NCT04976582

Brief Summary

Low back pain (LBP) is an extremely common problem that most people experience at some point in their life. It is the leading cause of activity limitation and work absence throughout much of the world. In India, occurrence of LBP is also alarming. Nearly 60% of the population has significant back pain at some time in their life. In Brazil, spinal pain (cervical, thoracic and lumbar) was considered the second most prevalent complaint, affecting approximately 13.5% of the population. It is estimated that globally 39% of the population will have at least one episode of back pain throughout their lives. In episodes of pain greater than 12 weeks (classified as chronic lower back pain), the prognosis is unfavorable and is highly associated with high treatment costs and work absenteeism. Non-specific low back pain" \[NSLBP\] is defined as, low back pain that is not attributable to a recognizable or known specific pathology - bone disorder in the spine \[fracture\], radicular nerve compression, slipped intervertebral disk, stenosis in lumbar spine, inflammatory disorder of spine \[ankylosing spondylitis\], cauda equine syndrome, congenital back disorder, infection in the spine \[discitis\], tumour in lumbar area, osteoporosis, meningitis, Cancer, HIV, autoimmune disorder \[RA\].

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 11, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

November 11, 2020

Last Update Submit

July 14, 2021

Conditions

Keywords

kinesio-taping, dry needling, low back pain

Outcome Measures

Primary Outcomes (1)

  • comparison of dry needling and kinesio taping in management of mechanical low back pain.

    mechanical low back pain will be measured using Roland Morris low back questionnaire and Pain Numeric Rating scale calculated as mean score.

    6 months

Secondary Outcomes (1)

  • Quality of life in patient with mechanical low back pain

    6 months

Study Arms (2)

interventional group

EXPERIMENTAL

experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.

Device: dry needle

control group

NO INTERVENTION

control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.

Interventions

modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.

Also known as: Exercise including McKenzie exercises
interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with age of 18 and above with non-specific chronic low back pain.
  • Back pain of mechanical origin, apparently without a defined cause, for at least 12 weeks duration.
  • Participants had not had any physical therapy treatment in the past six months and had never used Kinesio Taping and dry needling technique.
  • Being asymptomatic, latent MTrPs in the muscle of lumbar region (pain during examination).
  • The absence of skin allergies, Palpable taut bands (if muscle accessible).
  • Recognition of usual local pain suffered by the patient pressing on the sensitive nodule on the taut bands (focally). (identification of active MTPs).
  • Painful restriction of the full range of motion on passive stretching.
  • The consent to physical examination, dry needling and kinesio taping application.

You may not qualify if:

  • Severe injury in the last 12 months.
  • Previous spinal surgical intervention, neurological diseases or musculoskeletal dis-orders, pharmacological treatment at present.
  • infection, open wound, rash, decreased blood circulation in the treatment area
  • A pacemaker, or epilepsy, presence of skin diseases and pregnancy
  • Serious spinal pathologies such as a tumor, an inflammatory disease or former fracture of L1-S1, symptoms of spinal stenosis, disc protrusion or nerve root compromise and degeneration established in more than two levels
  • Subjects who had used or had prior knowledge of the Kinesio Taping and dry needling method.
  • generalized chronic pain, fibromyalgia, clinical sign of radiculopathy and peripheral nervous system diseases
  • spondylolysis with or without spondylolisthesis, arthritis or osteoporosis and Congenital or acquired deformity
  • ongoing psychiatric or somatic disease that excluded either one or both treatment alternatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adeela Asad

Islamabad, Federal Capital, 44000, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adeela Asad, m.phil

    Rawal Institue of Health Sciences Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeela Asad, m.phil

CONTACT

Asma Irshad, m.phil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Researcher and participants both are familiar with the procedure of interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be divided into two groups Group 1: control group in which kinesiotaping with conventional physical therapy treatment (modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered. Group 2: experimental group in which dry needling with conventional physical therapy treatment modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PRINICIPAL INVESTIGATOR

Study Record Dates

First Submitted

November 11, 2020

First Posted

July 26, 2021

Study Start

July 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations