Receives: Other: Ischemic compression; Other: Exercise and workplace modifications |
| Instrument assisted soft tissue mobilization Group | Active comparator | This group will receive 40 seconds of sweeping and 60 seconds of swiveling by instrument-assisted soft tissue mobilization on myofascial trigger points in the trapezius, levator scapulae, supraspinatus, infraspinatus, and splenius cervicis muscles, along with exercises and suggestions for workplace modifications. Receives: Other: Instrument assisted soft tissue mobilization Group; Other: Exercise and workplace modifications |
| Control Group | Experimental | This group will only receive exercises and suggestions for workplace modifications. Receives: Other: Exercise and workplace modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale(VAS)
VAS is a measurement tool commonly used to assess the intensity of pain or other symptoms. It consists of a horizontal line labeled with descriptive anchors at each end (e.g., 'no pain' to 'worst pain imaginable'). Patients mark on the line to indicate their subjective perception of symptom severity, with the distance from the starting point to the mark providing a quantitative measure. As the value on the scale increases, the perceived pain or symptom intensity also increases
Measured: Six weeks
Neck Disability Index (NDI)
NDI is a measurement tool used to assess functional limitations in the neck region. It is commonly employed in individuals experiencing neck pain to evaluate the extent of restrictions in daily activities. NDI allows patients to subjectively assess how much their neck pain affects their daily lives. The score on the scale indicates the degree of functional impairment experienced by the patient and is used to evaluate treatment outcomes. When the score decreases, it indicates a reduction in limitations.
Measured: Six weeks
Secondary outcomes (5)
The Work Role Functioning Questionnaire (WRFQ)
WRFQ evaluates functionality and work capacity by assessing individuals' roles and functions in the workplace. It covers aspects such as work performance, job retention, and job-related functionality. The questionnaire identifies both constraints and strengths in the workplace, offering insights into employees' perceptions of their job performance and role. It is widely used to assess return to work readiness and overall work ability, with higher scores indicating improved work performance.
Measured: Six weeks
Cervical range of motion
Individuals' active cervical range of motion includes flexion, extension, right-left lateral flexion, and rotation will measured with a universal goniometer.
Measured: Six weeks
Pain pressure threshold
The pressure algometer (model: JTECH USA Commander) will be applied perpendicularly to the trigger point. Participants will be instructed to report the onset of discomfort. Compression will be halted upon their report, and the measurement displayed on the algometer screen will be documented. Three readings will be taken with a 30-second interval between each trial, and the average value will be recorded for analysis.
Measured: Six weeks
SF- 12 quality of life
SF-12 Quality of Life (SF-12 QoL) is a standardized survey tool used to measure health-related quality of life in individuals. It consists of 12 questions that assess physical and mental health, daily functioning, emotional well-being, and overall perception of health status. The survey provides scores for physical and mental health components, reflecting the individual's perceived quality of life across these domains. SF-12 QoL is widely used in research and clinical settings to evaluate health outcomes, monitor changes in health status over time, and assess the impact of interventions on quality of life.
Measured: Six weeks
Global Rating of Change (GROC)
The satisfaction levels of the participants will be evaluated using the 5-point GROC scale at the end of 6 weeks. The scale ranges from -2 to +2, where -2 indicates "I am much worse," -1 indicates "I am worse," 0 indicates "I am the same," +1 indicates "I am better," and +2 indicates "I am much better."
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jun 2024
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
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 Istanbul University - CerrahpasaThe 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
- Three groups with conventional therapy control group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouna Khosravi, Istanbul University - Cerrahpasa
- Investigators
- Mouna Khosravi, MSc, Principal investigator, aculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece/Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485921
- Sponsor's protocol ID
- IstanbulUC-FTR-MK-01
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ischemic Compression and Instrument Assisted Soft Tissue Mobilization on Pain and Function in Patients With Nonspecific Neck Pain
- ClinicalTrials.gov ID
- NCT06485921
- Acronym / sponsor ID
- IstanbulUC-FTR-MK-01
- Conditions
- Neck Pain
- Keywords
- Neck pain, Trigger point, Exercise, Physical therapy, Manual therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 3 Jul 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 was to evaluate the impact of Ischemic Compression (IC) and Instrument Assisted Soft Tissue Mobilization (IASTM) on pain, functionality, cervical range of motion, pressure pain threshold, and quality of life in patients suffering from nonspecific neck pain.
