Quadratus Lumborum SyndromeNCT06407687
Compare Electrodry Needlig and Dry Needling in Mechanical Low Back Pain
A study testing Electro Dry Needlig and dry needling in people with Quadratus Lumborum Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mechanical low back pain (LBP) generally results from an acute traumatic event, but it may also be caused by cumulative trauma. The severity of an acute traumatic event varies widely, from twisting one's back to being involved in a motor vehicle collision. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadratus Lumborum Syndrome
- What is being tested?
- Electro Dry Needlig and dry needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2024to 15 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25 to 45 years.
- Male and females both included.
- Muscle hypersensitivity on palpation
- Deep aching pain in sides of the lower back.
- Positive side-bridge test (Right < 83.2 sec and Left < 81.5 sec)
- Positive Simon's criteria for Quadratus Lumborum
Show all 11Show fewer
- Patients with NPRS <7
- ODI score of < 40
- Decreased Lumber Side flexion and extension ROM
- Positive apperent Leg Length Discrepancy with more than 2 cm
- Negative Laslet's criteria for sacroiliac dysfunction
Who cannot join
- People with real leg length discrepancy
- People with any other medical condition Including Lumbar fracture, Spondylolisthesis, Ankylosing Spondylysis, Rheumatoid Arthritis. All these conditions will be ruled out with carefully history and examination.
- People taking any other form of treatment including corticosteroids, non-steroidal anti-inflammatory drugs or analgesics.
- People with previous history of surgical treatment for Lumbar spine. o People with neurological deficits or systemic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Electro Dry Needling Versus Dry Needling on Pain, Endurance and Range of Motion in Patients With of Quadratus Lumborum Syndrome
Mechanical low back pain (LBP) generally results from an acute traumatic event, but it may also be caused by cumulative trauma. The severity of an acute traumatic event varies widely, from twisting one's back to being involved in a motor vehicle collision. Mechanical LBP due to cumulative trauma tends to occur more commonly in the workplace and Quadratus Lumborum injury plays an important role in causing MLBP. The aim of this study is To compare the effects of Electrical Dry Needling and Dry Needling on pain, endurance and range of motion in patients with Quadratus Lumborum Syndrome.
Read the detailed description
A Randomized Clinical Trial will be conducted at Ali Afzal Shah Dispensary and Inam ul Haq Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using simple random sampling and patients will be divided in Group A and B. Group A will receive Electrical Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes Frequency 80-100 Hz, Duration 10-30 minutes and intensity as tolerated 1 session per week along with 5 day conventional physiotherapy a week for 4 weeks. Group 2 will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes once per week and 5 days of conventional Physiotherapy per week for 4 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Quadratus Lumborum Syndrome
- Being tested
- Electro Dry Needlig, dry needling
- Keywords
- Dry Needling, Endurance, pain, range of motion, Quadratus Lumborum Syndrome
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro Dry NeedligDevice
Electro Dry Needling is a modified form of dry needling which utilises an electro-stimulation unit connected via cables to fine filament needles. The combination of dry needling with electro-stimulation often prolongs the pain relief effect by blocking nerve pathways and preventing pain signals from travelling to the brain.
dry needlingDevice
Dry needling is a technique that acupuncturists, physical therapists and other trained healthcare providers use to treat musculoskeletal pain and movement issues.
| Study group | Role | What they receive |
|---|---|---|
| Electric dry needling | Experimental | Group A will receive Electrical Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes Frequency 80-100 Hz, Duration 10-30 minutes and intensity as tolerated. Receives: Device: Electro Dry Needlig |
| Dry needling | Active comparator | Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes. Receives: Device: dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 4th week
Leg length Discrepancy
Involves measuring limb length with a tape measure between 2 defined points, in the stand. Two common points are the anterior iliac spine and the medial malleolus or the anterior inferior iliac spine and lateral malleolus
Measured: 4th week
Endurance
The McGill Torso Endurance Tests are a useful battery of tests that assess all sides of the trunk allowing us to assess the endurance capacity of the torso muscles or if there is an imbalance between these three muscle groups which can contribute to low-back dysfunction and core instability.
