Clinical trial NCT04043741: Comparison of Dry Needling and Sustained Pressure in Para-spinal Muscles Trigger Points
Official title: Comparison of Dry Needling and Sustained Pressure in Trigger Points of Lumbar Paraspinal Muscles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Dry Needling
Oswestry disability index,
Paraspinal muscle length
Pain pressure threshold
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

1. Age between 20-50.
2. Patient of acute, sub acute, chronic Low back pain (LBP), Mechanical Low back pain (MLBP) and radiculopathies up to one year.
3. Patients having active (spontaneously painful) or latent (requiring palpation to reproduce the characteristic pain) MTrPs.

Exclusion Criteria:

1. 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.
2. Taking other treatment in the same period of the research.
3. Pregnant female.
4. Patients with Chronic Disease (kidney disease, Diabetic, and osteoporosis) and spinal diseases (herniated disc, spondylolisthesis) will be excluded.

Primary outcomes:
measure: The Oswestry Disability Index (ODI)
timeFrame: up to 2 weeks
measure: Para-spinal muscle length
timeFrame: up to 2 weeks
measure: Visual analog scale
timeFrame: up to 2 weeks
measure: Pain Pressure Threshold (PPT).
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
Study officials:
affiliation: Riphah International University
name: Abdul Ghafoor Sajjad, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fernandez-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.
citation: Kalichman 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.
citation: Bishwajit 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.
citation: Koppenhaver 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.
citation: Uemoto 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.
citation: Desai 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.