Low Back PainNCT04043741
Comparison of Dry Needling and Sustained Pressure in Para-spinal Muscles Trigger Points
A study testing Dry Needling and Sustain Pressure in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will compare the effect of dry needling and sustained pressure in the lumbar Paraspinal trigger points in terms of pain threshold and muscle length. There will be two groups ; experimental and control. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Dry Needling and Sustain Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2019to 30 Jun 2019
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-50.
- Patient of acute, sub acute, chronic Low back pain (LBP), Mechanical Low back pain (MLBP) and radiculopathies up to one year.
- Patients having active (spontaneously painful) or latent (requiring palpation to reproduce the characteristic pain) MTrPs.
Who cannot join
- Patients that were using any medication to reduce the pain and/or have any effect in the skeletal muscle including analgesics, anticoagulants and muscular relaxants.
- Taking other treatment in the same period of the research.
- Pregnant female.
- Patients with Chronic Disease (kidney disease, Diabetic, and osteoporosis) and spinal diseases (herniated disc, spondylolisthesis) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dry Needling and Sustained Pressure in Trigger Points of Lumbar Paraspinal Muscles
This study will compare the effect of dry needling and sustained pressure in the lumbar Paraspinal trigger points in terms of pain threshold and muscle length.
There will be two groups ; experimental and control. Half of study group will receive dry needling session along with stretching and strengthening exercises and half of study group will receive sustained pressure technique along with stretching and strengthening exercises .
Read the detailed description
The study is Randomized Control Trail , which is being conducted in Pakistan Railway hospital and Riphah international hospital (march 2019-june 2019) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. 50 individual are screened out according to inclusion criteria. Individuals are allocated randomly into two groups , 25 in experimental group and 25 in control group by sealed envelope method.Both groups will receive conventional physiotherapy protocol (hot pack, stretching exercises and strengthening exercises) and then experimental group will receive cervical sensorimotor control training. Assessment will be done on baseline, 2nd week, 4th week and 6th week.
Myofascial trigger point (MTrP) is moreover removed or inactivate by means of mechanical stimuli through filiform needle. A swift and repetitious needle insertions into myofascial trigger point is a treatment technique use for dry needling commonly has many therapeutic advantages. It interrupts motor end plates, muscle fibers and distal axons of myofascial trigger points and shortening of related sarcomere of myocytes.
Use of dry needling in combination Muscle Energy Technique (MET) has more significant effects in improving Visual Analog Scale (VAS), Pain Pressure Threshold (PPT) and Range of Motion (ROM) of females patients having latent trigger points in upper trapezius than alone use of MET.
Laser therapy has verified as to be more successful than dry needling in treating MTrPs. It is a preferred option for the patients having apprehensive behavior towards dry needling and health practioners inexpert with the dry needling procedure.
Dry needling is indicated for the treatment when MTrPs are present, may leads to functional restrictions. They are the source of constant peripheral nociceptive contribution which needs to be inactivated. Dry Needling (DN) is also indicated in fascial adhesions, soft tissue restrictions, shortened muscle fiber due to which restricted range of motion is present.Secondary trigger point (TrP) due to different neuromuscular dysfunctions for example in tendonitis, radiculopathies, disk pathology, migraines, carpal tunnel syndrome, tension type headache, joint dysfunction, cranio-mandibular dysfunction, phantom pain , additional regional urological syndromes and other exceptional neurogenic pruritus, Barre Lieou syndrome
- Conditions
- Low Back Pain
- Being tested
- Dry Needling, Sustain Pressure
- Keywords
- Dry Needling, Oswestry disability index,, Paraspinal muscle length, Pain pressure threshold
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
stretching exercises :single knee to chest (15 reps x 3 sets) double knee to chest(15 reps x 3 sets) strengthening exercises: extension exercises (15 reps x 3 sets)
Sustain PressureOther
Sustain Pressure (Number of repetition and hold according to trigger point chronic level)
+ Hot pack 10 to 15 minutes + Active muscle stretching exercise (10 repetition twice daily)
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | Dry needling (04 Sessions) and exercises Receives: Other: Dry Needling |
| Sustain Pressure | Active comparator | sustained pressure and Exercises Receives: Other: Sustain Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oswestry Disability Index (ODI)
Changes from the base line, The Oswestry Disability Index is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.At the end score is calculated by dividing the obtained score by total (50) multiplied by 100.As one question(section 8) was dropped in all participants ,so total score was considered as 45 instead of 50.
Measured: up to 2 weeks
Para-spinal muscle length
Changes from the base line, Muscle length assessment technique is use to measure available range of muscle. In paraspinal muscles length assessment patient would be sitting position. Palpate anterior superior iliac spine (ASIS) bilaterally and instruct the patient to flex forward producing posterior pelvic tilt. Feel when ASIS starts to move this is the end of thoracolumbar flexion and initiation of posterior pelvic tilt. , Patient forehead would come 10 inches of the knees normally.
