Myofacial Trigger PointsNCT05614830
Effectiveness Taif University P. O. Box 11099 Taif 21944 Effectiveness of Dry Needling in Management of Myofacial Trigger Point
A study testing Dry needling , and usual physical therapy program in people with Myofacial Trigger Points, run by Taif University.
Trial summary
myofascial pain syndrome is considered to be a chronic condition due to sensitive pressure points within the muscle recognized as trigger points Generally the aim of this study will be : To investigate the effectiveness of dry needling on trigger point in trapezius muscle Evaluate the pain level before and after the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofacial Trigger Points
- What is being tested?
- Dry needling , and usual physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically active trigger point and expression of symptoms of neck pain in trapezius which had lasted for at least 3 months.
- Having a pain level higher than 4 and lower than 8 on Visual Analogue Scale ( VAS )
- Did not receive any other form of neck treatment during the previous month.
Who cannot join
- Presence of cardiopulmonary disease , the application process requires the subject to be in prone position to expose the area of treatment, this position is un-preferable for cardiopulmonary patients
- History of neck surgery
- Trigger point treatment in the last 30 days
- Any contraindications for dry needling such as local infection, skin disease ,severe postural disorder , tumor , rheumatoid arthritis, cervical spine stenosis and bilateral upper extremity symptoms
- pregnancy
About this study
Official title: Effectiveness of Dry Needling in Management of Myofacial Trigger Point In Trapezius Muscle
myofascial pain syndrome is considered to be a chronic condition due to sensitive pressure points within the muscle recognized as trigger points
Generally the aim of this study will be :
- To investigate the effectiveness of dry needling on trigger point in trapezius muscle
- Evaluate the pain level before and after the applications of dry needling on trigger points
- compare between the effects of dry needling and physical therapy exercise program
- Conditions
- Myofacial Trigger Points
- Being tested
- Dry needling ,, usual physical therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling ,Other
The intervention group will receive sessions of dry needling to relief myofacial pain on trapezius
usual physical therapy programOther
Therapeutic exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Dry needling , |
| Control group | Active comparator | Usual physical therapy protocol 4 sessions, two sessions per week each session will include a group of therapeutic exercises Receives: Other: usual physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Will be determined using the visuals analogue scale (VAS)
Measured: 6 weeks
Neck disability index
questionnaire contains 10 items aiming to evaluate the limitation because of neck pain
Measured: 6 weeks
Secondary outcomes (2)
Depression
Will be determined using the Beck's Depression Inventory ( BDI)
Measured: 6 weeks
Neck Range of motion
Will be measured using CROM
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofacial Trigger PointsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Slwa Sami Alattar, Taif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614830
- Sponsor's protocol ID
- 44-004
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 14 Nov 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling in Management of Myofacial Trigger Point In Trapezius Muscle
- ClinicalTrials.gov ID
- NCT05614830
- Acronym / sponsor ID
- 44-004
- Conditions
- Myofacial Trigger Points
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 14 Nov 2022 (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.
myofascial pain syndrome is considered to be a chronic condition due to sensitive pressure points within the muscle recognized as trigger points
Generally the aim of this study will be :
- To investigate the effectiveness of dry needling on trigger point in trapezius muscle
- Evaluate the pain level before and after the applications of dry needling on trigger points
- compare between the effects of dry needling and physical therapy exercise program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Dry needling , |
| Control group | Active comparator | Other: usual physical therapy programUsual physical therapy protocol 4 sessions, two sessions per week each session will include a group of therapeutic exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically active trigger point and expression of symptoms of neck pain in trapezius which had lasted for at least 3 months.
- Having a pain level higher than 4 and lower than 8 on Visual Analogue Scale ( VAS )
- Did not receive any other form of neck treatment during the previous month.
Key exclusion criteria (5 listed)
- Presence of cardiopulmonary disease , the application process requires the subject to be in prone position to expose the area of treatment, this position is un-preferable for cardiopulmonary patients
- History of neck surgery
- Trigger point treatment in the last 30 days
- Any contraindications for dry needling such as local infection, skin disease ,severe postural disorder , tumor , rheumatoid arthritis, cervical spine stenosis and bilateral upper extremity symptoms
- pregnancy
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 |
|---|---|---|
| Dry needling ,The intervention group will receive sessions of dry needling to relief myofacial pain on trapezius | Other | Intervention group |
| usual physical therapy programTherapeutic exercise | Other | Control group |
Primary outcome
Pain level
Time frame: 6 weeks
Will be determined using the visuals analogue scale (VAS)
Neck disability index
Time frame: 6 weeks
questionnaire contains 10 items aiming to evaluate the limitation because of neck pain
2 secondary outcomes
Depression
Time frame: 6 weeks
Neck Range of motion
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling , and usual physical therapy program in people with Myofacial Trigger Points, run by Taif University.
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 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain level (time frame: 6 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 14 Nov 2022.