Measured: 4th week
Range of motion
Universal goniometer will be used to measure side binding ROM of Lumber Spine in atient with Quadratus Lumborum Syndrome.Universal goniometer is tool that has two arms and a fulcrum in which one arm remains fixed and the other arm moves to measure the ROM. The norm side bending ROM of Lumber Spine is 20 degress on each side. Its reliability is 0.97 and validity is 0.98
Measured: 4th week
Disability
ODI scoring is used to measure the disability of the patient. ODI score system consists of sections which includes a score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. And in this study the patients with moderate disability will be included for the study and its Reliability is 0.88 and validity is 0.93
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 Jun 2024
- Primary completion10 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Quadratus Lumborum SyndromeStudies 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
- Outcomes assessor
- 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
- NCT06407687
- Sponsor's protocol ID
- REC/RCR & AHS/23/0183
- Status last verified
- Dec 2024
- First submitted
- 6 May 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borenstein D. Mechanical low back pain--a rheumatologist's view. Nat Rev Rheumatol. 2013 Nov;9(11):643-53. doi: 10.1038/nrrheum.2013.133. Epub 2013 Sep 10.
PubMed 24018549Trompeter K, Fett D, Platen P. Prevalence of Back Pain in Sports: A Systematic Review of the Literature. Sports Med. 2017 Jun;47(6):1183-1207. doi: 10.1007/s40279-016-0645-3.
PubMed 28035587Wong AYL, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis Spinal Disord. 2017 Apr 18;12:14. doi: 10.1186/s13013-017-0121-3. eCollection 2017.
PubMed 28435906Pandey E, Kumar N, Das SJPOTJ. Effect of stretching on shortened quadratus lumborum muscle in non specific low back pain. 2018;11(2):80-6.
Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
PubMed 30252425MHMD H, Choudhury M, Mojumder M. A COMPARATIVE STUDY OF TREATMENT OF CHRONIC BACKACHE BETWEEN CONVENTIONAL METHOD AND TRIGGER POINT INJECTIONS (TPI).
Bryner P, HSR GD. Unilaterol bock poin: ci cose series of quodroitus lumborum. 1996.
Grover C, Christoffersen K, Clark L, Close R, Layhe S. Atraumatic Back Pain Due to Quadratus Lumborum Spasm Treated by Physical Therapy with Manual Trigger Point Therapy in the Emergency Department. Clin Pract Cases Emerg Med. 2019 May 29;3(3):259-261. doi: 10.5811/cpcem.2019.4.42788. eCollection 2019 Aug.
PubMed 31404175Fernández-de-las-Peñas C, Dommerholt JJTpdnae, approach c-b. Basic concepts of myofascial trigger points (TrPs). 2013:3-19.
de Franca GG, Levine LJ. The quadratus lumborum and low back pain. J Manipulative Physiol Ther. 1991 Feb;14(2):142-9.
PubMed 1826922
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Electro Dry Needling Versus Dry Needling on Pain, Endurance and Range of Motion in Patients With of Quadratus Lumborum Syndrome
- ClinicalTrials.gov ID
- NCT06407687
- Acronym / sponsor ID
- REC/RCR & AHS/23/0183
- Conditions
- Quadratus Lumborum Syndrome
- Keywords
- Dry Needling, Endurance, pain, range of motion, Quadratus Lumborum Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 9 May 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.
Mechanical low back pain (LBP) generally results from an acute traumatic event, but it may also be caused by cumulative trauma. The severity of an acute traumatic event varies widely, from twisting one's back to being involved in a motor vehicle collision. Mechanical LBP due to cumulative trauma tends to occur more commonly in the workplace and Quadratus Lumborum injury plays an important role in causing MLBP. The aim of this study is To compare the effects of Electrical Dry Needling and Dry Needling on pain, endurance and range of motion in patients with Quadratus Lumborum Syndrome.
Detailed description
A Randomized Clinical Trial will be conducted at Ali Afzal Shah Dispensary and Inam ul Haq Clinic Lahore through consecutive sampling technique on 40 patients which will be allocated using simple random sampling and patients will be divided in Group A and B. Group A will receive Electrical Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes Frequency 80-100 Hz, Duration 10-30 minutes and intensity as tolerated 1 session per week along with 5 day conventional physiotherapy a week for 4 weeks. Group 2 will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes once per week and 5 days of conventional Physiotherapy per week for 4 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric dry needling | Experimental | Device: Electro Dry NeedligGroup A will receive Electrical Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes Frequency 80-100 Hz, Duration 10-30 minutes and intensity as tolerated. |
| Dry needling | Active comparator | Device: dry needlingGroup B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 25 to 45 years.
- Male and females both included.
- Muscle hypersensitivity on palpation
- Deep aching pain in sides of the lower back.
- Positive side-bridge test (Right < 83.2 sec and Left < 81.5 sec)
Key exclusion criteria (4 listed)
- People with real leg length discrepancy
- People with any other medical condition Including Lumbar fracture, Spondylolisthesis, Ankylosing Spondylysis, Rheumatoid Arthritis. All these conditions will be ruled out with carefully history and examination.