Measured: up to 2 weeks
Visual analog scale
Changes from the base line, The visual analogue scale is one dimensional measure of pain intensity in adults inclusive those with chronic pain. The intensity of pain experienced by the patients on this scale range from no pain (score 0) to very severe pain (score 100). It is marked by paper and pencil on a line consist of horizontal (HVAS) or vertical (VVAS) comprised of 10centimeters (100mm) in length.
Measured: up to 2 weeks
Pain Pressure Threshold (PPT).
Changes from the base line, Algometer is a device used to recognize the minimum pressure or force which induce pain pressure threshold (PPT). It is uncomplicated portable tool with a spring install in it. Peak force or pressure provided by this device is kilopond (kp) = 10 N, Newton = 100 kilopascal (kPa).
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Mar 2019
- Primary completion30 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Ghafoor Sajjad, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043741
- Sponsor's protocol ID
- RiphahIU Aneela Zia
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bron C, Dommerholt JD. Etiology of myofascial trigger points. Curr Pain Headache Rep. 2012 Oct;16(5):439-44. doi: 10.1007/s11916-012-0289-4.
PubMed 22836591Fernandez-de-las-Penas C, Dommerholt J. Myofascial trigger points: peripheral or central phenomenon? Curr Rheumatol Rep. 2014 Jan;16(1):395. doi: 10.1007/s11926-013-0395-2.
PubMed 24264721Kalichman 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 20823359Bishwajit G, Tang S, Yaya S, Feng Z. Participation in physical activity and back pain among an elderly population in South Asia. J Pain Res. 2017 Apr 15;10:905-913. doi: 10.2147/JPR.S133013. eCollection 2017.
PubMed 28450787Koppenhaver SL, Walker MJ, Su J, McGowen JM, Umlauf L, Harris KD, Ross MD. Changes in lumbar multifidus muscle function and nociceptive sensitivity in low back pain patient responders versus non-responders after dry needling treatment. Man Ther. 2015 Dec;20(6):769-76. doi: 10.1016/j.math.2015.03.003. Epub 2015 Mar 13.
PubMed 25801100Uemoto L, Nascimento de Azevedo R, Almeida Alfaya T, Nunes Jardim Reis R, Depes de Gouvea CV, Cavalcanti Garcia MA. Myofascial trigger point therapy: laser therapy and dry needling. Curr Pain Headache Rep. 2013 Sep;17(9):357. doi: 10.1007/s11916-013-0357-4.
PubMed 23904202Desai MJ, Bean MC, Heckman TW, Jayaseelan D, Moats N, Nava A. Treatment of myofascial pain. Pain Manag. 2013 Jan;3(1):67-79. doi: 10.2217/pmt.12.78.
PubMed 24645933
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dry Needling and Sustained Pressure in Trigger Points of Lumbar Paraspinal Muscles
- ClinicalTrials.gov ID
- NCT04043741
- Acronym / sponsor ID
- RiphahIU Aneela Zia
- Conditions
- Low Back Pain
- Keywords
- Dry Needling, Oswestry disability index,, Paraspinal muscle length, Pain pressure threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 2 Aug 2019 (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 study will compare the effect of dry needling and sustained pressure in the lumbar Paraspinal trigger points in terms of pain threshold and muscle length.
There will be two groups ; experimental and control. Half of study group will receive dry needling session along with stretching and strengthening exercises and half of study group will receive sustained pressure technique along with stretching and strengthening exercises .
Detailed description
The study is Randomized Control Trail , which is being conducted in Pakistan Railway hospital and Riphah international hospital (march 2019-june 2019) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. 50 individual are screened out according to inclusion criteria. Individuals are allocated randomly into two groups , 25 in experimental group and 25 in control group by sealed envelope method.Both groups will receive conventional physiotherapy protocol (hot pack, stretching exercises and strengthening exercises) and then experimental group will receive cervical sensorimotor control training. Assessment will be done on baseline, 2nd week, 4th week and 6th week.
Myofascial trigger point (MTrP) is moreover removed or inactivate by means of mechanical stimuli through filiform needle. A swift and repetitious needle insertions into myofascial trigger point is a treatment technique use for dry needling commonly has many therapeutic advantages. It interrupts motor end plates, muscle fibers and distal axons of myofascial trigger points and shortening of related sarcomere of myocytes.
Use of dry needling in combination Muscle Energy Technique (MET) has more significant effects in improving Visual Analog Scale (VAS), Pain Pressure Threshold (PPT) and Range of Motion (ROM) of females patients having latent trigger points in upper trapezius than alone use of MET.
Laser therapy has verified as to be more successful than dry needling in treating MTrPs. It is a preferred option for the patients having apprehensive behavior towards dry needling and health practioners inexpert with the dry needling procedure.
Dry needling is indicated for the treatment when MTrPs are present, may leads to functional restrictions. They are the source of constant peripheral nociceptive contribution which needs to be inactivated. Dry Needling (DN) is also indicated in fascial adhesions, soft tissue restrictions, shortened muscle fiber due to which restricted range of motion is present.Secondary trigger point (TrP) due to different neuromuscular dysfunctions for example in tendonitis, radiculopathies, disk pathology, migraines, carpal tunnel syndrome, tension type headache, joint dysfunction, cranio-mandibular dysfunction, phantom pain , additional regional urological syndromes and other exceptional neurogenic pruritus, Barre Lieou syndrome
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 (04 Sessions) and exercises |
| Sustain Pressure | Active comparator | Other: Sustain Pressuresustained pressure and Exercises |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20-50.
