NCT04043741

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
Last Updated

August 2, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

July 30, 2019

Last Update Submit

August 1, 2019

Conditions

Keywords

Dry NeedlingOswestry disability index,Paraspinal muscle lengthPain pressure threshold

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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).

    up to 2 weeks

Study Arms (2)

Dry Needling

EXPERIMENTAL

Dry needling (04 Sessions) and exercises

Other: Dry Needling

Sustain Pressure

ACTIVE COMPARATOR

sustained pressure and Exercises

Other: Sustain Pressure

Interventions

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)

Dry Needling

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)

Sustain Pressure

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 22836591BACKGROUND
  • 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.

    PMID: 24264721BACKGROUND
  • 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.

    PMID: 20823359BACKGROUND
  • 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.

    PMID: 28450787BACKGROUND
  • 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.

    PMID: 25801100BACKGROUND
  • 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.

    PMID: 23904202BACKGROUND
  • 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.

    PMID: 24645933BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Abdul Ghafoor Sajjad, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
this study is randomized control trail, participants are randomly allocated through sealed envelope method
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 2, 2019

Study Start

March 1, 2019

Primary Completion

May 30, 2019

Study Completion

June 30, 2019

Last Updated

August 2, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations