Myofascial Trigger Point PainNCT04719689
Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis
A study testing Dry needling and Dry cupping in people with Myofascial Trigger Point Pain and Quadratus Lumborum Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project was a Randomized clinical trial conducted to Compare the effects of dry needling and dry cupping in Positional fault of pelvis due to Myofascial trigger points in Quadratus Lumborum so that we can have best treatment option for patients with myofascial trigger points. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Myofascial Trigger Point Pain, Quadratus Lumborum Syndrome, Positional Fault of Pelvis
- What is being tested?
- Dry needling and Dry cupping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2019to 1 Jul 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- On palpation the presence of at least 1 active trigger point in quadratus lumborum. So the patient presents with low back pain.
- Patients presents with positional fault of pelvis (lateral tilt)(4).
- Patients having chronic Low Back Pain for at least more than 6 months(3).
- Patients agree to get treatment sessions for the research work.
Who cannot join
- Participants should not have taken any medications like analgesics, anti-coagulants, Non-steroidal anti-inflammatory drugs or muscle relaxants during this study or even 3 days before this study.
- Participants should not have received any other treatment for the pain management, because it will affect the results of the study.
- Patients with bleeding disorders, local or systemic infection, acute muscle trauma.
- Patients with comorbid conditions.
- Patients with severe physical disability and true leg length discrepancy(1).
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis Due to Myofascial Trigger Points in Quadratus Lumborum
This project was a Randomized clinical trial conducted to Compare the effects of dry needling and dry cupping in Positional fault of pelvis due to Myofascial trigger points in Quadratus Lumborum so that we can have best treatment option for patients with myofascial trigger points.
Read the detailed description
Non Probability Convenient sampling was done. Patients following eligibility criteria from Physiotherapy department of Islam Central hospital, Sialkot were considered. Sample size was calculated with Epitool calculator. 26 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given Dry needling technique and Group B was given Dry Cupping along with conventional physiotherapy treatment (hot pack and stretching). Duration of research was almost 6 months. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.
- Conditions
- Myofascial Trigger Point Pain, Quadratus Lumborum Syndrome, Positional Fault of Pelvis, Myofascial Trigger Point in Quadratus Lumborum
- Being tested
- Dry needling, Dry cupping
- Keywords
- Dry needling, Dry cupping, Quadratus lumborum
- 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.
Dry needlingOther
Experimental group 1 got this intervention containing Dry needling for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus lumborum
Dry cuppingOther
Experimental group 2 got this intervention containing Dry cupping for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Dry needling, hot pack, stretching exercises. Receives: Other: Dry needling |
| Dry Cupping | Experimental | Dry cupping, hot pack, stretching exercises. Receives: Other: Dry cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain by 'Pressure Pain Algometer'
Change in Pain from baseline was checked at 6th session by Pressure Pain Algometer. A follow up reading was also taken after 1 month for checking prolonged post treatment effects.
Measured: Baseline, 6th session(at 3rd week), follow up session after 1 month
Change in Range of Motion of lumbar spine side flexion by 'Goniometer'
Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. A goniometer is a device that measures an angle or permits rotation of an object to a definite position
Measured: Baseline, 6th session(at 3rd week), follow up session after 1 month
Secondary outcomes (2)
Change in pain by 'Numeric Pain Rating Scale'
Change in pain from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. The Numerical Pain Rating Scale (NPRS) is an 11 point pain scale that is completed by a patient himself, under the supervision of researcher.
Measured: Baseline, 6th session(at 3rd week), follow up session after 1 month
Change in Range of Motion of lumbar side flexion by Measuring tape
Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. The method for using a tape measure to examine lateral flexion of the spine has been introduced in the literature.
Measured: Baseline, 6th session(at 3rd week), follow up session after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 Oct 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
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 Myofascial Trigger Point PainStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719689
- Sponsor's protocol ID
- REC/Lhr/20/0101 Huma Akhtar
- Status last verified
- Aug 2021
- First submitted
- 10 Jan 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavkovich R. EFFECTIVENESS OF DRY NEEDLING, STRETCHING, AND STRENGTHENING TO REDUCE PAIN AND IMPROVE FUNCTION IN SUBJECTS WITH CHRONIC LATERAL HIP AND THIGH PAIN: A RETROSPECTIVE CASE SERIES. Int J Sports Phys Ther. 2015 Aug;10(4):540-51.
PubMed 26347305Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
PubMed 20823359Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C, Endres HG, Trampisch HJ, Molsberger A. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007 Sep 24;167(17):1892-8. doi: 10.1001/archinte.167.17.1892.