- Patient of acute, sub acute, chronic Low back pain (LBP), Mechanical Low back pain (MLBP) and radiculopathies up to one year.
- Patients having active (spontaneously painful) or latent (requiring palpation to reproduce the characteristic pain) MTrPs.
Key exclusion criteria (4 listed)
- Patients that were using any medication to reduce the pain and/or have any effect in the skeletal muscle including analgesics, anticoagulants and muscular relaxants.
- Taking other treatment in the same period of the research.
- Pregnant female.
- Patients with Chronic Disease (kidney disease, Diabetic, and osteoporosis) and spinal diseases (herniated disc, spondylolisthesis) will be excluded.
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 Needlingstretching exercises :single knee to chest (15 reps x 3 sets) double knee to chest(15 reps x 3 sets) strengthening exercises: extension exercises (15 reps x 3 sets) | Other | Dry Needling |
| Sustain PressureSustain Pressure (Number of repetition and hold according to trigger point chronic level) + Hot pack 10 to 15 minutes + Active muscle stretching exercise (10 repetition twice daily) | Other | Sustain Pressure |
Primary outcome
The Oswestry Disability Index (ODI)
Time frame: up to 2 weeks
Changes from the base line, The Oswestry Disability Index is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.At the end score is calculated by dividing the obtained score by total (50) multiplied by 100.As one question(section 8) was dropped in all participants ,so total score was considered as 45 instead of 50.
Para-spinal muscle length
Time frame: up to 2 weeks
Changes from the base line, Muscle length assessment technique is use to measure available range of muscle. In paraspinal muscles length assessment patient would be sitting position. Palpate anterior superior iliac spine (ASIS) bilaterally and instruct the patient to flex forward producing posterior pelvic tilt. Feel when ASIS starts to move this is the end of thoracolumbar flexion and initiation of posterior pelvic tilt. , Patient forehead would come 10 inches of the knees normally.
Visual analog scale
Time frame: up to 2 weeks
Changes from the base line, The visual analogue scale is one dimensional measure of pain intensity in adults inclusive those with chronic pain. The intensity of pain experienced by the patients on this scale range from no pain (score 0) to very severe pain (score 100). It is marked by paper and pencil on a line consist of horizontal (HVAS) or vertical (VVAS) comprised of 10centimeters (100mm) in length.
Pain Pressure Threshold (PPT).
Time frame: up to 2 weeks
Changes from the base line, Algometer is a device used to recognize the minimum pressure or force which induce pain pressure threshold (PPT). It is uncomplicated portable tool with a spring install in it. Peak force or pressure provided by this device is kilopond (kp) = 10 N, Newton = 100 kilopascal (kPa).
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 2 Aug 2019.
- Background: PubMed 22836591Bron C, Dommerholt JD. Etiology of myofascial trigger points. Curr Pain Headache Rep. 2012 Oct;16(5):439-44. doi: 10.1007/s11916-012-0289-4.
- Background: PubMed 24264721Fernandez-de-las-Penas C, Dommerholt J. Myofascial trigger points: peripheral or central phenomenon? Curr Rheumatol Rep. 2014 Jan;16(1):395. doi: 10.1007/s11926-013-0395-2.
- 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 28450787Bishwajit G, Tang S, Yaya S, Feng Z. Participation in physical activity and back pain among an elderly population in South Asia. J Pain Res. 2017 Apr 15;10:905-913. doi: 10.2147/JPR.S133013. eCollection 2017.
- Background: PubMed 25801100Koppenhaver SL, Walker MJ, Su J, McGowen JM, Umlauf L, Harris KD, Ross MD. Changes in lumbar multifidus muscle function and nociceptive sensitivity in low back pain patient responders versus non-responders after dry needling treatment. Man Ther. 2015 Dec;20(6):769-76. doi: 10.1016/j.math.2015.03.003. Epub 2015 Mar 13.
- Background: PubMed 23904202Uemoto L, Nascimento de Azevedo R, Almeida Alfaya T, Nunes Jardim Reis R, Depes de Gouvea CV, Cavalcanti Garcia MA. Myofascial trigger point therapy: laser therapy and dry needling. Curr Pain Headache Rep. 2013 Sep;17(9):357. doi: 10.1007/s11916-013-0357-4.
- Background: PubMed 24645933Desai MJ, Bean MC, Heckman TW, Jayaseelan D, Moats N, Nava A. Treatment of myofascial pain. Pain Manag. 2013 Jan;3(1):67-79. doi: 10.2217/pmt.12.78.
- 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.
Abdul Ghafoor Sajjad, 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 Sustain Pressure in people with Low Back Pain, 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 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: finished, as of the sponsor's last update on 2 Aug 2019. 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?
The Oswestry Disability Index (ODI) (time frame: up to 2 weeks). The study lists 4 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 NCT04043741, which also lists 7 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 2 Aug 2019.