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Comparison of Dry Needling and Sustained Pressure in Para-spinal Muscles Trigger Points

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dry Needling
Sustain Pressure
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Dry Needling, Oswestry disability index,, Paraspinal muscle length, Pain pressure threshold

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling

Sustain Pressure

Arm Description

Dry needling (04 Sessions) and exercises

sustained pressure and Exercises

Outcomes

Primary Outcome Measures

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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
July 30, 2019
Last Updated
August 1, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04043741
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Dry Needling, Oswestry disability index,, Paraspinal muscle length, Pain pressure threshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
this study is randomized control trail, participants are randomly allocated through sealed envelope method
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
Dry needling (04 Sessions) and exercises
Arm Title
Sustain Pressure
Arm Type
Active Comparator
Arm Description
sustained pressure and Exercises
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Sustain Pressure
Intervention Description
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)
Primary Outcome Measure Information:
Title
The Oswestry Disability Index (ODI)
Description
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.
Time Frame
up to 2 weeks
Title
Para-spinal muscle length
Description
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.
Time Frame
up to 2 weeks
Title
Visual analog scale
Description
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.
Time Frame
up to 2 weeks
Title
Pain Pressure Threshold (PPT).
Description
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).
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ghafoor Sajjad, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22836591
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.
Results Reference
background
PubMed Identifier
24264721
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.
Results Reference
background
PubMed Identifier
20823359
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.
Results Reference
background
PubMed Identifier
28450787
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.
Results Reference
background
PubMed Identifier
25801100
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.
Results Reference
background
PubMed Identifier
23904202
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.
Results Reference
background
PubMed Identifier
24645933
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.
Results Reference
background

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Comparison of Dry Needling and Sustained Pressure in Para-spinal Muscles Trigger Points

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