- People taking any other form of treatment including corticosteroids, non-steroidal anti-inflammatory drugs or analgesics.
- People with previous history of surgical treatment for Lumbar spine. o People with neurological deficits or systemic illness
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 |
|---|---|---|
| Electro Dry NeedligElectro Dry Needling is a modified form of dry needling which utilises an electro-stimulation unit connected via cables to fine filament needles. The combination of dry needling with electro-stimulation often prolongs the pain relief effect by blocking nerve pathways and preventing pain signals from travelling to the brain. | Device | Electric dry needling |
| dry needlingDry needling is a technique that acupuncturists, physical therapists and other trained healthcare providers use to treat musculoskeletal pain and movement issues. | Device | Dry needling |
Primary outcome
NPRS
Time frame: 4th week
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Leg length Discrepancy
Time frame: 4th week
Involves measuring limb length with a tape measure between 2 defined points, in the stand. Two common points are the anterior iliac spine and the medial malleolus or the anterior inferior iliac spine and lateral malleolus
Endurance
Time frame: 4th week
The McGill Torso Endurance Tests are a useful battery of tests that assess all sides of the trunk allowing us to assess the endurance capacity of the torso muscles or if there is an imbalance between these three muscle groups which can contribute to low-back dysfunction and core instability.
Range of motion
Time frame: 4th week
Universal goniometer will be used to measure side binding ROM of Lumber Spine in atient with Quadratus Lumborum Syndrome.Universal goniometer is tool that has two arms and a fulcrum in which one arm remains fixed and the other arm moves to measure the ROM. The norm side bending ROM of Lumber Spine is 20 degress on each side. Its reliability is 0.97 and validity is 0.98
Disability
Time frame: 4th week
ODI scoring is used to measure the disability of the patient. ODI score system consists of sections which includes a score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. And in this study the patients with moderate disability will be included for the study and its Reliability is 0.88 and validity is 0.93
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 27 Dec 2024.
- Background: PubMed 24018549Borenstein D. Mechanical low back pain--a rheumatologist's view. Nat Rev Rheumatol. 2013 Nov;9(11):643-53. doi: 10.1038/nrrheum.2013.133. Epub 2013 Sep 10.
- Background: PubMed 28035587Trompeter K, Fett D, Platen P. Prevalence of Back Pain in Sports: A Systematic Review of the Literature. Sports Med. 2017 Jun;47(6):1183-1207. doi: 10.1007/s40279-016-0645-3.
- Background: PubMed 28435906Wong AYL, Karppinen J, Samartzis D. Low back pain in older adults: risk factors, management options and future directions. Scoliosis Spinal Disord. 2017 Apr 18;12:14. doi: 10.1186/s13013-017-0121-3. eCollection 2017.
- BackgroundPandey E, Kumar N, Das SJPOTJ. Effect of stretching on shortened quadratus lumborum muscle in non specific low back pain. 2018;11(2):80-6.
- Background: PubMed 30252425Will JS, Bury DC, Miller JA. Mechanical Low Back Pain. Am Fam Physician. 2018 Oct 1;98(7):421-428.
- BackgroundMHMD H, Choudhury M, Mojumder M. A COMPARATIVE STUDY OF TREATMENT OF CHRONIC BACKACHE BETWEEN CONVENTIONAL METHOD AND TRIGGER POINT INJECTIONS (TPI).
- BackgroundBryner P, HSR GD. Unilaterol bock poin: ci cose series of quodroitus lumborum. 1996.
- Background: PubMed 31404175Grover C, Christoffersen K, Clark L, Close R, Layhe S. Atraumatic Back Pain Due to Quadratus Lumborum Spasm Treated by Physical Therapy with Manual Trigger Point Therapy in the Emergency Department. Clin Pract Cases Emerg Med. 2019 May 29;3(3):259-261. doi: 10.5811/cpcem.2019.4.42788. eCollection 2019 Aug.
- BackgroundFernández-de-las-Peñas C, Dommerholt JJTpdnae, approach c-b. Basic concepts of myofascial trigger points (TrPs). 2013:3-19.
- Background: PubMed 1826922de Franca GG, Levine LJ. The quadratus lumborum and low back pain. J Manipulative Physiol Ther. 1991 Feb;14(2):142-9.
- Individual participant dataSharing planned: No
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 Electro Dry Needlig and dry needling in people with 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 11 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: finished, as of the sponsor's last update on 27 Dec 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?
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?
NPRS (time frame: 4th week). The study lists 5 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 NCT06407687, which also lists 10 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 27 Dec 2024; AzTrials last refreshed its copy on 1 Nov 2026.