Trigger Point Pain, MyofascialNCT06530329
Short-Term Effects of Ischemic Compression Applied in Addition to Classical Massage in the Treatment of Trigger Points
A study testing Classical massage and Ischemic compression in people with Trigger Point Pain, Myofascial, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage for the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Classical massage and Ischemic compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Jun 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 20-50
- Having a myofascial trigger point detected in the upper trapezius muscle for at least two weeks
- Being a student or staff of Halic University
- Being literate
Who cannot join
- Having a history of cervical surgery
- Having a malignant disease
- Pregnancy
- Menopause
- Having cooperation problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Short-Term Effects of Ischemic Compression Applied in Addition to Classical Massage on Pain, Functionality and Quality of Life in the Treatment of Myofascial Trigger Points on the Upper Trapezius Muscle in Women
The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage for the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life.
Read the detailed description
The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage in the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life. "Visual Analog Scale (VAS)" was used for pain assessment of individuals who accepted to participate in the study; universal goniometer was used to measure active neck active range of motions (AROM) for functionality; and "Short Form-36 (SF-36)" was used for quality of life. Then, the participants were randomly divided into two groups [Group 1: classical massage group; Group 2: classical massage + ischemic compression group]. Classical massage was applied to both groups three times a week for two weeks, and ischemic compression was applied to Group 2 in addition to classical massage. At the end of the treatment period, the participants were re-evaluated in terms of VAS, neck AROM and SF-36 scores.Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Classical massage, Ischemic compression
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical massageOther
Classical massage was started by general stroking 3 times. Then, it was continued by kneading 3 times. After the kneading movement, fibrocytic nodules on the muscle were searched and friction was applied to the found nodules one by one. The massage of the muscle was completed by applying stroking 3 times. The application was carried out 3 times a week for 2 weeks to evaluate the short-term effect.
Ischemic compressionOther
Ischemic compression was applied to the trigger points in the upper trapezius muscle using an average pressure of 1 kg at a right angle, and after compression, passive stretching was applied to the upper trapezius muscle 3 times in 20-second periods. The application was performed 3 times a week for 2 weeks to evaluate the short-term effect.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Classical massage group Receives: Other: Classical massage |
| Group 2 | Experimental | Classical massage + ischemic compression group Receives: Other: Classical massage; Other: Ischemic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain assessment was made with Visual Analog Scale (VAS). The subjects were informed that the number '0' on a 10 cm horizontal line indicated 'no pain' and the number '10' indicated 'unbearable pain'. The subjects were asked to mark the pain they felt on the VAS scale for 3 different areas, namely trapezius pain, neck pain and headache, and the points they marked were recorded as the severity of pain in cm. VAS measurements were performed twice in total, before and after treatment.
Measured: at baseline and at week 2.
Active Range of Motion
Active Range of Motion (AROM) measurement was evaluated using a universal goniometer. While the patient was in a sitting position, the pivot point, fixed arm and movable arm of the goniometer were placed in the specified reference areas. The patient was asked to actively perform neck flexion, extension, right-left lateral flexion and right-left rotation movements and the values at the end of the movements were recorded in degrees. AROM measurements were performed twice in total, before and after treatment.
Measured: at baseline and at week 2.
Short-Form 36
The Short Form-36 (SF-36) scale was used to assess quality of life. The lowest score represents the worst health status. SF-36 measurement was performed twice, before and after treatment.
Measured: at baseline and at week 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start15 Mar 2024
- Primary completion15 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Şahin Altaç, Halic University
- Investigators
- Duygu Sahin Altac, PT, MSc., Principal investigator, Halic Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530329
- Sponsor's protocol ID
- 28.07.2024-EDP&DA
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
PubMed 11871683Bethers AH, Swanson DC, Sponbeck JK, Mitchell UH, Draper DO, Feland JB, Johnson AW. Positional release therapy and therapeutic massage reduce muscle trigger and tender points. J Bodyw Mov Ther. 2021 Oct;28:264-270. doi: 10.1016/j.jbmt.2021.07.005. Epub 2021 Jul 14.
PubMed 34776151Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.
PubMed 25768071Sahin D, Kaya Mutlu E, Sakar O, Ates G, Inan S, Taskiran H. The effect of the ischaemic compression technique on pain and functionality in temporomandibular disorders: A randomised clinical trial. J Oral Rehabil. 2021 May;48(5):531-541. doi: 10.1111/joor.13145. Epub 2021 Jan 21.