Detailed description
Chronic nonspecific neck pain affects approximately 67% of the global population at least once in their lifetime. This type of neck pain, which is not linked to any specific cause or disease but often associated with the musculoskeletal system, can result from muscle strain or spasms in the neck. It causes functional limitations and decreases quality of life for those affected. Individuals frequently turn to healthcare services and pain-relieving medications in their efforts to manage this discomfort. Chronic nonspecific neck pain is recognized as a significant public health challenge due to its considerable socioeconomic impact. Several studies have indicated that myofascial trigger points in the neck region are associated with nonspecific neck pain and that myofascial trigger point therapy can reduce pain. Therefore, the role of myofascial trigger point therapy in the treatment of nonspecific neck pain has been emphasized in studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups with conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Ischemic compression GROUP | Active comparator | Other: Ischemic compression, Other: Exercise and workplace modificationsThis group will receive 90 seconds of ischemic compression on myofascial trigger points in the trapezius, levator scapulae, supraspinatus, infraspinatus, and splenius cervicis, along with exercises and suggestions for workplace modifications. |
| Instrument assisted soft tissue mobilization Group | Active comparator | Other: Instrument assisted soft tissue mobilization Group, Other: Exercise and workplace modificationsThis group will receive 40 seconds of sweeping and 60 seconds of swiveling by instrument-assisted soft tissue mobilization on myofascial trigger points in the trapezius, levator scapulae, supraspinatus, infraspinatus, and splenius cervicis muscles, along with exercises and suggestions for workplace modifications. |
| Control Group | Experimental | Other: Exercise and workplace modificationsThis group will only receive exercises and suggestions for workplace modifications. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having nonspecific neck pain and at least 3 myofascial trigger points in the back and neck muscles,
- Pain duration exceeding 3 months,
- Working with a computer for at least 20 hours per week for at least 1 year,
- Pain intensity rated as at least 3 on the Visual Analog Scale (VAS),
- Age between 18 and 50 years
Key exclusion criteria (7 listed)
- Use of anti-inflammatory, analgesic, anticoagulant, muscle relaxant, or antidepressant medications at the start of the study or within 1 week prior to the study,
- History of cervical spine surgery or trauma,
- Neck pain, including inflammatory rheumatic diseases,
- Malignancy or structural deformity,
- Coagulation disorders,
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 |
|---|---|---|
| Ischemic compressionParticipants will received a total of 12 treatment sessions over 6 weeks, with 2 sessions per week. | Other | Ischemic compression GROUP |
| Instrument assisted soft tissue mobilization GroupParticipants will received a total of 12 treatment sessions over 6 weeks, with 2 sessions per week. | Other | Instrument assisted soft tissue mobilization Group |
| Exercise and workplace modificationsParticipants will receive stretching and strengthening exercises for neck and scapular stabilizer muscles as a 6-week home program. | Other | Control Group, Instrument assisted soft tissue mobilization Group, Ischemic compression GROUP |
Primary outcome
Visual Analog Scale(VAS)
Time frame: Six weeks
VAS is a measurement tool commonly used to assess the intensity of pain or other symptoms. It consists of a horizontal line labeled with descriptive anchors at each end (e.g., 'no pain' to 'worst pain imaginable'). Patients mark on the line to indicate their subjective perception of symptom severity, with the distance from the starting point to the mark providing a quantitative measure. As the value on the scale increases, the perceived pain or symptom intensity also increases
Neck Disability Index (NDI)
Time frame: Six weeks
NDI is a measurement tool used to assess functional limitations in the neck region. It is commonly employed in individuals experiencing neck pain to evaluate the extent of restrictions in daily activities. NDI allows patients to subjectively assess how much their neck pain affects their daily lives. The score on the scale indicates the degree of functional impairment experienced by the patient and is used to evaluate treatment outcomes. When the score decreases, it indicates a reduction in limitations.
5 secondary outcomes
The Work Role Functioning Questionnaire (WRFQ)
Time frame: Six weeks
Cervical range of motion
Time frame: Six weeks
Pain pressure threshold
Time frame: Six weeks
SF- 12 quality of life
Time frame: Six weeks
Global Rating of Change (GROC)
Time frame: Six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
Mouna Khosravi, MSc principal investigator
aculty of Health Sciences, Istanbul University-Cerrahpasa, Büyükçekmece/Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic compression, Instrument assisted soft tissue mobilization Group and Exercise and workplace modifications in people with Neck Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 3 Jul 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 Turkey (Türkiye). 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?
Visual Analog Scale(VAS) (time frame: Six weeks). 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 3 Jul 2024.