PubMed 17893311Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. doi: 10.1249/01.mss.0000128145.75199.c3.
PubMed 15179160
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dry Needling and Dry Cupping in Positional Fault of Pelvis Due to Myofascial Trigger Points in Quadratus Lumborum
- ClinicalTrials.gov ID
- NCT04719689
- Acronym / sponsor ID
- REC/Lhr/20/0101 Huma Akhtar
- Conditions
- Myofascial Trigger Point Pain, Quadratus Lumborum Syndrome, Positional Fault of Pelvis, Myofascial Trigger Point in Quadratus Lumborum
- Keywords
- Dry needling, Dry cupping, Quadratus lumborum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 22 Jan 2021 (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.
This project was a Randomized clinical trial conducted to Compare the effects of dry needling and dry cupping in Positional fault of pelvis due to Myofascial trigger points in Quadratus Lumborum so that we can have best treatment option for patients with myofascial trigger points.
Detailed description
Non Probability Convenient sampling was done. Patients following eligibility criteria from Physiotherapy department of Islam Central hospital, Sialkot were considered. Sample size was calculated with Epitool calculator. 26 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given Dry needling technique and Group B was given Dry Cupping along with conventional physiotherapy treatment (hot pack and stretching). Duration of research was almost 6 months. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingDry needling, hot pack, stretching exercises. |
| Dry Cupping | Experimental | Other: Dry cuppingDry cupping, hot pack, stretching exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- On palpation the presence of at least 1 active trigger point in quadratus lumborum. So the patient presents with low back pain.
- Patients presents with positional fault of pelvis (lateral tilt)(4).
- Patients having chronic Low Back Pain for at least more than 6 months(3).
- Patients agree to get treatment sessions for the research work.
Key exclusion criteria (6 listed)
- Participants should not have taken any medications like analgesics, anti-coagulants, Non-steroidal anti-inflammatory drugs or muscle relaxants during this study or even 3 days before this study.
- Participants should not have received any other treatment for the pain management, because it will affect the results of the study.
- Patients with bleeding disorders, local or systemic infection, acute muscle trauma.
- Patients with comorbid conditions.
- Patients with severe physical disability and true leg length discrepancy(1).
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 needlingExperimental group 1 got this intervention containing Dry needling for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus lumborum | Other | Dry needling |
| Dry cuppingExperimental group 2 got this intervention containing Dry cupping for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum | Other | Dry Cupping |
Primary outcome
Change in Pain by 'Pressure Pain Algometer'
Time frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
Change in Pain from baseline was checked at 6th session by Pressure Pain Algometer. A follow up reading was also taken after 1 month for checking prolonged post treatment effects.
Change in Range of Motion of lumbar spine side flexion by 'Goniometer'
Time frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
Change in ROM from baseline was measured at 6th session. A follow up reading was taken after 1 month for checking prolonged post treatment effects. A goniometer is a device that measures an angle or permits rotation of an object to a definite position
2 secondary outcomes
Change in pain by 'Numeric Pain Rating Scale'
Time frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
Change in Range of Motion of lumbar side flexion by Measuring tape
Time frame: Baseline, 6th session(at 3rd week), follow up session after 1 month
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 30 Aug 2021.
- Background: PubMed 26347305Pavkovich R. EFFECTIVENESS OF DRY NEEDLING, STRETCHING, AND STRENGTHENING TO REDUCE PAIN AND IMPROVE FUNCTION IN SUBJECTS WITH CHRONIC LATERAL HIP AND THIGH PAIN: A RETROSPECTIVE CASE SERIES. Int J Sports Phys Ther. 2015 Aug;10(4):540-51.
- Background: PubMed 20823359Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
- Background: PubMed 17893311Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C, Endres HG, Trampisch HJ, Molsberger A. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007 Sep 24;167(17):1892-8. doi: 10.1001/archinte.167.17.1892.
- Background: PubMed 15179160Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. doi: 10.1249/01.mss.0000128145.75199.c3.
- 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.
Rabiya Noor, PhD principal investigator
Riphah International University
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 and Dry cupping in people with Myofascial Trigger Point Pain and Quadratus Lumborum Syndrome, run by Riphah International 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 4 inclusion and 6 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 30 Aug 2021. 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?
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?
Change in Pain by 'Pressure Pain Algometer' (time frame: Baseline, 6th session(at 3rd week), follow up session after 1 month). 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?
On the ClinicalTrials.gov record for NCT04719689, 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 30 Aug 2021.