PubMed 33411952
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Short-Term Effects of Ischemic Compression Applied in Addition to Classical Massage on Pain, Functionality and Quality of Life in the Treatment of Myofascial Trigger Points on the Upper Trapezius Muscle in Women
- ClinicalTrials.gov ID
- NCT06530329
- Acronym / sponsor ID
- 28.07.2024-EDP&DA
- Conditions
- Trigger Point Pain, Myofascial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 31 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 aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage for the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life.
Detailed description
The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage in the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life. "Visual Analog Scale (VAS)" was used for pain assessment of individuals who accepted to participate in the study; universal goniometer was used to measure active neck active range of motions (AROM) for functionality; and "Short Form-36 (SF-36)" was used for quality of life. Then, the participants were randomly divided into two groups [Group 1: classical massage group; Group 2: classical massage + ischemic compression group]. Classical massage was applied to both groups three times a week for two weeks, and ischemic compression was applied to Group 2 in addition to classical massage. At the end of the treatment period, the participants were re-evaluated in terms of VAS, neck AROM and SF-36 scores.Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Classical massageClassical massage group |
| Group 2 | Experimental | Other: Classical massage, Other: Ischemic compressionClassical massage + ischemic compression group |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being between the ages of 20-50
- Having a myofascial trigger point detected in the upper trapezius muscle for at least two weeks
- Being a student or staff of Halic University
- Being literate
Key exclusion criteria (5 listed)
- Having a history of cervical surgery
- Having a malignant disease
- Pregnancy
- Menopause
- Having cooperation problems
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 |
|---|---|---|
| Classical massageClassical massage was started by general stroking 3 times. Then, it was continued by kneading 3 times. After the kneading movement, fibrocytic nodules on the muscle were searched and friction was applied to the found nodules one by one. The massage of the muscle was completed by applying stroking 3 times. The application was carried out 3 times a week for 2 weeks to evaluate the short-term effect. | Other | Group 1, Group 2 |
| Ischemic compressionIschemic compression was applied to the trigger points in the upper trapezius muscle using an average pressure of 1 kg at a right angle, and after compression, passive stretching was applied to the upper trapezius muscle 3 times in 20-second periods. The application was performed 3 times a week for 2 weeks to evaluate the short-term effect. | Other | Group 2 |
Primary outcome
Visual Analog Scale
Time frame: at baseline and at week 2.
Pain assessment was made with Visual Analog Scale (VAS). The subjects were informed that the number '0' on a 10 cm horizontal line indicated 'no pain' and the number '10' indicated 'unbearable pain'. The subjects were asked to mark the pain they felt on the VAS scale for 3 different areas, namely trapezius pain, neck pain and headache, and the points they marked were recorded as the severity of pain in cm. VAS measurements were performed twice in total, before and after treatment.
Active Range of Motion
Time frame: at baseline and at week 2.
Active Range of Motion (AROM) measurement was evaluated using a universal goniometer. While the patient was in a sitting position, the pivot point, fixed arm and movable arm of the goniometer were placed in the specified reference areas. The patient was asked to actively perform neck flexion, extension, right-left lateral flexion and right-left rotation movements and the values at the end of the movements were recorded in degrees. AROM measurements were performed twice in total, before and after treatment.
Short-Form 36
Time frame: at baseline and at week 2.
The Short Form-36 (SF-36) scale was used to assess quality of life. The lowest score represents the worst health status. SF-36 measurement was performed twice, before and after treatment.
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 31 Jul 2024.
- Results publication: PubMed 11871683Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
- Results publication: PubMed 34776151Bethers AH, Swanson DC, Sponbeck JK, Mitchell UH, Draper DO, Feland JB, Johnson AW. Positional release therapy and therapeutic massage reduce muscle trigger and tender points. J Bodyw Mov Ther. 2021 Oct;28:264-270. doi: 10.1016/j.jbmt.2021.07.005. Epub 2021 Jul 14.
- Results publication: PubMed 25768071Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.
- Results publication: PubMed 33411952Sahin D, Kaya Mutlu E, Sakar O, Ates G, Inan S, Taskiran H. The effect of the ischaemic compression technique on pain and functionality in temporomandibular disorders: A randomised clinical trial. J Oral Rehabil. 2021 May;48(5):531-541. doi: 10.1111/joor.13145. Epub 2021 Jan 21.
- 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.
Duygu Sahin Altac, PT, MSc. principal investigator
Halic Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical massage and Ischemic compression in people with Trigger Point Pain, Myofascial, run by Halic University 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 4 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: finished, as of the sponsor's last update on 31 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?
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?
Visual Analog Scale (time frame: at baseline and at week 2.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06530329, which also lists 4 linked publications.
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 31 Jul 2024.