PainNCT06457581
Effectiveness of Dry Needling Adjuvant to Selective Serotonin Reputake Inhibitors vs TP Injection for Pain Management
A study testing Dry Needling, Trigger points injections and serotonin reuptake inhibitor (SSRI) in people with Pain and Fibromyalgia, run by Superior University at 1 site in Pakistan.
Trial summary
The principal objective is to contribute valuable insights that hold direct implications for medical practice and patient care, with the potential to influence health policy pertaining to fibromyalgia management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Fibromyalgia
- What is being tested?
- Dry Needling, Trigger points injections and serotonin reuptake inhibitor (SSRI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable on SSRIs for at least three months (for Group A)
- Age between 18 and 65 years
- Participants suffering from recent cervical pain without any pathology
Who cannot join
- Presence of any other chronic pain conditions.
- Contraindications to SSRIs or trigger point injections.
- Pregnancy or lactation.
- History of psychiatric disorders other than depression and anxiety
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chaudary Muhammad Akram Teaching Hospital
Lahore, Punjab Province
About this study
Official title: Effectiveness of Dry Needling Adjuvant to Selective Serotonin Reputake Inhibitors Versus Trigger Point Injection for Pain Management in Fibromyalgia
The principal objective is to contribute valuable insights that hold direct implications for medical practice and patient care, with the potential to influence health policy pertaining to fibromyalgia management.
Read the detailed description
The study aims to outline distinct patient subgroups manifesting heightened responsiveness to one therapeutic intervention vis-à-vis the other, thereby facilitating the formulation of more personalized and efficacious treatment modalities.
- Conditions
- Pain, Fibromyalgia
- Being tested
- Dry Needling, Trigger points injections, serotonin reuptake inhibitor (SSRI)
- Medical subject headings
- Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
Group A will undergo dry needling sessions twice a week over eight weeks, specifically targeting trigger points and tender points. Simultaneously, a consistent dosage of selective serotonin reuptake inhibitor (SSRI) will be administered and maintained throughout the entire duration of the study.
Trigger points injectionsProcedure or surgery
Group B will undergo a comprehensive intervention involving trigger point injections administered biweekly over eight weeks. These injections will specifically target trigger points. Additionally, a control measure will be implemented through simulated needling at non-specific points.
serotonin reuptake inhibitor (SSRI)Drug
serotonin reuptake inhibitor (SSRI)
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Other | Not described Receives: Other: Dry Needling; Drug: serotonin reuptake inhibitor (SSRI) |
| Trigger points injections | Experimental | Not described Receives: Procedure: Trigger points injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
It includes 19 items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: 12 Months
Fibromyalgia Impact Questionnaire:
It includes questions related to physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being. Scores on the FIQ range from 0 to 100, with higher scores indicating greater impact and symptom severity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457581
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/724
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling Adjuvant to Selective Serotonin Reputake Inhibitors Versus Trigger Point Injection for Pain Management in Fibromyalgia
- ClinicalTrials.gov ID
- NCT06457581
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/724
- Conditions
- Pain, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 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 principal objective is to contribute valuable insights that hold direct implications for medical practice and patient care, with the potential to influence health policy pertaining to fibromyalgia management.
Detailed description
The study aims to outline distinct patient subgroups manifesting heightened responsiveness to one therapeutic intervention vis-à-vis the other, thereby facilitating the formulation of more personalized and efficacious treatment modalities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Other | Other: Dry Needling, Drug: serotonin reuptake inhibitor (SSRI) |
| Trigger points injections | Experimental | Procedure: Trigger points injections |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable on SSRIs for at least three months (for Group A)
- Age between 18 and 65 years
- Participants suffering from recent cervical pain without any pathology
Key exclusion criteria (4 listed)
- Presence of any other chronic pain conditions.
- Contraindications to SSRIs or trigger point injections.
- Pregnancy or lactation.
- History of psychiatric disorders other than depression and anxiety
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 NeedlingGroup A will undergo dry needling sessions twice a week over eight weeks, specifically targeting trigger points and tender points. Simultaneously, a consistent dosage of selective serotonin reuptake inhibitor (SSRI) will be administered and maintained throughout the entire duration of the study. | Other | Dry Needling |
| Trigger points injectionsGroup B will undergo a comprehensive intervention involving trigger point injections administered biweekly over eight weeks. These injections will specifically target trigger points. Additionally, a control measure will be implemented through simulated needling at non-specific points. | Procedure or surgery | Trigger points injections |
| serotonin reuptake inhibitor (SSRI)serotonin reuptake inhibitor (SSRI) | Drug | Dry Needling |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 Months
It includes 19 items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Fibromyalgia Impact Questionnaire:
Time frame: 12 months
It includes questions related to physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being. Scores on the FIQ range from 0 to 100, with higher scores indicating greater impact and symptom severity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling, Trigger points injections and serotonin reuptake inhibitor (SSRI) in people with Pain and Fibromyalgia, run by Superior University at 1 site in Pakistan.
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 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: status not confirmed, as of the sponsor's last update on 13 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 1 site in Pakistan. 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?
Pittsburgh Sleep Quality Index (PSQI) (time frame: 12 Months). 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 13 Jun 2024.